Selected Abstracts from Elevate-Derm Fall Conference 2025

J Clin Aesthet Dermatol. 2026;19(1–2 Suppl 1):S14–S31.

November 12–16, 2025 in Tampa, Florida

Acne

Early and sustained effects of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel

Presenters: Leon H. Kircik, MD;¹ Edward (Ted) Lain, MD, MBA;² Hilary Baldwin, MD;³ Linda Stein Gold, MD;⁴ Joshua A. Zeichner, MD;¹ Karol Wroblewski, PharmD;⁵ Eric Guenin, PharmD, PhD, MPH;⁶ Michael Gold, MD;⁷ Valerie D. Callender, MD;⁸ Zoe D. Draelos, MD;⁹ Julie C. Harper, MD¹⁰

Affiliations: ¹Icahn School of Medicine at Mount Sinai, New York, NY; ²Austin Institute for Clinical Research, Austin, TX; ³The Acne Treatment and Research Center, Brooklyn, NY; ⁴Henry Ford Hospital, Detroit, MI; ⁵Rutgers University, New Brunswick, NJ; ⁶Ortho Dermatologics,* Bridgewater, NJ; ⁷Tennessee Clinical Research Center, Nashville, TN; ⁸Howard University College of Medicine, Washington, DC; ⁹Dermatology Consulting Services, PLLC, High Point, NC; ¹⁰Dermatology & Skin Care Center of Birmingham, Birmingham, AL

*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

Introduction: The combination of a topical antibiotic, retinoid, and benzoyl peroxide (BPO) is one of the most effective therapies for acne and has demonstrated greater efficacy versus monotherapy or dyads. However, it is unknown if triple combinations impart rapid efficacy along with minimal tolerability issues, which might improve patient adherence. The only triple-combination acne topical, clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% (CAB) gel, has demonstrated efficacy and favorable tolerability in clinical trials. This pooled analysis assessed efficacy and safety of CAB versus vehicle following four and 12 weeks of treatment.

Methods: Pooled data from four double-blind, 12-week trials (Phase II, NCT03170388 and NCT04892706; Phase III, NCT04214639 and NCT04214652) of participants aged nine years or older (≥12 years in NCT04892706) with moderate-to-severe acne were used to assess change from baseline in inflammatory/noninflammatory lesions and treatment success (percentage of participants achieving ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 or 1 [clear/almost clear]). Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also evaluated.

Results: Analyses were performed on data from 1,115 participants randomized to CAB or vehicle (n=618 and n=497, respectively). At Week 4, inflammatory lesions were reduced by over 50 percent with CAB, with continued reductions of over 75 percent at Week 12, significantly greater than with vehicle (Week 4, 53.8% vs. 39.6%, respectively; Week 12, 76.9% vs. 52.9%; p<0.001 both). Similar trends were observed for noninflammatory lesions (p<0.001 both). Treatment success was achieved by 51.0 percent of CAB-treated participants versus 18.3 percent with vehicle (p<0.001) at Week 12, with significant differences observed at Week 4 (10.7% vs. 4.2%; p<0.001). Application-site pain was the only treatment-related TEAE in five percent or more of CAB-treated participants. By Week 4, transient increases in mean safety/tolerability scores for scaling, erythema, itching, stinging, and burning with CAB generally resolved to at/near baseline levels. 

Conclusion: In this pooled analysis, treatment with fixed-dose CAB led to rapid clinical improvements as early as Week 4 with favorable tolerability. Though long-term topical acne treatment might be needed to achieve clear skin, the fast-acting efficacy of the only approved triple-combination product for acne—coupled with its once-daily dosing and tolerability—might improve patient satisfaction and treatment adherence.

Funding/financial support: Ortho Dermatologics

 

Long-term clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel use and assessing Cutibacterium acnes susceptibility: a 6-month open-label analysis   

Presenters: Mahmoud Ghannoum,¹ Ahmed Eltokhy,¹ James Sewake,¹ Thomas McCormick,¹ Neal Bhatia,² Hilary Baldwin,³ Linda Stein Gold,⁴ Julie C. Harper,⁵ Joshua A. Zeichner,⁶ Edward (Ted) Lain,⁷ Valerie D. Callender,⁸ Eric Guenin,⁹ Zoe D. Draelos¹⁰

Affiliations: ¹Case Western Reserve University, School of Medicine, Cleveland, OH; ²Therapeutics Clinical Research, San Diego, CA; ³The Acne Treatment and Research Center, Brooklyn, NY; ⁴Henry Ford Hospital, Detroit, MI; ⁵Dermatology & Skin Care Center of Birmingham, Birmingham, AL; ⁶Icahn School of Medicine at Mount Sinai, New York, NY; ⁷Austin Institute for Clinical Research, Austin, TX; ⁸Callender Dermatology and Cosmetic Center, Glenn Dale, MD; ⁹Ortho Dermatologics,* Bridgewater, NJ; ¹⁰Dermatology Consulting Services, High Point, NC

*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

Introduction: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only triple-combination acne topical—demonstrated superior efficacy to vehicle with favorable safety/tolerability in 12-week clinical trials. Real-world acne treatment, however, might require six months for maximum benefits in some cases. A concern with long-term antibiotic use is the development of antibiotic resistance in the causative bacterium, Cutibacterium acnes (C. acnes). This analysis evaluated the impact of long-term CAB gel use on C. acnes.

Methods: Data were pooled from two identical, 24-week, single-center, open-label studies to assess once-daily CAB in 50 participants aged 12 years or older with moderate/severe acne (Investigator’s Global Assessment [IGA] of 3/4). Brucella blood agar plates were monitored for colony formation following inoculation with central forehead swabs at baseline and Week 24. C. acnes clindamycin susceptibility was evaluated via minimum inhibitory concentration (MIC) values obtained using Epsilometer tests. Lower MIC indicated higher susceptibility; isolates with MIC 8µg/mL or greater were deemed resistant. 

Results: Of 45 participants who completed the studies, C. acnes strains were isolated from 82 percent (37/45) at baseline; the remaining samples produced no bacterial growth. Following CAB treatment for 24 weeks, participants with cultivable isolates were reduced by nearly half (44%; 20/45), indicating C. acnes elimination. At Week 24, MIC values remained low (mean: 0.19µg/mL) for all susceptible strains isolated, and only one participant with no growth at baseline had cultivable C. acnes (deemed clindamycin susceptible). Only the five participants (11%) with resistant C. acnes isolates at baseline also had resistant isolates at study end; all of these participants had acne improvements at Week 24 (1–3 point IGA decreases; 40–100% lesion reductions).

Conclusion: Treatment with CAB gel for 24 weeks did not lead to antibiotic resistance development, was efficacious in the participants with clindamycin-resistant C. acnes at baseline, and resulted in about 50-percent reduction from baseline in participants with cultivable C. acnes isolates. Taken together with previously published efficacy analyses, these data suggest CAB is well suited to the long-term treatment of acne.

Funding/financial support: Ortho Dermatologics

 

Long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for acne: pooled results from two 6-month studies 

Presenters: Zoe D. Draelos, MD;¹ Hilary Baldwin, MD;² Julie C. Harper, MD;³ Mahmoud Ghannoum, PhD;⁴ Linda Stein Gold, MD;⁵ Emil A. Tanghetti, MD;⁶ Eric Guenin, PharmD, PhD, MPH;⁷ Leon H. Kircik, MD⁸

Affiliations: ¹Dermatology Consulting Services, High Point, NC; ²The Acne Treatment and Research Center, Brooklyn, NY; ³Dermatology & Skin Care Center of Birmingham, Birmingham, AL; ⁴Case Western Reserve University, Cleveland, OH; ⁵Henry Ford Hospital, Detroit, MI; ⁶Center for Dermatology and Laser Surgery, Sacramento, CA; ⁷Ortho Dermatologics,* Bridgewater, NJ; ⁸Icahn School of Medicine at Mount Sinai, New York, NY 

*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

Introduction: Given the chronic nature of acne, some patients might require long-term treatment lasting months to years. Even after lesion resolution, scarring and dyspigmentation might persist and can be more bothersome to patients than the acne itself. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only approved triple-combination topical acne treatment—demonstrated superior efficacy to vehicle and its component dyads and favorable safety/tolerability in 12-week clinical trials. This pooled analysis assessed long-term efficacy and tolerability of CAB gel, as well as impacts on acne scarring and dyspigmentation.

Methods: Data were pooled from two identical, 24-week, single-center, open-label studies of once-daily CAB in 50 participants aged 12 years or older with moderate/severe acne (Investigator’s Global Assessment [IGA] score of 3/4). Endpoints included changes from baseline in IGA score and inflammatory/noninflammatory lesions. Investigator-assessed skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), and participant-assessed tolerability (itching, burning, redness, swelling) were evaluated on a five-point scale (0 [none] to 4 [severe]). Scarring was evaluated using the Goodman Qualitative Scar Scale. Adverse events were assessed. 

Results: Among 45 participants who completed the studies, the mean age was 22 years, 76 percent were female, and all Fitzpatrick skin types were represented. At Week 24, treatment success (≥2-grade reduction in IGA score from baseline and clear/almost clear skin) was achieved by 67 percent of participants, inflammatory lesions were reduced by 88 percent, and noninflammatory lesions decreased by 68 percent (p<0.001 vs. baseline, both). PIH, PIE, and scarring decreased by 71, 77, and 33 percent from baseline, respectively p<0.001, all). Mean skin dryness scores were low (<0.15), and most participants (>70%) reported no tolerability issues across all time points. A total of seven adverse events occurred; four were related to study product, and three led to study discontinuation.

Conclusion: In this pooled analysis, significant and continued improvements in acne lesions, scarring, and dyspigmentation were observed with once-daily CAB over six months of treatment, with favorable safety and tolerability. These data support the long-term use of CAB as a topical acne treatment.

Funding/financial support: Ortho Dermatologics

 

Atopic Dermatitis

Dupilumab monotherapy in patients with skin of color and moderate-to-severe atopic dermatitis: results from a Phase IV, open-label study

Presenters: Andrew F. Alexis,¹ Orit Markowitz,^2,3 Tiffany Mayo,⁴ Valerie D. Callender,^5,6 Noah A. Levit,⁷ Changming Xia,⁸ Stephane Levy,⁸ Joseph Zahn,⁸ Zhixiao Wang,⁸ Mike Bastian,⁹ Brad Shumel⁸

Affiliations: ¹Weill Cornell Medicine, New York, NY, US; ²Columbia University, New York, NY, US; ³OptiSkin, New York, NY, US; ⁴University of Alabama at Birmingham, Birmingham, AL, US; ⁵Howard University College of Medicine, Washington, DC, US; ⁶Callender Dermatology & Cosmetic Center, Glenn Dale, MD, US; ⁷Dermatology Physicians of Connecticut, Fairfield, CT, US; ⁸Regeneron Pharmaceuticals Inc., Tarrytown, NY, US; ⁹Sanofi, Frankfurt, Germany

Introduction: Skin of color (SoC) patients with atopic dermatitis (AD) experience high disease prevalence, severity, and quality-of-life burden, but have historically been underrepresented in clinical trials. Subgroup analyses of dupilumab Phase III studies, despite limited sample size, showed a risk–benefit profile in patients with SoC comparable to that of the overall AD population.¹ The DISCOVER, Phase IV, open-label, single-arm, 24-week study (NCT05590585) aimed to further evaluate the efficacy and safety of dupilumab in patients with SoC and moderate-to-severe AD.

Methods: Eligible patients were aged 12 years or older and had Fitzpatrick skin types IV, V, or VI and moderate-to-severe AD. Patients self-reporting as White/Caucasian were ineligible. Patients received dupilumab monotherapy every two weeks for 24 weeks (≥30kg to <60kg body weight: 200mg; ≥60kg: 300mg). The primary endpoint was 75-percent improvement in Eczema Area and Severity Index score (EASI75). The secondary endpoint was four-point or greater improvement on Peak Pruritus Numeric Rating Scale (PP-NRS). Pigmentary changes were evaluated using clinician-reported Post-Inflammatory Hyperpigmentation Severity Scale (PHSS; 0 [normal] to 8 [severe]) and the newly developed patient-reported Xerosis NRS. Safety was also evaluated. Data are reported as observed.

Results: From the 120 patients in this study, 81.7 percent were Black, 10.8 percent Asian, and 7.5 percent other; 42.5, 48.3, and 9.2 percent had Fitzpatrick skin types IV, V, and VI, respectively. At Week 24, 76.0 percent achieved EASI75 (primary endpoint); 52.7 and 65.6 percent achieved a four-point or greater or three-point or greater improvement in PP-NRS at Week 24, respectively. Mean PHSS score decreased by 52.9 percent, from 5.1 at baseline (moderate/marked) to 2.4 at Week 24 (slightly noticeable). Patients “very/extremely bothered” by dry skin per Xerosis NRS decreased from 77.8 percent at baseline to 17.5 percent by Week 24. No treatment-related serious adverse events were reported.

Conclusion: Dupilumab monotherapy improved AD signs and symptoms, and reduced AD-related post-inflammatory hyperpigmentation and patient-reported xerosis in SoC patients with moderate-to-severe AD.

Reference: 

1. Alexis AF, et al. Efficacy of dupilumab in different racial subgroups of adults with moderate-to-severe atopic dermatitis in three randomized, placebo-controlled Phase 3 trials. J Drugs Dermatol. 2019;18:804–813.

 

Effectiveness of 12-months tralokinumab treatment in 654 adults with atopic dermatitis with head & neck area involvement: final real-world data from the prospective, noninterventional, international, single-cohort TRACE study

Presenters: Marni Wiseman,¹ Fatima Albreiki,² Andrew Pink,³ Adrian Rodriguez,⁴ Teodora Festini,⁵ Ida Vittrup,⁵ Frank Vinther,⁵ Diamant Thaçi⁶

Affiliations: ¹SKiNWISE DERMATOLOGY, CA; ²Tawam Hospital, UAE; ³St John’s Institute of DermatologyUK; ⁴Nashville Skin, USA; ⁵LEO Pharma A/S, DK; ⁶University of Lübeck, Germany.

Introduction: Around 70 percent of patients with moderate-to-severe atopic dermatitis (AD) have head & neck (H&N) area involvement, associated with embarrassment, stigmatization, and negative impact on quality of life (QoL) and mental health. AD in the H&N area can be difficult to treat. Tralokinumab, a monoclonal antibody targeting interleukin (IL)-13 indicated for treating moderate-to-severe AD, was effective and well tolerated in Phase III clinical trials. Here, we present real-world effectiveness data from 12-month tralokinumab treatment in patients with AD with H&N involvement.

Methods: TRACE is a prospective, noninterventional, international, multicenter, single-cohort study of adults with AD, who received tralokinumab according to national approved label at treating physician’s discretion; concomitant medications were allowed. Of 835 patients enrolled (November 2021 to June 2023), we evaluated 654 patients with baseline AD involvement on the face, scalp, and neck. Assessments included AD localization and disease severity scores (Investigator’s Global Assessment [IGA], Eczema Area and Severity Index [EASI], Dermatology Life Quality Index [DLQI], Peak Pruritus Numeric Rating Scale [PP-NRS], Sleep-NRS), per individual clinical practice. Data are presented as observed.

Results: The proportion of patients with AD with H&N involvement decreased markedly to 68.1 percent (n=565) and 51.8 percent (n=367) at Months 3 and 12. Treatment with tralokinumab reduced AD severity across all endpoints. Among those with data, the proportion of patients with clear or almost clear skin (IGA 0/1) increased from 1.5 percent at baseline (n=619) to 36.2 percent (n=509) and 64.7 percent (n=317) at Months 3 and 12. Among patients with baseline IGA of 2 or greater, 45.0 percent (n=489) at Month 3 and 70.7 percent (n=304) at Month 12 had a two-point or greater IGA improvement. The proportion of patients with severe disease (IGA 4) decreased markedly from 40.1 percent at baseline (n=619) to 4.3 percent (n=509) and 2.2 percent (n=317) at Months 3 and 12. The proportion of patients with EASI of 7 or less (no or mild eczema) increased dramatically from 13.0 percent (n=525) at baseline to 69.5 percent (n=426) and 89.3 percent (n=290) at Months 3 and 12. The mean DLQI score improved from 13.1 at baseline (n=373) to 5.1 (n=143) at Month 12, while the proportion of patients with DLQI of 5 or less (no-to-small QoL impairment) increased from 19.0 percent at baseline to 67.8 percent at Month 12. From baseline to Month 12, mean PP-NRS decreased from 6.4 (n=395) to 3.3 (n=140), and the proportion with PP-NRS of 4 or less increased from 21.0 percent to 70.0 percent. Mean sleep NRS decreased from 5.2 (n=313) at baseline to 2.2 (n=108) at Month 12. Among patients with baseline Sleep-NRS of 2 or greater, 70.7 percent had a two-point or greater improvement at Month 12. Dupilumab-naïve (n=510) and dupilumab-experienced (n=144) patients improved similarly, though higher baseline disease severity was seen in dupilumab-naïve patients.

Conclusion: In adult patients with AD with H&N involvement, 12-month treatment with tralokinumab improved H&N involvement, overall AD severity, and QoL in a real-world setting. Improvements were similar regardless of prior dupilumab use.

Acknowledgements and funding sources: This study was sponsored by LEO Pharma A/S, Ballerup, Denmark. Medical writing support was provided by Christina El-Naaman Gregersen (independent consultant funded by LEO Pharma A/S). This work was previously presented at EADV 2025.

Growth improvement in children 6 to 11 years old with severe atopic dermatitis treated with dupilumab irrespective of TCS use

Presenters: Alan D. Irvine,¹ Amy S. Paller,^2,3 Elaine C. Siegfried,^4,5 Michael J. Cork,^6,7 Lisa A. Beck,⁸ Jiangnan Lyu,⁹ Annie Zhang,¹⁰ Stephane Levy,⁹ Sonya L. Cyr⁹

Affiliations: ¹School of Medicine, Trinity College Dublin, Dublin, Ireland; ²Northwestern University Feinberg School of Medicine, Chicago, IL, US; ³Ann & Robert H. Lurie Children’s Hospital, Chicago, IL, US; ⁴Saint Louis University, St. Louis, MO, US; ⁵Cardinal Glennon Children’s Hospital, St. Louis, MO, US; ⁶Immunity and Cardiovascular Disease, Sheffield Dermatology Research, University of Sheffield, Sheffield, UK; ⁷Sheffield Children’s Hospital, Sheffield, UK; ⁸University of Rochester Medical Center, Rochester, NY, US; ⁹Regeneron Pharmaceuticals Inc., Tarrytown, NY, US; ¹⁰Sanofi, Cambridge, MA, US

Introduction: Children with atopic dermatitis (AD) have risk factors for impaired growth, lower bone mineral density, and increased fractures. Here, we assess the impact of topical corticosteroid (TCS) use on growth in children treated with dupilumab versus placebo.

Methods: Children 6 to11 years of age with severe AD were enrolled in the Phase III, 16-week, placebo-controlled LIBERTY AD PEDS trial (NCT03345914). The proportion of patients below the 30th height percentile at baseline with a five-percentile or greater change from baseline in height at Week 16 of dupilumab treatment versus placebo (n=114) was previously reported. TCS use was standardized. Cumulative TCS use, and TCS- and inhaled corticosteroid (ICS)–free days were recorded. Multiple logistic regression models were conducted, and the response variable was defined as achieving a five-percentile or greater increase in height from baseline to Week 16 in patients below the 30th baseline height percentile. Covariates were cumulative TCS dose and medication-free days from baseline (TCS alone and TCS + ICS).

Results: While TCS use was standardized in the trial, patients treated with dupilumab (n=181) used TCS less frequently than those receiving placebo (n=123; 219.11g [standard deviation: 305.40] vs. 292.4g [287.36]), and had more TCS-free days (21.42 [24.95] vs. 12.17 [20.37]) and more TCS + ICS–free days (17.60 [24.72] vs. 9.10 [16.17]). In the unadjusted model (n=114, of whom 45 received placebo + TCS and 69 dupilumab + TCS), the odds ratio (OR) for dupilumab versus placebo was 3.74 (p=0.01), indicating that patients in the treatment group were 3.7 times more likely to achieve a five-percentile or greater height increase versus the placebo group. The cumulative dose covariate-adjusted model demonstrated a significant impact of dupilumab treatment with an OR of 4.21 (p=0.01). In both the medication-free days covariate-adjusted models, a significant impact of dupilumab treatment was observed with an OR of 4.11 (p=0.01; TCS medication-free days) and 3.63 (p=0.02; number of TCS + ICS–free days).

Conclusion: TCS use and the number of medication-free days appear to be independent of the effect of 16 weeks of dupilumab treatment on increased growth in children aged 6 to 11 years versus placebo. This suggests that the reduction of TCS use in patients treated with dupilumab might not be contributing to increased growth observed or that any potential negative effects of TCS use on growth could be counteracted by dupilumab.

Initial super response to tralokinumab leads to stable long-term response in patients with moderate-to-severe atopic dermatitis: responder and predictor analysis from the ECZTRA 3 & ECZTEND trials

Presenters: Andrew Blauvelt,¹ Marjolein de Bruin-Weller,² Norito Katoh,³ Mark G. Kirchhof,^4,5 Ketty Peris,⁶ Andrew Pink,⁷ John Stinson,⁸ Peter van Iperen,⁸ Rie von Eyben,⁸ Stephan Weidinger⁹

Affiliations: ¹Blauvelt Consulting, LLC, US; ²University Medical Center Utrecht, NL; ³Kyoto Prefectural University of Medicine, JP; ⁴University of Ottawa, CA; ⁵The Ottawa Hospital, CA; ⁶Università Cattolica del Sacro Cuore, IT; ⁷St John’s Institute of Dermatology, UK; ⁸LEO Pharma A/S, DK; ⁹University Hospital Schleswig-Holstein, DE

Introduction: Unpredictable periods of worsening signs and symptoms are common with atopic dermatitis (AD). Tralokinumab, a high-affinity monoclonal antibody neutralizing interleukin-13, is approved in multiple countries to treat moderate-to-severe AD in individuals 12 years of age or older. Here, stability of treatment responses and predictors of long-term success tralokinumab were assessed.

Methods: This post hoc analysis included Week 16 responders in Phase III ECZTRA 3 trial. (NCT03363854) treated with tralokinumab 300mg once every two weeks (Q2W) plus optional topical corticosteroid (TCS) who subsequently enrolled in the open-label extension trial ECZTEND (NCT03587805). Week 16 responder groups included patients achieving 75- or 90-percent improvement in Eczema Area and Severity Index score (EASI75 or EASI90), Dermatology Life Quality Index of 0 or 1 (DLQI 0/1), or EASI90 with DLQI 0/1, with patients achieving EASI90 considered “super responders.” Data were evaluated through Week 120 in ECZTEND (≤3 years total tralokinumab treatment) and analyzed in a mixed effects model for repeated measures, allowing for both between- and within-subject variability. Absolute EASI at Week 16 was evaluated as a predictor for long-term treatment success (greater improvement from Baseline through Week 120) among EASI75 or super responders.

Results: At Week 16 in ECZTRA 3, 56 percent (n/N, 141/252), 33 percent (83/252), 25 percent (62/252), and 15 percent (39/252) of patients achieved EASI75, EASI90, DLQI 0/1, and EASI90 with DLQI 0/1, respectively. Among these Week 16 responder groups, 86 percent (121/141), 92 percent (76/83), 81 percent (50/62), and 90 percent (35/39) entered the ECZTEND trial. In each responder group, 60 percent of patients or greater remained in the ECZTEND trial up to Week 120 and 13 percent of discontinuations or less were attributed to either lack of efficacy or adverse events. A stable EASI predicted trend-line of 90-percent or greater improvement from baseline was maintained through Week 120 in ECZTEND for both EASI75 responders and super responders. In EASI75 and super responders, a lower absolute EASI at Week 16 was a strong predictor for improvements in EASI over 120 weeks (p<0.0001). The proportion of patients in the EASI90 with DLQI 0/1 Week 16 responder group (n=35) who achieved EASI90 with DLQI 0/1 was greater than 48 percent at each visit in ECZTEND.

Conclusion: Response trends among patients with moderate-to-severe AD who achieved Week 16 endpoints (ie, EASI75/90, DLQI 0/1, or EASI90 with DLQI 0/1) with tralokinumab predict stable responses for up to three years with continued treatment, regardless of fluctuations in individual response trajectories. These results might help clinicians predict long-term treatment success based on response after 16 weeks of tralokinumab treatment, especially in EASI90 super responders with low absolute EASI.

Acknowledgements and funding sources: This analysis was sponsored by LEO Pharma A/S (Ballerup, Denmark). Medical writing and editorial support from Alphabet Health (New York, NY, US) by Venecia Valdez, PhD, and Meredith Whitaker, PhD, was funded by LEO Pharma A/S. This work was previously presented at EADV 2025.

Pharmacokinetics and safety of tralokinumab in children (aged 6 to <12 years) with moderate-to-severe atopic dermatitis: an interim analysis of the TRAPEDS 1 Phase II trial 

Presenters: Michael Cork,^1,2 Marlies de Graaf,³ Eulalia Baselga Torres,⁴ Suzanne Pasmans,⁵ Ziad Reguiai,⁶ Merle Kurvits,⁷ Hannah Lo,⁸ Shannon Schneider,⁸ Anders Søhoel,⁷ Patrick Thøgersen,⁹ Carsten Flohr,¹⁰ Lawrence F. Eichenfield¹¹

Affiliations: ¹Sheffield Dermatology Research, Division of Clinical Medicine, University of Sheffield, Sheffield, UK; ²Sheffield Children’s Hospital, NIHR, CRDC, Sheffield, UK; ³Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, the Netherlands; ⁴Department of Dermatology, Hospital Sant Joan de Déu, Spain; ⁵Department of Dermatology, Center of Pediatric Dermatology, Erasmus MC University Medical Center‐Sophia Children’s Hospital, Rotterdam, the Netherlands; ⁶Dermatology Department, Polyclinique Courlancy-Bezannes, Reims, France; ⁷LEO Pharma A/S, Ballerup, Denmark; ⁸LEO Pharma Inc., Madison, NJ, USA; ⁹Previously LEO Pharma A/S, Ballerup, Denmark; ¹⁰Unit for Paediatric and Population-Based Dermatology Research, St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, London, UK; ¹¹Departments of Dermatology and Pediatrics, University of California San Diego School of Medicine, La Jolla, CA, US

Introduction: Tralokinumab is approved for moderate-to-severe AD in patients aged 12 years or greater. Here, we present the first data for tralokinumab in children aged 6 to less than 12 years with moderate-to-severe AD, with the primary objective of establishing the pharmacokinetic (PK) profile and secondary objective of assessing safety to confirm dosing in children.

Methods: Interim analysis of the ongoing TRAPEDS 1 (NCT05388760) trial included the initial (Week [W] 0–16) and open-label (W16–68) treatment periods. Patients were randomized 1:1 to low-dose (150mg every 4 weeks [Q4W] if 17kg to <40kg [n=10], 150mg Q2W if ≥40kg [n=3]) or high-dose (150mg Q2W if 17kg to <40kg [n=11], 300mg Q2W if ≥40kg [adult dosing; n=4]) tralokinumab for W0 to W16. For W16 to W68, all patients received open-label tralokinumab 150mg Q2W plus optional topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI).

Results: Baseline age and weight were similar between groups. At W16, systemic exposure of tralokinumab in the low-dose group was approximately half that of the high-dose group (geometric mean serum concentration: 47.15µg/mL vs. 105.02µg/mL), with levels of 8,087µg/mL for W16 to W68. A similar safety profile was observed between groups; almost all adverse events (AEs) were mild or moderate in severity with two serious AEs deemed unrelated to drug and no anti-drug antibodies were detected. 

Conclusion: These results showed that tralokinumab had a PK profile consistent with previous observations in adults treated with 300mg Q2W and was largely well tolerated with no safety concerns in children aged 6 to less than 12 years with moderate-to-severe AD.

Acknowledgements and funding sources: The TRAPEDS1 (NCT05388760) trial was sponsored by LEO Pharma A/S (Ballerup, Denmark). Medical writing and editorial support from Alphabet Health (New York, NY, USA) by Gina Sanchez, PhD, was funded by LEO Pharma Inc (Madison, NJ, USA). This work was previously presented at PeDRA 2025. 

Sustained improvement in atopic dermatitis disease control and treatment satisfaction with dupilumab in clinical practice: 6-year follow-up results from the RELIEVE-AD study

Presenters: Zhixiao Wang,¹ Min Yang,² Jingdong Chao,¹ Bruno Martins,² Kerry Noonan,³ Brad Shumel,¹ Debra Sierka³

Affiliations: ¹Regeneron Pharmaceuticals Inc., Tarrytown, NY, US; ²Analysis Group, Boston, MA, US; ³Sanofi, Cambridge, MA, US

Introduction: In RELIEVE-AD, adults with moderate-to-severe atopic dermatitis (AD) initiated dupilumab in real-world clinical practice. Previous analyses showed that most dupilumab-treated patients reported controlled disease and high treatment satisfaction, which were maintained for up to five years. Here, we report six-year disease control and treatment satisfaction from RELIEVE-AD. 

Methods: RELIEVE-AD is a single-arm, prospective, observational study in adults with moderate-to-severe AD prescribed dupilumab and enrolled in the United States (US) dupilumab patient support program who agreed to participate in online surveys at baseline and at Months 1, 2, 3, 6, 9, 12, 33, 48, 60, and 72. The outcomes include disease control, assessed using the Atopic Dermatitis Control Tool (ADCT; 6-item, total range 0–24, with a total score <7 indicating controlled disease); percentage of patients who reported no intense episodes of itching in the past week based on the corresponding ADCT item; and treatment satisfaction (using a 7-point Likert scale ranging from “extremely satisfied” to “extremely dissatisfied”). Statistical significance analysis, comparing each time point with baseline, was determined using generalized estimating equations to account for correlated data from the same patients. Normal distributions with an identity link function were used for continuous outcomes, and binomial distributions with a logit link function were used for categorical outcomes. Only patients who responded to at least one of the Month 33 or Month 48 surveys were contacted for the Month 72 survey.

Results: Of the 469 patients at baseline who responded at Month 33 and/or Month 48, 298 patients completed the Month 72 survey. Mean age at baseline was 46.2 years and 61.7 percent were female patients. The mean total ADCT score was significantly lower (p<0.001) at all posttreatment initiation time points, decreasing from 15.8 at baseline to 3.7 at Month 72. Controlled disease (ADCT <7) was reported by 5.9 percent of patients at baseline, increasing to 61.0 percent at Month 1 and maintained throughout the study period, then further increasing up to 82.6 percent at Month 72 (p<0.001 for all time points vs. baseline). The percentage of patients reporting no intense episodes of itching over the last week increased from 3.2 percent at baseline to 58.7 percent at Month 72 (p<0.001 for all time points vs. baseline). Patient satisfaction with current AD treatments improved over time, with 84.2 percent reporting being “extremely/very/somewhat satisfied” at Month 72 versus 17.8 percent at baseline. Subgroup analysis in patients remaining on dupilumab at Month 72 (n=210) showed that they reported higher controlled disease (90%) and treatment satisfaction (95.2% being “extremely/very/somewhat satisfied”).

Conclusion: Most adult patients (>80%) with moderate-to-severe AD treated with dupilumab, who remained in this long-term study, reported controlled disease and remained satisfied with their treatment six years after dupilumab initiation in real-world clinical practice. 

Tapinarof cream 1% once daily: maintenance of low disease activity including pruritus through end of the treatment-free interval in a long-term extension trial in patients down to 2 years of age with atopic dermatitis

Presenters: Jonathan I. Silverberg,¹ Robert Bissonnett,² Linda Stein Gold,³ Philip M. Brown,⁴ Mark Boguniewicz,⁵ David Rosmarin,⁶ Autumn F. Burnette,⁷ Wendy Cantrell,⁸ Matthew J. Bruno,⁹ Anna M. Tallman⁴

Affiliations: ¹The George Washington University School of Medicine and Health Sciences, Washington, DC, US; ²Innovaderm Research Inc., Montreal, QC, Canada; ³Henry Ford Health System, Detroit, MI, US; ⁴Formerly of Dermavant Sciences, an Organon Company, Jersey City, NJ, US; ⁵National Jewish Health and University of Colorado School of Medicine, Denver, CO, US; ⁶Indiana University School of Medicine, Indianapolis, IN, US; ⁷Howard University Hospital, Washington, DC, US; ⁸Village Dermatology, Birmingham, AL, US; ⁹Dermatology & Skin Cancer Surgery Center, Allen, TX, US

Introduction: Tapinarof cream 1% (VTAMA®, Dermavant Sciences, an Organon Company) is a nonsteroidal, topical aryl hydrocarbon receptor agonist approved by the Food and Drug Administration (FDA) for the treatment of atopic dermatitis (AD) in adults and children down to two years of age. In the ADORING 3 long-term trial, tapinarof cream 1% once daily (QD) demonstrated high rates (51.9%) of complete disease clearance (validated Investigator’s Global Assessment for Atopic Dermatitis™ [vIGA-AD™]: 0) in adults and children with AD. Discontinuation of topical therapy for AD might be associated with rapid return of disease. After discontinuing tapinarof per protocol, patients maintained clear or almost clear skin (vIGA-AD™: 0 or 1) for 79.8 (mean) consecutive days. Here we characterize disease activity at the end of treatment-free (remittive) intervals. 

Methods: Patients from ADORING 1 and 2, from a four-week maximal usage pharmacokinetics trial, and tapinarof-naïve patients with mild AD, or moderate or severe AD, that did not meet ADORING 1 or 2 inclusion criteria, received tapinarof cream 1% QD for up to 48 weeks. Patients entering ADORING 3 with vIGA-AD™ of 1 or greater received tapinarof until vIGA-AD™ reached 0. Those entering with or achieving vIGA-AD™ of 0 (n=378) discontinued tapinarof and were assessed for maintenance of vIGA-AD™ of 0 or 1 off-treatment (treatment-free interval). Patients whose AD returned to mild or above (vIGA-AD™ ≥2) were retreated until vIGA-AD™ reached 0. Patients could experience more than one treatment-free interval during the trial. Disease activity and itch were assessed using vIGA-AD™, Eczema Area and Severity Index (EASI), and Peak Pruritus-Numerical Rating Scale (PP-NRS).

Results: Patients (83.0% pediatric) entered ADORING 3 with vIGA-AD™ of 0 to 4 (clear–severe). Low disease activity was maintained at the end of the first treatment-free interval (mean 79.8 days); 84.0 percent had vIGA-AD™ of 2. Mean EASI was 3.4 (standard deviation ±3.2); mean weekly PP-NRS was 2.9 (±2.2). Similar low disease activity was seen at the end of subsequent treatment-free intervals. 

Conclusion: A high proportion of patients demonstrated low disease activity, including itch, after about 80 consecutive days off-treatment. Tapinarof monotherapy induced complete disease clearance followed by prolonged treatment-free (remittive) intervals and low disease activity in patients with AD. Slow reemergence of mild symptoms during treatment-free intervals is unlike most topicals where a rapid disease rebound is often observed.

Funding/financial support: Dermavant Sciences, an Organon Company

Treatment-free disease control after tralokinumab in patients with moderate-to-severe atopic dermatitis

Presenters: Andrew Blauvelt,¹ Tina Bhutani,² Ben Ehst,³ Naiem Issa,^4–6 Matthew Zirwas,^7–9 Ulla Ivens,¹⁰ Hannah Lo,¹¹ Shannon Schneider,¹¹ Raj Chovatiya^12,13

Affiliations: ¹Blauvelt Consulting, LLC, Annapolis, MD, US; ²University of California San Francisco, San Francisco, CA, US; ³Oregon Medical Research Center, Portland, OR, US; ⁴Forefront Dermatology, Vienna, VA, US; ⁵University of Miami Miller School of Medicine, Miami, FL, US; ⁶George Washington University School of Medicine and Health Sciences, Washington, DC, US; ⁷Ohio University, Athens, OH, US; ⁸DOCS Dermatology, Bexley, OH, US; ⁹Probity Medical Research, Bexley, OH, US; ¹⁰LEO Pharma A/S, Ballerup, DK; ¹¹LEO Pharma Inc., Madison, NJ, US; ¹²Rosalind Franklin University of Medicine and Science, North Chicago, IL, US; ¹³Center for Medical Dermatology + Immunology Research, Chicago, IL, US

Introduction: Tralokinumab, a monoclonal antibody targeting interleukin (IL)-13, is approved for treatment of moderate-to-severe atopic dermatitis (AD) in individuals 12 years of age or older.

Methods: Enduring treatment-free disease control was assessed post hoc using pooled data from Phase III ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885) patients rerandomized to placebo after achieving primary endpoints (Investigator’s Global Assessment [IGA] 0/1 and/or 75-percent improvement in Eczema Area and Severity Index score [EASI75]) at Week 16 with tralokinumab every two weeks (Q2W) (n=73). Treatment-free disease control was defined as no use of rescue therapy (ie, topical corticosteroid [TCS]), no transfer to open-label arm (tralokinumab Q2W + optional TCS), and no permanent trial discontinuation due to lack of efficacy.

Results: Patients maintained treatment-free disease control for a median of 22.3 weeks. At 26 weeks off treatment, 38.4 percent (28/73) of patients maintained treatment-free disease control, with 32.1 percent (9/28) and 17.9 percent (5/28) of those patients meeting IGA of 0 and Itch Numeric Rating Scale (NRS) of 0/1, respectively. Patients who maintained treatment-free disease control had lower baseline mean body surface area (BSA; 33.6% vs. 52.6%) and EASI (25.3 vs. 31.4) and more robust Week 16 response (eg, IGA 0: 25% [7/28] vs. 0% [0/45]) than those who did not. Of patients who transferred to open-label tralokinumab after experiencing a predetermined decline from their Week 16 response (n=31), 69 percent regained IGA of 0/1 or EASI75 by 24 weeks of open-label treatment, with a median recapture time of 12.1 weeks.

Conclusion: Approximately 40 percent of Week 16 responders maintained treatment-free disease control for six months with no rescue therapy, indicating that some patients might experience a remittive effect following specific neutralization of IL-13 with tralokinumab.

Acknowledgments and funding sources: The analyses and medical writing support were funded by LEO Pharma Inc., Madison, NJ, US. The authors would like to thank Oluf Hansen for assisting with the statistical analyses. Medical writing support was provided by Alphabet Health from Venecia Valdez, PhD and Clair Geary, PhD. This work was previously presented at the 82nd Annual Meeting of the Society for Investigative Dermatology (SID), May 7–10, 2025.

 

Chronic Hand Eczema

Delgocitinib cream formulation development for chronic hand eczema: insights from patient preference and skin penetration studies

Presenters: Christopher Bunick,¹ Christoph Schlapbach,² Umut Erhan,³ Douglas Maslin,^3,4 Vibeke Hougaard Sunesen,³ Gitte Pommergaard Pedersen,³ Linda Stein Gold⁵

Affiliations: ¹Yale School of Medicine, US; ²University of Bern, CH; ³LEO Pharma A/S, DK; ⁴Addenbrooke’s Hospital, UK; ⁵Henry Ford Health, US

Introduction: Chronic hand eczema (CHE) is an inflammatory skin disease associated with significant physical and psychosocial burdens and limited approved treatment options. Delgocitinib cream 20mg/g (2%) is a nonsteroidal topical pan-Janus kinase (JAK) inhibitor formulated for application on hands, containing minimal penetration-enhancing excipients and without addition of PG and PEG. It was well tolerated with minimal systemic exposure and has demonstrated efficacy versus cream vehicle in adults with moderate-to-severe CHE in DELTA 1 and 2. To support the initial development of the delgocitinib cream formulation, two studies assessed (1) patients’ preference for formulation and (2) delgocitinib skin penetration.

Methods: The Patient Preference Market Research Study (PPMRS) was conducted as Hall test-style group sessions with patients with CHE, in which five early formulation options (no active substance) were tested simultaneously (3 light creams, 1 lipid cream, and 1 ointment). Formulation characteristics of consistency/feel, application, and appearance were tested. Skin penetration was assessed in an in vivo dermal Open Flow Microperfusion study (OFM) in pigs. Four probes at each of two application sites were inserted within the dermis of two pigs. A single dose of delgocitinib cream formulation was applied to the skin surface (10mg/cm²) of the application sites and OFM samples were collected in three-hour intervals for 12 hours.

Results: In the PPMRS, 74 adults with CHE were included, and of those 54 percent were female and 79 percent were 18 to 54 years. Overall, 49 percent of the patients had been diagnosed with CHE for 15 years or longer (23% for 10–14 years), with 77 percent reporting CHE impacted their lives to a “moderate” or “very large” extent. The treatment features being considered most important by patients were quick absorption (58%), not being sticky (43%), and not being greasy (42%). One of the light cream samples performed the best according to perception of consistency/feel (62%), application (77%), and appearance (69%), and was the most preferred product overall among the five samples. Based on these results, this formulation was selected to further guide development of delgocitinib cream. Demographic factors, such as age, disease history, spot/whole hand application, and impact on quality of life, did not influence product preference. In the OFM, it was shown that delgocitinib distributed into the dermis. The mean (standard deviation) OFM concentration based on the area under the curve over the 12 hours sampling time was 121 (102) nM.

Conclusion: Delgocitinib cream is well suited to patients with CHE, as it was developed based on preferences of patients with CHE and was shown to deliver the active substance to the site of inflammation within the dermis. The cream was developed with minimal penetration-enhancing excipients, and without addition of PG and PEG, which might contribute to the low systemic exposure seen in later clinical delgocitinib studies.

Acknowledgements and funding sources: The Patient Preference Market Research and Open Flow Microperfusion studies were sponsored by LEO Pharma A/S (Ballerup, Denmark). Medical writing and editorial support from Alphabet Health (New York, NY) by Juliel Espinosa, PhD, and Susanne Ulm, PhD, was funded by LEO Pharma A/S. This work was previously presented at EADV Spring 2025.

DELTA TEEN Phase III trial: efficacy and safety of delgocitinib cream in adolescents with moderate-to-severe chronic hand eczema

Presenters: Sonja Molin,^1,2 Eulalia Baselga,³ J. Navarro-Triviño,⁴ Ziad Reguiai,⁵ Sofie De Schepper,⁶ James Halpern,⁷ Danielle Marcoux,⁸ John Su,^9,10 Paweł Brzewski,^11,12 Stine Dalsbø Antonsen,¹³ Line Conradsen Hiort,¹³ Anders Søhoel,¹³ Patrick Thøgersen,¹³ Diana Rubel^14,15

Affiliations: ¹Charité-Universitätsmedizin Berlin, DE; ²Queen’s University, CA; ³Hospital Sant Joan de Deu, ES; ⁴Hospital Universitario San Cecilio, ES; ⁵Polyclinique Courlancy, FR; ⁶University Hospital of Ghent, BE; ⁷Walsall Healthcare NHS Trust, UK; ⁸Sainte-Justine University Hospital Centre, University of Montreal, CA; ⁹The Royal Children’s Hospital Melbourne, AU; ¹⁰Monash University, Eastern Health, AU; ¹¹Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, PL; ¹²UAFM Kraków, PL; ¹³LEO Pharma A/S, DK; ¹⁴Woden Dermatology, AU; ¹⁵Australian National University, AU

Introduction: Chronic hand eczema (CHE) is a common, multifactorial, inflammatory skin disease associated with itch, pain, and a significant physical and psychosocial burden. Delgocitinib cream 20mg/g, a topical, nonsteroidal, pan-Janus kinase (JAK) inhibitor, is now approved across Europe and other markets for the treatment of moderate-to-severe CHE in adults. The DELTA TEEN trial aimed to assess the efficacy and safety of delgocitinib cream in adolescents with moderate-to-severe CHE.

Methods: DELTA TEEN (NCT05355818) was a randomized, double-blind, vehicle-controlled, multisite, Phase III trial. Adolescents (12–17 years) with moderate-to-severe CHE were randomized 3:1 to twice-daily applications of delgocitinib cream (n=74) or cream vehicle (n=24) for 16 weeks followed by a two-week safety follow-up period. The primary endpoint was Investigator’s Global Assessment of CHE (IGA-CHE) treatment success (TS) at Week (W) 16, defined as an IGA-CHE score of 0/1 (clear/almost clear) with a two-step or greater improvement from baseline. Key secondary endpoints were 90-percent or greater improvement in the Hand Eczema Severity Index (HECSI90) and four-point or greater reductions in Hand Eczema Symptom Diary (HESD) itch, pain, and total scores from baseline to W16 in patients with a baseline score of four points or greater. The primary and key secondary endpoints were analyzed using Bayesian analyses.

Results: Superiority of delgocitinib cream to cream vehicle was demonstrated for the primary endpoint IGA-CHE TS (63.5% vs. 29.2% responders, probability=0.999) and all key secondary endpoints, including HECSI-90 (71.6% vs. 37.5% responders) four-point or greater improvements in HESD itch (64.8% vs. 36.8% responders), pain (63.3% vs. 33.3% responders), and total score (55.6% vs. 31.3% responders). No serious adverse events (AEs) were reported, and all AEs reported with delgocitinib cream were mild or moderate in severity. The overall proportion and rate of patients reporting AEs were slightly higher for delgocitinib cream (50.0%, 298.88 events per 100 patient years of observation [PYO]) than for cream vehicle (33.3%, 232.33 events per 100 PYO). Few AEs assessed as probably or possibly related to the trial drug and AEs leading to withdrawal from trial or permanent discontinuation were reported, with numerically lower rates for delgocitinib cream (7.76 and 7.76 events per 100 PYO) than cream vehicle (36.68 and 12.23 events per 100 PYO).

Conclusion: Delgocitinib cream 20mg/g demonstrated superior efficacy compared to cream vehicle and was well tolerated in adolescents with moderate-to-severe CHE, with no safety concerns identified over 16 weeks of treatment.

Funding and acknowledgements: The DELTA TEEN trial was sponsored by LEO Pharma A/S, Ballerup, Denmark. Medical writing support was provided by Sidse Ørnbjerg Würtz (independent consultant funded by LEO Pharma A/S, Ballerup, Denmark). This work was previously presented at EADV 2025.

Demographics and clinical characteristics of patients with chronic hand eczema – results from the CHECK study in the United States

Presenters: Eric Simpson,¹ Sanjeev Balu,² Aseel Bin Sawad,² Eydna Didriksen Apol,³ Shannon Schneider,² Douglas Maslin,³ Perrine Le Calvé,⁴ Bleuenn Rault,⁴ Raj Chovatiya^5,6

Affiliations: ¹Oregon Health & Science University, US; ²LEO Pharma, US; ³LEO Pharma A/S, DK; ⁴Oracle Life Sciences, FR; ⁵Rosalind Franklin University of Medicine and Science Chicago Medical School, US; ⁶Center for Medical Dermatology + Immunology Research, US

Introduction: Chronic hand eczema (CHE) is a persistent, heterogeneous, multifactorial, and sometimes debilitating disease characterized by itch and pain. Sociodemographic factors might influence severity, possibly contributing to diagnosis, treatment, and outcome disparities. Understanding severity variations is key to improving care and treatment/prevention. Here, we reported clinical characteristics of CHE in the United States (US) and identified sociodemographic factors associated with CHE severity. 

Methods: Chronic Hand Eczema Epidemiology, Care, and Knowledge of Real-life Burden (CHECK-US) was an online survey conducted among 10,636 adults representative of the US general population, recruited via online panels. MST Scale was used to assess skin color. A published photographic guide was used to assess severity in the past week. 

Results: A total of 982 participants self-reported physician-diagnosed CHE and completed the questionnaire. Of these, 54.4 percent were male (n=534) and the mean (standard deviation [SD]) age was 37.1 (12.4) years. Most participants were employed (n=750) and lived in urban areas (n=851). Among participants, 72.5 percent identified as White (n=712) and 15.8 percent as Black or African American (n=155). In terms of skin tone, 59.3 percent (n=583) reported light tone (MST 1–3), 30.4 percent (n=298) medium (MST 4–6), and 9.9 percent (n=97) dark (MST 7–10). The most frequently reported comorbidities were emotional or mental conditions (n=266).

Mean (SD) age at first CHE symptoms was 22.4 (13.6) years and 24.7 (13.8) years at formal diagnosis. The most frequently reported subtype was atopic hand eczema (52.6%), and 46.5 percent reported multiple subtypes. Fingers/between fingers (59.8%) and dorsal hand (52.1%) were the most frequently affected anatomical areas in the past week. Most participants (75.8%) reported multiple affected areas. When describing flares, 66.8 percent of participants indicated increased itching, 59.8 percent reported increased redness, and 36.1 percent reported increased pain. 

Almost two-thirds of participants with CHE (65.1%) self-assessed as having moderate-to-severe CHE in the past week, while 34.9 percent had mild CHE. The proportion of moderate-to-severe CHE was higher among male individuals (70.6% vs. 58.4% among female individuals; p<0.001) and individuals aged 18 to 39 years (70.8% vs. 55.4% for 40–69 years of age; p<0.001). The highest proportions of moderate-to-severe CHE were observed among participants identifying as Black or African American (77.3%) race. The majority of individuals with light skin tones (60.3%) reported moderate-to-severe CHE, compared to 69.8 percent with medium and 78.6 percent with dark skin tones. 

Conclusion: A significant proportion of participants with CHE reported multiple subtypes, either etiological or morphological, symptom severity, and anatomical areas of involvement, highlighting the clinical heterogeneity of CHE. These data suggest that moderate-to-severe CHE is more common among younger adults, male individuals, and individuals with darker skin tones, highlighting potential disparities in disease characteristics and severity that warrant further research.

Acknowledgements and funding sources: This analysis was sponsored by LEO Pharma. Medical writing support from Oracle Life Sciences and editorial support from Alphabet Health by Gina Sanchez, PhD, was funded by LEO Pharma. This work was previously presented at Fall Clinical 2025.

Healthcare resource utilization and financial burden among patients with chronic hand eczema – results from the CHECK study in the United States

Presenters: Raj Chovatiya,^1,2 Sanjeev Balu,³ Aseel Bin Sawad,³ Eydna Didriksen Apol,⁴ Shannon Schneider,³ Douglas Maslin,⁴ Bleuenn Rault,⁵ Alexanne Morillo,⁵ Eric Simpson⁶

Affiliations: ¹Rosalind Franklin University of Medicine and Science Chicago Medical School, US; ²Center for Medical Dermatology + Immunology Research, US; ³LEO Pharma, US; ⁴LEO Pharma A/S, DK; ⁵Oracle Life Sciences, FR; ⁶Oregon Health & Science University, US

Introduction: Chronic hand eczema (CHE) is a persistent inflammatory skin disease that often requires long-term management. In addition to impactful patient-reported burden, CHE imparts a substantial economic burden due to ongoing needs for consultations with healthcare providers (HCPs), preventive care, and treatments, as well as associated decreased work productivity. There are limited patient-reported data regarding healthcare resource utilization (HRU) and financial burden of CHE in the United States (US). Here, we evaluated HRU and out of pocket (OOP) costs of CHE management in the US stratified by disease severity. 

Methods: Chronic Hand Eczema Epidemiology, Care, and Knowledge of Real-life Burden (CHECK-US) was an online survey among adult participants who self-reported a physician diagnosis of CHE recruited via general population online panels in the US. Disease severity during the week prior to completing the survey was self-assessed by participants using a guide which helped them identify the severity of their disease using a set of pictures of hand eczema ranging from clear to very severe. 

Results: Among 982 participants who self-reported a physician-diagnosed CHE, 534 (54.4%) were male. Mean (standard deviation [SD]) age was 37.1 (12.4) years. Of the group, 65.1 percent (n=639) of the participants reported moderate-to-severe CHE. 

In the previous 12 months, 88.9 percent (n=873) met with a HCP in relation with their CHE in the outpatient setting; 56.8 percent (n=558) with a dermatologist, 28.6 percent (n=281) with a general practitioner, 9.7 percent (n=96) had not seen any HCP, and 1.3 percent could not recall. Among participants with moderate-to-severe CHE, 92.6 percent (n=592/639) had met with an HCP in the past 12 months, compared to 82.1 percent of participants with mild CHE (n=282/343). Among participants with moderate-to-severe CHE, 89.0 percent (n=568) had at least one outpatient office visit related to CHE in the past 12 months, compared to 74.3 percent (n=255) among participants with mild disease.

Over the past 12 months, participants with moderate-to-severe CHE had significantly higher mean (SD) monthly out-of-pocket (OOP) costs for emollients or other topical treatments than those with mild CHE ($134.1 [182.4] vs. $105.9 [174.2], p<0.001). Patterns were similar for mean (SD) monthly OOP costs for other products used to manage their CHE ($117.9 [182.3] vs. $87.1 [164.0], p<0.001).

Conclusion: The results from this population-based study show the financial burden of CHE management with substantial HRU and OOP costs, especially in individuals with moderate-to-severe CHE. Health-related costs can be a source of significant stress and a barrier to care, particularly for the uninsured. This mandates the need to optimize CHE care to avoid excess HRU and spending.

Acknowledgements and funding sources: This analysis was sponsored by LEO Pharma. Medical writing support from Oracle Life Sciences and editorial support from Alphabet Health by Gina Sanchez, PhD, was funded by LEO Pharma. This work was previously presented at Fall Clinical 2025.

Prevalence of self-reported physician diagnosis of chronic hand eczema in adults: a cross-sectional study of more than 10,000 participants in the general population – results from the CHECK study in the United States

Presenters: Raj Chovatiya,^1,2 Sanjeev Balu,³ Aseel Bin Sawad,³ Eydna Didriksen Apol,⁴ Shannon Schneider,³ Douglas Maslin,⁴ Lysel Brignoli,⁵ Perrine Le Calvé,⁵ Eric Simpson⁶

Affiliations: ¹Rosalind Franklin University of Medicine and Science Chicago Medical School, US; ²Center for Medical Dermatology + Immunology Research, US; ³LEO Pharma, US; ⁴LEO Pharma A/S, DK; ⁵Oracle Life Sciences, FR; ⁶Oregon Health & Science University, US

Introduction: Prevalence data for chronic hand eczema (CHE) in the United States (US) is limited, in part due to the absence of a specific International Classification of Diseases (ICD) diagnostic code and lack of specific US guidelines for the treatment of CHE. There is an unmet need for population-based prevalence data to better understand the associated patient-reported and healthcare burden. Here, we estimated the prevalence of self-reported physician-diagnosed CHE among adults aged 18 to 69 years in the general population in the US and described the variation in prevalence according to key sociodemographic characteristics.

Methods: Chronic Hand Eczema Epidemiology, Care, and Knowledge of Real-life Burden in the US (CHECK-US) enrolled participants using online panels. Participants were representative of the general population on sex, age, state, employment status, urban/rural setting, and race. CHE was defined as self-reported eczema on the hand(s)/wrist(s) in the past 12 months, persisting for three or more months or with two or more flares. Information on self-reported physician diagnosis of CHE was collected. Prevalence estimates with 95-percent confidence intervals (CIs) are reported.

Results: Among 10,636 participants, 27.2 percent (n=2,895) reported eczema/dermatitis. Lifetime prevalence of hand eczema was 13.6 percent (12.9–14.3%). The majority (n=1,212) had hand eczema in the past 12 months, corresponding to 11.4 percent of the overall population. Among this group, 1,019 patients who fulfilled the criteria defining chronicity and reported a physician diagnosis were classified as patients with physician-diagnosed CHE, corresponding to 9.6 percent (9.0–10.2%) of the overall population.

Prevalence of physician-diagnosed CHE was higher among respondents who were male versus female (10.5% [9.7–11.4%] vs. 8.7% [7.9–9.5%]; p<0.01), employed versus nonemployed, (10.3% [9.6–11.1%] vs. 7.8% [6.9–8.7%]; p<0.001) and living in urban versus rural areas (10.4% [9.7–11.1%] vs. 6.3% [5.2–7.6%]; p<0.001). Prevalence was highest in participants aged 18 to 39 years (13.4% [12.4–14.5%]) and lowest in those aged 50 to 69 years (4.2% [3.6–4.9%]). Prevalence was the highest among people who self-identified with more than one racial group (n=38/328, 11.6% [8.1–15.9%]) and those who identified as American Indian or Alaska Native (n=17/143, 11.6% [6.5–18.7%]), followed by people who identified as Black or African American (n=164/1453, 11.3% [9.7–13.0%]). 

Conclusion: These results from the largest epidemiologic study of CHE in the US reveal that CHE is a common skin disease with an overall self-reported physician-diagnosed CHE prevalence of 9.6 percent in the US general population, with higher rates among male individuals, employed participants, urban area residents, and adults under the age of 40 years. Additional studies are needed to better understand epidemiologic variations among populations in the US.

Acknowledgements and funding sources: This analysis was sponsored by LEO Pharma. Medical writing support from Oracle Life Sciences and editorial support from Alphabet Health by Gina Sanchez, PhD, was funded by LEO Pharma. This work was previously presented at Fall Clinical 2025.

Self-reported disease severity, symptoms, and treatment of chronic hand eczema – results from the CHECK study in the United States

Presenters: Raj Chovatiya,^1,2 Sanjeev Balu,³ Aseel Bin Sawad,³ Eydna Didriksen Apol,⁴ Shannon Schneider,³ Douglas Maslin,⁴ Bleuenn Rault,⁵ Alexanne Morillo,⁵ Eric Simpson⁶

Affiliations: ¹Rosalind Franklin University of Medicine and Science Chicago Medical School, North Chicago, US; ²Center for Medical Dermatology + Immunology Research, Chicago, US; ³LEO Pharma Madison, NJ, US; ⁴LEO Pharma A/S, Ballerup, Denmark; ⁵Oracle Life Sciences, Paris, France; ⁶Oregon Health & Science University, Portland, US

Introduction: Chronic hand eczema (CHE) ranges from mild disease, which is generally treated with emollients and preventative measures, to moderate-to-severe disease, that might require additional treatment, generally with topical corticosteroids (TCS), or other topical and rarely systemic treatments. Few studies have explored the range of CHE disease severity and treatment utilization in the United States (US). Here, we investigated self-reported CHE severity, symptoms, and treatments to manage the disease in the US.

Methods: Chronic Hand Eczema Epidemiology, Care, and Knowledge of Real-life Burden (CHECK-US) was an online cross-sectional survey conducted among 10,636 adult participants from the general population in the US, recruited via online panels. The survey was designed to capture self-assessed CHE severity, CHE treatment, and symptoms. A previously published, validated photographic guide was used by participants to self-assess severity in the past week and worst severity in the past 12 months. Three visual analog scales (VASs) were used to assess itch, pain, and sleep disturbance in the past 24 hours. Data were descriptively analyzed.

Results: Among 10,636 participants, 982 reported physician-diagnosed CHE and completed the full questionnaire. The overall mean (standard deviation [SD]) age of this group was 37.1 years (12.4), and 54.4 percent (n=534) were male. At the time of survey response, approximately two-thirds had moderate-to-severe CHE (65.1%; n=639) and at some point in the past 12 months, most participants (87.8%; n=862) reported moderate-to-severe disease.

Most participants had used TCS at some point to treat their CHE (80.9%; n=794). Among those, 73.0 percent (n=580/794) used at least two types of TCS, with 16.6 percent (n=132/794) using between 5 to 10 types.

Among those with physician-diagnosed CHE, 31.8 percent (n=312/982) used TCS within the previous month without being concurrently treated with systemic or phototherapy. Among these participants, 63.9 percent (n=199/312) assessed their current CHE as moderate-to-severe. In this group, the mean (SD) VAS was 5.1 (2.5) for itch, 3.9 (2.8) for pain, and 3.7 (2.8) for sleep disturbance versus 3.1 (2.9), 2.2 (2.7), and 1.9 (2.6), respectively, for participants using TCS with mild CHE.

Conclusion: The majority of individuals with physician-diagnosed CHE continue to have moderate-to-severe disease despite being on prescription treatment. Those using TCS reported continued itch, pain, and sleep disturbance, indicating a significant unmet need in this population. Additionally, most participants cycled through multiple TCS treatment options, suggesting a need for therapeutic alternatives for optimal CHE management.

Acknowledgements and funding sources: This analysis was sponsored by LEO Pharma. Medical writing support from Oracle Life Sciences and editorial support from Alphabet Health by Gina Sanchez, PhD, was funded by LEO Pharma. This work was previously presented at Fall Clinical 2025.

The impact of chronic hand eczema on occupation, work productivity, and activity impairment – results from the CHECK study in the United States

Presenters: Eric Simpson,¹ Sanjeev Balu,² Aseel Bin Sawad,² Eydna Didriksen Apol,³ Shannon Schneider,² Douglas Maslin,³ Lysel Brignoli,⁴ Alissar Moussalem,⁴ Raj Chovatiya^5,6

Affiliations: ¹Oregon Health & Science University, US; ²LEO Pharma, US; ³LEO Pharma A/S, DK; ⁴Oracle Life Sciences, FR; ⁵Rosalind Franklin University of Medicine and Science Chicago Medical School, US; ⁶Center for Medical Dermatology + Immunology Research, US

Introduction: Hand eczema (HE) is the most frequent occupational skin disease and is associated with a high socioeconomic burden, due to financial costs associated with sick leave, loss in productivity, and loss of employment. Chronic HE (CHE) is HE that lasts three months or longer and/or relapses two or more times per year. CHE can be caused or exacerbated by exposure to irritants and/or contact allergens encountered in daily activities, such as occupations involving wet work (eg, healthcare workers, cleaners, hairdressers and barbers), domestic work, or childcare activities. Here we investigated the impact of CHE on occupation or household/leisure activities, work productivity, and activity impairment in the United States (US).

Methods: Chronic Hand Eczema Epidemiology, Care, and Knowledge of Real-life Burden (CHECK-US) was an online cross-sectional survey conducted among 10,636 adult participants of the general population in the US. Participants were representative of the general population regarding sex, age, state, employment status, urban/rural setting, and race. The Work Productivity and Activity Impairment (WPAI) questionnaire was asked to all participants.

Results: Among participants who self-reported physician-diagnosed CHE and completed the full questionnaire (n=982), 27.9 percent (n=274) attributed their disease to their occupation, and 34.9 percent (n=343) to their household/leisure activities.

Among participants with physician-diagnosed CHE who attributed their disease to their occupation (n=274), 33.5 percent (n=92) reported an occupation classified as a “wet occupation” (ie, that involves frequent or prolonged exposure of hands/wrists to water), and 23.3 percent (n=64) reported an occupation classified as a “food occupation” (eg, bakers, butchers, kitchen workers). Sixty-nine percent (n=190) reported CHE improvement when away from work.

For participants reporting CHE related to either occupation or daily activities (n=425), 43.6 percent (n=185) had to change household or leisure activities, 32.2 percent (n=137) had to change work assignment or reduce working hours, and 15.3 percent (n=65) changed job or retired early. Among currently working participants who completed the WPAI questionnaire (n=611), the mean (standard deviation [SD]) overall work impairment was 41.0 percent (36.5%), the presenteeism score, reflecting the degree of impairment while working, was 37.4 percent (34.3%), and the absenteeism score, reflecting the proportion of work hours missed due to CHE, was 13.6 percent (23.5%). Among all 982 participants, the mean (SD) activity impairment was 42.7 percent (33.7%). 

Conclusion: A significant proportion of individuals with CHE relate their disease to their occupation and/or household/leisure activities and subsequently alter their occupation and/or daily activities to reduce CHE-triggering exposures. This was reflected in elevated WPAI scores with upward of 40 percent of impairment. This research highlights how occupational hazards can trigger CHE, and how much of a significant burden the disease might be on work productivity and daily activities. 

Acknowledgements and funding sources: This analysis was sponsored by LEO Pharma. Medical writing support from Oracle Life Sciences and editorial support from Alphabet Health by Gina Sanchez, PhD, was funded by LEO Pharma. This work was previously presented at Fall Clinical 2025.

 

Melanoma 

Clinical use of the i31-GEP for SLNB for T1–T2a cutaneous melanoma significantly and safely reduces unnecessary procedures

Presenters: Timothy Beard, MD;¹ Stanley P. Leong, MD;² Rajan P. Kulkarni, MD;³ Brian Martin, PhD;⁴ Kelli Ahmed, PhD;⁴ Andrew Ward, PhD;⁵ Rohit Sharma, MD;⁶ J. Michael Guenther, MD;⁷ Shawn Young, MD⁸

Affiliations: ¹Summit Medical Group, Bend, OR; ²California Pacific Medical Center and Research Institute, San Francisco, CA; ³Oregon Health and Science University, Portland, OR; ⁴Castle Biosciences, Friendswood, TX; ⁵University of Tennessee Medical Center, Knoxville, TN; ⁶Marshfield Clinic, Marshfield, WI; ⁷St. Elizabeth Physicians General & Vascular Surgery, Ft. Mitchell, KY; ⁸Cancer Centers of Colorado (SCL Health), Denver, CO

Introduction: Accurate identification of patients with cutaneous melanoma at low risk (<5%) of sentinel lymph node (SLN) positivity can help patients avoid SLN biopsy (SLNB), reducing unnecessary surgery, complications, and healthcare costs. The integrated 31-gene expression profile (i31-GEP) test integrates the 31-GEP with Breslow thickness, ulceration status, mitotic rate, and age to provide a more precise estimate of SLN positivity than using clinicopathologic features alone. The purpose of this study was to prospectively validate the performance of the i31-GEP for SLNB risk prediction.

Methods: Patients enrolled in the prospective DECIDE study were evaluated using the i31-GEP as part of SLNB decision-making. T1a with at least one high-risk factor, T1b or T2a tumors were included in the current analysis (n=471). SLNB utility was compared using 1:1 matched cohorts of patients from the DECIDE study and an independent population published by Whitman et al (2021), for whom the i31-GEP was not considered in the SLNB decision-making process.

Results: In the DECIDE study, 221/471 patients (46.9%) underwent SLNB. Of these, the i31-GEP classified 58 patients as having less than five percent risk of SLN positivity, none of which (0%) had a positive node. The positivity rate in those predicted to have five percent or greater risk was 9.8 percent (16/163). Compared to the matched Whitman cohort, 25 percent fewer SLNBs were performed among patients in DECIDE, in which the i31-GEP was included in clinical decision-making (p<0.001).

Discussion: The i31-GEP for SLNB accurately identified patients with less than five percent risk of SLN positivity who can safely forego SLNB, sparing patients from SLNB-associated morbidity and reducing healthcare costs.

 

Miscellaneous

Efficacy and safety of apremilast for the treatment of Japanese patients with palmoplantar pustulosis: 52-week results from a Phase III, randomized, placebo-controlled study

Presenters: Yukari Okubo,¹ Tadashi Terui,² Satomi Kobayashi,³ Akimichi Morita,⁴ Shinichi Imafuku,⁵ Yayoi Tada,⁶ Bruce Strober,⁷ Melinda Gooderham,⁸ Wendy Zhang,⁹ Junichiro Shimauchi,¹⁰ Masamoto Murakami¹¹ 

Affiliations: ¹Tokyo Medical University, Tokyo, Japan; ²Nihon University School of Medicine, Tokyo, Japan; ³Seibo International Catholic Hospital, Tokyo, Japan; ⁴Nagoya City University, Nagoya City, Japan; ⁵Fukuoka University, Fukuoka, Japan; ⁶Teikyo University, Tokyo, Japan; ⁷Central Connecticut Dermatology Research, Cromwell, CT, US; ⁸SKiN Centre for Dermatology, Ontario, Canada; ⁹Amgen Inc., Thousand Oaks, CA, US; ¹⁰Amgen K.K., Tokyo Japan; ¹¹Miyazaki University, Miyazaki, Japan

Introduction: Palmoplantar pustulosis (PPP) is a chronic dermatitis associated with itching and pain, with limited treatment options. In a Phase III trial, apremilast—recently approved in Japan for moderate-to-severe PPP—showed efficacy in Japanese patients with moderate-to-severe PPP versus placebo at Week 16.¹ Here, we report efficacy and safety of apremilast over 52 weeks in Japanese patients with moderate-to-severe PPP.

Methods: In this randomized, placebo-controlled, double-blind, confirmatory Phase III study, adults with PPP Area and Severity Index (PPPASI) total score of 12 or greater, PPPASI pustules/vesicles severity score of 2 or greater, and inadequate response to topicals were randomized 1:1 to apremilast 30mg twice daily or placebo for 16 weeks, after which all patients received apremilast through Week 52 (apremilast/apremilast or placebo/apremilast, respectively). Week 52 endpoints included 50-, 75-, and 90-percent or greater improvement in PPPASI total score (PPPASI50, -75, and -90, respectively); changes from baseline in PPPASI total score, Palmoplantar Pustulosis Severity Index (PPSI) total score, patient’s visual analog scale (VAS) for pruritus and pain/discomfort, Dermatology Life Quality Index (DLQI), and treatment-emergent adverse events (TEAEs); data are reported as observed. 

Results: Among 176 patients randomized (apremilast, n=88; placebo, n=88), 164 (93.2%) completed Week 52 (apremilast/apremilast, n=84 [95.5%]; placebo/apremilast, n=80 [90.9%]). Improvements at Week 16 were maintained or further improved at Week 52 in patients continuing apremilast for PPPASI50 (79.8%), PPPASI75 (47.6%), and PPPASI90 (20.2%) responses, as well as change from baseline in PPPASI total score (−14.7), PPSI total score (−4.6), pruritus VAS (−19.1), pain/discomfort VAS (−18.8), and DLQI (−2.4). Comparable improvements were also seen at Week 52 in patients who transitioned from placebo to apremilast at Week 16. TEAEs were consistent with the known apremilast safety profile. 

Conclusion: Improvements in PPP observed with apremilast treatment at Week 16 were maintained/further improved through Week 52. No new safety signals were observed.

References:

1. Terui. AAD 2024 Annual Meeting.

Efficacy and safety of deucravacitinib in patients with discoid lupus erythematosus and/or subacute cutaneous lupus erythematosus: results from PAISLEY CLE, a global, Phase II randomized, double-blind, placebo-controlled trial

Presenters: Victoria P. Werth,¹ Alice B. Gottlieb,² Cynthia Aranow,³ François Chasset,⁴ Benjamin F. Chong,⁵ David Fiorentino,⁶ Joerg Wenzel,⁷ Shimon Korish,⁸ Richard Meier,⁸ Rachana Agrawal,⁸ Joseph F. Merola⁵

Affiliations: ¹University of Pennsylvania, Philadelphia, PA, US; ²Icahn School of Medicine at Mount Sinai, New York, NY, US; ³Feinstein Institutes for Medical Research, Molecular Medicine and Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, US; ⁴Sorbonne Université, Hôpital Tenon, Paris, France; ⁵The University of Texas Southwestern Medical Center, Dallas, TX, US; ⁶Stanford University School of Medicine, Redwood City, CA, US; ⁷University Hospital of Bonn, Bonn, Germany; ⁸Bristol Myers Squibb, Princeton, NJ, US

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved for the treatment of moderate-to-severe plaque psoriasis in adults, has demonstrated significant improvements in cutaneous manifestations in the Phase II PAISLEY systemic lupus erythematosus (SLE) trial. Here, we report data from the Week 16 placebo-controlled period of the Phase II PAISLEY cutaneous lupus erythematosus (CLE) trial (NCT04857034) of deucravacitinib versus placebo in patients with discoid lupus erythematosus (DLE) and/or subacute CLE (SCLE).

Methods: Eligible adults were randomized 1:1:1 to placebo or deucravacitinib (3 or 6mg twice daily [BID]). Patients with or without SLE were enrolled, with SLE participation limited to 50 percent or less. The primary endpoint was mean percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score at Week 16. Mean change from baseline in CLASI-A and 50-percent or greater improvement in CLASI (CLASI50) were secondary endpoints; 70-percent or greater improvement in CLASI (CLASI70) was a post hoc analysis. P-value less than 0.1 represented statistical significance. Safety was also assessed.

Results: Deucravacitinib provided significantly improved mean percent change from baseline in CLASI-A versus placebo (placebo [n=24], −28.4%; deucravacitinib 3mg BID [n=25], −47.5%, p=0.0670; 6mg BID [n=25], −50.0%, p=0.0385), mean change from baseline in CLASI-A (−5.3 vs. −9.3 [p=0.0425] and −8.7 [p=0.0805]), and CLASI50 response (19.0% vs. 56.7% [p=0.0092] and 52.3% [p=0.0193]). Deucravacitinib 3mg BID was associated with a higher CLASI70 response versus placebo (15.9% vs. 49.5% [p=0.0184] and 29.5% [p=0.2713]). No new safety signals were observed. Adverse event (AE) rates were 50.0 percent versus 68.0 percent and 79.2 percent; most AEs with deucravacitinib were mild to moderate and consistent with the known safety profile.

Conclusion: In patients with DLE/SCLE, deucravacitinib showed statistically significant and clinically meaningful improvements in CLASI-A outcomes and was well tolerated, supporting further evaluation in the ongoing Phase III POETYK SLE trials (NCT05617677, NCT05620407).

Acknowledgements: This study was supported by Bristol Myers Squibb.

We would like to thank the patients and families who made this study possible and the clinical teams who participated.

All authors contributed to and approved this abstract; professional medical writing and editorial assistance were provided by Christine Billecke, PhD, of Nucleus Global, funded by Bristol Myers Squibb.

Disclosures: VPW: Research support: Amgen, AstraZeneca, Biogen, Celgene, Gilead, Janssen, Lupus Research Alliance/Bristol Myers Squibb, and Viela Bio; Consultancy: AbbVie, Amgen, Argenx, AstraZeneca, Beacon Bioscience, Biogen, Bristol Myers Squibb, Celgene, Corcept, Crisalis, CSL Behring, Cugene, Eli Lilly, EMD Serono, Genentech, Gilead, GSK, Idera, Incyte, Janssen, Kirin, MedImmune, Medscape, Nektar, Principia, Resolve, UCB, and Viela Bio. ABG: Advisory board/consultancy: Amgen, AnaptysBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, DICE Therapeutics, Eli Lilly, Highlight Therapeutics, Janssen, Novartis, Sanofi, Teva, UCB, and XBiotech (stock options for RA); Research/educational grants: Bristol Myers Squibb, Highlight Therapeutics, Janssen, and UCB (all paid to Icahn School of Medicine at Mount Sinai). CA: Alumnis, AstraZeneca, Bristol Myers Squibb, GSK, Merck, and Synthekine. FC: Grant/research support: AstraZeneca, Bristol Myers Squibb, and GSK; Advisory board: AstraZeneca, Celgene, GSK, Horizon Therapeutics, Kiowa Kirin, Lilly, Novartis, and Principabio; Speaker: Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, GSK, and Novartis; National coordination for clinical trial in CLE: AstraZeneca, Biogen, and Bristol Myers Squibb. BFC: Consultant and/or investigator: Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, EMD Serono, and Lupus Research Alliance; Royalties: MAPI Trust; Speaker: Cesas Medical. DF: Contracted research: Kyverna, Priovant, and Serono; Paid consultant: Arsenal, Biogen, Bristol Myers Squibb, IMVT, Johnson & Johnson, Pfizer, and UCB; Data and safety monitoring board: Argenyx. JW: Research funding: Almirall, AstraZeneca, Bristol Myers Squibb, GSK, Incyte, and Spirig; Presentations: Biogen, Janssen, Kyowa Kirin, LEO Pharma, Medac, Novartis, and Sanofi; Advisory boards: Actelion, AstraZeneca, Bayer, Biogen, Bristol Myers Squibb, GSK, Incyte, Janssen, and Merck; Clinical studies: ArrayBio, GSK, LEO Pharma, Merck/Serono, Novartis, Pfizer, and Roche. SK: Employee and shareholder at the time of study conduct: Bristol Myers Squibb. RM and RA: Employees and shareholders: Bristol Myers Squibb. JFM: Consultant and/or investigator: AbbVie, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte, Janssen, LEO Pharma, MoonLake Immunotherapeutics, Novartis, Pfizer, Sanofi-Regeneron, Sun Pharma, and UCB.

 

Psoriasis and Psoriatic Arthritis

Apremilast efficacy in patients with early oligoarticular psoriatic arthritis affecting weightbearing joints by body mass index: results from FOREMOST

Presenters: Kristina Callis Duffin,¹ Ulrich Mrowietz,² Joseph F. Merola,³ Dafna D. Gladman,⁴ William Tillett,⁵ April Armstrong,⁶ Peter Nash,⁷ Shauna Jardon,⁸ Cynthia Deignan,⁸ Lichen Teng,⁸ Arthur Kavanaugh⁹

Affiliations: ¹University of Utah, Salt Lake City, UT, US; ²University Medical Center Schleswig-Holstein, Kiel, Germany; ³UT Southwestern Medical Center, Dallas, TX, US; ⁴Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, ON, Canada; ⁵University of Bath, Bath, UK; ⁶University of California Los Angeles, Los Angeles, CA, US; ⁷School of Medicine, Griffith University, Brisbane, Queensland, Australia; ⁸Amgen Inc., Thousand Oaks, CA, US; ⁹Division of Rheumatology Autoimmunity and Inflammation, University of California San Diego, La Jolla, CA, US

Introduction: Despite limited joint involvement, oligoarticular (oligo; ≤4 active joints) psoriatic arthritis (PsA) can significantly impact quality of life and physical functioning.^1–3 In the FOREMOST study, fewer patients receiving apremilast (APR) versus placebo (PBO) progressed from four or fewer to more than four active (swollen and/or tender) joints at Week 16.⁴ This post hoc analysis of FOREMOST evaluated the effect of APR treatment on weight-bearing joints in early oligo PsA, overall and by body mass index (BMI), through 48 weeks. 

Methods: FOREMOST (NCT03747939) enrolled 308 patients with early oligo PsA and limited joint involvement (≥1–≤4 swollen joint count [SJC] and ≥1–≤4 tender joint count [TJC]; 66–68 joints assessed). Patients were randomized 2:1 to APR 30mg or PBO through Week 24 (early escape Week 16), followed by open-label APR through Week 48 (APR/APR or PBO/APR, respectively).⁴ This post hoc analysis assessed joint activity and Health Assessment Questionnaire Disability Index (HAQ-DI) in 187 patients who received one or more doses of APR with active weight-bearing joints⁵ at baseline (APR/APR, n=125; PBO/APR, n=62), by baseline BMI categories (<25kg/m², ≥25kg/m² to <30kg/m², ≥30kg/m²), through Week 48. 

Results: APR and PBO were similar at baseline, including mean SJC (1.5 and 1.2, respectively), TJC (1.9 and 1.8), active joint count (2.1 and 1.9), BMI (30.8 and 31.0kg/m²). At Week 16, SJC, TJC, and active joint count, respectively, improved with APR versus PBO (mean change: –1.1 vs. –0.1; –0.6 vs. 0.7; and –0.7 vs. 0.8, respectively), with sustained improvements through Week 48 in APR/APR or PBO/APR (–1.2 or –0.6; –0.9 or –0.6; and –1.0 or –0.4, respectively). Patients with baseline HAQ-DI above 0.5 (APR, n=92, mean score: 1.262; PBO, n=46, mean score: 1.239) reported improved scores with APR versus PBO at Week 16 (mean change: –0.356 vs. –0.175), with improvements sustained through Week 48 in APR/APR or PBO/APR (–0.364 or –0.408). More patients receiving APR versus PBO achieved HAQ-DI of 0.5 or less at Week 16 (32.5% vs. 22.2%), increasing to about 40 percent through Week 48 in both groups. Results were similar across BMI categories.

Conclusion: These findings demonstrate APR improves clinical and patient-reported outcomes in patients with early oligo PsA involving active weight-bearing joints, irrespective of BMI.

References:

1. Gladman. J Rheumatol. 2021.
2. Kasiem. Scand J Rheumatol. 2021.
3. Ogdie. Ann Rheum Dis. 2019.
4. Gossec. Ann Rheum Dis. 2024.
5. Mizelle. Ann Rheum Dis. 2023.

Deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in patients with moderate-to-severe scalp psoriasis: 52-week efficacy and safety results of a Phase IIIb/IV, multicenter, randomized, double-blinded, placebo-controlled trial (PSORIATYK SCALP)

Presenters: Kristina Callis Duffin,¹ Christopher E.M. Griffiths,² Matthias Hoffmann,³ Andrew Blauvelt,⁴ Eugene Balagula,⁵ Andrew Napoli,⁵ Yichen Zhong,⁵ Chun-Yen Cheng,⁵ Rachel Dyme,⁵ Virginia Hala,⁵ Andreas Pinter,⁶ Mark Lebwohl⁷

Affiliations: ¹University of Utah, Salt Lake City, UT, US; ²Dermatology Centre, University of Manchester, Manchester, and King’s College Hospital and King’s College London, London, UK; ³Private Practice, Witten, Germany; ⁴Blauvelt Consulting, Annapolis, MD, US; ⁵Bristol Myers Squibb, Princeton, NJ, US; ⁶University Hospital of the Goethe University, Frankfurt am Main, Germany; ⁷Icahn School of Medicine at Mount Sinai, New York, NY, US

Introduction: Deucravacitinib is approved for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Scalp psoriasis affects about 80 percent of patients; is associated with itching, flaking, pain, and bleeding; disproportionately reduces quality of life (QoL); and is challenging to treat with topical agents. In PSORIATYK SCALP, deucravacitinib was superior to placebo at Week 16 and well tolerated in patients with moderate-to-severe scalp psoriasis, including those with more limited overall psoriasis. We report deucravacitinib efficacy and safety through Week 52.

Methods: Adults with moderate-to-severe scalp psoriasis (baseline Scalp-Specific Physician’s Global Assessment [ss-PGA] ≥3, scalp surface area ≥20%, Psoriasis Scalp Severity Index [PSSI] ≥12) and body surface area (BSA) three percent or greater were randomized 1:2 to placebo or deucravacitinib 6mg once daily. At Week 16, all patients received open-label deucravacitinib through Week 52. The primary efficacy outcome was ss-PGA 0/1; key secondary outcomes were PSSI 90, change from baseline in scalp-specific itch numeric rating scale (NRS), and static PGA (sPGA) 0/1 at Week 16. Efficacy was evaluated through Week 52 in the overall population and subpopulation with sPGA of 3 or greater.

Results: Patients were randomized to deucravacitinib (n=103) or placebo (n=51); 94 continued deucravacitinib and 45 switched from placebo to deucravacitinib at Week 16. In the overall population, Week 16 responses were maintained/improved at Weeks 24 and 52 in patients receiving continuous deucravacitinib (ss-PGA 0/1: 48.5%, 53.4%, 50.5%, respectively; PSSI 90: 38.8%, 39.8%, 47.6%, respectively; mean change from baseline in scalp-specific itch NRS: −3.2, −3.7, −3.4, respectively). SPGA 0/1 response rates were maintained at Weeks 24 (46.9%) and 52 (47.9%) in the subpopulation. The placebo to deucravacitinib and continuous deucravacitinib groups had comparable responses at Week 52. The most common adverse events (AEs) in patients receiving one or more deucravacitinib doses were nasopharyngitis (27.0%), COVID-19 (14.9%), upper respiratory tract infection (14.2%), acne (7.4%), headache (7.4%), pustular acne (6.1%), and oral herpes (5.4%). Five serious AEs (SAEs) were reported (myocardial infarction, meniscus injury, ligament disorder, colorectal adenocarcinoma, pulmonary embolism). One death was reported (myocardial infarction). No new safety signals were observed.

Conclusion: Deucravacitinib was efficacious and well tolerated through Week 52 in patients with moderate-to-severe scalp psoriasis, including those with more limited overall psoriasis. Clinical/patient-reported responses at Week 16 were maintained through Week 52 in patients receiving continuous deucravacitinib. Patients crossing over from the placebo to deucravacitinib and continuous deucravacitinib groups had comparable responses at Week 52.

Acknowledgments: This study was sponsored by Bristol Myers Squibb.

Writing and editorial assistance was provided by Ann Marie Fitzmaurice, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.

Disclosures: KCD: Consultant (with honoraria): AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, CorEvitas Psoriasis Registry, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, and Stiefel; Speaker: Novartis; Investigator: AbbVie, Amgen/Celgene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, Regeneron, Stiefel, and UCB. CEMG: Honoraria and/or research grants: AbbVie, Almirall, Amgen, AnaptysBio, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Evelo Biosciences, GlaxoSmithKline, Inmagene, Janssen, Kyowa Kirin, LEO Pharma, Novartis, ONO Pharmaceuticals, Pfizer, Sanofi, and UCB. MH: Advisory board member: AbbVie, Almirall, Dermasence, Galderma, Incyte, Janssen, LEO Pharma, Leti Pharma, Novartis, Pfizer, Sanofi, and UCB; Consultant: AbbVie, Almirall, Dermasence, Galderma, Incyte, Janssen, LEO Pharma, Leti Pharma, Novartis, Pfizer, Sanofi, and UCB; Investigator: AbbVie, ALK, Almirall, Alumis, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermasence, Dermira, Eli Lilly, Forward, Galderma, Incyte, Janssen, Kiniksa, LEO Pharma, Leti Pharma, Meda Pharma, Medac, Meiji Pharma, Merck, Nektar Therapeutics, Novartis, Pierre Fabre, Pfizer, Sanofi, ScheringPlough, Smerud Medical Research, Stallergenes Greer, and UCB. AB: Speaker (with honoraria): Eli Lilly and UCB; Scientific adviser (with honoraria): AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Celldex, CTI BioPharma, Dermavant, EcoR1, Eli Lilly, Escient, Evelo Biosciences, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Oruka, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB, Union, Ventyx, Vibliome, and Xencor; Clinical study investigator (institution received clinical study funds): AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, DermBiont, Eli Lilly, Evelo Biosciences, Evommune, Galderma, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Takeda, UCB Pharma, and Ventyx; Stock owner: Lipidio and Oruka. EB, AN, and C-YC: Employees and shareholders at the time of study conduct: Bristol Myers Squibb. YZ, RD, and VH: Employees and shareholders: Bristol Myers Squibb. AP: Advisor, paid speaker, and/or clinical trial investigator: AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Biontec, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, GSK, Eva Pharma, Galderma, Hexal, Incyte, Janssen-Cilag, Klinge Pharma, LEO Pharma, Lilly, MC2, Medac, Merck, Merck Serono, Mitsubishi, MoonLake Immunotherapeutics, Novartis, Pascoe, Pfizer, Tigercat Pharma, Regeneron, Roche, Sandoz Biopharmaceuticals, Sanofi Genzyme, Schering-Plough, UCB, and Züllig Pharma. ML: Research funds on behalf of Mount Sinai: AbbVie, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Clexio, Dermavant, Eli Lilly, Incyte, Inozyme, Janssen, Pfizer, Regeneron, and UCB; Consultant: Almirall, AltruBio, Apogee, Arcutis, AstraZeneca, Atomwise, Avotres, Boehringer Ingelheim, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, Dermsquared, Evommune, Facilitation of International Dermatology Education, Forte Biosciences, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Regeneron, Seanergy, Strata, Takeda, Trevi, and Verrica.

Deucravacitinib in patients with psoriasis with a history of malignancy: follow-up after 4 years of deucravacitinib treatment in the POETYK PSO program

Presenters: Mark Lebwohl,¹ Neil J. Korman,² Melinda Gooderham,³ Alice B. Gottlieb,¹ Peter Foley,⁴ Kilian Eyerich,⁵ Marco Romanelli,⁶ Bruce Strober,⁷ Akimichi Morita,⁸ Linfeng Li,⁹ Carolin Daamen,¹⁰ John Vaile,¹⁰ Ramesh Badaka,¹⁰ Alessandra Alió,¹⁰ Lluís Puig¹¹

Affiliations: ¹Icahn School of Medicine at Mount Sinai, New York, NY, US; ²Case Western Reserve University, University Hospitals of Cleveland, Cleveland, OH, US; ³SKiN Centre for Dermatology, Peterborough, Queen’s University, Kingston, and Probity Medical Research, Waterloo, ON, Canada; ⁴The University of Melbourne, St. Vincent’s Hospital Melbourne, and Skin Health Institute, Melbourne, and Probity Medical Research, Carlton, VIC, Australia; ⁵University of Freiburg Faculty of Medicine, Freiburg, Germany; ⁶University of Pisa, Pisa, Italy; ⁷Yale University School of Medicine, New Haven, and Central Connecticut Dermatology Research, Cromwell, CT, US; ⁸Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; ⁹Beijing Friendship Hospital and Capital Medical University, Beijing, China; ¹⁰Bristol Myers Squibb, Princeton, NJ, US; ¹¹Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona School of Medicine, Barcelona, Spain

Introduction: The global Phase III POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, included patients with psoriasis with a history of malignancy. This descriptive analysis evaluated malignancy events in deucravacitinib-treated patients with malignancy prior to enrolling in the POETYK PSO-1, PSO-2, and long-term extension (NCT04036435) trials.

Methods: Patients in the pooled population who received one or more doses of deucravacitinib at any time over four years (data cutoff: November 1, 2023) were screened to identify those with a history of malignancy at baseline with no evidence of recurrence for over five years prior to enrollment. Baseline patient demographics and disease characteristics, type of prior malignancy, total deucravacitinib exposure, deucravacitinib treatment discontinuation, and occurrence of malignancy were evaluated for each patient with a history of malignancy.

Results: Among 1,519 deucravacitinib-treated patients, 19 had a history of malignancy (12 had a history of malignancy excluding nonmelanoma skin cancer [NMSC]; 7 had NMSC). Patients with a history of malignancy were older (mean age: 64.3 vs. 46.6 years), had longer disease duration (mean: 36.2 vs. 18.7 years), and had shorter deucravacitinib exposure (median: 814 vs. 1,298 days) compared with the total pooled population. Six of the 12 (50.0%) patients with a history of malignancy excluding NMSC discontinued treatment due to patient withdrawal (n=2), occurrence of malignancy (n=1), adverse events (n=1), lost to follow-up (n=1), or study site termination (n=1). Among the 12 patients with a history of malignancy excluding NMSC, there was one occurrence of malignancy.

Conclusion: Malignancies were infrequently observed with deucravacitinib treatment in patients with psoriasis with a history of malignancy. Analysis of larger patient populations over a longer duration of follow-up using real-world data will help to further characterize the safety of deucravacitinib in patients with psoriasis with a history of malignancy. 

Acknowledgments: This study was sponsored by Bristol Myers Squibb.

Writing and editorial assistance was provided by Ann Marie Fitzmaurice, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.

Disclosures: ML: Research funds on behalf of Mount Sinai: AbbVie, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Clexio, Dermavant, Eli Lilly, Incyte, Inozyme, Janssen, Pfizer, Regeneron, and UCB; Consultant: Almirall, AltruBio, Apogee, Arcutis, AstraZeneca, Atomwise, Avotres, Boehringer Ingelheim, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, Dermsquared, Evommune, Facilitation of International Dermatology Education, Forte Biosciences, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Regeneron, Seanergy, Strata, Takeda, Trevi, and Verrica. NJK: Advisory board and consulting fees: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Principia, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB; Grant support/principal investigator: AbbVie, Amgen, Argenx, Bristol Myers Squibb, Celgene, Chemocentryx, Eli Lilly, Galderma, Kyowa Kirin, LEO Pharma, Menlo Therapeutics, Principia, Prothena, Rhizen, Syntimmune, Trevi, and XBiotech; Speaker: AbbVie, Eli Lilly, Janssen, Novartis, Regeneron, and Sanofi Genzyme. MG: Advisory board, principal investigator, consulting, and lecture fees: AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Eli Lilly, Janssen, Novartis, Sanofi Genzyme, Sun Pharma, and UCB; Advisory board, primary investigator, and lecture fees: Galderma SA, LEO Pharma, Pfizer, and Regeneron; Advisory board, primary investigator, and consultant fees: Aslan; Primary investigator and consultant fees: Akros Pharma and Kyowa Kirin; Primary investigator: Aristea Therapeutics, AnaptysBio, Bristol Myers Squibb, Coherus Biosciences, Dermira, GSK, Incyte, MedImmune, Meiji Seika, Merck, MoonLake Immunotherapeutics, and Nimbus Therapeutics; Advisory board: Asana Biosciences. ABG: Research/educational grants: Bristol Myers Squibb, Janssen, MoonLake Immunotherapeutics, and UCB (all paid to Mount Sinai School of Medicine); Advisory board member and consultant with honoraria: Amgen, Eli Lilly, Highlights Therapeutics, Janssen, Novartis, Sanofi, Sun Pharma, Takeda, Teva, UCB, and XBiotech (stock options for RA). PF: Grant support: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galderma, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, and UCB; Investigator: AbbVie, Alumis, Amgen, Arcutis, Argenx, Aslan, AstraZeneca, Avalo, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Celtaxsys, Claruvis, CSL, Cutanea, Dermira, Eli Lilly and Company, Evelo, Galderma, Genentech, Geneseq, GSK, Hexima, Incyte, Janssen, Kymab, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi, Sun Pharma, Takeda, Teva, UCB, Valeant, and Zai Lab; Advisory boards: AbbVie, Amgen, Arrotex, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galderma, GSK, Janssen, LEO Pharma, Mayne Pharma, Merck, Novartis, Pfizer, Sanofi, Sun Pharma, UCB, and Valeant; Consultant: Apogee, Aslan, Bristol Myers Squibb, Eli Lilly and Company, Galderma, GenesisCare, Janssen, LEO Pharma, Mayne Pharma, MedImmune, Novartis, Oruka, Pfizer, Roche, UCB, and Wintermute; Travel grants: AbbVie, Eli Lilly and Company, Galderma, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Roche, Sun Pharma, and Sanofi; Speaker or received honoraria: AbbVie, Almirall, Amgen, Celgene, Eli Lilly and Company, Galderma, GSK, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Roche, Sanofi, Sun Pharma, UCB, and Valeant. KE: Advisor and/or received speakers fees: AbbVie, Almirall, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Pfizer, Novartis, Sanofi, and UCB. MR: Advisory board and consulting fees: AbbVie, Bristol Myers Squibb, Convatec, Eli Lilly, Janssen, Novartis, Sanofi Genzyme, and Urgo. BS: Consultant with honoraria: AbbVie, Acelyrin, Alamar, Almirall, Alumis, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Capital One, Celltrion, CorEvitas Psoriasis Registry, Dermavant, Eli Lilly, Imagenebio, Janssen, Kangpu, LEO Pharma, Maruho, Meiji Seika Pharma, Monte Carlo, Novartis, Okura, Pfizer, Protagonist, Rapt, Regeneron, Sanofi Genzyme, SG Cowen, Takeda, UCB, and Union Therapeutics; Speaker: AbbVie, Arcutis, Dermavant, Eli Lilly, Incyte, Janssen, Regeneron, and Sanofi Genzyme; Co-scientific director with consulting fee and investigator: CorEvitas Psoriasis Registry; Editor-in-chief (with honoraria): Journal of Psoriasis and Psoriatic Arthritis; Stockholder: Connect Biopharma and Mindera Health. AM: Honoraria as meeting chair/lecturer: AbbVie, AYUMI, Boehringer Ingelheim Japan, Celgene K.K., Eisai, Eli Lilly Japan K.K., Inforward, Janssen Pharmaceutical K.K., Kyowa Kirin, Maruho Co., Mitsubishi Tanabe Pharma, Nippon Kayaku, Novartis Pharma K.K., Taiho, Torii, and Ushio; Funding: AbbVie G.K., Eisai, Eli Lilly Japan K.K., Kyowa Hakko Kirin, LEO Pharma K.K., Maruho, Mitsubishi Tanabe Pharma, Novartis Pharma K.K., Taiho, and Torii; Consulting fees: AbbVie GK, Boehringer Ingelheim Japan, Bristol Myers Squibb, Celgene K.K., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Janssen Pharmaceutical K.K., Kyowa Kirin, Maruho, Mitsubishi Tanabe Pharma, Nichi-Iko, Nippon Kayaku, Novartis Pharma K.K., Pfizer Japan, Sun Pharma, Torii, and UCB Japan. LL: Nothing to disclose. CD: Employee and shareholder at the time of study conduct: Bristol Myers Squibb. JV, RB, and AA: Employees and shareholders: Bristol Myers Squibb. LP: Honoraria or consultation fees: AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Eli Lilly, Fresenius Kabi, Gebro, Janssen, LEO Pharma, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Regeneron, Roche, Samsung Bioepis, Sandoz, Sanofi, and UCB; Research grants or participation in clinical trials (paid to institution): AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB; Speakers bureau: Celgene, Eli Lilly, Janssen, MSD, Novartis, and Pfizer.

Durability of response to the targeted oral peptide icotrokinra for high-impact site psoriasis: 1-year ICONIC-TOTAL findings 

Presenters: Edward Lain,¹ Richard B. Warren,² Melinda Gooderham,³ Robert Bissonnette,⁴ Yu-Huei Huang,⁵ Julien Ringuet,⁶ Matthias Hoffmann,⁷ Andreas Pinter,⁸ Joseph F. Merola,⁹ Jessica Rubens,¹⁰ Dorothy Fan,¹⁰ Ming-Chun Hsu,¹⁰ Shu Li,¹⁰ Ya-Wen Yang,¹⁰ Cynthia DeKlotz,¹⁰ Eingun James Song¹¹

Affiliations: ¹Austin Institute for Clinical Research, Sanova Dermatology, Austin, TX, US; ²Dermatology Centre, Northern Care Alliance NHS Foundation Trust & Division of Musculoskeletal/Dermatological Sciences Manchester Academic Health Science Centre, University of Manchester, Manchester, UK; ³SKiN Centre for Dermatology, Dept of Medicine Queen’s University, Probity Medical Research, Peterborough, ON, Canada; ⁴InnovadermResearch, Montréal, QC, Canada; ⁵Dept of Dermatology, Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan City, Taiwan; ⁶Centre de Recherche Dermatologique du Québec Métropolitain, Dept of Dermatology, McGill University, Montreal, QC, Canada; ⁷Dermatology Practice Dr. Matthias Hoffmann, Witten, Germany; ⁸University Hospital Frankfurt am Main, Frankfurt am Main, Germany; ⁹Depts of Dermatology, Medicine, Rheumatology, UT Southwestern Medical Center, Dallas, TX, US; ¹⁰Johnson & Johnson, Spring House/Horsham, PA, US; ¹¹Frontier Dermatology, Mill Creek, WA, US

Introduction: Icotrokinra (ICO), a first-in-class, targeted oral peptide that precisely binds and blocks the interleukin (IL)-23 receptor, is being evaluated in a Phase III trial of participants with plaque psoriasis (PsO) involving high-impact sites. Through Week (W) 16, ICO demonstrated significantly higher rates of overall skin, scalp, and genital PsO clearance, numerically higher hand/foot PsO clearance rates, and a similar adverse event (AE) profile versus placebo (PBO) (Gooderham MJ, NEJM Evidence, 2025, In press). Clinical response and safety through one year of ICO are reported here. 

Methods: ICONIC-TOTAL patients (≥12 years, body surface area ≥1%, Investigator’s Global Assessment [IGA] ≥2) with at least moderate scalp (n=252), genital (n=140), and/or hand/foot (n=71) PsO were randomized (2:1) to once-daily oral administration of ICO 200mg (n=208) or PBO (n=103), with PBO-to-ICO transition at W16 (n=92). Achievement rates (employing nonresponder imputation) of clear/almost clear (0/1) or completely clear (0) skin for overall IGA, scalp specific-IGA (ss-IGA), static Physician’s Global Assessment of Genitalia (sPGA-G), and hand/foot PGA (hf-PGA); modified Nail PsO Severity Index (mNAPSI) mean percent change from baseline; and exposure-adjusted AE rates were assessed through W52. 

Results: Eighty-eight percent (275/311) of the randomized patients completed treatment through W52. ICO response rates increased through W24 and were maintained through W52 (IGA 0/1: 67%; ss-IGA 0/1: 72%; sPGA-G 0/1: 85%; hf-PGA 0/1: 62%), with comparable W52 response rates among PBO-to-ICO patients. High proportions of ICO-randomized patients achieved complete clearance by W52 (IGA 0: 44%; ss-IGA 0: 57%; sPGA-G 0: 73%; hf-PGA 0: 58%). The mNAPSI mean percent improvement increased from W16 (33%) to W52 (62%) in ICO-randomized patients. AE and serious AE rates were similar through W52 compared to through W16 across treatment groups, with no safety signals identified. 

Conclusion: The targeted oral peptide ICO demonstrated high and durable rates of high-impact site PsO clearance and no safety signals through one year of treatment.

Generalized pustular psoriasis control is limited on traditional small-molecule therapy as measured by the GPP Physician’s Global Assessment (GPPGA) and Dermatology Life Quality Index (DLQI): baseline data from the EFFISAYIL® 2 trial

Presenters: Arash Mostaghimi,¹ Joseph F. Merola,² Alice B. Gottlieb,² Douglas DiRuggiero,³ Jason Guercio,⁴ Ming Tang,⁵ Christian Thoma,⁶ Mark G. Lebwohl⁷

Affiliations: ¹Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, US; ²UT Southwestern Medical Center, Dallas, TX, US; ³Skin Cancer & Cosmetic Dermatology Center, Rome, GA, US; ⁴Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, US; ⁵Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, China; ⁶Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; ⁷Icahn School of Medicine at Mount Sinai, New York, NY, US

Introduction: Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares leading to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved to treat GPP in adults and pediatric patients aged 12 years or older and weighing 40kg or greater. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Most patients entering the trial were receiving a traditional small-molecule therapy prior to randomization and all had a baseline GPP Physician’s Global Assessment (GPPGA)¹ total score of 0 or 1. Here, we report the GPPGA total score and Dermatology Life Quality Index (DLQI) score at baseline stratified by small-molecule medication received prior to randomization in EFFISAYIL® 2.

Methods: Patients were stratified by baseline medication use, including medications received by five or more patients or no medication. GPPGA was assessed as the proportion of patients with a score of 1. For DLQI, mean and standard deviation (SD) were calculated.

Results: Despite treatment with traditional small-molecule therapies before entering EFFISAYIL® 2, most patients in each baseline medication group did not have clear skin (GPPGA total score: 1) and all groups reported poor quality of life (mean DLQI >5). These observations were consistent with findings among patients who did not receive small-molecule therapy before randomization. The respective proportion of patients with a GPPGA total score of 1 by each medication group was 95.6 percent (n=43) for acitretin, 84 percent (n=21) for cyclosporine, 66.7 percent (n=10) for methotrexate, and 80 percent (n=4) for any two small molecules (ie, acitretin, methotrexate, cyclosporine), compared with 87.1 percent (n=27) for those not receiving prior small-molecule therapy. The mean (SD) DLQI scores at baseline were 8.3 (5.6) for acitretin (n=45), 7.7 (7.4) for cyclosporine (n=25), 9.9 (7.4) for methotrexate (n=15), and 5.4 (7.2) for two small molecules (n=5), compared with 8.1 (6.1) for no therapy.

Conclusion: Despite being treated with traditional small-molecule therapy before randomization, many patients entering EFFISAYIL® 2 still demonstrated incomplete skin clearance, as shown by GPPGA total score and DLQI scores, reflecting a moderate effect on a patient’s life. These findings suggest that approved, targeted therapy should be considered to reduce the clinical burden of GPP.

Reference:

1. Burden AD, et al. Br J Dermatol. 2023;189(1):138–140.

Maintenance of response with icotrokinra, a targeted oral peptide, for the treatment of moderate-to-severe plaque psoriasis: randomized treatment withdrawal in adults (Weeks 24–52) and continuous treatment in adolescents (through Week 52) from the Phase III ICONIC-LEAD trial

Presenters: J Soung,¹ Y Cui,² R Bissonnette,³ M Lebwohl,⁴ Á González-Cantero,⁵ A Pinter,⁶ P Rich,⁷ VH Prajapati,⁸ M Miller,⁹ J Cafone,⁹ J Jiang,⁹ S Li9, C Deklotz9, Y-W Yang,⁹ AE Pink¹⁰

Affiliations: ¹Southern California Clinical Research, CA, US; ²China-Japan Friendship Hospital, Beijing, China; ³Innovaderm Research, Montréal, Canada; ⁴Icahn School of Medicine at Mount Sinai, NY, US; ⁵Ramón y Cajal University Hospital, Spain; ⁶University Hospital Frankfurt am Main, Germany; ⁷Oregon Dermatology Research Center, OR, US; ⁸Dermatology Research Institute, Calgary, Canada; ⁹Johnson & Johnson, Spring House/Horsham, PA, US; ¹⁰St. John’s Institute of Dermatology, UK

Introduction: In the Phase III ICONIC-LEAD study (NCT06095115), icotrokinra (ICO), a targeted oral peptide that precisely binds the interleukin (IL)-23 receptor to inhibit signaling, demonstrated significantly higher rates of skin clearance versus placebo (PBO) at Week (W) 16 and no safety signal through W24 in moderate-to-severe plaque psoriasis (PsO). We report maintenance of ICO response during randomized-withdrawal period in adults (W24–52), longer-term ICO effects in adolescents (through W52), and safety through W52.

Methods: Adults and adolescents (≥12 years of age) with moderate-to-severe plaque PsO (body surface area [BSA] ≥10%; Psoriasis Area and Severity Index [PASI] score ≥12; Investigator’s Global Assessment [IGA] score ≥3) were randomized 2:1 to once daily (QD) ICO 200mg through W24 or PBO through W16 followed by ICO 200mg QD. At W24, ICO-randomized adults who achieved 75-percent or greater improvement in PASI (PASI75) or IGA 0/1 response (W24 ICO responders) were rerandomized 1:1 to continue ICO or receive PBO (treatment withdrawal; with ICO 200mg QD upon loss of ≥50% W24 PASI improvement). Adolescents continued ICO 200mg QD through W52. Key secondary endpoints were PASI75/PASI90 at W52; time to loss of response (LOR; PASI75/PASI90) among rerandomized adults.

Results: Among 412 adults randomized to ICO, 341 were PASI75 or IGA 0/1 responders at W24; 169 and 172 rerandomized to ICO and PBO, respectively. W24 ICO responders rerandomized to ICO had superior maintenance of PASI response versus PBO at W52 (PASI75: 89% vs. 30%; PASI90: 84% vs. 21% among W24 PASI75 or PASI90 responders, respectively; adjusted p<0.001). Among W24 ICO PASI75 or PASI90 responders, median time to LOR through W52 was not reached (NR) in participants continuing ICO versus 16.9 (PASI75) and 10.1 (PASI90) weeks among participants rerandomized to PBO (adjusted p<0.001). Among ICO W24 IGA 0/1 responders, higher proportions of ICO versus PBO rerandomized participants achieved IGA 0/1 at W52 (nominal p<0.001). Median time to LOR (IGA 0/1) was NR in participants continuing ICO versus 10.1 weeks among participants rerandomized to PBO (nominal p<0.001). All ICO adolescent participants achieved PASI75 by W32 (W24 response rates–IGA 0/1: 86%; PASI90: 89%; W52 response rates–IGA 0/1: 82%; PASI90: 86%; PASI75: 95%). No ICO safety signal was identified through W52.

Conclusion: Among adult W24 ICO responders, participants rerandomized to ICO had superior maintenance of skin response versus those rerandomized to PBO, indicating continued ICO treatment effectively maintained skin response. Adolescents receiving ICO through W52 exhibited robust, durable rates of skin clearance. ICO safety through W52 was consistent with that observed through W24.

SPECTREM: guselkumab impact on nail psoriasis and psoriatic arthritis through Week 48 in participants with low BSA, moderate psoriasis with high-impact site involvement

Presenters: AB Gottlieb,¹ JF Merola,¹ KA Papp,^2,3 M Wiseman,^4,5 WJ Loo,⁶ JK Tung,⁷ T Alkousakis,⁸ D Chan,⁸ SD Chakravarty,^8,9 J Jeyarajah,⁸ RG Langley¹⁰

Affiliations: ¹UT Southwestern Medical Center, Dallas, TX, US; ²Alliance Clinical Trials and Probity Medical Research, Waterloo, ON, Canada; ³Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada; ⁴SkinWise Dermatology, MB, Canada; ⁵University of Manitoba, Winnipeg, MB, Canada; ⁶DermEffects, London, ON, Canada; ⁷University of Pittsburgh Medical Center, Pittsburgh, PA, US; ⁸Johnson & Johnson, Horsham/Spring House, PA, US; ⁹Drexel University College of Medicine, Philadelphia, PA, US; ¹⁰Dalhousie University, Halifax, NS, Canada

Introduction: The Phase IIIb SPECTREM study evaluated guselkumab (GUS) efficacy in patients with low body surface area (BSA; 2–15%), moderate (Investigator’s Global Assessment [IGA] 3) plaque psoriasis (PsO) involving one or more high-impact sites (scalp/face/intertriginous areas/genitals). At Week (W) 16, over 70 percent of GUS-treated patients achieved clear/minimal PsO overall and at high-impact sites. We report clinical and patient-reported outcomes through W48 for patients with baseline (BL) nail PsO or psoriatic arthritis (PsA).

Methods: Patients were randomized 2:1 to GUS 100mg (n=225; W0/W4, then every 8 weeks [Q8W]) or placebo (n=113; W0/W4/W12 with crossover to GUS at W16/W20, then Q8W). Nail PsO was defined as Nail Psoriasis Severity Index (NAPSI) greater than 0 at BL; NAPSI improvements were assessed over time. PsA was based on history of rheumatologist-diagnosed PsA or Psoriasis Epidemiology Screening Tool score of 3 or greater at screening. PsA physical/social/psychological impact was assessed via Psoriatic Arthritis Impact of Disease questionnaire (PsAID-12; range: 0–10; patient-acceptable symptom score [PASS] ≤4.0; minimal clinically important improvement: ≥3.0-point reduction).

Results: In the overall SPECTREM population, mean BL data reflect moderate skin disease (PASI: 9.0; BSA: 7.6%); 24.9 percent of patients (84/338) had nail PsO; 21.0 percent (71/338) had PsA. GUS-randomized patients with BL nail PsO had mean/median NAPSI scores of 18.1/17.0. NAPSI improvements were evident at the first assessment timepoint (W8; mean/median scores: 13.3/9.0; mean percent improvement from BL: 19.2%). NAPSI scores continued to improve; at W48, mean/median scores were 4.3/2.0, mean percent improvement from BL was 55.7 percent, and 50-, 75-, 90-, and 100-percent or greater improvement in NAPSI (NAPSI50, -75, -90, -100) response rates were 71.7, 60.4, 50.9, and 43.4 percent. 

Compared with the overall SPECTREM population, patients with PsA had similarly high rates of scalp (83.1% vs. 83.1%) and intertriginous (60.1% vs. 60.6%) PsO; genital (43.8% vs. 53.5%) and nail (24.9% vs. 46.5%) PsO were more common in those with PsA. Among GUS-randomized patients with PsA, mean/median PsAID-12 scores decreased from 5.8/5.5 (moderate impact on health) at BL to 3.1/2.7 (below PASS threshold) at W8. Scores below PASS threshold were maintained from W8 to W48; mean/median decreases (improvements) from BL to W48 were both −3.4.

Conclusion: GUS provided rapid, substantial improvements in nail PsO, a predictor of PsA. At BL, most participants with PsA had PsAID-12 scores above the PASS threshold, indicating a need for improved PsA control. GUS provided rapid, durable lowering of PsAID-12 scores, suggesting clinically meaningful improvements in patient-reported symptoms and impact of PsA. Results suggest that GUS is an effective treatment for patients with low BSA, moderate PsO with high-impact site involvement, including those at risk for or who have comorbid PsA.

Spesolimab impact on health-related quality of life and health status measured by the short form-36 (SF-36) and EQ-5D-5L among patients with generalized pustular psoriasis (GPP): results from the EFFISAYIL® 2 trial

Presenters: Matthias Augustin,¹ Alice B. Gottlieb,² Yayoi Tada,³ Lluís Puig,⁴ Boni Elewski,⁵ Melinda Gooderham,⁶ Georgios Kokolakis,⁷ Joseph F. Merola,² Min Zheng,⁸ Richard G. Langley,⁹ Shah Alam Khan,¹⁰ Bhargav Lakshminarasimhan,¹⁰ Nichiren Pillai,¹⁰ Mika Nokela,¹⁰ Ming Tang,¹¹ Richard B. Warren¹² 

Affiliations: ¹University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany; ²UT Southwestern Medical Center, Dallas, TX, US; ³Teikyo University School of Medicine, Tokyo, Japan; ⁴Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; ⁵University of Alabama at Birmingham, Birmingham, AL, US; ⁶SKiN Centre for Dermatology, Peterborough, Ontario, Canada; ⁷Charité-Universitätsmedizin Berlin, Berlin, Germany; ⁸Zhejiang University School of Medicine, Hangzhou, Zhejiang, China; ⁹Dalhousie University, Halifax, Nova Scotia, Canada; ¹⁰Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; ¹¹Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, China; ¹²Northern Care Alliance NHS Foundation Trust, Salford Royal, Salford, & University of Manchester, Manchester, UK

Introduction: Generalized pustular psoriasis (GPP) is a serious, chronic, systemic neutrophilic disease with a heterogenous, unpredictable clinical course. The EFFISAYIL® 2 trial (NCT04399837) evaluated the use of spesolimab, an interleukin (IL)-36 receptor antibody, for GPP flare prevention. We analyzed Short Form-36 (SF-36) and EuroQol 5-Dimension 5-Level (EQ-5D-5L) scores collected during EFFISAYIL® 2 in patients who received the approved spesolimab dose regimen.

Methods: This analysis included patients who received spesolimab 600mg subcutaneous (SC) loading dose followed by 300mg SC every four weeks or placebo over 48 weeks. SF-36 domain scores (range: 0–100; higher scores indicate better health-related quality of life [HRQoL]) were collected at baseline and 12-week timepoints through Week 48 for patients without flares. EQ-5D-5L scores (range: 0–1; higher scores indicate better health status) were collected at baseline, Weeks 4, 8, 12, 24, 36, and 48, and during a flare. 

Results: Thirty patients received spesolimab and 31 received placebo. Baseline characteristics were consistent across groups. Among patients without a flare receiving spesolimab (n=27; 90%), mean changes from baseline at Week 48 for the SF-36 physical and mental component summary scores were 5.83±12.78 and 4.45±10.36, respectively, versus 4.21±6.10 and 3.08±14.46, respectively, for placebo. Improvements at Week 48 in most individual SF-36 domains favored spesolimab versus placebo. Among patients without a flare receiving spesolimab, mean EQ-5D-5L index score improved from 0.68±0.30 at baseline to 0.84±0.21 (vs. placebo: 0.70±0.24 to 0.80±0.19) at Week 48 (mean change from baseline: 0.16±0.34 vs. 0.10±0.12). Mean changes from baseline in EQ5D-5L domain scores at Week 48 favored spesolimab versus placebo. 

Conclusion: These findings underscore the potential role of spesolimab in improving physical and social functioning, bodily pain, and mental health, resulting in improved overall HRQoL for patients with GPP. 

Spesolimab improves Generalized Pustular Psoriasis Physician’s Global Assessment (GPPGA), affected body surface area, and quality of life in generalized pustular psoriasis: EFFISAYIL® 2 trial analyses

Presenters: Bruce E. Strober,¹ Joseph F. Merola,² Alice B. Gottlieb,³ Arash Mostaghimi,⁴ Boni E. Elewski,⁵ Jennifer L. Hsiao,⁶ Jason E. Hawkes,⁷ Aaron S. Farberg,⁸ Kenneth B. Gordon,⁹ Laura Ferris,¹⁰ Douglas DiRuggiero,¹¹ Tina Bhutani,¹² Jason Guercio,¹³ Ming Tang,¹⁴ Christian Thoma,¹⁵ Mark G. Lebwohl³

Affiliations: ¹Yale University School of Medicine, New Haven, CT, US; ²UT Southwestern Medical Center, Dallas, TX, US; ³Icahn School of Medicine at Mount Sinai, New York, NY, US; ⁴Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, US; ⁵University of Alabama School of Medicine, Birmingham, AL, US; ⁶Ronald Reagan UCLA Medical Center, Santa Monica, CA, US; ⁷Oregon Medical Research Center, Portland, OR, US; ⁸Bare Dermatology, Dallas, TX, US; ⁹Medical College of Wisconsin, Milwaukee, WI, US; ¹⁰University of Pittsburgh, Pittsburgh, PA, US; ¹¹Skin Cancer & Cosmetic Dermatology Center, Rome, GA, US; ¹²Synergy Dermatology, San Francisco, CA, US; ¹³Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, US; ¹⁴Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, China; ¹⁵Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany

Introduction: Generalized pustular psoriasis (GPP) is an inflammatory, neutrophilic, potentially life-threatening skin disease characterized by episodic flares of widespread skin pustulation and chronic skin symptoms. EFFISAYIL® 2 investigated the effects of subcutaneous (SC) spesolimab, an anti-interleukin-36 receptor monoclonal antibody, on GPP symptoms and patient quality of life (QoL).

Methods: The patients in this analysis received the Food and Drug Administration (FDA)–approved dose of 300mg SC spesolimab every four weeks (Q4W) after a 600mg SC loading dose (n=30). GPP Physician’s Global Assessment (GPPGA) total score, average body surface area (BSA) involvement, pain visual analog scale (VAS), and Psoriasis Symptom Scale (PSS) scores were recorded at baseline and Weeks 4, 16, and 48. Dermatology Life Quality Index (DLQI) was measured at baseline and Weeks 4, 12, 36, and 48. 

Results: In this analysis, average age was 40 years, 60 percent of patients were female, and patients were either Asian (70%) or White (30%). The proportion of patients with GPPGA of 0 increased over time, from 10.0 percent at baseline to 27.6 percent at Week 4, 48.1 percent at Week 16, and 52.2 percent at Week 48. Continuous treatment with spesolimab decreased average total BSA involvement over time (baseline: 13.3%; Week 4: 10.6%; Week 16: 9.4%; Week 48: 4.5%). BSA involvement also decreased over time when patients were stratified by time since their GPP diagnosis (≤5 years [n=13]: 14.7%, 15.0%,11.7%, 5.0%, respectively; or >5 years [n=17]: 12.3%, 7.0%, 7.6%, 4.1%, respectively) and by use of systemic medication to treat GPP at baseline (yes [n=22]: 11.1%, 8.2%, 6.4%, 3.6%, respectively; or no [n=8]: 19.5%, 18.3%, 19.8%, 7.4%, respectively). Mean pain VAS and PSS scores also decreased over time (Pain VAS: 29.1, 20.7, 12.6, 11.3, respectively; PSS: 5.34, 4.23, 3.19, 2.96, respectively). DLQI scores decreased from 11.14 at baseline to 8.62 at Week 4, 5.83 at Week 12, 5.35 at Week 36, and 4.57 at Week 48.

Conclusion: Continuous treatment with SC spesolimab improved GPPGA, BSA involvement, pain VAS, PSS, and DLQI scores over 48 weeks. These findings suggest SC spesolimab can effectively control GPP and improve patient QoL.

Unmet needs and disease burden: perspectives from adults with psoriasis and clinicians treating psoriasis in the United States

Presenters: L Stein Gold,¹ J Soung,² N Trenkler,³ M Taylor,⁴ L Conklin,³ J Lewis,⁵ T Fitzgerald,³ W Peters,⁴ Y-W Yang,³ G Li,³ M Shahriari⁶

Affiliations: ¹Henry Ford Health System, West Bloomfield, MI, US; ²Southern California Dermatology, Santa Ana, CA, US; ³Johnson & Johnson, Horsham, PA/Raritan, NJ, US; ⁴Thermo Fisher Scientific, Waltham, MA, US; ⁵National Psoriasis Foundation, Memphis, TN, US; ⁶Central Connecticut Dermatology, Cromwell, CT, US 

Introduction: Incorporating both patient and dermatology provider (DP) perspectives is critical to optimizing care for individuals with psoriasis (PsO). We sought to characterize patient clinical profiles, quantify disease burden, evaluate treatment preferences and goals, and assess impact of PsO on quality of life (QoL), with the aim of informing shared decision-making and advancing patient-centered treatment strategies.

Methods: A web-based cross-sectional survey was conducted (March–May 2025) among United States (US) adults with PsO, eligible for systemic therapy (per International Psoriasis Council guidelines) and US DPs. Dermatology Life Quality Index (DLQI) assessed the impact of PsO on patients’ QoL.

Results: A total of 400 adults with PsO (mean age: 44 years; 52.0% female) and 200 DPs provided responses. Over two-thirds of patients reported their PsO had lasted more than three years; approximately one-quarter reported disease duration longer than 10 years. A total of 44.8 percent of participants reported psoriatic arthritis. Depression (41.3%) and hypertension (24.8%) were frequently reported comorbidities. Pruritus affected 90.8 percent of patients; 89.5 percent experienced sleep disruption, and 78.8 percent reported difficulties concentrating on daily activities. Perceived disease burden was influenced by multiple perspectives, including skin symptoms (67.3%), severity (47%), lesion location (45.5%), lack of effective treatments (24.8%), impact on social activities (24.3%) and mental health (23.5%). PsO most affected scalp (66.5%), arms (58.5%), elbows (57.3%), legs (55.3%), hands (47.0%), and knees (46.3%); anatomical location influenced the extent to which the PsO was considered bothersome. Oral treatment was preferred among both patients and DPs (50.5% and 47.5%, respectively), followed by topicals (34.3% and 20.0%, respectively) and injectables (15.3% and 22.0%, respectively). A total of 91.2 percent (83/91) of patients on injectables expressed willingness to switch to a safe and equally effective new oral therapy. Patients prioritized achieving clear skin (73.0%), reducing itch (68.3%), and maintaining long-term PsO control (46.0%) as their primary treatment goals. DPs ranked treatment effectiveness (84.5%), potential side effects (51.5%), and long-term safety (49%) as the top factors when choosing treatment. Impact of PsO on QoL was substantial; 54.8 percent had scored DLQI of 11 or greater (very large/extremely large impact), and 21.3 percent scored 6 to 10 (moderate impact). Top reasons by patients for past treatment discontinuation were limited efficacy for orals (58.2%) and side effects for injectables (43.7%); DPs identified dislike of needles (69.0%), cost/insurance coverage (60.5%), and discomfort with self-injection (43.5%) as the top concerns of their patients regarding injectables.

Conclusion: Psoriasis confers significant disease burden with profound impacts on patient QoL. There remains an unmet need for oral PsO therapies that deliver high levels of skin clearance with a favorable safety profile, enabling patients and DPs to achieve optimal outcomes without compromising efficacy, safety, or the preference for oral route of administration.