Selected Poster Abstracts from 16th Annual Dermatology Pearls Conference

J Clin Aesthet Dermatol. 2024;17(11-12 Suppl 1):S19–27.

Acne

Efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel in hispanic participants with moderate-to-severe acne

Presenters: Valerie Callender,^1,2 Hilary Baldwin,^3,4 Linda Stein Gold,⁵ Fran E. Cook- Bolden,^6,7 Andrew F. Alexis,⁷

Affiliations: ¹Callender Dermatology and Cosmetic Center, Glenn Dale, MD; ²Howard University College of Medicine, Washington, DC; ³The Acne Treatment and Research Center, Brooklyn, NY; ⁴Robert Wood Johnson University Hospital, New Brunswick, NJ; ⁵Henry Ford Hospital, Detroit, MI; ⁶Fran E. Cook-Bolden, MD, PLLC, New York, NY; ⁷Weill Cornell Medicine, New York, NY

Introduction: Acne vulgaris is a common dermatologic condition and a leading dermatologic diagnosis in Black and Hispanic patients. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for the treatment of acne. In three published clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. The objective of these analyses was to determine the efficacy, safety, and tolerability of CAB in Hispanic participants of these studies.

Methods: In one Phase 2 (NCT03170388) and two Phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants at least nine years of age with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score [EGSS] and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts at Week 12. Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also assessed. Pooled data across all three studies were analyzed for participants who self-identified as Hispanic/Latino (herein referred to as Hispanic; n=90 CAB; n=57 vehicle gel).

Results: At week 12, over half of Hispanic participants achieved treatment success with CAB versus less than one-quarter with vehicle gel (56.2% vs 18.4%; P<0.001). CAB treatment provided greater than 75 percent reductions in inflammatory/noninflammatory lesion counts at Week 12 vs 56.4 percent and 45.0 percent, respectively, with vehicle (P<0.001, both). TEAE rates with CAB in the Hispanic population were similar to those in the overall study populations (27% vs 24.6–36.2%). Most TEAEs were of mild-to-moderate severity, and discontinuations due to AEs were low (<4%). Mean cutaneous safety and tolerability scores (0=none to 3=severe) with CAB at all visits were less than 1 (mild), similar to the overall study populations. Hyperpigmentation scores decreased from baseline (0.6) to Week 12 (0.3) following CAB treatment.

Conclusion: In Hispanic participants with moderate-to-severe acne treated with CAB, over half achieved treatment success and acne lesion reductions were reduced by more than 75 percent by Week 12, without any additional safety signals. These results, combined with those of previous post hoc analyses in Black study participants, demonstrate that CAB is an efficacious, safe, and tolerable acne treatment for patients of different racial and ethnic groups.

Funding/financial disclosures: Funding was provided by Ortho Dermatologics.

Efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel in participants with moderate-to-severe acne: the patient journey 

Presenters: Hilary Baldwin,¹ Julie Harper,² Joshua Zeichner,³ Zoe Draelos,⁴ Lawrence Eichenfield,⁵ Michael Gold,⁶ Linda Stein Gold,⁷ Leon Kircik,³

Affiliations: ¹The Acne Treatment and Research Center, Brooklyn, NY; ²Dermatology & Skin Care Center of Birmingham, Birmingham, AL; ³Icahn School of Medicine at Mount Sinai, New York, NY; ⁴Dermatology Consulting Services, PLLC, High Point, NC; ⁵University of California, San Diego School of Medicine, La Jolla, CA; ⁶Tennessee Clinical Research Center, Nashville, TN; ⁷Henry Ford Hospital, Detroit, MI

Introduction: When treating acne, the main goal of treatment is to clear lesions quickly to manage and/or mitigate sequelae. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne treatment. In three published clinical studies of participants with moderate-to- severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. Herein are presented detailed efficacy and safety data from five clinical study patients to document their CAB treatment journey.

Methods: In two Phase 3 (NCT04214652, NCT04214639), double-blind, 12-week studies, participants at least nine years of age with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and percent change from baseline in inflammatory/noninflammatory lesion counts at Week 12. Dosing compliance, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. Descriptive data from each of the selected cases who completed 12 weeks of CAB treatment are summarized.

Results: Participants (n=5) ranged from 13–32 years. At Week 12, three achieved treatment success, one achieved a two-grade reduction from severe to mild, and one achieved a one-grade reduction from moderate to mild. Percent reductions from baseline to Week 12 in inflammatory/noninflammatory lesion counts ranged from 74.7 percent to 100 percent. No participants reported TEAEs or serious AEs. Some cutaneous safety and tolerability scores increased at Weeks 2, 4, or 8, but generally decreased back to/below baselines levels by Week 12, similar to the overall study populations. Most scores at Week 12 were 0 (none) or 1 (mild), with only one participant reporting scores of 2 (moderate) for itching, burning, and stinging.

Conclusion: In the overall Phase 3 clinical trials, fixed-dose, triple-combination CAB gel has demonstrated good efficacy, safety, and tolerability. All five cases presented here achieved substantial (>70%) acne lesion reductions, with 4/5 cases achieving treatment success or a two- grade EGSS reduction by Week 12. While patterns in cutaneous safety/tolerability were variable across cases, transient increases with CAB generally resolved to baseline values within two months of treatment. These clinical study cases reinforce the importance of patient education regarding efficacy and safety of acne treatment, including the importance of treatment adherence, managing patient expectations, and the potential for increased cutaneous effects, which are often transient.

Funding/financial disclosures: Funding was provided by Ortho Dermatologics.

Efficacy and safety of fixed-dose triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for moderate-to-severe acne vulgaris in children and adolescents

Presenters: Lawrence Eichenfield,¹ Adelaide  Hebert,² Julie Harper,³ Hilary Baldwin,⁴ Neal Bhatia,⁵ Linda Stein Gold,⁶ Leon Kirck,⁷ Emmy Graber,⁸ Emil Tanghetti,⁹ Andrew Alexis,¹⁰ James Del Rosso,¹¹

Affiliations: ¹University of California, San Diego School of Medicine, La Jolla, CA; ²UTHealth McGovern Medical School Houston, Houston, TX; ³Dermatology & Skin Care Center of Birmingham, Birmingham, AL; ⁴The Acne Treatment and Research Center, Brooklyn, NY; ⁵Therapeutics Clinical Research, San Diego, CA; ⁶Henry Ford Hospital, Detroit, MI; ⁷Icahn School of Medicine at Mount Sinai, New York, NY; ⁸The Dermatology Institute of Boston, Boston, MA; ⁹Center for Dermatology and Laser Surgery, Sacramento, CA; ¹⁰Weill Cornell Medicine, New York, NY; ¹¹JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV

Introduction: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose triple-combination formulation approved for acne and is indicated for use in patients aged at least 12 years of age. As topical acne treatment in pediatric patients might be complicated by tolerability issues and/or a perceived lack of efficacy, the objective of these post hoc analyses was to investigate the efficacy and safety of CAB in children and adolescents.

Methods: Data were pooled from two Phase 3 double-blind, randomized, 12-week studies (NCT04214639; NCT04214652). Eligible participants at least nine years of age with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. These post hoc analyses evaluated adolescents aged 12 to 17 years (CAB: n=123; vehicle: n=50). Endpoints included at least a two-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success), least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts, and treatment-emergent adverse events (TEAEs). Descriptive efficacy and safety data for five children aged 10 to 11 years enrolled in the study are also summarized (CAB: n=3; vehicle: n=2).

Results: At Week 12, 51.5 percent of CAB–treated participants aged at least 12 years of age achieved treatment success versus 24.9 percent with vehicle gel (P<0.01). CAB treatment resulted in significant reductions of more than 70 percent in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) versus vehicle (50.5% and 42.9%; P<0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (>3% in any treatment group) treatment- related TEAE was application site pain. Less than 2.5 percent of participants withdrew due to AEs. For the five children aged fewer than 12 years, all three treated with CAB achieved treatment success, with reductions in inflammatory/noninflammatory lesions ranging from 76 percent to 100 percent; neither of the vehicle-treated participants achieved treatment success. Only one CAB–treated younger participant experienced TEAEs (application site pain, application site dryness, and erythema [all mild or moderate]) and none discontinued the study.

Conclusion: In two pooled Phase 3 studies, once-daily fixed-dose triple combination CAB gel was well tolerated and efficacious in pediatric participants with moderate-to-severe acne, with over half achieving treatment success at Week 12.

Funding/financial disclosures: Funding was provided by Ortho Dermatologics.

Fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for moderate-to-severe acne: comparison of four clinical trials

Presenters: Leon Kircik,^1–3 Zoe Draelos,⁴ Michael Gold,⁵ Neil Sadick,^6,7 Neal Bhatia,⁸

Affiliations: ¹Icahn School of Medicine at Mount Sinai, New York, NY; ²Indiana University School of Medicine, Indianapolis, IN; ³Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY; ⁴Dermatology Consulting Services, PLLC, High Point, NC; ⁵Tennessee Clinical Research Center, Nashville, TN; ⁶Weill Cornell Medicine, New York, NY; ⁷Sadick Dermatology, New York, NY; ⁸Therapeutics Clinical Research, San Diego, CA 

Introduction: Combination therapies targeting multiple processes of acne pathogenesis are recommended for most patients with acne. A three-pronged approach using an antibiotic, retinoid, and antibacterial might also increase treatment efficacy versus monotherapy or dual-combination products. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (BPO) polymeric mesh gel (CAB) is the first fixed-dose, triple-combination topical approved by the FDA for the treatment of acne. The objective of this analysis was to compare treatment success and effect size of once-daily CAB with its three constituent dyad gels, branded adapalene 0.3%/BPO 2.5% gel, and vehicle across four clinical studies.

Methods: Two Phase 2 (NCT03170388, NCT04892706) and two Phase 3 (NCT04214652, NCT04214639) double-blind, randomized, 12-week studies enrolled participants with moderate-to-severe acne. In all studies, treatment success at Week 12 (defined as a ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) was a coprimary endpoint. Other coprimary endpoints (reduction from baseline in inflammatory and noninflammatory lesions) are not shown here. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. A post hoc analysis of number needed to treat (NNT)—the number of patients who need to be treated with an intervention for one additional patient to achieve success versus vehicle—was performed to provide an additional measure of treatment effect and to indirectly compare data across studies.

Results: Across studies, approximately half of CAB-treated participants achieved treatment success by Week 12 (range: 49.6–52.5%) versus less than one-fourth with vehicle (range: 8.1– 24.9%; P<0.01, all) and less than one-third with component dyads or branded adapalene 0.3%/BPO 2.5% (range: 27.8–32.9%; P≤0.001, all). Treatment success rates were significantly greater for all active treatments versus vehicle (P<0.01, all). NNT values for CAB (3–5) were lower (better) than for constituent dyads (5–6) or branded adapalene 0.3%/BPO 2.5% (7), further indicative of greater efficacy. TEAEs with CAB were mostly of mild-to-moderate severity. TEAE and discontinuation rates were similar or lower with CAB gel than with adapalene/BPO dyad gels. Mean cutaneous safety/tolerability scores with CAB gel were less than one (mild) at all timepoints.

Conclusion: CAB gel demonstrated significantly greater efficacy in the treatment of moderate-to-severe acne than dyad gels and branded adapalene 0.3%/BPO 2.5% gel, with approximately half of participants achieving clear/almost clear skin by 12 weeks with CAB. Due to acne pathogenesis, a triple-combination treatment might result in clinical success more often than two-ingredient combination products.

Funding/financial disclosures: Funding for this study was provided by Ortho Dermatologics.

Atopic dermatitis

Clinically meaningful responses in tralokinumab-treated adolescents with atopic dermatitis not achieving IGA 0/1 at week-16

Presenters: Amy Paller,¹ Andrew Blauvelt,² Weily Soong,³ Chih-ho Hong,⁴ Marie L.A. Schuttelaar,⁵ Shannon Schneider,⁶ Marie Holst Moerch,⁷ Eric Simpson,⁸

Affiliations: ¹Feinberg School of Medicine, Northwestern University, USA; ²Oregon Medical Research Center, USA; ³Allervie Health-Alabama Allergy & Asthma Center, USA; ⁴University of British Columbia, Canada; ⁵University Medical Centre Groningen, University of Groningen, The Netherlands; ⁶LEO Pharma Inc, USA; ⁷LEO Pharma A/S, Denmark; ⁸Oregon Health & Science University, USA

Introduction: In the monotherapy Phase 3 trial (ECZTRA 6, NCT03526861) in adolescents with moderate-to-severe atopic dermatitis (AD) treated with tralokinumab, IGA of clear/almost clear skin (IGA 0/1) at Week 16 was a primary endpoint. IGA 0/1 can be a high standard to achieve for patients with moderate-to-severe AD and might not fully reflect achievement of other clinically meaningful parameters, such as improvement in signs, symptoms, and/or quality-of-life (QoL).

Methods: Adolescents (12–17 years) were randomized to subcutaneous tralokinumab 150mg or 300mg, or placebo, every two weeks. Patients who did not achieve IGA 0/1 at Week 16 and/or utilized rescue therapy were included in this post hoc analysis. Nonresponder imputation was used for patients who utilized rescue therapy or had missing data. Clinically meaningful responses were defined as EASI-50, at least a three-point improvement in pruritus NRS, or at least a six-point improvement in CDLQI.

Results: At Week 16, 78.6 percent and 82.5 percent of tralokinumab-treated patients (150mg/300mg) versus 95.7 percent (placebo) exhibited IGA>1 and/or used rescue therapy. 36.4 percent (150mg) and 52.5 percent (300mg) of patients with IGA>1 in the tralokinumab arms, compared to 21.1 percent (placebo), achieved clinically meaningful responses in at least one measure: EASI-50, pruritus NRS, or CDLQI. Greater proportions of tralokinumab-treated patients (150mg/300mg vs. placebo) achieved EASI-50 (31.2%/41.3% vs. 10.0%) and at least a three-point improvement in pruritus NRS (21.6%/22.8% vs. 8.0%). A greater proportion of tralokinumab 300mg patients versus placebo (35.2% vs. 15.0%) achieved at least a six-point improvement in CDLQI.

Conclusion: Many tralokinumab-treated adolescents who did not achieve IGA 0/1 at Week 16 and/or used rescue therapy still achieved clinically meaningful improvements in AD signs, symptoms, and/or QoL.

Funding/financial disclosures: This study was sponsored by LEO Pharma A/S (Ballerup, Denmark). Medical writing and editorial support from Alphabet Health (New York, NY) by Matthew Hartmann, PhD, was sponsored by LEO Pharma (Madison, NJ). This work was previously presented at ACAAI 2022.

Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema: pooled results of the Phase 3 DELTA-1 and -2 trials

Presenters: Robert Bissonnette,¹ Margitta Worm,² Richard B Warren,^3,4 Tove Agner,⁵ Melinda Gooderham,^6,7 Marie Louise Schuttelaar,⁸ Keith Baranowski,⁹ Ursula Plohberger,⁹ Laura Soerensen,⁹ Sibylle Schliemann¹⁰

Affiliations: ¹Innovaderm Research, Montreal, Quebec, Canada; ²Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Charité Universitätsmedizin Berlin, Germany; ³Dermatology Centre, Northern Care Alliance NHS Foundation Trust; ⁴NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, United Kingdom; ⁵Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; ⁶Department of Dermatology, Queens University, Peterborough, Ontario, Canada; ⁷SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada; ⁸University Medical Centre Groningen, University of Groningen, Netherlands; ⁹LEO Pharma A/S, Ballerup, DK; ¹⁰Department of Dermatology, University Hospital Jena, Jena, Germany

Introduction: Chronic hand eczema (CHE) is a frequent inflammatory skin disease associated with pain, pruritus, and significant occupational, functional, social, and psychological burden. Delgocitinib is a topical pan-JAK inhibitor that showed a dose-dependent efficacy in adults with CHE in a Phase 2b trial. The objectives of this analysis were to study (1) the efficacy of twice-daily applications of delgocitinib cream 20mg/g, as assessed by Investigator’s Global Assessment for CHE treatment success (primary outcome), and the secondary outcomes ≥75%/≥90% improvement in Hand Eczema Severity Index and ≥4-point improvement in the Dermatology Life Quality Index, and (2) the safety of twice-daily applications of delgocitinib cream 20mg/g compared with cream vehicle in the treatment of adults with moderate to severe CHE in a pooled analysis of the DELTA-1 and DELTA-2 trials.

Methods: In the Phase 3 DELTA-1 (NCT04871711) and DELTA-2 (NCT04872101) trials, adults with moderate to severe CHE were randomized 2:1 to twice-daily delgocitinib cream 20mg/g or cream vehicle for 16 weeks. The primary endpoint was the Investigator’s Global Assessment for CHE (IGA-CHE) treatment success at Week 16, defined as IGA-CHE score of 0/1 (clear/almost clear, i.e., no/barely perceptible erythema and no other signs), with at least a two-step improvement from baseline. Key secondary endpoints included ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) and at least a four-point improvement in the Dermatology Life Quality Index (DLQI). This DELTA-1 and -2 pooled analysis included 639 patients treated with delgocitinib cream and 321 with cream vehicle.

Results: At Week 16, a significantly greater proportion of delgocitinib-treated patients, versus cream vehicle, achieved IGA-CHE treatment success (24.3% vs. 8.4%; P<0.001), HECSI-75 (49.4% vs. 20.9%; P<0.001), HECSI-90 (30.3% vs. 10.6%; P<0.001), and DLQI ≥4-point improvement (73.3% vs. 47.8%; P<0.001). Most frequent adverse events (occurring in ≥5% of patients) were COVID-19, nasopharyngitis, and headache with similar rates in both treatment groups.

Conclusion: In the DELTA-1 and -2 pooled analysis, delgocitinib cream twice-daily confirmed its clinical efficacy in patient- and clinician-reported efficacy outcomes versus cream vehicle in adult patients with CHE and suggests an innovative treatment option in this often difficult-to-treat patient population.

Funding/financial disclosures: No funding was provided for this study.

Laboratory parameters in adolescent patients aged 12 to 17 with moderate-to-severe atopic dermatitis treated with tralokinumab up to Week 52: results from the Phase 3 ECZTRA 6 trial

Presenters: Amy Paller,¹ Michael Cork,² Chih-ho Hong,³ Weily Soong,⁴ Shannon Schneider,⁵ Hannah Lo,⁵ Line Rosendahl Meldgaard Pedersen,⁶ Emilia Vacko,⁶ Andreas Wollenberg,⁷ 

Affiliations: ¹Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; ²Sheffield Dermatology Research, Department of Infection, Immunity, and Cardiovascular Disease, The University of Sheffield and Sheffield Children’s Hospital, NIHR Clinical Research Facility, Sheffield, United Kingdom; ³University of British Columbia, Vancouver, BC, Canada; ⁴AllerVie Health- Alabama Allergy and Asthma Center, Birmingham, AL, USA; ⁵LEO Pharma Inc., Madison, NJ, USA; ⁶LEO Pharma A/S, Ballerup, DK; ⁷Department of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich, Germany

Introduction: Tralokinumab, a high-affinity, monoclonal antibody that targets IL-13, is approved in the EU and Canada for adolescents (aged ≥12 years) with inadequately controlled moderate-to-severe atopic dermatitis (AD), and it does not require laboratory monitoring. The Phase 3 ECZTRA 6 (NCT03526861) clinical trial demonstrated efficacy and safety up to 52 weeks in that population.

Objective: To further characterize the safety profile of tralokinumab by evaluating laboratory parameters of adolescents in the ECZTRA 6 trial.

Methods: ECZTRA 6 subjects received tralokinumab 150mg (n=98), 300mg (n=97) or placebo (n=94) every two weeks (Q2W) from Week 0–16 after a loading dose at Week 0 (twice the subsequent dose), and then randomized to maintenance [original tralokinumab dose either Q2W or every four weeks (Q4W) or placebo Q2W] or open-label (tralokinumab 300mg Q2W) until Week 52. Laboratory parameters included hematology, serum biochemistry, and urinalysis throughout the trial (Weeks 0, 8, 16, 28, and 52).

Results: Overall (n=289 subjects), laboratory baseline parameters were similar across treatment groups. Mean and median changes of most hematology parameters showed minor fluctuations within the normal ranges through Week 52, except for eosinophils. At baseline, elevated mean eosinophil counts (>0.5 109/L) were observed for 40.8 percent (tralokinumab 150mg), 48.5 percent (tralokinumab 300mg), and 43.6 percent (placebo) of subjects in each respective treatment group. Some tralokinumab-treated patients had small transient increases in eosinophils (maximum mean change from baseline 0.2×109/L) before Week 16. Continued treatment with tralokinumab or placebo did not correspond with further increase in eosinophil levels over time, and no adverse events of eosinophilia were reported. Mean levels of most biochemistry parameters, including electrolytes, renal and liver function parameters, and lipid panel, were within normal range at baseline, and mean and median changes showed minor fluctuations within normal ranges in all treatment arms. Mean lactate dehydrogenase levels were around or above the upper limit of normal at baseline and decreased to within the normal ranges during the trial across all groups. Overall, no clinically meaningful differences were observed in hematology, biochemistry, or urinalysis parameters between active treatment groups or placebo.

Conclusion: Similar to findings in adult trials, no meaningful changes in laboratory parameters were observed in adolescents through Week 52 with tralokinumab treatment. No routine laboratory monitoring is needed for adult or adolescent AD patients treated with tralokinumab.

Funding/financial disclosures: The ECZTRA 6 trial was sponsored by LEO Pharma A/S, Ballerup, Denmark. Medical writing and editorial assistance were provided by Juliel Espinosa, PhD, from Alphabet Health, funded by LEO Pharma. This work was originally presented at Fall Clinical 2023.

Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with chronic hand eczema: results of the Phase 3 open-label extension DELTA-3 trial

Presenters: Melinda Gooderham,^1,2 Sonja Molin,³ Robert Bissonnette,⁴ Margitta Worm,⁵ Marie-Noëlle Crépy,^6,7 Luca Stingeni,⁸ Richard B Warren,^9,10 Sibylle Schliemann,¹¹ Cherry Lou Balita- Crisostomo,¹² Marie Louise Oesterdal,¹² Tove Agner¹³

Affiliations: ¹Queens University, Kingston, Ontario, Canada; ²SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada; ³Queen’s University, Kingston, Canada; ⁴Innovaderm Research, Montreal, Quebec, Canada; ⁵Charité Universitätsmedizin Berlin, Germany; ⁶University Hospital of Centre of Paris, Cochin Hospital, AP-HP, Paris, France; ⁷University Hospital of Centre of Paris, Hôtel-Dieu Hospital, AP-HP, Paris, France; ⁸University of Perugia, Perugia, Italy; ⁹Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, United Kingdom; ¹⁰NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom; ¹¹University Hospital Jena, Jena, Germany; ¹²LEO Pharma A/S, Ballerup, Denmark; ¹³Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark

Introduction: In patients with moderate-to-severe chronic hand eczema (CHE), delgocitinib cream, a topical pan-Janus kinase inhibitor, was well tolerated and demonstrated significant improvement in all efficacy endpoints in DELTA-1 and -2. The objectives of this study were to evaluate the long-term safety and efficacy of twice-daily applications of delgocitinib cream 20mg/g as needed for up to 36 weeks in adults with CHE in the Phase 3 open-label DELTA-3 trial (NCT04949841), an extension trial of the 16-week DELTA-1 (NCT04871711) and DELTA-2 (NCT04872101) trials.

Methods: In DELTA-3, subjects who completed the 16-week treatment period in DELTA-1 and DELTA-2 were treated on an as-needed basis with twice-daily delgocitinib cream 20 mg/g for 36 weeks (n=801). Subjects with Investigator’s Global Assessment for CHE (IGA-CHE) ≥2 received delgocitinib cream until symptoms resolved (i.e., IGA-CHE 0/1 [clear/almost clear]). Primary endpoint was number of treatment-emergent adverse events (TEAEs). Key secondary endpoints were IGA-CHE 0/1 and ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores; Hand Eczema Symptom eDiary captured patient-reported worst severity of itch/pain over the past 24 hours.

Results: No safety concerns were identified during delgocitinib cream treatment in DELTA-1 (n=325; R=305.4; PYO=100.9), DELTA-2 (n=313; R=280.6; PYO=95.9) and DELTA-3 (n=801; R=231.1; PYO=535.7). In DELTA-3, the most frequent TEAEs were COVID-19 and nasopharyngitis. In DELTA-3, IGA-CHE 0/1, HECSI-75, HECSI-90 and at least a four-point itch/pain reduction were maintained from baseline (24.6%, 51.8%, 31.8%, and 50.6%/51.9%, respectively) to Week 36 (30.0%, 58.6%, 36.6%, and 52.4%/55.4%, respectively) among delgocitinib cream-treated subjects in the parent trials. Among those treated with cream vehicle in parent trials, response rates improved from baseline (9.1%, 23.7%, 12.0%, and 26.3%/32.3%, respectively) to Week 36 (29.5%, 51.5%, 35.7%, and 41.3%/43.3%, respectively).

Conclusion: Overall, with delgocitinib cream 20 mg/g treatment no safety concerns were identified and efficacy further improved, supporting the benefit of long-term as-needed use of delgocitinib cream in patients with moderate-to-severe CHE.

Funding/financial disclosures: No funding was provided for this study.

Long-term safety and efficacy of roflumilast cream 0.15% in patients aged ≥6 years with mild-to-moderate atopic dermatitis: a 52-week, Phase 3, open-label extension trial (INTEGUMENT-OLE)

Presenters: Eric L. Simpson,¹ Lawrence F. Eichenfield,² Kim A. Papp,³ Seth B. Forman,⁴ Adelaide A. Hebert,⁵ Mercedes E. Gonzalez,⁶ Melinda J. Gooderham,⁷ H. Chih-ho Hong,⁸ Vimal H. Prajapati,⁹ Emma Guttman-Yassky,¹⁰ Jonathan I. Silverberg,¹¹ Melissa S. Seal,¹² David Krupa,¹² Patrick Burnett,¹² Scott Snyder,¹² David H. Chu,¹² Robert C. Higham,¹² David R. Berk¹² 

Affiliations: ¹Oregon Health & Science University, Portland, OR, USA; ²Rady’s Children’s Hospital-San Diego, Departments of Dermatology and Pediatrics, University of California San Diego, San Diego, CA, USA; ³Probity Medical Research and Alliance Clinical Trials, Waterloo, ON, Canada, and University of Toronto, Toronto, ON, Canada; ⁴ForCare Medical Center, Tampa, FL, USA; ⁵UT Health McGovern Medical School, Houston, TX, USA; ⁶Pediatric Skin Research, LLC, Miami, FL, USA; ⁷SKiN Centre for Dermatology, Probity Medical Research, and Queen’s University, Peterborough, ON, Canada; ⁸Probity Medical Research and University of British Columbia, Department of Dermatology and Skin Science, Surrey, BC, Canada; ⁹Dermatology Research Institute, Probity Medical Research, Skin Health & Wellness Centre, and University of Calgary, Calgary, AB, Canada; ¹⁰Icahn School of Medicine at Mount Sinai, New York, NY, USA: ¹¹Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA; ¹²Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA

Introduction: Roflumilast, a highly potent phosphodiesterase 4 inhibitor, is approved as a nonsteroidal, once-daily cream for atopic dermatitis (AD).

Methods: In this open-label 52-week safety trial (INTEGUMENT-OLE; NCT04804605), patients aged at least six years with mild-to-moderate AD who completed a four-week randomized vehicle-controlled Phase 3 trial of roflumilast cream continued or switched to once-daily roflumilast cream 0.15%. Starting at Week 4 of this trial, patients who achieved Validated Investigator Global Assessment for AD (vIGA-AD) of 0 (Clear) switched to twice-weekly (BIW) application. The primary endpoint was safety; secondary endpoints included vIGA-AD, Eczema Area and Severity Index (EASI), and Worst Itch-Numeric Rating Scale (WI-NRS). “Disease control” was defined as duration of vIGA-AD 0/1 (Almost Clear) on BIW application following achievement of vIGA-AD 0.

Results: Among the 657 patients treated for up to 56 weeks, 241 (36.7%) reported treatment-emergent adverse events (AEs); most AEs were mild or moderate. Overall, 4.7 percent of patients had AEs considered treatment-related and 3.0 percent discontinued the trial because of AEs. The most common AEs (>2% of patients) were COVID-19, upper respiratory tract infection, nasopharyngitis, and headache. At Week 52, 55.7 percent, 61.1 percent, and 53.6 percent of patients achieved vIGA-AD 0/1, at least a 75-percent reduction in EASI, and at least a four-point reduction in WI-NRS (among patients aged ≥12 years with baseline WI-NRS ≥4), respectively. Of the 130 (19.8%) patients who achieved disease control, median duration was 281 days per Kaplan-Meier analysis.

Conclusion: Long-term treatment of patients with AD with roflumilast cream 0.15% was well tolerated, consistent with parent trials, and effective through Week 52 (up to 56 weeks of treatment), including among patients who achieved vIGA-AD 0 and switched to BIW application.

Funding/financial disclosures: Funding was provided by Arcutis Biotherapeutics, Inc.

Real-world baseline characteristics and persistence in adult patients initiating tralokinumab in the CorEvitas Atopic Dermatitis Registry

Presenters: Eric Simpson,¹ Sanjeev Balu,² C. Jean Choi,³ Alvin Li,³ Oksana Pugach,³ Shannon Schneider,² Jonathan Silverberg,⁴

Affiliations: ¹Department of Dermatology, Oregon Health & Science University, Portland, OR, USA; ²LEO Pharma Inc., Madison, NJ, USA; ³CorEvitas, LLC, Waltham, MA, USA; ⁴The George Washington School of Medicine and Health Sciences, Washington, DC, USA

Introduction: Tralokinumab is a monoclonal antibody that targets IL-13, a key driver of atopic dermatitis (AD). In clinical trials, tralokinumab demonstrated favorable efficacy and safety profiles for moderate-to-severe AD. However, data on real-world patients and treatment persistence is limited.

Objective: To describe baseline characteristics and persistence at six months in US adults with AD initiating tralokinumab in the CorEvitas AD registry.

Methods: The CorEvitas AD Registry is prospective and noninterventional, collecting data from adults with AD. Registry patients who initiated tralokinumab between 2/1/2022 and 5/31/2023 with baseline data were analyzed. Baseline demographics and clinical characteristics were summarized using descriptive statistics and stratified by advanced systemic therapy (AST) experience, defined as a history of dupilumab, abrocitinib, or upadacitinib for AD. A six-month follow-up was defined as a visit 5 to 9 months following tralokinumab initiation.

Results: Of 259 patients, mean age was 50.8 years, and patients were majority female (60.2%), White (78.0%), worked full-time (55.2%), had private health insurance (77.6%), and concomitantly used topical therapy (78.4%). Most patients had moderate-to-severe disease, with mean Eczema Area and Severity Index (EASI) 14.2. Patients experienced a mean peak pruritus numerical rating scale of 6.2, and mean Dermatology Life Quality Index of 9.8. At tralokinumab initiation, 33.6 percent of patients were AST-experienced, of whom 95.4 percent had used dupilumab.

Among AST-naïve patients, 80.8 percent used topical steroids, 36.0 percent topical calcineurin inhibitors, and 10.5 percent topical PDE4 inhibitors. AST-naïve patients had higher severity at baseline by mean BSA and mean EASI. Among patients with six-month follow-up (n=81), 74.1 percent remained persistent on tralokinumab, 73.3 percent of whom were AST-naïve. Mean EASI of persistent patients improved from 13.8 to 3.3 at six months. Of 21 patients who discontinued tralokinumab, 52.4 percent were AST-experienced. Reasons for discontinuation included lack of efficacy, safety, and insurance.

Conclusion: In this US real-world study, adults with AD had a high disease burden, and 74.1 percent of patients who initiated tralokinumab were persistent at six months. Further studies on tralokinumab persistence with longer follow-up are warranted.

Funding/financial disclosures: This study is sponsored by CorEvitas, LLC. This analysis and editorial support from Alphabet Health (New York, NY) by Gina Sanchez, PhD, was sponsored by LEO Pharma Inc. (Madison, NJ). This work was previously presented at RAD 2024 and AMCP Nexus 2024.

Real-world effectiveness of persistent tralokinumab use on clinician and patient-reported outcomes in patients with atopic dermatitis (AD) in the CorEvitas Atopic Dermatitis Registry

Presenters: Jonathan Silverberg,¹ Sanjeev Balu,² C. Jean Choi,³ Alvin Li,³ Oksana Pugach,³ Shannon Schneider,² Eric Simpson,⁴

Affiliations: ¹The George Washington School of Medicine and Health Sciences, Washington, DC, USA; ²LEO Pharma Inc., Madison, NJ, USA; ³CorEvitas, LLC, Waltham, MA, USA; ⁴Department of Dermatology, Oregon Health & Science University, Portland, OR, USA

Introduction: Tralokinumab is a high-affinity monoclonal antibody targeting IL-13, a driver of inflammation in AD. The ECZTRA trials showed tralokinumab is effective and safe, but real- world evidence is limited.

Objective: To assess the change from baseline in clinician-assessed and patient-reported outcomes (PROs) among US adults with AD post six months of persistent tralokinumab use in the prospective, noninterventional CorEvitas AD registry, which launched in July 2020.

Methods: This analysis includes registry patients with baseline data, who started tralokinumab between 2/1/2022 and 5/31/2023 and were persistent on it at six-month follow-up. Baseline data were summarized using descriptive statistics and stratified by advanced systemic therapy (AST) experience. Outcome measures included: validated Investigator’s Global Assessment for AD (vIGA-AD), ≥50%/≥75% improvement in Eczema Area and Severity Index (EASI-50/75), Dermatology Life Quality Index (DLQI), mean weekly pruritis numerical rating scale, and mean change in Work Productivity and Activity Impairment (WPAI).

Results: In the 60 patients, mean age and AD duration were 49.1 and 15.0 years. Most were female (56.7%), White (85.0%), worked full-time (63.3%), and AST-naïve (AST-N, 73.3%). At baseline, most patients had moderate-to-severe AD (EASI≥ 7: 67%; vIGA-AD 3: 83.3%; vIGA- AD 4: 6.7%). Disease severity was lower in AST-experienced (AST-E) patients, all of whom were dupilumab-experienced. A notable proportion of patients experienced improvements from baseline to FU: vIGA-AD≤1 (6.7% to 55.0%), EASI≤7 (33.3% to 85.0%), and DLQI≤5 (38.3% to 66.7%). In patients with baseline EASI≥7.1, 85.0 percent and 77.5 percent achieved EASI-50 (AST-N: 90.9%; AST-E: 57.1%) and EASI-75 (AST-N: 84.8%; AST-E: 42.9%), respectively, at the 6-month follow-up. In those with baseline vIGA-AD 3 or 4, 79.6 percent and 66.7 percent  achieved EASI-50 (AST- N: 83.3%; AST-E: 66.7%) and EASI-75 (AST-N: 76.2%; AST-E: 33.3%) at follow-up. In those with baseline DLQI≥4, 71.4 percent achieved at least a four-point improvement at follow-up (AST-N: 78.1%; AST-E: 50.0%). In patients with baseline mean weekly pruritus NRS≥3, 69.8 percent achieved ≥3-point improvement at follow-up (AST-N: 70.0%; AST-E: 69.2%). Improvements were also reported in WPAI.

Conclusion: In this real-world study, AD patients experienced improvements in clinician- assessed outcomes and PROs after six-months of persistent tralokinumab, regardless of prior AST use.

Funding/financial disclosures: This study is sponsored by CorEvitas, LLC. This analysis, and editorial support from Alphabet Health (New York, NY) by Jenisha Ghimire, PhD, was funded by LEO Pharma Inc. (Madison, NJ). This work was previously presented at RAD 2024.

Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to- severe atopic dermatitis

Presenters: Andrew Blauvelt,¹ H. Chih-ho Hong,² Ketty Peris,³ Norito Katoh,⁴ Marie Tauber,⁵ Mahreen Ameen,⁶ Melinda Gooderham,⁷ Christian Bjerregård Øland,⁸ Ann-Marie Tindberg,⁸ Le Gjerum,⁸ Kristian Reich,⁹

Affiliations: ¹Oregon Medical Research Center, Portland, OR, USA; ²University of British Columbia, Vancouver, BC, Canada; ³Dermatologia, Università Cattolica del Sacro Cuore, Rome, Italy; ⁴Kyoto Prefectural University of Medicine Graduate School of Medical Science, Japan; ⁵Department of Allergology and Clinical Immunology, Lyon Sud hospital and Inserm U1111 CIRI, Lyon, France; ⁶Royal Free London National Health Services Foundation Trust, London, UK; ⁷SKiN Centre for Dermatology, Peterborough, ON, Canada; Department of Dermatology, Queen’s University, Kingston, ON, Canada; ⁸LEO Pharma A/S, Ballerup, Denmark; ⁹Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Introduction: To ensure minimal residual disease and to prevent relapses, recently published consensus reports have defined optimal long-term treatment targets for atopic dermatitis (AD). Tralokinumab, a monoclonal antibody specifically neutralizing interleukin-13, is approved for the treatment of moderate-to-severe AD. ECZTEND (NCT03587805) is an ongoing open-label, five-year extension trial investigating the long-term safety and efficacy of tralokinumab 300mg every other week (Q2W) plus optional topical corticosteroids (TCS).

Objective: To determine the proportion of patients treated for up to four years with tralokinumab in AD clinical trials who: 1) exhibit stable improvement, with no or minimal fluctuations, in lesion extent and severity long-term (ie, response in ≥80% of attended visits), and 2) exhibit a stable long-term composite response (ie, up to 4 years of tralokinumab treatment and response in ≥80% of attended trial visits) in signs and symptoms of AD, and quality of life based on recent treat-to-target recommendations (EASI≤7 and either DLQI≤5 or Itch NRS≤4).

Methods: This post hoc analysis included 347 patients who were continuously treated with tralokinumab for 52 weeks in the identically designed Phase 3 monotherapy trials ECZTRA 1 & 2 and subsequently for up to 152 weeks in ECZTEND as of the April 30, 2022, data cutoff. Stability of long-term response, with no or minimal fluctuations, was defined as meeting the target endpoints of at least 80 percent of attended visits between Weeks 16–152 in ECZTEND. Endpoints analyzed were EASI≤7, EASI≤2, and a composite long-term treatment target: EASI≤7 and either DLQI≤5 or worst weekly pruritus NRS≤4.

Results: A stable EASI≤7 response (at ≥80% of attended visits) was observed in 70.2 percent (233/332) of tralokinumab-treated patients over Weeks 16–152 of ECZTEND. A stable EASI≤2 response was observed in 34.0 percent (113/332) of patients, and a long-term optimal composite target, EASI≤7 and either DLQI≤5 or Itch NRS≤4, was observed in 60.5 percent (201/332) of patients.

Conclusion: High proportions of clinical trial patients maintained stable responses, with no or minimal fluctuations in efficacy, with continued tralokinumab 300mg Q2W plus optional TCS for up to four years of treatment.

Funding/financial disclosures: This ECZTEND trial was sponsored by LEO Pharma A/S (Ballerup, Denmark). Medical writing and editorial support from Alphabet Health (New York, NY) by Juliel Espinosa, PhD, was funded by LEO Pharma A/S. This work was previously presented at AAD 2024.

Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe chronic hand eczema in the Phase 3 DELTA-2 trial

Presenters: Melinda Gooderham,^1,2 Diamant Thaçi,³ Tina Damgaard,⁴ Daniel Madsen,⁴ Anders Soehoel,⁴ Robert Bissonnette⁵

Affiliations: ¹Department of Dermatology, Queens University, Peterborough, Ontario, Canada; ²SKiN Centre for Dermatology and Probity Medical Research, Peterborough, Ontario, Canada; ³Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany; ⁴LEO Pharma A/S, Ballerup, Denmark; ⁵Innovaderm Research, Montreal, Quebec, Canada

Introduction: In the DELTA-2 (NCT04872101) Phase 3 trial, delgocitinib cream 20mg/g, a topical pan-Janus kinase inhibitor, was well-tolerated and demonstrated significant improvement in all efficacy endpoints versus cream vehicle in adults with moderate-to-severe chronic hand eczema (CHE). The objectives of this analysis were 1) to examine systemic exposure of delgocitinib cream 20mg/g in adults with moderate to severe CHE in the randomized, double-blind, vehicle-controlled DELTA-2 trial; 2) to compare the DELTA-2 systemic exposure with corresponding data following oral administration of delgocitinib in a Phase 1 trial; and 3) to present a summary of safety related to delgocitinib cream from the randomized, double-blind, vehicle-controlled DELTA-2 trial.

Methods: Pharmacokinetic blood sampling in DELTA-2 was performed two to six hours after delgocitinib application at Weeks 1, 4, and 16 using a liquid chromatography/mass spectrometry-based method (lower limit of quantitation: 5pg/mL). In the Phase 1 trial (NCT05050279), single oral doses of delgocitinib were tested in healthy volunteers with sampling performed for up to 24 hours postadministration.

Results: In DELTA-2, minimal systemic exposure was recorded in 313 delgocitinib-treated patients, with the highest geometric mean plasma concentration being 0.21ng/mL at Week 1 (n=286). In the Phase 1 trial, the lowest oral delgocitinib dose tested (1.5mg; n=8) is regarded as subtherapeutic and showed a peak systemic exposure (geometric mean C_max) of 7.2ng/mL. In DELTA-2, adverse events (AEs) were reported by 45.7 percent (n=143/313; delgocitinib cream) and 44.7 percent (n=71/159; cream vehicle) of patients, with COVID-19 being most common (11.5% vs 12.6%, respectively). The rate of possibly or probably related AEs was low and similar between delgocitinib cream and cream vehicle. No deaths were reported. Few serious AEs were reported with none assessed as related to the study drug.

Conclusion: The DELTA-2 trial demonstrated minimal systemic exposure in association with a favorable safety profile, supporting a lack of meaningful systemic effect from twice-daily applications of delgocitinib cream in patients with moderate-to-severe CHE.

Funding/financial disclosures: No funding was provided for this study.

Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis

Presenters: Jennifer Soung,¹ Vivian Laquer,² Matthew Zirwas,³ Peter van Iperen,⁴ John Stinson,⁴ Katrine Lykke Albertsen,⁴ Linda Stein Gold⁵

Affiliations: ¹Southern California Dermatology, Santa Ana, CA, USA; ²First OC Dermatology Research, Fountain Valley, CA, USA; ³Dermatologists of Southwest Ohio, Bexley, OH, USA; ⁴LEO Pharma A/S, Ballerup, Denmark; ⁵Henry Ford Health System, Detroit, MI, USA

Introduction: Tralokinumab, a high-affinity monoclonal antibody that specifically neutralizes interleukin-13, is approved in multiple countries for adults and adolescents with moderate-to-severe atopic dermatitis (AD)*. Tralokinumab was initially developed as a pre-filled syringe and has recently been developed as a pre-filled pen, which offers a more convenient method ofadministration and reduces the number of injections per dose to two injections for the loading dose and one injection for subsequent doses. The Phase 3 open-label trial INJECZTRA (NCT05194540) assessed the efficacy, safety, and usability of the tralokinumab pre-filled pen in adult and adolescent patients with moderate-to-severe AD.

Methods: In total, 136 patients (105 adults, 31 adolescents) received tralokinumab administered with the pre-filled pen for 16 weeks. An initial loading dose (600mg tralokinumab, 2 injections) was administered at baseline. At this time, patients were trained in correct handling and use of the tralokinumab pre-filled pen. During the rest of the trial, patients self-administered 300mg tralokinumab (1 injection) every two weeks at the trial site or at home. Patients’ ability to successfully self-administer tralokinumab with the pre-filled pen was assessed at the site at Week 4 and at home at Week 8. Primary endpoints were IGA 0/1 and EASI-75 at Week 16. Secondary endpoints included number of adverse events. Topical corticosteroids (TCS) were allowed as rescue medication; patients using TCS were considered nonresponders.

Results: At baseline, 33.1 percent of patients had severe AD (ie, an IGA score of 4) (adults 32.4%; adolescents 35.5%) and mean EASI score was 25.2 (adults 24.9; adolescents 26.1). At Week 16, 28.7 percent of patients achieved IGA 0/1 (adults 28.6%; adolescents 29.0%) and 43.5 percent of patients achieved EASI-75 (adults 44.8%; adolescents 38.7%). Overall, 96.2 percent of patients successfully self-administered tralokinumab at Week 4 (adults 98.0%; adolescents 89.7%) and 97.5 percent of patients successfully self-administered tralokinumab at Week 8 (adults 96.9%; 100.0% adolescents). Overall, 86 adverse events were reported in 50 patients (66 adverse events in 37 adults; 20 adverse events in 13 adolescents). The most common adverse events were injection site reaction (5.9%), atopic dermatitis (4.4%), and conjunctivitis (2.9%).

Conclusion: Tralokinumab formulated as a pre-filled pen was efficacious and well tolerated. Both adult and adolescent patients were able to self-administer tralokinumab successfully with the pre-filled pen. There were no new, and fewer adverse events, compared to the pivotal trials in adults and adolescents. Across all efficacy endpoints, efficacy data were numerically better or comparable to the pivotal adult and adolescent data.*Approved dose for adults 300mg every two weeks. Approved dose for adolescents 300mg every two weeks in the EU, 150mg every two weeks in the USA.

Funding/financial disclosures: The INJECZTRA study was funded by LEO Pharma A/S (Ballerup, Denmark). Medical writing and editorial support from Alphabet Health (New York, NY) by Gina Sanchez, PhD was sponsored by LEO Pharma A/S (Ballerup, Denmark). This work was previously presented at Winter Clinical Miami 2024.

Tralokinumab real-world patient-reported outcomes in moderate-to-severe atopic dermatitis adult patients in the United States: 6-month interim analysis

Presenters: Peter Lio,¹ Yestle Kim,² Sanjeev Balu,³ Halley Costantino,⁴ Dawn Bates,⁴ Cassandra Rene,⁴ Amanda Lopez,⁵ Jennifer Soung,⁶

Affiliations: ¹Northwestern University Feinberg School of Medicine and Medical Dermatology Associates of Chicago, IL, USA; ²Madrigal Pharmaceuticals, West Conshohocken, PA, USA (Former LEO Pharma employee); ³LEO Pharma, Madison, NJ, USA; ⁴Cerner Enviza, an Oracle Company, Kansas City, MO, USA; ⁵Patient Living with Atopic Dermatitis; ⁶Harbor-UCLA Medical Center

Introduction: Tralokinumab, an IL-13 targeted biologic approved in the United States (US) for adult patients with moderate-to-severe atopic dermatitis (AD), improved patient-reported outcomes (PROs) in clinical trials and after four weeks of use in the real-world setting. This six-month interim analysis evaluated the real-world impact of tralokinumab on PROs in adult patients.

Methods: This is an interim analysis of an ongoing 52-week patient survey study enrolling US patients with AD from the Adbry^TM Advocate^TM Program. Patients completed the baseline survey close to tralokinumab initiation. Data on demographics and PROs including weekly itch numeric rating scale (NRS), eczema-related weekly sleep NRS, Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM-9) were collected. Percent and absolute changes from baseline to six months of treatment were calculated. Outcomes are stratified by previous dupilumab use. The percentage of patients experiencing minimal clinically important difference (MCID) was also calculated for itch NRS (3-point reduction) and DLQI (4-point reduction).

Results: As of May 2023, 102 patients completed baseline, one-month, and six-month surveys. Of these patients, 59.8 percent were female, mean age was 44.2 years (SD=15.7), 82.4 percent were white, and 85.3 percent had private insurance. A total of 84.3 percent were previously treated with topical corticosteroids (TCS) and 52.9 percent were dupilumab-experienced patients. Over six months, there was an improvement in the mean sleep interference NRS (40%), average weekly itch NRS (39%), worst weekly itch NRS (33%), PO- SCORAD (37%), and DLQI (52%). There were improvements in mean TSQM-9 global satisfaction (11.06 points), TSQM-9 convenience (3.92 points), and TSQM-9 effectiveness (14.60 points) scores. Median MCIDs were met by 57.1 percent on the sleep interference NRS, 51.7 percent of patients on the average weekly itch NRS, 50.0 percent on the worst weekly itch NRS, and 68.7 percent on the DLQI. Relative to the dupilumab-experienced cohort, the dupilumab-naïve patients showed markedly improved outcomes (median MCIDs of 65.6% vs. 48.4% on sleep NRS; 59.5% vs. 44.4% on average weekly itch NRS; 61.4% vs. 39.6% on worst weekly itch NRS; 61.4% vs. 35.3% on PO- SCORAD; and 75.6% vs. 61.9% on DLQI).

Conclusion: This six-month interim analysis shows that tralokinumab improved quality of life outcomes related to itch, sleep, and treatment satisfaction when used either in dupilumab-naïve or in dupilumab-experienced patients. These patients will continue to be followed for up to 52 weeks of treatment with tralokinumab.

Funding/financial disclosures: This study was funded by LEO Pharma Inc.

Psoriasis

Patient-reported outcomes with roflumilast foam 0.3% in patients with scalp and body psoriasis in the Phase 3 ARRECTOR trial

Presenters: Melinda J. Gooderham,¹ Jerry Bagel,² Seth B. Forman,³ Leon H. Kircik,⁴ Marni Wiseman,⁵ Benjamin Lockshin,⁶ Jennifer Soung,⁷ David Krupa,⁸ Saori Kato,⁸ David R. Berk,⁸ David H. Chu⁸

Affiliations: ¹SKiN Centre for Dermatology, Probity Medical Research and Queen’s University, Peterborough, ON, Canada; ²Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA; ³ForCare Medical Center, Tampa, FL, USA; ⁴Icahn School of Medicine at Mount Sinai, New York, New York; Indiana Medical Center, Indianapolis, Physicians Skin Care, PLLC and Skin Sciences, PLLC, Louisville, Kentucky, USA; ⁵SKiNWISE Dermatology, Probity Medical Research and University of Manitoba, Winnipeg, MB, Canada; ⁶DermAssociates, LLC, Rockville, MD, USA; ⁷Southern California Dermatology, Santa Ana, CA, USA; ⁸Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA

Introduction: Patients with scalp or body psoriasis consider itch the most burdensome symptom. Roflumilast foam 0.3% is a once-daily, nonsteroidal, highly potent phosphodiesterase 4 inhibitor formulation under investigation for treatment of scalp and body psoriasis.

Methods: This Phase 3 trial (NCT05028582) was conducted in patients at least 12 years of age with scalp and body psoriasis, minimum Scalp-Investigator Global Assessment (S-IGA) score of moderate, and minimum Body-IGA (B-IGA) of mild. Overall body surface area affected by psoriasis was 25 percent or less. Patients were randomized 2:1 to once-daily roflumilast foam 0.3% (n=281) or vehicle (n=151) for eight weeks. Primary results were reported previously. Patient-reported outcomes (PROs) included the Psoriasis Symptom Diary (PSD; ≥18 years only), Scalpdex, Dermatology Life Quality Index (DLQI; ≥17 years only), Scalp-Itch-Numeric Rating Scale (SI-NRS), and Worst-Itch-Numeric Rating Scale (WI-NRS).

Results: In patients with SI-NRS and/or WI-NRS≥2 at baseline, significantly greater proportions of the roflumilast group than the vehicle group achieved SI-NRS and/or WI-NRS scores of 0 or 1 at Week 8 (SI-NRS: 52.3% vs. 24.1%; P<0.0001; WI-NRS: 55.4% vs. 19.8%; P<0.0001). Similar improvements were reflected in other PROs at Week 8, with a significantly greater proportion of the roflumilast group achieving a PSD total score of 0 (19.6% vs. 7.1%; P=0.0012). The roflumilast group also had significantly greater reductions in least-squares mean change from baseline in PSD items related to itching/pain/scaling (–10.9 vs. –5.8; P<0.0001), Scalpdex score (–23.4 vs –12.8; P<0.0001), and DLQI score (–4.4 vs. –2.4; P<0.0001).

Conclusion: Roflumilast foam 0.3% improved quality of life associated with scalp and body psoriasis itching, pain, and scaling.

Funding/financial disclosures: Funding was provided by Arcutis Biotherapeutics, Inc.

Seborrheic dermatitis

Roflumilast foam 0.3% once daily in patients with seborrheic dermatitis: Improvement in patient reported outcomes and pruritus from a Phase 3 trial (STRATUM)

Presenters: Neal D. Bhatia,¹ Fran E. Cook-Bolden,² Janet C. DuBois,³ Laura K. Ferris,⁴ Linda Stein Gold,⁵ Irina Turchin,⁶ Matthew J. Zirwas,⁷ David Krupa,⁸ Patrick Burnett,⁸ David R. Berk,⁸ David H. Chu⁸

Affiliations: ¹Therapeutics Clinical Research, San Diego, California, USA; ²Park South Medical, Bronx, NY, USA; ³DermResearch, Inc., Austin, TX, USA; ⁴University of Pittsburgh, Department of Dermatology, Pittsburgh, PA, USA; ⁵Henry Ford Medical Center, Detroit, MI, USA; ⁶Brunswick Dermatology Center, Fredericton, NB, Canada; ⁷Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley, OH, USA; ⁸Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.

Introduction: Roflumilast is a nonsteroidal, highly potent phosphodiesterase 4 inhibitor developed as once-daily cream and foam formulations approved for atopic dermatitis and seborrheic dermatitis (SD). Roflumilast cream 0.3% is approved as a once-daily, nonsteroidal cream for patients with chronic plaque psoriasis, including sensitive areas such as intertriginous, face, and genital areas. Efficacy and safety of once-daily roflumilast foam 0.3% in patients aged at least nine years with at least moderate SD from this Phase 3 randomized, controlled trial (STRATUM; NCT04973228) were reported previously. Patient-reported outcomes (PROs) from STRATUM are reported here.

Methods: STRATUM was conducted in patients aged at least nine years with SD affecting 20 percent or more body surface area, including the scalp, face, trunk, and/or intertriginous areas, for at least three months. Patients were randomized 2:1 to once-daily roflumilast foam 0.3% or vehicle for eight weeks. PROs included Worst Itch-Numeric Rating Scale (WI-NRS; rated from 0 [no itch] to 10 [worst itch imaginable]), Scalpdex, and Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI). Safety (treatment-emergent adverse events [TEAEs]) and local tolerability were also evaluated.

Results: Overall, 304 patients received roflumilast foam 0.3% and 153 received vehicle foam. Among patients with baseline WI-NRS score of at least 2, a greater proportion of the roflumilast group than the vehicle group achieved WI-NRS score 0/1 at Week 8 (70.7% vs 52.9%; P=0.0085), with improvements in itch compared with vehicle as early as 48 hours after first application (mean percent change from baseline [CfB]: –27.87% vs –13.11%; nominal P=0.0024). The roflumilast group also had greater improvements in least squares (LS) mean CfB DLQI (–3.8 vs –2.7; nominal P<0.001), while those with scalp involvement had greater improvements in LS mean CfB Scalpdex score (–23.21 vs –15.42; nominal P<0.001) at Week 8. Treatment-related TEAEs were reported for eight (2.6%) and five (3.3%) patients in the roflumilast and vehicle groups, respectively. Local tolerability was similar between roflumilast and vehicle.

Conclusion: Treatment with once-daily roflumilast foam 0.3% reduced pruritus, improved quality of life, and was well tolerated in patients with SD.

Funding/financial disclosures: Funding was provided by Arcutis Biotherapeutics, Inc.