Selected Abstracts from Elevate-Derm Summer Conference 2025

Categories:

J Clin Aesthet Dermatol. 2025;18(9–10 Suppl 1):S16–S30.

Abstracts from July 23–27, 2025 in Park City, Utah

Acne

A case report of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel to treat acne induced by Janus kinase inhibitor treatment

Presenters: Nicole Olszewski,¹ Christopher G. Bunick, MD, PhD²

Affiliations: ¹Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT; ²Department of Dermatology and Program in Translational Biomedicine, Yale School of Medicine, New Haven, CT

Introduction: Janus kinase inhibitors (JAKis)—developed to treat inflammatory and immune-mediated diseases—have shown an increased risk of acne development, especially when used to treat dermatologic conditions. There are no treatment guidelines for JAKi-induced acne. Some of the most efficacious treatments for acne vulgaris (AV) are triple combinations, including benzoyl peroxide (BPO), a topical retinoid, and an oral/topical antibiotic. Fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% (CAB) gel has demonstrated good efficacy, safety, and tolerability in Phase II and III clinical trials of participants with moderate-to-severe AV. This case report highlights the possible utility of once-daily CAB treatment for JAKi-induced acne.

Methods: A 15-year-old female patient was administered the oral JAKi upadacitinib (15mg daily, titrated up to 30mg daily) for 16 weeks to treat atopic dermatitis (AD) that inadequately responded to 16 weeks of dupilumab treatment. The patient had mild, preexisting comedonal and inflammatory facial AV prior to JAKi treatment, which worsened over the first few months of JAKi treatment. By Week 16, the patient had moderate-to-severe inflammatory acne with erythema and postinflammatory hyperpigmentation. The patient applied CAB gel to the face once daily for approximately 20 weeks (without any other acne treatments) while continuing upadacitinib.

Results: CAB treatment provided substantial improvements in acne without adverse effects. The patient’s acne severity was reduced from moderate-to-severe to mild-to-almost clear, and there were no significant acne-induced sequelae (scarring, postinflammatory hyperpigmentation, or erythema). The patient continues treatment with both CAB and upadacitinib 15mg daily.

Conclusion: JAKi treatment was highly effective in controlling the patient’s AD when dupilumab could not, making successful acne treatment important for sustaining effective AD therapy. Treatment guidelines for AV and treatment recommendations for JAKi-induced acne often recommend oral drugs, such as isotretinoin, for moderate-to-severe acne. This case, however, demonstrates that topical CAB gel can treat moderate-to-severe JAKi-induced inflammatory acne.

Funding/financial disclosures: Ortho Dermatologics (writing and editorial support only).

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

*Ortho Dermatologics is a division of Bausch Health US, LLC.

Introduction: Treatments that lead to fast and substantial acne clearance with minimal tolerability issues are desirable and can increase patient adherence. A three-pronged approach using a topical antibiotic, topical retinoid, and benzoyl peroxide (BPO) has been shown to be one of the most effective acne treatments, with greater efficacy versus monotherapy or dual-combination products. However, it is unknown if triple-combination therapy provides more rapid improvement.

Clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% (CAB) gel is the only fixed-dose, triple-combination topical approved for acne. CAB has demonstrated efficacy and favorable tolerability in clinical trials. Efficacy and safety of CAB following four and 12 weeks of treatment was evaluated versus vehicle gel.

Methods: Data were pooled from four double-blind, 12-week trials of participants with moderate-to-severe acne (Phase II, NCT03170388 and NCT04892706; Phase III, NCT04214639 and NCT04214652). Patients were aged nine years or older (≥12 years in NCT04892706). Endpoints included least squares (LS) mean percent change from baseline in inflammatory and 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 assessed.

Results: The analysis included 1,115 participants (CAB, n=618, vehicle, n=497). At Week 4, inflammatory lesions were reduced by over 50 percent in CAB-treated participants, with continued improvements to greater-than-75-percent reduction at Week 12, significantly greater than vehicle (Week 4, 53.8% vs. 39.6%, respectively; Week 12, 76.9% vs. 52.9%; both p<0.001). Similar trends were observed for noninflammatory lesions (both p<0.001). At Week 12, over half (51.0%) of CAB-treated participants achieved treatment success versus 18.3 percent of vehicle-treated participants (p<0.001); significant differences with CAB versus vehicle were seen 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. Transient increases in mean safety/tolerability scores for scaling, erythema, itching, stinging, and burning with CAB generally resolved at/near baseline levels by Week 4.

Conclusion: Fixed-dose CAB gel was well tolerated, with rapid therapeutic effects. While extended topical acne treatment is often 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 positively impact patient satisfaction and treatment adherence.

Funding/financial disclosures: Ortho Dermatologics

Atopic Dermatitis

Dupilumab monotherapy prevents flares and provides sustained control of atopic dermatitis over 1 year across various dose regimens

Presenters: Eric L. Simpson,¹ Margitta Worm,² Robert Bissonnette,³ Servando E. Marron,^4,5 Hiroshi Mitsui,⁶ Stefan Beissert,⁷ H. Chih-ho Hong,^8,9 Andreas Pinter,¹⁰ Amy Praestgaard,¹¹ Deborah Griffis,¹² Ana B. Rossi¹¹

Affiliations: ¹Department of Dermatology, Oregon Health & Science University, Portland, OR; ²Charité-Universitätsmedizin Berlin, Berlin, Germany; ³Innovaderm Research, Montreal, QC, Canada; ⁴Aragon Psychodermatology Research Group (GAI+PD) partnered with Aragon Health Sciences Institute (IACS), University Hospital Miguel Servet, Zaragoza, Spain; ⁵University of Zaragoza, Zaragoza, Spain; ⁶University of Yamanashi, Yamanashi, Japan; ⁷TU-Dresden, Dresden, Germany; ⁸Department of Dermatology and Skin Science, University of British Columbia, Surrey, BC, Canada; ⁹Probity Medical Research, Waterloo, ON, Canada; ¹⁰Department of Dermatology, University Hospital Frankfurt am Main, Frankfurt am Main, Germany; ¹¹Sanofi, Cambridge, MA; ¹²Regeneron Pharmaceuticals Inc., Tarrytown, NY

Introduction: Disease control in atopic dermatitis (AD) can be defined as absence of flares (worsening of disease requiring escalation of treatment), an important goal for both physicians and patients. The objective of this study is to report the efficacy of dupilumab monotherapy to prevent flares and maintain disease control in adults treated with various dose regimens during the maintenance phase.

Methods: In this post hoc analysis, adults with moderate-to-severe AD who received dupilumab 300mg every two weeks (q2w) in SOLO 1/2 (NCT02277743/NCT02277769) and achieved optimal response of clear/almost clear skin (Investigator’s Global Assessment 0/1) and/or 75-percent or greater reduction from baseline in Eczema Area and Severity Index at Week 16, were rerandomized in SOLO-CONTINUE (NCT02395133) for an additional 36 weeks to dupilumab 300mg monotherapy q2w (n=80), q4w (n=41), q8w (n=39), or placebo (n=39). This analysis reports the proportions of flare-free patients (no topical or systemic rescue treatment) and those not using topicals during SOLO-CONTINUE. Data are presented as observed.

Results: Around 80 to 90 percent of patients did not use topical rescue treatment over one year of dupilumab monotherapy, regardless of maintenance dose regimens (Week 52: q2w, 90%; q4w, 79%; q8w, 89%). About two-thirds (63%) of patients rerandomized to placebo did not use topical rescue treatment. During the maintenance period, the proportion of flare-free patients remained high and stable across dupilumab arms (q2w, 83%; q4w, 78%; q8w, 79%) compared with those rerandomized to placebo (41%).

Conclusion: Treatment with dupilumab monotherapy over one year prevented flares in most patients who were optimal responders at Week 16, across maintenance dose regimens (q2w, q4w, q8w) compared with placebo.

Long-term efficacy and safety of lebrikizumab is maintained in patients with moderate-to-severe atopic dermatitis: results up to 3 years from ADjoin

Presenters: Emma Guttman-Yassky,¹ Alan Irvine,² Eric Simpson,³ Melinda Gooderham,⁴ Stephan Weidinger,⁵ Lynda Spelman,⁶ Jonathan Silverberg,⁷ Heidi Crane,⁸ Hany Elmaraghy,⁸ Louise DeLuca-Carter,⁸ Maria Lucia Buziqui Piruzeli,⁸ Chaoran Hu,⁸ Evangeline Pierce,⁸ Helena Agell,⁹ Diamant Thaci¹⁰

Affiliations: ¹Icahn School of Medicine at Mount Sinai, New York, NY; ²Children’s Health Ireland, Dublin, Ireland; ³Oregon Health & Science University, Portland, OR; ⁴SKiN for Dermatology, Probity Medical Research and Queen’s University, Peterborough, ON, Canada; ⁵University Hospital Schleswig-Holstein, Kiel, Germany; ⁶Veracity Clinical Research, Queensland, Australia; ⁷George Washington University School of Medicine and Health Sciences, Washington, DC; ⁸Eli Lilly and Company, Indianapolis, IN; ⁹Almirall S.A., Barcelona, Spain; ¹⁰Institute and Comprehensive Center for Inflammatory Medicine at the University of Lübeck, Lübeck, Germany

Introduction: We report efficacy and safety of lebrikizumab (LEB) in long-term extension study ADjoin following up to 152 Weeks (W) of continuous LEB treatment with/without TCS.

Methods: Patients in ADvocate1&2 who achieved per-protocol response (≥75% reduction in Eczema Area and Severity Index [EASI75] or Investigator’s Global Assessment [IGA] 0/1 without rescue) following 16W of LEB treatment were rerandomized 2:2:1 to LEB 250mg every two weeks (Q2W), LEB 250mg Q4W, or placebo (LEB withdrawal). Patients who completed W52 of ADvocate1&2 could enroll in ADjoin. Patients who completed 16W of ADhere could enroll into ADjoin; per-protocol LEB responders were randomized 2:1 to LEB 250mg Q2W or Q4W. Intermittent use of topicals was allowed in ADvocate1&2 W16 to W52; topicals and short-term systemics were allowed in ADjoin. Data are reported for W16 LEB responders originating from ADvocate1&2 (N=181) and ADhere (N=86) who received LEB 250mg Q2W or Q4W in ADjoin. Efficacy outcomes were assessed based on all collected data (as observed analysis) up to W100 of ADjoin (total 152W and 116W of LEB treatment for patients from ADvocate1&2 and ADhere, respectively). Safety was reported from ADjoin enrollment up to the data cutoff of April 24, 2024.

Results: In patients from ADvocate1&2, at W152, IGA 0/1 was maintained by 82.9 percent (34/41; Q2W) and 84.0 percent (42/50; Q4W) and EASI75 was maintained by 90.5 percent (57/63; Q2W) and 94.1 percent (64/68; Q4W) of patients. In patients from ADhere, at W116, IGA 0/1 was maintained by 86.7 percent (26/30; Q2W) and 91.7 percent (11/12; Q4W) and EASI75 was maintained by 94.9 percent (37/39; Q2W) and 90.9 percent (20/22; Q4W) of patients. EASI90 was reported by 79.4 percent (50/63; Q2W) and 86.8 percent (59/68; Q4W) of ADvocate1&2 patients at W152 and 84.6 percent (33/39; Q2W) and 86.4 percent (19/22; Q4W) of ADhere patients at W116.

During 100W of ADjoin, most adverse events (AEs) reported were mild (29.2%, 78/267) or moderate (33.3%, n=89) in severity. Serious AEs were reported by 3.7 percent (n=10) of patients. There was one death due to natural causes in the ADhere Q2W arm. AEs leading to treatment discontinuation were reported by 2.6 percent (n=7) of patients.

Conclusion: Efficacy outcomes were maintained long-term, with up to three years of continuous LEB treatment, in both LEB 250mg Q2W and Q4W arms. The safety profile of LEB in ADjoin was consistent with previous LEB studies in patients with moderate-to-severe AD.

Note: Presented at Fall CDC 2024.

Funding/financial disclosures: This study was funded by Dermira, a wholly-owned subsidiary of Eli Lilly and Company. Almirall, S.A. has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications including atopic dermatitis in Europe. Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside of Europe.

Maintenance of optimal response over 2 years in patients with atopic dermatitis treated with dupilumab

Presenters: Thomas Bieber,¹ Eric L. Simpson,² Lisa A. Beck,³ Kyu Joong Ahn,⁴ Mark Tang,⁵ Sung Eun Chang,⁶ Amy Praestgaard,⁷ Brad Shumel,⁸ Ana B. Rossi⁷

Affiliations: ¹Christine Kühne – Center for Allergy Research and Education, Medicine Campus Davos, Davos, Switzerland; ²Department of Dermatology, Oregon Health & Science University, Portland, OR; ³Department of Dermatology, University of Rochester Medical Center, Rochester, NY; ⁴Konkuk University School of Medicine, Konkuk University Medical Center, Seoul, Republic of Korea; ⁵Mount Alvernia Medical Centre, Singapore; ⁶Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; ⁷Sanofi, Cambridge, MA; ⁸Regeneron Pharmaceuticals Inc., Tarrytown, NY

Introduction: Sustained disease control is an important goal of long-term therapies for atopic dermatitis (AD). The objective of this study is to report maintenance of optimal response in patients treated with dupilumab for over two years.

Methods: In this post hoc analysis, adults with moderate-to-severe AD who received dupilumab 300mg every two weeks (q2w) in SOLO 1/2 (NCT02277743/NCT02277769) and achieved optimal response of clear/almost clear skin (Investigator’s Global Assessment [IGA] 0/1) and/or 75-percent or greater reduction from baseline in Eczema Area and Severity Index (EASI75) at Week 16, were rerandomized in SOLO-CONTINUE (NCT02395133) for an additional 36 weeks to dupilumab 300mg monotherapy q2w (n=73), q4w (n=36), q8w (n=34), or placebo (n=36), followed by 60 weeks of dupilumab 300mg weekly in an open-label extension study (NCT01949311).

Endpoints reported include mean EASI and the proportion of patients maintaining IGA 0/1 or EASI75. This analysis is based on a modified nonresponder imputation method with patients discontinuing due to lack of efficacy (all studies) or receiving systemic rescue treatment (SOLO 1/2; SOLO-CONTINUE) considered as nonresponders.

Results: At Week 16, 94 percent of optimal responders had mild AD (EASI ≤7). Patients maintained response across dupilumab arms through Week 52 (IGA 0/1 or EASI75 q2w/q4w/q8w: 92%/78%/91%; EASI: 3.0/4.1/4.6) up to Week 112 (IGA 0/1 or EASI75: 98%/95%/95%; EASI: 1.6/0.9/2.3). About half of patients rerandomized to placebo in SOLO-CONTINUE showed loss of optimal response at Week 52 for IGA 0/1 or EASI75 (53%) followed by rapid improvement after dupilumab reinitiation (Week 56: IGA 0/1 or EASI75: 92%) that was sustained to Week 112 (IGA 0/1 or EASI75: 95%; EASI: 0.9).

Conclusion: Long-term dupilumab treatment in adults with AD demonstrated maintenance of optimal response over two years with sustained improvement in clinical signs. Efficacy was rapidly regained after 36 weeks of withdrawal.

Matching-adjusted indirect comparison of efficacy in patients with moderate-to-severe atopic dermatitis treated with lebrikizumab plus topical corticosteroids versus dupilumab plus topical corticosteroids

Presenters: Raj Chovatiya,^1,2 Leon Kircik,³ Yousef Binamer,⁴ Lluís Puig,⁵ Tiago Torres,⁶ Bülent Akmaz,⁷ Martin Dossenbach,⁸ Gaia Gallo,⁸ Chao Yang,⁸ Yuxin Ding,⁸ Yung-Tsu Cho⁹

Affiliations: ¹Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, US; ²Center for Medical Dermatology + Immunology Research, US; ³Icahn School of Medicine at Mount Sinai, US; ⁴King Faisal Specialist Hospital and Research Centre, Saudi Arabia; ⁵Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Spain; ⁶Centro Hospitalar Universitário de Santo António, University of Porto, Portugal; ⁷Almirall S.A., Spain; ⁸Eli Lilly and Company, US; ⁹National Taiwan University Hospital, Taiwan

Introduction: Lebrikizumab and dupilumab are monoclonal antibodies for patients with moderate-to-severe atopic dermatitis (AD). Without head-to-head clinical trials, indirect treatment comparisons (ITCs) can be used to evaluate relative efficacy. A recent study compared the Week 16 efficacy of lebrikizumab+topical corticosteroids (TCS) versus dupilumab+TCS using Bucher’s ITC, which anchored on the placebo arm while not adjusting for between-trial population difference. This method can lead to biased conclusions when effect modifiers are not balanced between trials. A matching-adjusted indirect comparison (MAIC) is a more suitable ITC method because it adjusts for population differences between trials that might impact treatment effect. This study compared the Week 16 efficacy of lebrikizumab every two weeks plus TCS (Q2W+TCS) versus dupilumab Q2W+TCS in patients with moderate-to-severe AD using an anchored MAIC.

Methods: Lebrikizumab efficacy Q2W+TCS was assessed using individual patient data from the placebo-controlled ADhere trial. Dupilumab efficacy Q2W+TCS was assessed using aggregate patient data (n=421) from the placebo-controlled CHRONOS trial. Week 16 data from both trials were included. An anchored MAIC was used where the respective placebo+TCS arm was used as the common comparator. Adult ADhere patients (n=165) were reweighted to align with reported aggregate statistics for effect modifiers of patients in the CHRONOS trial. Study-level matching was performed, and matching covariates included age, sex, race, and baseline scores on the Eczema Area and Severity Index (EASI) and the Investigator’s Global Assessment (IGA).

Efficacy endpoints evaluated at Week 16 were EASI improvement of 75 percent or greater (EASI75), IGA score of 0/1 (IGA 0/1), Peak Pruritus Numerical Rating Scale score improvement of four points or greater (PP-NRS≥4), and Dermatology Life Quality Index score improvement of four points or greater (DLQI≥4).

Missing data for efficacy endpoints in both trials were handled using nonresponder imputation. Relative treatment effects were quantified using odds ratios (ORs) with 95-percent confidence intervals (CIs).

Results: At Week 16, the ORs (95% CIs) for lebrikizumab Q2W+TCS versus dupilumab Q2W+TCS were 1.14 (0.42–3.09) for EASI75, 1.39 (0.42–4.60) for IGA 0/1, 0.48 (0.17–1.37) for PP-NRS≥4, and 0.89 (0.29–2.70) for DLQI≥4. None of the ORs were statistically different.

Conclusion: When using an anchored MAIC, a population-adjusted ITC, lebrikizumab Q2W+TCS and dupilumab Q2W+TCS showed similar efficacy at Week 16 across multiple endpoints in patients with moderate-to-severe AD.

Note: Previously presented at the Maui Derm NP+PA Fall 2024 Meeting.

Funding/financial disclosures: This study was funded by Eli Lilly and Company. Almirall, S.A. has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe. Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside of Europe.

Patients maintain stable response with no or minimal fluctuations during 3 years of continuous treatment with lebrikizumab during long-term extension trial

Presenters: Jonathan I. Silverberg,¹ Linda Stein Gold,² Peter Lio,³ James Del Rosso,⁴ Andreas Wollenberg,⁵ Jose Manuel Carrascosa,⁶ Gaia Gallo,⁷ Yuxin Ding,⁷ Helena Agell,⁸ Christian Vestergaard⁹

Affiliations: ¹George Washington University School of Medicine and Health Sciences, US; ²Dermatology Clinical Research, Henry Ford Health System, US; ³Northwestern University Feinberg School of Medicine, US; ⁴JDR Dermatology Research, US; ⁵Department of Dermatology and Allergy, Augsburg University Hospital, Germany and Comprehensive Center for Inflammation Medicine, University of Luebeck, Germany; ⁶Hospital Universitari Germans Trias i Pujol, Spain; ⁷Eli Lilly and Company, US; ⁸Almirall, Barcelona, Spain; ⁹Aarhus University Hospital, Denmark

Introduction: Lebrikizumab (LEB) demonstrated stability of response up to two years as monotherapy treatment in adults and adolescents (≥40kg) with moderate-to-severe atopic dermatitis (AD) from the pivotal Phase III trials.

Methods: We assessed the stability of response up to three years of LEB treatment in the population of per-protocol responder patients at Week 16 after the induction with LEB every two weeks (Q2W), who were rerandomized to LEB Q2W or Q4W for 36 weeks of maintenance period in ADvocate 1 and 2, and continued the same treatment (LEB Q2W, n=82; LEB Q4W, n=99) in ADjoin, the LEB long-term extension study, for up to three years. Response at Week 16 was defined as an Investigator’s Global Assessment (IGA) of 0/1 or a 75-percent or greater reduction in Eczema Area and Severity Index (EASI75) without rescue medication in ADvocate 1 and 2. Topical rescue medications were permitted during the analysis period (Weeks 16–152). This analysis reported the proportion of LEB-treated patients who maintained EASI75 (in Week 16 EASI75 responders) and absolute EASI of seven or less response (in Week 16 EASI ≤7 responders), at the individual level, in 80 percent or more of attended visits from Week 16 to 152. Pruritus Numeric Rating Scale (PNRS) was collected up to Week 104. The proportion of LEB-treated patients who achieved PNRS three-point or greater improvement among Week 16 EASI75 responders and maintained the PNRS response in 80 percent or more of attended visits from Week 16 to 104 was reported. Observed data was analyzed despite rescue medication use or discontinuation from treatment.

Results: A stable EASI75 response from Week 16 to 152 was reported in 92.9 percent of patients receiving LEB Q4W and 92.7 percent for LEB Q2W. A stable EASI of seven or less response from Week 16 to 152 was achieved for 96.8 percent of those receiving LEB Q4W and 97.3 percent for those receiving LEB Q2W. In patients with baseline PNRS of three or greater, achieving EASI75 and PNRS three-point or greater improvement at Week 16, a stable PNRS three-point or greater improvement from Week 16 to 104 was achieved by 93.8 percent (n=65) of patients receiving LEB Q4W and 88.7 percent (n=62) for LEB Q2W. During ADjoin (Weeks 52–152), the use of low-moderate and high potency topical corticosteroids (TCS) was 9.1 percent (n=9) in both TCS potency categories for LEB Q4W, whereas for LEB Q2W, it was 4.9 (n=4) and 6.1 (n=5) percent, respectively.

Conclusion: LEB provides long-term stability in skin response and itch relief with no or minimal fluctuations measured by EASI75, EASI of seven or less, and PNRS.

Note: Presented at RAD 7th Annual Conference; Chicago, US; 7–9 June 2025.

Raising the bar of efficacy in atopic dermatitis: lebrikizumab maintains depth of response over 3 years in Week 16 responders

Presenters: Eric Simpson,¹ Tilo Biedermann,² Leon Kircik,³ Raj Chovatiya,^4,5 Ignasi Figueras-Nart,⁶ Marta Casillas,⁷ Gaia Gallo,⁷ Yuxin Ding,⁷ Evangeline Pierce,⁷ Helena Agell,⁸ Christian Vestergaard⁹

Affiliations: ¹Oregon Health & Science University, Portland, OR; ²Department of Dermatology and Allergy, Technical University of Munich, School of Medicine and Health, Munich, Germany; ³Icahn School of Medicine at Mount Sinai, New York, NY; ⁴Rosalind Franklin University of Medicine and Science, Chicago Medical School, North Chicago, IL; ⁵Center for Medical Dermatology + Immunology Research, Chicago, IL; ⁶Department of Dermatology, Bellvitge University Hospital, University of Barcelona, Barcelona, Spain; ⁷Eli Lilly and Company, Indianapolis, IN; ⁸Almirall S.A, Barcelona, Spain; ⁹Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark

Introduction: In prior analyses of the Phase III monotherapy trials, ADvocate1, ADvocate2, and the long-term extension study ADjoin (NCT04392154), many patients treated with lebrikizumab maintained a deep response (defined by total skin clearance and minimal itch) up to two years.¹ Here, we report sustained depth of response and maintenance in patient-assessed severity with lebrikizumab treatment up to three years (1 year in ADvocate1 and -2 and 2 years in ADjoin).

Methods: Lebrikizumab responders at Week 16 (achieved ≥75% improvement in Eczema Area and Severity Index [EASI75] or Investigator’s Global Assessment [IGA] of 0/1 without rescue therapy) who completed ADvocate1 and ADvocate2 (1 full year) and enrolled in ADjoin, received lebrikizumab 250mg every two or four weeks (Q2W or Q4W) for an additional two years.

Deep response was assessed using IGA 0 (clear skin), EASI90, EASI100 (≥90% or 100% EASI improvement), and Patient-Oriented Eczema Measure (POEM) of 0/1 (clear/almost clear skin). POEM measures patient-reported symptoms, including itch, skin dryness, and sleep disturbance over the previous week. Analyses were descriptive using as-observed data.

Results: At Week 100 of ADjoin (3 years of lebrikizumab treatment), IGA 0 was reported for 63.4 percent (26/41) of patients receiving lebrikizumab Q2W and 50.0 percent (25/50) receiving lebrikizumab Q4W. EASI90/EASI100 was reported for 79.4 percent (50/63)/49.2 percent (31/63) of patients receiving lebrikizumab Q2W and 86.8 percent (59/68)/50.0 percent (34/68) receiving lebrikizumab Q4W. POEM 0/1 was reported for 24.0 percent (12/50) of patients receiving lebrikizumab Q2W and 32.7 percent (18/55) receiving lebrikizumab Q4W.

Conclusion: A large percentage of Week 16 lebrikizumab responders maintained total or near total skin clearance through three years of lebrikizumab treatment.

Note: Previously presented at the American Academy of Dermatology – 83rd Annual Meeting; Florida, US; 7–11 March, 2025.

Reference:

Simpson E, Biedermann T, Kircik L, et al. Raising the bar of efficacy in atopic dermatitis: lebrikizumab maintains depth of response over 2 years. Br J Dermatol. 2024;191(Suppl 2).

Sustained disease control among adults with moderate-to-severe atopic dermatitis in clinical practice: 5-year follow-up results from the RELIEVE-AD study

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

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

Introduction: Atopic dermatitis (AD) often requires long-term therapy, highlighting the importance of assessing long-term effectiveness. The objective of this study is to report five-year data from RELIEVE-AD on AD disease control.

Methods: RELIEVE-AD is a single-arm, prospective, observational study of adults with moderate-to-severe AD receiving dupilumab who participated in surveys at baseline (BL) and one, two, three, six, nine, 12, 33, 48, and 60 months (M). Disease control was assessed with the Atopic Dermatitis Control Tool (ADCT; range 0–24, score <7 indicating controlled disease; minimal clinically important difference [MCID]: 5-point change in total score). Statistical significance (comparing each time point to BL) was determined using generalized estimating equations to account for correlated data from the same patients. Only patients who responded to at least one of the M33 or M48 surveys were contacted for the M60 survey.

Results: Among 471 patients at BL, 329 (69.9%) patients completed the M60 survey. Mean total ADCT score decreased from 15.9 at BL to 3.8 at M60, and the proportion of patients reporting controlled disease increased from 5.3 to 81.2 percent. At M1, 81.1 percent of patients reported clinically meaningful improvement, persisting at M60 to 86.0 percent. The percentage of patients reporting no intense episodes of itching in the last week increased from 3.0 percent at BL to 57.1 percent at M60.

Conclusion: In this long-term real-world study, a majority of patients with AD reported sustained disease control for five years after initiating dupilumab treatment.

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

Introduction: Tapinarof cream 1% (VTAMA®, Dermavant Sciences, an Organon Company) is a nonsteroidal, topical aryl hydrocarbon receptor agonist approved by the United States 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 may 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™ was 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™ was 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 re-emergence of mild symptoms during treatment-free intervals is unlike most topicals where a rapid disease rebound is often observed.

Funding/financial disclosures: Funding support was provided by Dermavant Sciences, an Organon Company.

The TCS/TCI-free rate remains high and stable while on lebrikizumab for treatment of moderate-to-severe atopic dermatitis over 1 year

Presenters: James Del Rosso,¹ Audrey Nosbaum,² Alexandra Golant,³ Takeshi Nakahara,⁴ Jenny E. Murase,^5,6 Andrew Pink,⁷ Sonia Montmayeur,⁸ Meihua Qiao,⁹ Sherry Chen,⁹ Ignasi Pau-Charles,¹⁰ Thomas Bieber¹¹

Affiliations: ¹JDR Dermatology Research, Las Vegas, NV; ²Groupement Hospitalier Sud, Allergologie et Immunologie Clinique, Pierre-Benite, France; ³Mount Sinai, New York, NY; ⁴Dept. of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; ⁵Dept. of Dermatology, University of California, San Francisco, CA; ⁶Dept. of Dermatology, Palo Alto Foundation Medical Group, Mountain View, CA; ⁷Guy’s and St. Thomas’ NHS Foundation Trust, London, UK; ⁸Eli Lilly and Company, Indianapolis, IN; ⁹Tigermed, Somerset, NJ; ¹⁰Almirall, Barcelona, Spain; ¹¹Medicine Campus, Davos, Switzerland

Introduction: The ADvocate1 and ADvocate2 Phase III trials investigated lebrikizumab (LEB), a monoclonal antibody selectively targeting interleukin-13, for the treatment of patients with moderate-to-severe atopic dermatitis (AD). Topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI) are commonly used as concomitant treatment for AD. However, long-term use can result in side effects. Thus, remaining free of TCS/TCI usage is important for evaluating the benefit of systemic AD therapies. The aim of this study was to summarize and assess the proportion of patients without TCS or TCI usage over the course of the maintenance period based on pooled ADvocate1 and ADvocate2 studies.

Methods: This study consisted of pooled ADvocate1 and ADvocate2 data for patients responding to LEB at Week 16 (induction period). Responders (n=291) were rerandomized in a 2:2:1 ratio to receive 250mg LEB every two weeks (Q2W; n=113), 250mg LEB every four weeks (Q4W; n=118), or placebo every two weeks (LEB withdrawal/PBO; n=60) for 36 weeks (maintenance period). Lack of TCS/TCI use was interpreted as an advantageous outcome of LEB treatment. Data are presented as observed data.

Results: Across the maintenance period, high proportions of patients in all groups (Q2W: 90.3%; Q4W: 88.1%; PBO: 86.7%) did not use TCS. Higher proportions (Q2W: 96.5%; Q4W: 98.3%; PBO: 95%) did not use TCI. Importantly, 88.5 percent of Q2W, 86.4 percent of Q4W, and 81.7 percent of PBO patients did not use either TCS or TCI. This high TCS/TCI-free rate remained stable over the course of the maintenance period.

Conclusion: Most patients with moderate-to-severe AD responding to LEB remained free of TCS, TCI, and TCS/TCI use throughout the first year of treatment.

Melanoma

The 31-GEP stratifies risk of death in patients with stage I to IIA cutaneous melanoma: a SEER real-world evidence study

Presenters: Harrison Nguyen, MD, MBA, MPH;¹ Christine N. Bailey, MPH;² Brian Martin, PhD;² Sonia K. Morgan-Linnell, PhD;² Valentina I. Petkov, MD, MPH;³ Michael Tassavor, MD, MS⁴

Affiliations: ¹Houston Skin, Houston, TX; ²Castle Biosciences, Friendswood, TX; ³Surveillance, Epidemiology, and End Results Program, National Cancer Institute, Bethesda, MD; ⁴MDCS Dermatology: Medical Dermatology and Cosmetic Surgery, New York City, NY

Introduction: Current American Joint Committee on Cancer (AJCC) staging stratifies patients with cutaneous melanoma (CM) by their risk of dying from their disease. Patients with early-stage I to IIA CM are considered at low risk of poor outcomes; however, recent evidence suggests many of these patients have a higher risk of death than AJCC staging suggests. Thus, tools to complement AJCC staging can help clinicians recommend more personalized, risk-appropriate surveillance and treatment options. The 31-gene expression profile (31-GEP) is prospectively validated to stratify the risk of death in patients with CM. Here, we assessed melanoma-specific survival (MSS) and overall survival (OS) risk stratification by the 31-GEP in a large, real-world cohort of patients with early-stage CM clinically tested with the 31-GEP.

Methods: Central cancer registries participating in the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program linked patients with CM diagnosed from 2013 to 2019 to 31-GEP test results. For this analysis, we selected stage I to IIA CM clinically tested with the 31-GEP (n=6,892). Survival was estimated using Kaplan-Meier analysis, and differences between groups were compared using the log-rank test. Multivariable Cox regression was used to identify predictors of melanoma-specific and all-cause mortality.

Results: Patients with stage I to IIA CM and a Class 1A 31-GEP result had higher five-year MSS than those with a Class 1B/2A or Class 2B result (98.8%, 94.7%, and 91.6%%, respectively, p<0.001). Similarly, patients with a Class 1A 31-GEP result had significantly higher five-year OS than those with Class 1B/2A or 2B results (93.8%, 88.5%, and 78.7%, respectively, p<0.001). In multivariable analysis, Class 1B/2A (hazard ratio [HR]: 2.81, p<0.001), Class 2B (HR: 3.34, p<0.001), and age (HR: 1.05, p<0.001) were significant predictors of melanoma-specific mortality. Breslow thickness, ulceration, and mitotic rate were not significant. A Class 1B/2A result (HR: 1.46, p=0.015), Class 2B result (HR: 1.91, p<0.001), and age (HR: 1.09, p<0.001) were significant predictors of all- cause mortality.

Conclusion: In a large, real-world cohort of patients with stage I to IIA CM, the 31-GEP stratified MSS and OS and was a strong predictor of melanoma-specific and all-cause mortality. In a population of patients considered low risk per AJCC staging, the 31-GEP can identify patients at high risk of mortality who might benefit from increased surveillance and management to improve outcomes.

Miscellaneous

CSU disease activity band shift after long-term treatment with remibrutinib in the Phase III REMIX-1 and REMIX-2 studies

Presenters: Martin Metz,^1,2 Ana M. Giménez-Arnau,³ Petra Staubach,⁴ Marta Ferrer Puga,⁵ Kanokvalai Kulthanan,⁶ Xinghua Gao,⁷ Karine Lheritier,⁸ Christine-Elke Ortmann,⁸ Nadine Chapman-Rothe,⁸ Sibylle Haemmerle,⁸ Atsushi Fukunaga,⁹ Michihiro Hide¹⁰

Affiliations: ¹Urticaria Center of Reference and Excellence Institute of Allergology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health; ²Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology; ³Department of Dermatology, Hospital del Mar and Research Institute, Universitat Pompeu Fabra; ⁴Department of Dermatology, University Medical Center; ⁵Department of Allergy and Clinical Immunology, Clinica Universidad de Navarra; ⁶Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; ⁷Department of Dermatology, The First Hospital of China Medical University, National Health Commission Key Laboratory of Immunodermatology, Key Laboratory of Immunodermatology of Ministry of Education; ⁸Novartis Pharma AG; ⁹Department of Dermatology, Division of Medicine for Function and Morphology of Sensory Organs, Faculty of Medicine, Osaka Medical and Pharmaceutical University, Takatsuki-city; ¹⁰Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital

Introduction: Remibrutinib has previously shown superior efficacy versus placebo in patients with chronic spontaneous urticaria (CSU) inadequately controlled with H1 antihistamines. The objective of this analysis was to explore the shift in weekly Urticaria Activity Score (UAS7) bands after treatment with remibrutinib versus placebo in the REMIX studies.

Methods: In REMIX-1/-2, patients with CSU were randomized 2:1 to oral remibrutinib 25mg twice daily (bid) or placebo over a 24-week DB treatment period, followed by 28 weeks of open-label treatment with remibrutinib 25mg bid. CSU disease activity bands were defined by five standard UAS7 ranges: UAS7 28 to 42 (severe), UAS7 16 to less than 28 (moderate), UAS7 greater than 6 to less than 16 (mild), UAS7 greater than 0 to 6 (well-controlled) and UAS7 0 (complete response).

Results: This pooled analysis included 606 patients from the remibrutinib arm and 306 from the placebo arm. At baseline, 215 (35.5%) and 386 (63.7%) patients from the remibrutinib arm and 122 (39.9%) and 181 (59.2%) patients from the placebo arm had moderate/severe CSU disease activity, respectively. In the remibrutinib arm, 63.7 percent of patients were in the severe band at baseline, dropping to 24.9, 17.2, 9.1, 7.8, and 8.1 percent at Weeks 1, 2, 12, 24, and 52, respectively. Similarly, of 35.5 percent of patients in the moderate band at baseline, the number dropped to 30.7, 24.1, 10.6, 7.9, and 7.3 percent at Weeks 1, 2, 12, 24, and 52, respectively. The proportion of patients in the mild category initially increased and then decreased again from 0.8 percent at baseline to 32.5, 26.2, 24.4, 19.6, and 13.7 percent at Weeks 1, 2, 12, 24, and 52, respectively. The proportion of patients who showed complete response increased from 0.3 percent at Week 1 to 16.2 percent at Week 2, 28.5 percent at Week 12, 33.7 percent at Week 24, and 35.1 percent at Week 52.

Conclusion: Remibrutinib reduced CSU disease activity as early as Week 1 in patients with CSU, and the fast response was sustained over long-term treatment.

Role of the study sponsor: This study was sponsored by Novartis Pharma AG, Basel, Switzerland. The funding source was involved in study design, data analysis, drafting, and approval of this abstract. Medical writing support was provided by Brianna Fitzmaurice, PhD, of Global Business Solutions and was funded by Novartis Pharmaceuticals Corporation. This abstract was developed in accordance with Good Publication Practice (GPP 2022) guidelines. Authors confirm that this work is original, and all statements declared as facts are based on thorough examination and investigation for accuracy. Authors had full control of the content and made the final decision on all aspects of this publication.

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; ⁸SKiN Centre for Dermatology, Ontario, Canada; ⁹Amgen Inc., Thousand Oaks, CA; 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 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.

Reference: Terui. AAD 2024 Annual Meeting

Efficacy and safety of oral deucravacitinib in patients with cutaneous manifestations of lupus erythematosus: results from PAISLEY CLE, a global, randomized, placebo-controlled, Phase II trial

Presenters: Joseph F. Merola,¹ Alice B. Gottlieb,² Cynthia Aranow,³ François Chasset,⁴ Joerg Wenzel,⁵ David Fiorentino,⁶ Cristina Arriens,⁷ Benjamin F. Chong,¹ Annegret Kuhn,^8,9 Ronald F. van Vollenhoven,⁹ Shimon Korish,¹⁰ Nikolay Delev,¹⁰ Richard Meier,¹⁰ Rachana Agrawal,¹⁰ Thomas Lehman,¹⁰ Brandon Johnson,¹⁰ Brandon Becker,¹⁰ Jiyoon Choi,¹⁰ Coburn Hobar,¹⁰ Victoria P. Werth¹¹

Affiliations: ¹University of Texas Southwestern Medical Center, Dallas, TX; ²Icahn School of Medicine at Mount Sinai, New York, NY; ³Institute of Molecular Medicine, Feinstein Institutes for Medical Research, Molecular Medicine and Medicine, Donald and Barbara Zucker School of Medicine, Hofstra/Northwell, Hempstead, NY; ⁴Sorbonne Université, Hôpital Tenon, and CIMI INSERM, Paris, France; ⁵University Hospital of Bonn, Bonn, Germany; ⁶Stanford University School of Medicine, Redwood City, CA; ⁷University of Oklahoma Health Sciences Center, Oklahoma City, OK; ⁸University of Muenster, Muenster, Germany; ⁹Amsterdam University Medical Centers, Amsterdam, the Netherlands; ¹⁰Bristol Myers Squibb, Princeton, NJ; ¹¹University of Pennsylvania, Philadelphia, PA

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, approved for moderate-to-severe plaque psoriasis, demonstrated significant improvements in cutaneous manifestations in the Phase II PAISLEY systemic lupus erythematosus (SLE) trial. We report results from the Phase II PAISLEY cutaneous lupus erythematosus (CLE) trial (NCT04857034).

Methods: Adults with DLE/SCLE (≤50% had SLE) with active, moderate/severe cutaneous disease (Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity [CLASI-A] score ≥8) were randomized 1:1:1 to placebo or deucravacitinib (3mg or 6mg twice daily [BID]) through week (W) 16. At W16, patients receiving deucravacitinib continued the dose; patients receiving placebo were rerandomized to either deucravacitinib dose until W52. Primary endpoint (W16) was mean percent change from baseline (CFB) in CLASI-A score. Secondary endpoints (W16) were 50-percent or greater improvement in CLASI (CLASI50) and mean CFB in CLASI-A; exploratory endpoints included CFB in patient-reported skin pain at W16, as measured by visual analog scale, and mean percent CFB in CLASI-A score to W52. P-value less than 0.1 represents statistical significance. Exploratory endpoints were analyzed descriptively. Safety was assessed.

Results: Patients were randomized to placebo (n=24), deucravacitinib 3mg BID (n=25), or 6mg BID (n=25). Sixty-three (85.1%) patients completed W16. At W16, deucravacitinib significantly improved mean percent CFB in CLASI-A versus placebo (placebo, −28.4%; 3mg BID, −47.5% [p=0.0670]; 6mg BID, −50.0% [p=0.0385]), and mean CFB in CLASI-A (−5.3 vs. −9.3 [p=0.0425] and −8.7 [p=0.0805]). More patients receiving deucravacitinib versus placebo achieved CLASI50 (19.0% vs. 56.7% [p=0.0092] and 52.3% [p=0.0193]). Improvements in mean percent CFB in CLASI-A were observed as early as W4, trending toward continued improvement to W52. Skin pain was numerically improved with deucravacitinib versus placebo at W16. No new safety signals were observed. Most adverse events were mild/moderate; none led to treatment discontinuation.

Conclusion: In patients with DLE/SCLE, statistically significant and clinically meaningful improvements were observed in CLASI-A outcomes with deucravacitinib at W16. Deucravacitinib was well tolerated; AEs were consistent with the known safety profile. These data support further evaluation of deucravacitinib in the ongoing Phase III POETYK SLE trials.

Acknowledgments: We thank the patients and families who made this study possible, as well as the clinical teams that participated. All authors contributed to and approved the abstract; professional medical writing and editorial assistance was provided by Christine Billecke, PhD, of Nucleus Global, funded by Bristol Myers Squibb.

Funding/financial disclosures: The study was supported by Bristol Myers Squibb.

Disclosures: 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

ABG: Research/educational grants: Bristol Myers Squibb, Janssen, MoonLake Immunotherapeutics, and UCB (all paid to Mount Sinai School of Medicine); Honoraria/speaker fees/advisory board/consultant: Amgen, Eli Lilly, Highlight Therapeutics, Janssen, Novartis, Sanofi, Sun Pharma, Takeda, Teva, UCB, and XBiotech (stock options for RA)

CA: Alumis, 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, Kyowa Kirin, Lilly, Novartis, and Principia Bio; Speaker: Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, GSK, and Novartis; National coordination for clinical trial in CLE: AstraZeneca, Biogen, and Bristol Myers Squibb

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.

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

CrA: Grant support: AstraZeneca and Bristol Myers Squibb; Advisor or review panel: AstraZeneca, Aurinia, Bristol Myers Squibb, Cabaletta, GSK, Health & Wellness Partners, Kezar, Synthekine, and UCB; Speaker/honoraria: AstraZeneca and Aurinia

BFC: Consultant and/or investigator: Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, EMD Serono, and Lupus Research Alliance; Royalties: MAPI Trust; Speaker: CESAS Medical

AK: Consultancy: Almirall/Hermal, Bristol Myers Squibb, and EMD Serono

RFvV: Research support: Bristol Myers Squibb, Eli Lilly, and GSK; Research support, consultancy, and speaker: UCB; Support for educational programs, consultancy, and speaker: Pfizer; Support for educational programs: Roche; Consultancy and speaker: AbbVie, Galapagos, and Janssen; Consultancy: AstraZeneca, Biogen, Biotest, Celgene, Gilead, and Servier

SK, BB, and CH: Employees and shareholders at the time of study conduct: Bristol Myers Squibb

ND, RM, RA, TL, and BJ: Employees and shareholders: Bristol Myers Squibb

JC: Employee and shareholder at the time of study conduct: Bristol Myers Squibb; Shareholder: Johnson & Johnson

VPW: Research support: Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Corbus, CSL Behring, Gilead, Horizon, Pfizer, Priovant, Regeneron, Rome Pharmaceuticals, Ventus, and Viela; Consultancy: AbbVie, Alpine Immune Sciences, Amgen, AnaptysBio, Argenix, AstraZeneca, Biogen, Bristol Myers Squibb, Cabaletta Bio, Calyx, Caribou, Crisalis, CSL Behring, Cugene, EMD Serono, Evommune, Gilead, GSK, Horizon, Immunovant, Innovaderm, Janssen, Kyowa Kirin, Lilly, Merck, Nektar, Nuvig, Pfizer, Regeneron, Rome Pharmaceuticals, Sanofi, Takeda, UCB, Ventus, Viela Bio, and Xencor; Royalties: MAPI Trust; Speaker: CESAS Medical

Impact of chronic spontaneous urticaria on health-related quality of life domains: country-specific data from patients participating in the Urticaria Voices study

Presenters: Tonya A. Winders,¹ Jonathan A. Bernstein,² Jessica Mccarthy,³ Pallavi Saraswat,⁴ Nadine Chapman-Rothe,⁵ Tara Raftery,⁶ Karsten Weller⁷

Affiliations: ¹Global Allergy and Airways Patient Platform; ²Bernstein Allergy Group and Clinical Research Center; ³Novartis Pharmaceuticals Corporation; ⁴Novartis Healthcare Pvt. Ltd.; ⁵Novartis Pharma AG; ⁶Novartis Ireland Ltd.; ⁷Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin

Introduction: Pooled data on the unmet needs of patients with chronic spontaneous urticaria (CSU), burden of disease on health-related quality of life (HRQoL), and worldwide patients’ experiences on living with CSU were previously reported from the Urticaria Voices study. Herein, we report country-wide data on the impact of CSU on HRQoL domains.

Methods: The Urticaria Voices study was a global, cross-sectional online survey conducted from February to September 2022 in patients with CSU in Canada, France, Germany, Italy, Japan, United Kingdom (UK), and United States (US). Eligible patients had a self-reported clinician-provided diagnosis of CSU and were currently following a physician-prescribed treatment. Data were analyzed descriptively, and the results are reported as percentage (n/N) or in terms of top three box scores of high importance.

Results: Overall, 582 patients with CSU participated in the study: 62 percent were female, mean (standard deviation) age was 42 (11.9) years, and 79 percent (460/582) reported being on H1 antihistamines (AH), 84 percent of whom had inadequate control (Urticaria Control Test <12). Globally, 36 percent (207/582) of patients reported overall high negative impact of CSU on HRQoL domains, particularly for mental and emotional wellbeing (36% [207/582]), social life and intimate relationships (31% [179/582]) and activities of daily living (29% [166/582]). At the country level, the proportion of patients reporting high negative impact of CSU varied from those in Italy (23% [15/64]) and Germany (52% [41/79]). The high negative impact of CSU on HRQoL domains was similar across countries, with some differences including mental and emotional wellbeing (23% [18/79] in Germany and 44% [32/73] in Canada), social life and intimate relationships (16% [13/79] in Germany and 40% [29/73] in Canada) and activities of daily living (14% [11/79] in Germany and 37% [32/87] in the UK). Globally, patients reported being negatively impacted by stress due to the spontaneous nature of CSU (37% [214/582]), avoiding social interactions (31% [178/582]), lack of intimacy (24% [137/582]), and being stared at in public or asked whether they were contagious (33% [192/582]). In addition to their prescribed treatments for CSU, currently, 21 percent (122/582) of patients consulted a dietitian, 19 percent (111/582) used psychological support, 19 percent (108/582) used homeopathic therapy, 18 percent (104/582) reported practicing meditation, 15 percent (90/582) consulted a sleep clinic, and 13 percent (73/582) used acupuncture for relief from their CSU symptoms.

Conclusion: Across countries, patients with CSU report high levels of negative impact across HRQoL domains. Mental and emotional wellbeing were most consistently ranked as being negatively impacted. Most patients report ongoing symptomatic disease despite treatment, with some seeking additional interventions, such as dietitian support, psychological support, and homeopathic therapy.

REMIX-1/-2: early symptom improvements with remibrutinib in chronic spontaneous urticaria from Week 1

Presenters: Sarbjit Saini,¹ Robert Szalewski,² Xinghua Gao,³ Sabine Altrichter,^4–7 Sibylle Haemmerle,⁸ Noriko Seko,⁹ Michihiro Hide^10,11

Affiliations: ¹Johns Hopkins Asthma and Allergy Center, Baltimore, MD; ²Allergy, Asthma, and Immunology Associates PC, Lincoln, NE; ³The First Hospital of China Medical University, Shenyang, China; ⁴Department of Dermatology and Venerology, Kepler University Hospital, Linz, Austria; ⁵Center for Medical Research, Johannes Kepler University, Linz, Austria; ⁶Institute for Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany; ⁷Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Berlin, Germany; ⁸Novartis Pharma AG, Basel, Switzerland; ⁹Novartis Pharma KK, Tokyo, Japan; ¹⁰Hiroshima City Hiroshima Citizens Hospital Hiroshima, Japan; ¹¹Hiroshima University, Hiroshima, Japan

Introduction: Remibrutinib, an oral, highly selective Bruton tyrosine kinase inhibitor, has shown superior efficacy versus placebo in symptom improvement at Week 12 in patients with chronic spontaneous urticaria (CSU). Here, early treatment responses from Week 1 were assessed in the Phase III REMIX studies.

Methods: REMIX-1/-2 are multicenter, randomized, double-blind, placebo-controlled Phase III studies assessing remibrutinib’s efficacy/safety in patients with CSU inadequately controlled by H1 antihistamines. Patients were randomized 2:1 to oral remibrutinib 25mg twice daily or placebo (24 weeks). In this post hoc analysis, least squares (LS) mean change from baseline (CFB) in weekly Urticaria Activity Score (UAS7), Itch Severity Score (ISS7), and Hives Severity Score (HSS7) were assessed at Weeks 1, 2, 4, 12, and 24.

Results: This analysis included 462 and 450 patients randomized in REMIX-1 and REMIX-2, respectively. Remibrutinib showed significant improvements versus placebo in LS mean CFB-UAS7 as early as Week 1 (REMIX-1: –11.3 vs. –4.0 [p<0.001]; REMIX 2: –11.3 vs. –2.9 [p<0.001]), Week 2 (REMIX-1: –15.6 vs. –6.2 [p<0.001]; REMIX-2: –15.1 vs. –5.2 [p<0.001]), and Week 4 (REMIX-1: –18.6 vs. –10.4 [p<0.001]; REMIX-2: –17.4 vs. –7.1 [p<0.001]). Significant improvements versus placebo in CFB-UAS7 were sustained through Week 24, with similar trends for ISS7 and HSS7.

Conclusion: In REMIX-1/-2, remibrutinib demonstrated fast and significant improvements in CSU symptoms, including itch and hives, versus placebo as early as Week 1, with further improvements through Week 24. Remibrutinib has the potential to be an effective treatment option with an early onset of response in patients with CSU inadequately controlled by H1 antihistamines.

Psoriasis and Psoriatic Arthritis

Apremilast efficacy in patients with early oligoarticular psoriatic arthritis affecting weight-bearing 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; ²University Medical Center Schleswig-Holstein, Kiel, Germany; ³UT Southwestern Medical Center, Dallas, TX; 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; ⁷School of Medicine, Griffith University, Brisbane, Queensland, Australia; ⁸Amgen Inc., Thousand Oaks, CA; ⁹Division of Rheumatology Autoimmunity and Inflammation, University of California San Diego, La Jolla, CA

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 (APR/APR, n=125; PBO/APR, n=62) with active weight-bearing joints⁵ at baseline, by baseline BMI categories (<25kg/m², ≥25–<30kg/m², ≥30kg/m²), through Week 48.

Results: APR and PBO were similar at baseline: mean SJC (1.5 and 1.2, respectively), TJC (1.9 and 1.8), active joint count (2.1 and 1.9), BMI (30.8kg/m² 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 greater than 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:

Gladman. J Rheumatol. 2021.
Kasiem. Scand J Rheumatol. 2021.
Ogdie. Ann Rheum Dis. 2019.
Gossec. Ann Rheum Dis. 2024.
Mizelle. Ann Rheum Dis. 2023.

Deucravacitinib in moderate-to-severe plaque psoriasis: 5-year, long-term safety and efficacy results from the Phase III POETYK PSO-1, PSO-2, and LTE trials

Presenters: April W. Armstrong,¹ Richard B. Warren,² Bruce Strober,³ Andrew Blauvelt,⁴ Yayoi Tada,⁵ Thierry Passeron,⁶ Diamant Thaçi,⁷ Carolin Daamen,⁸ Zoran Popmihajlov,⁸ John Vaile,⁸ Janice Li,⁸ Mark Lebwohl⁹

Affiliations: ¹University of California Los Angeles, Los Angeles, CA; ²Dermatology Centre, Northern Care Alliance NHS Foundation Trust, and Manchester Academic Health Science Centre, University of Manchester, Manchester, UK; ³Yale University School of Medicine, New Haven, and Central Connecticut Dermatology Research, Cromwell, CT; ⁴Blauvelt Consulting, Annapolis, MD; ⁵Teikyo University School of Medicine, Tokyo, Japan; ⁶Université Côte d’Azur, University Hospital of Nice, Nice, France; ⁷Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany; ⁸Bristol Myers Squibb, Princeton, NJ; ⁹Icahn School of Medicine at Mount Sinai, New York, NY

Introduction: Oral targeted therapies for plaque psoriasis with long-term efficacy and safety are needed. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in multiple countries for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was efficacious and well tolerated in the global, 52-week, Phase III POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) parent trials. Here, we report deucravacitinib safety and efficacy through five years (Week 256; cutoff date, 9/2/2024).

Methods: Patients were randomized 1:2:1 to oral placebo, deucravacitinib 6mg once daily, or apremilast 30mg twice daily. After Week 52, patients enrolled in the POETYK long-term extension (LTE) (NCT04036435) trial received open-label deucravacitinib 6mg once daily. Safety was evaluated in patients (n=1,519) receiving one or more deucravacitinib doses through five years in the POETYK PSO-1, PSO-2, or LTE trials. Exposure-adjusted incidence rate per 100 person-years was used to assess adverse events. Efficacy was analyzed using modified nonresponder imputation in patients who received continuous deucravacitinib from Day 1 of the parent trials and were enrolled and treated in the LTE. Outcomes included 75-/90-percent or greater improvement in Psoriasis Area and Severity Index (PASI75/90) and Static Physician’s Global Assessment (sPGA) 0/1.

Results: Deucravacitinib was well tolerated with no new safety signals. In patients receiving continuous deucravacitinib as described above (n=513), high clinical response rates were generally maintained from Year 1 (PASI75, 72.1% [95% confidence interval (CI): 68.2–76.1%]; PASI90, 45.9% [95% CI: 41.5–50.4%]; sPGA 0/1: 57.5% [95% CI: 53.1–61.9%]) to Year 5 (PASI75, 67.3% [95% CI: 62.0–72.6%]; PASI90: 46.3% [95% CI: 41.2–51.5%]; sPGA 0/1: 52.6% [95% CI: 47.0–58.1%]).

Conclusion: Deucravacitinib demonstrated a consistent safety profile through five years with no emergence of any new safety signals. Clinical efficacy rates were maintained through five years of continuous treatment with once-daily oral deucravacitinib. These data support the long-term safety and durable efficacy profile through five years of treatment with deucravacitinib, a first-in-class TYK2 inhibitor treatment for psoriasis.

Acknowledgments: Writing and editorial assistance was provided by Kimberly MacKenzie, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.

Funding/financial disclosures: This study was sponsored by Bristol Myers Squibb.

AWA: Research investigator, scientific advisor, and/or speaker: AbbVie, Almirall, Arcutis, Aslan, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, EPI Health, Incyte, Janssen, LEO Pharma, Mindera Health, Nimbus, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB

RBW: Research grants: AbbVie, Almirall, Amgen, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, and UCB; Consulting fees: AbbVie, Almirall, Amgen, Astellas, Boehringer Ingelheim, Celgene, DICE Therapeutics, Eli Lilly, GlaxoSmithKline, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, UCB, and Union Therapeutics

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, Inmagene, Janssen/J&J Innovative Medicine, Kangpu Biopharmaceuticals, LEO Pharma, Maruho, Meiji Seika Pharma, Monte Rosa Therapeutics, Novartis, Pfizer, Protagonist, RAPT Therapeutics, Regeneron, Sanofi, Sun Pharma, Takeda, TD Cowen, UCB, Union Therapeutics, Ventyx Biosciences, and vTv Therapeutics; Speaker: AbbVie, Arcutis, Dermavant, Eli Lilly, Incyte, Janssen/J&J Innovative Medicine, Regeneron, and Sanofi; Co-scientific director (consulting fee) and investigator: CorEvitas Psoriasis Registry; Editor-in-chief (with honorarium): Journal of Psoriasis and Psoriatic Arthritis; Stock options: Connect Biopharma and Mindera Health

AB: Speaker (with honoraria): 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 Biosciences, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Lipidio, Microbion, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Q32 Bio, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB, Union Therapeutics, Ventyx Biosciences, 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 Biosciences; Stock owner: Lipidio and Oruka

YT: Research grants: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Jimro, Kyowa Kirin, LEO Pharma, Maruho, Sun Pharma, Taiho Pharmaceutical, Tanabe-Mitsubishi, Torii, and UCB; Honoraria: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Eli Lilly, Janssen, Jimro, Kyowa Kirin, LEO Pharma, Maruho, Novartis, Pfizer, Sun Pharma, Taiho, Tanabe-Mitsubishi, Torii, and UCB; Consulting fees: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, Maruho, Novartis, Taiho, and UCB

TP: Advisory board and consulting fees: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, Takeda, and UCB

DT: Research support and principal investigator (clinical trial funds to institution): AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, and UCB; Consultant: AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, LEO Pharma, Novartis, Pfizer, and UCB; Lecturer: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, La Roche-Posay, Sanofi, Target RWE, and UCB; Scientific advisory board member: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB

CD: Employee and shareholder at the time of study conduct: Bristol Myers Squibb

ZP, JV, and JL: Employees and shareholders: Bristol Myers Squibb

ML: Research funds on behalf of Mount Sinai: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Eli Lilly, Incyte, Janssen, Ortho Dermatologics, Regeneron, and UCB; Consultant: Almirall, AltruBio, AnaptysBio, Arcutis, Avotres, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, EPI Health, Evommune, Forte Biosciences, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, Strata, Trevi, and Verrica

Efficacy and safety of deucravacitinib in patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drugs (bDMARDs) or previously received TNF-α inhibitor treatment: Week 16 results from POETYK PsA-2, a multicenter, randomized, double-blind, placebo-controlled Phase III study

Presenters: Philip J. Mease,¹ Vinod Chandran,² Alexis Ogdie,³ Evan Siegel,⁴ Ricardo Blanco,⁵ Diamant Thaçi,⁶ Alice B. Gottlieb,⁷ April W. Armstrong,⁸ Kejia Wang,⁹ Michael Plewinski,⁹ Atul Deodhar¹⁰

Affiliations: ¹Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA; ²University of Toronto and Krembil Research Institute, University Health Network, Toronto, ON, Canada; ³Hospital of the University of Pennsylvania, Philadelphia, PA; ⁴Arthritis and Rheumatism Associates, Rockville, MD; ⁵Hospital Universitario Marqués de Valdecilla, Immunopathology Group, IDIVAL, Santander, Spain; ⁶Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany; ⁷Icahn School of Medicine at Mount Sinai, New York, NY; ⁸University of California Los Angeles, Los Angeles, CA; ⁹Bristol Myers Squibb, Princeton, NJ; ¹⁰Oregon Health & Science University, Portland, OR

Introduction: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor under investigation for treatment of active psoriatic arthritis (PsA).

Deucravacitinib has an established clinical profile in moderate-to-severe psoriasis with more than four years of long-term data and is approved in multiple countries for this indication. Here, for the randomized, double-blind, Phase III study (POETYK PsA-2; NCT04908189) in patients with active PsA, we report data from the Week 16 placebo-controlled period.

Methods: The primary endpoint was 20-percent or greater improvement in the American College of Rheumatology (ACR20) criteria (Week 16). Key secondary endpoints included 75-percent or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI75) and change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) versus placebo (Week 16). Safety and tolerability were evaluated. Apremilast was included as a safety reference arm without formal statistical analysis planned for efficacy.

Results: Patients received deucravacitinib 6mg once daily (n=312), placebo (n=312), or apremilast 30mg twice daily (n=105). ACR20 was achieved in significantly more patients receiving deucravacitinib versus placebo (54.2% vs. 39.4%, p=0.0002; apremilast: 41.9%). More patients receiving deucravacitinib achieved PASI75 (40.9% vs. 15.4%, p<0.0001) and reported greater changes in HAQ-DI (−0.32 vs. −0.21, p=0.0013) versus placebo. Adverse events (AEs) were reported in 54.7, 62.8, and 73.3 percent of patients in the placebo, deucravacitinib, and apremilast arms, respectively, with serious AEs occurring in 1.0, 1.9, and 3.8 percent, respectively, and AEs leading to discontinuation occurring in 1.3, 2.2, and 10.5 percent, respectively. Results were consistent with deucravacitinib’s established safety profile; no new safety signals were identified.

Conclusion: Deucravacitinib, the first oral TYK2 inhibitor evaluated in a Phase III PsA study, showed superior efficacy versus placebo at Week 16 across multiple endpoints, including skin, overall disease activity, and quality of life, with a favorable safety profile versus apremilast that is consistent with that established in the Phase II PsA study and the psoriasis clinical program.

Acknowledgments: We thank the patients and families who made this study possible, as well as the clinical teams that participated. All authors contributed to and approved the abstract. Professional medical writing and editorial assistance was provided by Stephanie V. Koebele, PhD, of Nucleus Global, funded by Bristol Myers Squibb.

Funding/financial disclosures: The study was supported by Bristol Myers Squibb.

PJM: Research grants: AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; Consulting and/or speaker fees: AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Century, Cullinan, Eli Lilly, Janssen, MoonLake Immunotherapeutics, Novartis, Pfizer, and UCB

VC: Research grants: Eli Lilly and Johnson & Johnson; Consulting/Advisory boards: AbbVie, Bristol Myers Squibb, Eli Lilly, Fresenius Kabi, Johnson & Johnson, Novartis, and UCB; Spousal employment: AstraZeneca

AO: Consulting/advisory boards: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Corona, Gilead, Janssen, Eli Lilly, Novartis, Pfizer, and UCB; Grants to University of Pennsylvania: Novartis and Pfizer; Grants to Forward/NDB: Amgen; Royalties to spouse: Novartis

ES: Consultant and/or speaker fees: AbbVie, Amgen/Horizon, Bristol Myers Squibb, Janssen, and UCB

RB: Speakers bureau: AbbVie, Bristol Myers Squibb, Galapagos, Janssen, Lilly, MSD, Pfizer, and Roche; Consultant: AbbVie, Bristol Myers Squibb, Janssen, Lilly, MSD, Pfizer, and Roche; Grant/research support: AbbVie, MSD, and Roche

DT: Research support and principal investigator (clinical trials funds to institution): AbbVie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, GSK, Janssen-Cilag, LEO Pharma, MSD, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, and UCB; Consultant: AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, LEO Pharma, Novartis, Pfizer, and UCB; Lecturer: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Eli Lilly, LEO Pharma, MSD, Novartis, Pfizer, Roche-Posay, Sandoz-Hexal, Sanofi, Target RWE, and UCB; Scientific advisory board: AbbVie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen-Cilag, LEO Pharma, Morphosis, MSD, Novartis, Pfizer, Sanofi, and UCB

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)

AWA: Grants and personal fees: AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, LEO Pharma, and Novartis; Personal fees: Boehringer Ingelheim/Parexel, Celgene, Dermavant, Genentech, GSK, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Science 37, Sun Pharma, and Valeant; Grants: Dermira, Kyowa Hakko Kirin, and UCB, outside the submitted work

KW and MP: Employees and shareholders: Bristol Myers Squibb

AD: Consulting and/or advisory boards: Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, and UCB; Research grants: Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, MoonLake Immunotherapeutics, Novartis, Pfizer, and UCB

Icotrokinra, a targeted oral peptide that selectively blocks the interleukin-23 receptor, for the treatment of moderate-to-severe plaque psoriasis: results through Week 24 of the Phase III, randomized, double-blind, placebo-controlled ICONIC-LEAD trial

Presenters: Robert Bissonnette,¹ Jennifer Soung,² Adelaide Hebert,³ Andrew E. Pink,⁴ Andreas Pinter,⁵ Yuling Shi,⁶ Megan Miller,⁷ Joseph Cafone,⁷ Jing Zhi (Gigi) Jiang,⁸ Cynthia DeKlotz,⁷ Mark G. Lebwohl⁹

Affiliations: ¹Innovaderm Research, Montreal, QC, Canada; ²Southern California Dermatology, Santa Ana, CA; ³UTHealth McGovern Medical School, Houston, TX; ⁴St. John’s Institute of Dermatology, King’s College London and Guy’s and St. Thomas’s Hospitals, London, UK; ⁵Department of Dermatology, University Hospital Frankfurt, Frankfurt am Main, Germany; ⁶Department of Dermatology, Shanghai Skin Disease Hospital; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China; ⁷Johnson & Johnson, Spring House, PA; ⁸Johnson & Johnson, Milpitas, CA; ⁹Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York City, NY

Introduction: Icotrokinra (ICO), a first-in-class, targeted oral peptide that selectively binds the interleukin-23 receptor and inhibits signaling, demonstrated significant, durable skin clearance and a safety profile similar to placebo in Phase II studies in plaque psoriasis. Findings from the first Phase III ICO study in participants with moderate-to-severe plaque psoriasis are reported.

Methods: The pivotal, Phase III, double-blind, placebo-controlled ICONIC-LEAD trial (NCT06095115) randomized adults and adolescents (≥12–<18 years) with moderate-to-severe plaque psoriasis (body surface area [BSA] ≥10%; Psoriasis Area and Severity Index [PASI] ≥12; overall Investigator’s Global Assessment [IGA] ≥3) 2:1 to once-daily (QD) ICO 200mg through Week 24 or placebo through Week 16 followed by transition to ICO 200mg QD. Coprimary endpoints were IGA 0/1 (clear [0]/almost-clear [1] skin and ≥2-grade improvement from baseline) and 90-percent or greater improvement in PASI (PASI90) responses at Week 16.

Results: ICONIC-LEAD randomized 684 participants (ICO=456/placebo=228). The coprimary endpoints were met: 65 percent of ICO-treated participants versus eight percent of placebo-treated participants achieved IGA 0/1, and 50 versus four percent, respectively, achieved PASI90 at Week 16 (both p<0.001). ICO completely cleared skin at significantly higher rates than placebo at Week 16 (IGA 0: 33% vs. 1%; PASI100: 27% vs. <1%; both multiplicity-adjusted p<0.001). ICO response rates continued to increase through Week 24, including IGA 0/1 in 74 percent, PASI90 in 65 percent, IGA 0 in 46 percent, and PASI100 in 40 percent of participants. Similar proportions of ICO-treated participants and placebo-treated participants had one or more adverse events (49% in each group; most commonly nasopharyngitis and upper respiratory tract infection) and gastrointestinal-related events (6% per group) through Week 16. No safety signals emerged through Week 24.

Conclusion: ICO demonstrated significantly higher rates of skin clearance and a favorable safety profile in adults and adolescents with moderate-to-severe plaque psoriasis.

Inhibition of structural damage progression with guselkumab, a selective IL-23i, in participants with active PsA: results through Week 24 of the Phase IIIb, randomized, double-blind, placebo-controlled APEX study

Presenters: Philip Mease,^1,2 Christopher Ritchlin,³ Laura Coates,⁴ Alexa Kollmeier,⁵ Bei Zhou,⁶ Yusang Jiang,⁶ Karen Bensley,⁶ Koeun Im,⁷ Rattandeep Batra,⁸ Soumya Chakravarty,^9,10 Proton Rahman,¹¹ Désirée van der Heijde¹²

Affiliations: ¹Rheumatology Research, Providence Swedish Medical Center, Seattle, US; ²University of Washington School of Medicine, Seattle, US; ³Department of Medicine, Allergy/Immunology and Rheumatology, University of Rochester Medical Center, Rochester, US; ⁴Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Oxford, UK; ⁵Johnson & Johnson, San Diego, US; ⁶Johnson & Johnson, Spring House, US; ⁷Johnson & Johnson, Cambridge, US; ⁸Johnson & Johnson, Toronto, Canada; ⁹Johnson & Johnson, Horsham, US; ¹⁰Drexel University College of Medicine, Philadelphia, US; ¹¹Craig L. Dobbin Genetics Research Centre, Faculty of Medicine, Division of Rheumatology, Memorial University of Newfoundland, St. Johns, Canada; ¹²Leiden University Medical Center, Leiden, The Netherlands

Introduction: Guselkumab (GUS), a dual-acting selective interleukin (IL)-23 inhibitor, has demonstrated efficacy and a favorable safety profile in patients with active PsA. The objective of this study was to report findings through Week 24 (W24) of the ongoing APEX study (NCT04882098) in active PsA, further evaluating GUS effects on clinical and radiographic outcomes.

Methods: APEX enrolled biologic-naïve adults with active PsA and two or more erosive joints on hand/foot radiographs, despite previous nonbiologic disease-modifying antirheumatic drugs (DMARDs)/apremilast/nonsteroidal anti-inflammatory drugs (NSAIDs). Patients were randomized 5:7:7 to subcutaneous GUS 100mg every four weeks (Q4W); GUS 100mg at W0, W4, Q8W; or PBO Q4W. Primary and major secondary endpoints at W24 were 1) 20-percent or greater improvement in the American College of Rheumatology (ACR20) response rate; 2) mean change from baseline in PsA-modified van der Heijde-Sharp (vdH-S) score (each multiplicity-controlled for GUS Q4W and Q8W vs. PBO). Efficacy analyses include the modified full analysis set (mFAS; n=1,020, excluding Ukrainian sites unable to support study operations); safety analyses include 1,054 treated patients.

Results: In the mFAS (Q4W/Q8W/PBO: 273/371/376 patients), baseline characteristics were generally balanced. Mean age was 53 years; 55 percent of patients were male. At baseline, mean PsA duration (7.3 years), PsA-modified vdH-S total (27.0)/erosion (13.5) scores, and tender (20.7)/swollen (11.9) joint counts indicated established, highly active joint disease. Primary and major secondary endpoints were met. At W24, significantly greater proportions of GUS Q4W/Q8W (67%/68%) versus PBO (47%) patients achieved ACR20 response (both p<0.001) and patients receiving GUS Q4W/Q8W exhibited significantly less radiographic progression versus PBO (least squares mean changes in PsA-modified vdH-S score, 0.55/0.54 vs. 1.35; p=0.002/<0.001). Similar response patterns were seen for joint space narrowing and erosion scores, proportions of patients with no radiographic progression, and additional clinical efficacy outcomes. Through W24, adverse events (AEs) occurred in 38/42/37 percent of patients (most commonly respiratory infections, headache, diarrhea, psoriatic arthropathy), and serious AEs occurred in two/three/three percent of patients receiving GUS Q4W/GUS Q8W/PBO, respectively. No new safety signals were identified.

Conclusion: APEX is the first study to show significant inhibition of structural damage progression with both dosing regimens of GUS, a dual-acting selective IL-23 inhibitor. The GUS safety profile in these biologic-naïve patients with active PsA is consistent with that previously established for GUS across a broad range of patients with PsA, psoriasis, and/or inflammatory bowel disease.

Roflumilast foam 0.3% in patients with psoriasis of the scalp and body: improvements in patient-reported outcomes and quality of life in the ARRECTOR trial

Presenters: Melinda J. Gooderham,¹ Javier Alonso-Llamazares,² Neal Bhatia,³ Laura K. Ferris,⁴ Leon Kircik,^5–7 Wei Jing Loo,⁸ Kim A. Papp,⁹ David Krupa,¹⁰ Melissa S. Seal,¹⁰ Diane Hanna,¹⁰ David R. Berk,¹⁰ Patrick Burnett¹⁰

Affiliations: ¹SKiN Centre for Dermatology, Probity Medical Research, and Queen’s University, Peterborough, ON; ²Driven Research LLC, Coral Gables, FL; ³Therapeutics Clinical Research, San Diego, CA; ⁴University of North Carolina, Department of Dermatology, Chapel Hill, NC; ⁵Icahn School of Medicine at Mount Sinai, New York, NY; ⁶Indiana University School of Medicine, Indianapolis, IN; ⁷Physicians Skin Care, PLLC and Skin Sciences, PLLC, Louisville, KY; ⁸DermEffects, Probity Medical Research, and Western University, London, ON; ⁹Probity Medical Research and Alliance Clinical Trials, Waterloo, ON, and Temerty School of Medicine, University of Toronto, Toronto, ON; ¹⁰Arcutis Biotherapeutics, Inc., Westlake Village, CA

Introduction: Psoriasis of the scalp or body negatively affects quality of life, with patients considering pruritus the most burdensome symptom. Roflumilast foam 0.3% is a potent phosphodiesterase 4 inhibitor approved for treatment of psoriasis of the scalp and body.

Methods: The Phase III ARRECTOR trial (NCT05028582) was conducted in patients aged 12 years or older with psoriasis of the scalp and body of at least moderate (≥3) on the Scalp-Investigator’s Global Assessment (S-IGA) and mild (≥2) on the Body-IGA (B-IGA) and affecting 25 percent or less of body surface area overall. Patients were randomized 2:1 to apply roflumilast foam 0.3% or vehicle foam once daily for eight weeks. Patient-reported outcomes included Scalp Itch-Numeric Rating Scale (SI-NRS), Worst Itch-NRS (WI-NRS), Psoriasis Symptom Diary (PSD; ≥18 years only), and Scalpdex. All p-values are nominal.

Results: There were 281 and 151 patients enrolled into the roflumilast foam 0.3% and vehicle foam groups, respectively. In patients with SI-NRS and/or WI-NRS of 2 or greater at baseline, greater proportions of the roflumilast group than the vehicle group achieved no/minimal itch scores (0/1) at Week 8 (SI-NRS 0/1: 52.3% vs. 24.1%; p<0.0001; WI-NRS 0/1: 55.4% vs. 19.8%; p<0.0001). Consistent improvement was observed across PSD domains of patient-reported signs and symptoms of psoriasis (severity and bothersomeness), as well as improvement in emotional domains (embarrassment). Significantly greater reductions were observed for roflumilast versus vehicle at Week 8 in Scalpdex total score (–23.4 vs. –12.8; p<0.0001), and Scalpdex domain scores (emotions: –23.1 vs. –12.4; symptoms: –29.0 vs. –15.0; function: –20.7 vs. 11.7; all p<0.0001).

Conclusion: Treatment with roflumilast foam 0.3% improved patient-reported outcomes and quality of life in patients with psoriasis of the scalp and body.

Funding/financial disclosures: Sponsored by Arcutis Biotherapeutics, Inc.

Phase III results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with Iiotrokinra, a targeted oral peptide that selectively inhibits the IL-23 receptor

Presenters: Melinda J. Gooderham,¹ Edward Lain,² Robert Bissonnette,³ Yu-Huei Huang,⁴ Charles Lynde,⁵ Matthias Hoffmann,⁶ Eingun James Song,⁷ Jessica H. Rubens,⁸ Amy M. DeLozier,⁸ Ming-Chun Hsu,⁸ Richard B. Warren⁹

Affiliations: ¹SKiN Centre for Dermatology, Queen’s University, and Probity Medical Research, Peterborough, ON, Canada; ²Austin Institute for Clinical Research, Sanova Dermatology, Austin, TX; ³Innovaderm Research, Montreal, QC, Canada; ⁴Chang Gung Memorial Hospital and Chang Gung University, Taoyuan City, Taiwan; ⁵University of Toronto, Lynde Institute for Dermatology and Lynderm Research Inc, Markham, ON, Canada; ⁶Dermatology Practice Dr.Matthias Hoffmann, Witten, Germany; ⁷Frontier Dermatology, Mill Creek, WA; ⁸Johnson & Johnson, Spring House, PA; ⁹Dermatology Centre, Northern Care Alliance NHS Foundation Trust and Division of Musculoskeletal and Dermatology Sciences Manchester Academic Health Science Centre, University Manchester, Manchester, UK

Introduction: Icotrokinra (ICO), a first-in-class, targeted oral peptide that binds and inhibits the interleukin-23 receptor (IL-23R), was evaluated in ICONIC-TOTAL (NCT06095102). This Phase III trial included plaque psoriasis (PsO) severity of body surface area (BSA) of one percent or greater/Investigator’s Global Assessment (IGA) of 2 or greater, and employed a novel basket-like design to evaluate three cohorts of adults and adolescents (≥12–<18 years) with at least moderate, difficult-to-treat, high-impact skin sites: scalp (scalp specific-IGA [ss-IGA] ≥3), genital (Static Physician’s Global Assessment of Genitalia [sPGA-G] ≥3), and/or hand/foot (hand/foot Physician’s Global Assessment [hf-PGA] ≥3).

Methods: A total of 311 randomized patients (ICO=208/placebo [PBO]=103) with scalp (n=252), genital (n=140), and/or hand/foot (n=71) PsO received once-daily ICO 200mg or PBO through Week (W)16. Primary (IGA 0/1: clear [0]/almost clear [1] and ≥2-grade improvement) and key secondary (ss-IGA0/1, sPGA-G0/1, hf-PGA0/1) endpoints were assessed at W16.

Results: ICO versus PBO met primary (IGA 0/1: 57% vs. 6%; p<0.001) and secondary (ss-IGA 0/1: 66% vs. 11%, sPGA-G 0/1: 77% vs. 21%; both p<0.001) endpoints, and showed higher hf-PGA 0/1 (42% vs. 26%; p=0.144). Patient-reported scalp/genital PsO improvements were statistically significantly superior to PBO. Proportions of ICO and PBO patients with one or more adverse events (AEs) were 50 and 42 percent (most common: nasopharyngitis) and gastrointestinal AEs were 7.2 and 7.8 percent, respectively.

Conclusion: ICO demonstrated significantly higher rates of overall skin, scalp, and genital PsO clearance versus PBO with a favorable safety profile. Basket-like trial designs can be used to efficiently study special skin sites in patients with PsO and other diseases.