Selected Poster Abstracts from 15th Annual Dermatology Pearls Conference

J Clin Aesthet Dermatol. 2024;17(1–2 Suppl 1):S33–S37.


Atopic Dermatitis

Efficacy and safety of roflumilast cream 0.15% in adults and children aged ≥6 with mild-to-moderate atopic dermatitis in two Phase III trials (INTEGUMENT-1 and INTEGUMENT-2)

Presenters: Eric Simpson,1 Lawrence Eichenfield,2 Melinda Gooderham,3 Mercedes E. Gonzalez,4 Adelaide Hebert,5 Kim Papp,6 Vimal Prajapati,7 David Krupa,8 Patrick Burnett,8 David Berk,8 Robert Higham8

Affiliations: 1Oregon Health & Science University, Portland, OR; 2University of California, San Diego and Rady Children’s Hospital, San Diego, CA; 3SKiN Centre for Dermatology, Probity Medical Research and Queen’s University, Peterborough, ON, Canada; 4Pediatric Skin Research, LLC Miami, FL; 5University of Texas Health McGovern Medical School, Houston, TX; 6Probity Medical Research and Alliance Clinical Research, Waterloo, ON, Canada; 7Dermatology Research Institute, Skin Health &Wellness Centre, University of Calgary, and Probity Medical Research, Calgary, AB, Canada; 8Arcutis Biotherapeutics, Inc., Westlake Village, CA

Introduction: Roflumilast is a selective, highly potent phosphodiesterase 4 inhibitor under investigation as a nonsteroidal, once-daily cream for the treatment of atopic dermatitis (AD). INTEGUMENT-1 (n=654; NCT04773587) and INTEGUMENT-2 (n=683; NCT04773600) were identical Phase III, randomized, controlled trials (RCTs) conducted in patients with AD aged six years or older with baseline Eczema Area and Severity Index (EASI) score of five or greater and Validated Investigator’s Global Assessment-AD (vIGA-AD) score of mild or moderate.

Methods: Patients were randomized 2:1 to apply once-daily roflumilast cream 0.15% or vehicle for four weeks. The primary efficacy endpoint was vIGA-AD success (defined as score of 0 [clear] or 1 [almost clear] with 2-grade improvement from baseline) at Week 4. Secondary endpoints included 75-percent improvement in EASI (EASI75).

Results: At Week 4, significantly more roflumilast-treated than vehicle-treated patients achieved vIGA-AD success (INTEGUMENT-1: 32.2% vs. 15.2%, p<0.0001; INTEGUMENT-2: 28.9% vs. 12.0%, p<0.0001) and EASI75 (INTEGUMENT-1: 43.2% vs. 22.0%, p<0.0001; INTEGUMENT-2: 42.0% vs. 19.7%, p<0.0001). Incidence of treatment-emergent adverse events (AEs) was low in both arms, with most assessed as mild-to-moderate in severity. No AE occurred in more than 3.5 percent of patients in either arm, with low rates of application site pain in both the roflumilast- and vehicle-treated patients (INTEGUMENT-1: 2.1% vs. 0.5%, respectively; INTEGUMENT-2: 0.9% vs. 0.9%, respectively). Local tolerability was favorable, with over 90 percent of roflumilast-treated patients reporting no or mild sensation across arms in both trials at any timepoint.

Conclusion: Once-daily roflumilast cream 0.15% improved AD across multiple efficacy endpoints while demonstrating favorable safety and tolerability in two Phase III trials.

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

Long-term safety and efficacy of tralokinumab in adolescents with moderate-to-severe atopic dermatitis: an interim analysis of ECZTEND

Presenters: Eric Simpson,1 Amy Paller,2 Andreas Wollenberg,3 Anthony Bewley,4 Michael Cork,5 Chih-ho Hong,6 Weily Soong,7 Peter Almgren,8 Le Gjerum,8 Anna Carlsson,8 Andrew Blauvelt9

Affiliations: 1Department of Dermatology, Oregon Health & Science University, Portland, OR; 2Feinberg School of Medicine, Northwestern University, Chicago, IL; 3Department of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich, Germany; 4Barts Health NHS Trust, London, UK; 5Sheffield Dermatology Research, Department of Infection, Immunity, and Cardiovascular Disease, The University of Sheffield and Sheffield Teaching Hospitals, NIHR Clinical Research Facility, Sheffield, UK; 6University of British Columbia, Vancouver, BC, Canada; 7AllerVie Health-Alabama Allergy and Asthma Center, Birmingham, AL; 8LEO Pharma A/S, Ballerup, Denmark; 9Oregon Medical Research Center, Portland, OR

Introduction: Atopic dermatitis (AD) is more prevalent in children than adults, with an unmet need for more treatments for moderate-to-severe AD. The interleukin (IL)-13 inhibitor tralokinumab is approved in multiple countries for adults with moderate-to-severe AD. In the Phase III ECZTRA 6 trial (NCT03526861), greater proportions of adolescents (aged 12–17 years, n=289) receiving tralokinumab achieved the primary endpoints of Investigator’s Global Assessment (IGA) 0/1 (150mg/300mg: 21.4%/17.5% vs. placebo: 4.3%; p<0.001/p=0.002) and EASI75 (150mg/300mg: 28.6%/27.8% vs. placebo: 6.4%; p<0.001/p<0.001) at Week 16. Patients completing ECZTRA 6 at sites that participated in the open-label extension trial, ECZTEND (NCT03587805), were eligible to enter ECZTEND. Of 247 patients who completed ECZTRA 6, 127 chose to enroll in ECZTEND.

Objective: To evaluate the efficacy and safety of long-term tralokinumab treatment for moderate-to-severe AD in adolescents.

Methods: ECZTRA 6 participants enrolling in ECZTEND received subcutaneous tralokinumab 300mg every two weeks after a 300mg loading dose, with optional topical corticosteroids. The primary endpoint was the number of adverse events from baseline to Week 268. Secondary endpoints are IGA 0/1 and EASI-75.

Results: The safety analysis set includes all participants from ECZTRA 6 in ECZTEND, who had up to three years of tralokinumab treatment at data cutoff (≤52 weeks in ECZTRA 6 + ≤104 weeks in ECZTEND, n=127). The safety profile was largely consistent with that observed in ECZTRA 6 and for adults in ECZTEND. In an interim efficacy analysis set restricted to patients with 56 weeks in ECZTEND (n=109), 84.4 (n=92/109) and 61.5 percent (n=67/109) of participants achieved EASI75 and IGA 0/1 (as observed; relative to ECZTRA 6 baseline).

Conclusion: This analysis suggests long-term tralokinumab is efficacious and well tolerated for adolescents with moderate-to-severe AD.

Funding/financial disclosures: The ECZTEND study was sponsored by LEO Pharma. Medical writing and editorial assistance were provided by Clair Geary, PhD, and Meredith Whitaker, PhD, from Alphabet Health, funded by LEO Pharma. This work was previously presented at AAD 2023.

ES reports grants and/or personal fees from AbbVie, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, FortéBio, Galderma, Incyte, Kyowa Kirin, LEO Pharma, MedImmune, Menlo Therapeutics, Merck, Novartis, Ortho Dermatologics, Pfizer, Pierre Fabre Dermo Cosmetique, Regeneron, Sanofi, Tioga, and Valeant. AP has been an investigator for AbbVie, Incyte, Eli Lilly, and Regeneron; Data Safety Monitoring Board for AbbVie, Bausch, and Galderma; and consultant for Abbvie, Almirall, Anaptysbio, Arena, BiomX, Boehringer Ingelheim, Eli Lilly, Forte, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi Genzyme. AW has received grants, personal fees, or nonfinancial support from AbbVie, Aileens, Almirall, Beiersdorf, Bioderma, Chugai, Eli Lilly, Galapagos, Galderma, Hans Karrer, LEO Pharma, L’Oréal, Maruho, MedImmune, Merck, Novartis, Pfizer, Pierre Fabre, Regeneron, Santen, and Sanofi-Aventis. A. Bewley has been a consultant for and received consultancy fees or travel bursaries from AbbVie, Almiral, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, Sanofi, and UCB. MC has served as a clinical trial investigator for Astellas, Galapagos, Johnson & Johnson, LEO Pharma, La Roche-Posay, MSD, Novartis, Perrigo, Regeneron, Sanofi Genzyme, and Stiefel; has served as an advisory board member, consultant, and/or invited lecturer for Pfizer Inc., Amgen, Astellas, Bayer, Johnson & Johnson, LEO Pharma, L’Oréal, MSD, Novartis, Regeneron, Sanofi Genzyme, Stiefel, and Unilever; has received honoraria from Astellas, Johnson & Johnson, LEO Pharma, Novartis, Regeneron, Sanofi Genzyme, and Stiefel; and has received research funding from Bayer. CH is a researcher, consultant, and/or advisor for AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Celgene, Dermavant, Dermira, DS Biopharma, Galderma, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Lilly, MedImmune, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, and UCB. WS has received research funding from AbbVie, AstraZeneca, Cara, Galderma, Genentech, GlaxoSmithKline, Glenmark, Innovaderm, LEO Pharma, Mandala, Menlo, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Relaxar, Sanofi, Symbio, Teva, and Vanda Pharmaceuticals; and has received speaker fees from AstraZeneca, GlaxoSmithKline, Optinose, Regeneron Pharmaceuticals, Inc., and Sanofi; and has received consulting fees from AbbVie, Genentech, Regeneron Pharmaceuticals, Inc., and Teva. PA, LG, and AC are employees of LEO Pharma. A. Blauvelt has served as a speaker (received honoraria) for AbbVie, Arcutis, Bristol Myers Squibb, Eli Lilly, Pfizer, Regeneron, Sanofi, and UCB; served as a scientific adviser (received honoraria) for AbbVie, Abcentra, Affibody, Aligos, Almirall, Alumis, Amgen, Anaptysbio, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, EcoR1, Eli Lilly, Escient, Evelo, Evommune, Forte, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo, Merck, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, TLL Pharmaceutical, TrialSpark, UCB, Vibliome, and Xencor; and has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Almirall, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly, Evelo, Evommune, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sun Pharma, and UCB.

Real-world tralokinumab use in dupilumab-experienced patients: a retrospective multicenter case series

Presenters: Edward I. Herman,1 Jessica Burgy,2 Mona Shahriari3

Affiliations: 1South Shore Dermatology Physicians, North Easton, MA; 2Columbia Dermatology, Columbia, SC; 3Yale University School of Medicine, New Haven, CT; CCD Research

Introduction: There is a need for treatment options that offer patients with atopic dermatitis (AD) long-term disease control along with a favorable safety profile. Head-to-head studies of the two available United States Food and Drug Administration (FDA)-approved biologics, dupilumab and tralokinumab, for adults with moderate-to-severe AD have not been performed, and real-world evidence of tralokinumab use in patients that were previously treated with dupilumab is limited.

Objective: To further characterize the tralokinumab efficacy and safety profile by evaluating clinical findings in patients previously treated with dupilumab in routine clinical practice who later switched to tralokinumab.

Methods: Nine adult patients with moderate-to-severe AD previously treated with dupliumab and subsequently switched to tralokinumab were included. Data collected during routine clinical practice related to tralokinumab treatment included duration of treatment, dose, Investigator’s Global Assessment (IGA), body surface area (BSA), patient-reported outcomes (PROs), and adverse events (AEs).

Results: Median (range) baseline IGA score and IGA score at time of tralokinumab administration were four (3–4) and three (2–4), respectively. Median baseline BSA and BSA at time of tralokinumab administration were 20 percent (4–30%) and 10 percent (1–30%), respectively. Disease duration ranged from 1 to 2 years to over 20 years. Duration of dupilumab treatment was 2 to 8 months (n=6). Reasons for discontinuing dupilumab treatment included AEs (n=5) and inadequately controlled AD on dupilumab (n=3). All nine dupilumab-experienced patients were administered on-label tralokinumab (every 2 weeks, n=1; every 4 weeks, n=1) and had been on tralokinumab for 2 to 8 months. At the time of data collection, median (range) IGA and BSA for these patients were zero (0–3) and zero percent (0–10%), respectively. All patients experienced improvements in PROs; 67 percent (n=6/9) reported improvements in itch, with Numerical Rating Scale (NRS) scores of 0/1, 44 percent (n=4/9) reported general clearance of AD signs and symptoms, and 44 percent (n=4/9) reported overall satisfaction of being on tralokinumab. AEs of conjunctivitis (n=3) and joint pain (n=1) completely resolved in patients upon switching from dupilumab to tralokinumab. No AEs were reported, except in one patient with possible mild seborrheic dermatitis/head-neck dermatitis eruption that was treated with topicals, and one patient with herpes labialis; it was unclear if this AE was related to tralokinumab treatment.

Conclusion: This case series suggests that tralokinumab is a potentially effective therapy in patients with moderate-to-severe AD who have failed dupilumab due to lack of efficacy or AEs.

Funding/financial disclosures: Medical writing and editorial support from Alphabet Health by Juliel Espinosa, PhD, was funded by LEO Pharma, Inc. (Madison, NJ) according to Good Publication Practice guidelines (https://www.ismpp.org/gpp-2022). This work was previously presented at CCD 2023.

EIH and JB have no relevant disclosures. MS has been a consultant (received honoraria) for AbbVie, Arcutis, Amgen, Bristol Myers Squibb, Dermavant, Janssen, LEO Pharma, Eli Lilly USA, Novartis, Ortho Dermatologics, Sanofi-Genzyme, Regeneron, UCB; has served as a speaker for Abbvie, Arcutis, Bristol Myers Squibb, Eli Lilly USA, Janssen, Dermavant, Leo Pharma, Sanofi-Genzyme, Regeneron; and has been and investigator for AbbVie, CorEvitas Psoriasis Registry, Dermira, Cara, Dermavant, Novartis, Union, Mindera.

Real-world tralokinumab use in patients with moderate-to-severe atopic dermatitis resistant to systemic therapy: a retrospective case series

Presenter: Elena Pezzolo1,2

Affiliations: 1San Bortolo Hospital, Vicenza, Italy; 2Study Centre of the Italian Group for the Epidemiologic Research in Dermatology (GISED), Bergamo, Italy

Introduction: The systemic biologics dupilumab and tralokinumab are approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) in multiple countries. Head-to-head studies of dupilumab and tralokinumab have not been performed, however, and real-world evidence of tralokinumab use in patients with moderate-to-severe AD who were previously treated with systemic therapies, such as dupilumab, is limited.

Objective: To characterize the tralokinumab efficacy and safety profile by evaluating clinical findings in patients with moderate-to-severe AD resistant to other systemic therapies, including dupilumab, in normal clinical practice who switched to tralokinumab.

Methods: Adult patients with moderate-to-severe AD who were previously treated with one or more systemic therapies and subsequently switched to tralokinumab were included. Data collected during routine clinical practice related to tralokinumab treatment included duration of treatment, dose, Investigator’s Global Assessment (IGA), patient-reported outcomes (PROs), and adverse events (AEs).

Results: Patients (n=36) included 15 dupilumab-experienced patients (mean [range] age: 40.9 [19–80] years; 6/15 [40%] female) and 21 non-dupilumab-experienced patients (mean [range] age: 58 (21–83) years; 14/21 [66.7%] female). Mean (range) disease duration was higher for the dupilumab-experienced group (17.5 [3.0–34.0] years) versus the non-dupilumab-experienced group (7.7 [1.0–21.0] years). Conjunctivitis was the most common comorbidity in both groups (n=8/15 [53.3%] vs. n=5/21 [23.8%]). All patients reported having previously used oral corticosteroids, while 17 of 36 (47.2%) and 15 of 36 (41.7%) used cyclosporine and dupilumab, respectively. All dupilumab-experienced patients had been treated with dupilumab for four months or longer; reasons for discontinuing treatment included inadequately controlled AD on dupilumab (n=12/15 [80%]), conjunctivitis (n=2/15 [13.3%]), and psoriasis (n=1/15 [6.7%]). All 36 patients were administered on-label tralokinumab (300mg) every two weeks and had been on tralokinumab for four months or longer. Similar improvements from baseline were observed in all efficacy outcomes, including improvement in mean Eczema Area and Severity Index (EASI) score from 20.1 and 28.1 to 5.5 and 5.0 at four months for the dupilumab-experienced and non-dupilumab-experienced patients, respectively. Reported AEs possibly related to tralokinumab treatment included injection site reaction (dupilumab-experienced group: n=1; non-dupilumab-experienced group: n=2) and conjunctivitis (dupilumab-experienced group: n=2; non-dupilumab-experienced group: n=1), with one dupilumab-experienced patient reporting that the conjunctivitis was milder on tralokinumab.

Conclusion: This case series supports tralokinumab as a potentially effective therapy in patients with moderate-to-severe AD resistant to other systemic therapies, including those who have discontinued dupilumab treatment due to lack of efficacy or AEs.

Funding/financial disclosures: Medical writing and editorial support from Alphabet Health by Juliel Espinosa, PhD, was funded by LEO Pharma, Inc. (Madison, NJ) according to Good Publication Practice guidelines (https://www.ismpp.org/gpp-2022). This work was previously presented at CCD 2023.

EP has been consultant and speaker for Sanofi Genzyme, LEO Pharma, Novartis, Almirall, Janssen, and AbbVie.

Successful tralokinumab treatment for hand and foot atopic dermatitis in a patient with skin of color: a case report

Presenters: Chloe J. Walker, MD, MHS;1 Porcia B. Love, MD, FAAD1,2

Affiliations: 1River Region Dermatology and Laser, Montgomery, AL; 2University of Alabama at Birmingham School of Medicine, Montgomery Regional Medical Campus, Montgomery, AL

Introduction: Atopic dermatitis (AD) is the most common chronic inflammatory skin condition known to disproportionately affect patients with skin of color, impacting 19 percent of African American children. In darker skin types, AD commonly presents as pruritic violaceous, ashen gray, or dark brown patches and plaques on extensor surfaces with secondary lichenification, papulation, and hyperpigmentation. Tralokinumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically targets interleukin (IL)-13, a dominant proinflammatory type 2 cytokine and a key driver of AD signs and symptoms. Based on trials of tralokinumab monotherapy and combination with topical corticosteroids that demonstrated efficacy and safety, tralokinumab was approved for the treatment of moderate-to-severe AD in adult patients who have failed prescribed topical therapies. There is limited literature discussing tralokinumab clinical efficacy in patients with skin of color, especially in those with hand or foot involvement, which, notoriously, may be difficult to treat. We report a case of AD in a patient with skin of color with hand-foot involvement treated with tralokinumab to highlight the experience of this underrepresented patient population.

Methods: The patient was a 21-year-old female with Fitzpatrick skin type V who presented with a one-year history of pruritic, hyperpigmented, eczematous plaques on the bilateral palms and dorsal feet. The patient previously failed topical tacrolimus, fexofenadine, and montelukast and was currently being treated with topical triamcinolone, clobetasol, and oral hydroxyzine. Past medical history was remarkable for hypertension, seasonal allergic rhinitis, and childhood AD. The patient was continued on clobetasol 0.05% topical ointment five days weekly, triamcinolone 0.1% topical ointment twice weekly, oral cetirizine twice daily, oral hydroxyzine once daily as needed, and ceramide-based moisturizers. After failed oral and topical therapy for six months, the patient was initiated on a tralokinumab 600mg loading dose, followed by 300mg every other week.

Results: After two months of tralokinumab monotherapy, the patient achieved improvement in itch and almost clear skin on the bilateral palms. The patient also noted some improvement of the dorsal feet, with no major adverse events reported. The patient continued on maintenance treatment with tralokinumab 150mg every other week.

Conclusion: New emerging, targeted biological therapies are improving AD management for patients of diverse age groups and ethnicities. Ethnic populations have been shown to have complex immunologic variabilities manifesting in AD, which may potentially impact response to treatment. This case demonstrates successful treatment with tralokinumab in a patient with skin of color and AD. Tralokinumab may be considered as monotherapy or in combination with topical therapy for patients with recalcitrant AD with hand-foot involvement.

Funding/ financial disclosures: Medical writing and editorial support from Alphabet Health by Michelle Dookwah-Smith, PhD was funded by LEO Pharma, Inc. (Madison, NJ) according to Good Publication Practice guidelines (https://www.ismpp.org/gpp-2022). The authors have no relevant disclosures to report.

Psoriasis

Deucravacitinib long-term efficacy and safety in plaque psoriasis: 2-year results from the Phase III POETYK PSO Program

Presenters: Richard B. Warren,1 Howard Sofen,2 Shinichi Imafuku,3 Jacek C. Szepietowski,4 Andrew Blauvelt,5 Lynda Spelman,6 Jessica Toms,7 Alex Buck,7,8 Subhashis Banerjee,7 Alan Menter9

Affiliations: 1Dermatology Centre, Northern Care Alliance NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; 2University of California, Los Angeles School of Medicine and Dermatology Research Associates, Los Angeles, CA; 3Faculty of Medicine, Fukuoka University Hospital, Fukuoka, Japan; 4Wroclaw Medical University, Wroclaw, Poland; 5Oregon Medical Research Center, Portland, OR; 6Veracity Clinical Research, Brisbane, QLD, Australia; 7Bristol Myers Squibb, Princeton, NJ; 8Cytel Inc., Cambridge, MA; 9Baylor University Medical Center, Dallas, TX

Introduction: The efficacy and safety of deucravacitinib were assessed in patients enrolled in the Phase III, double-blind POETYK PSO-1 and PSO-2 trials and the open-label POETYK long-term extension (LTE) trial.

Methods: The 52-week POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials randomized patients with moderate-to-severe plaque psoriasis 1:2:1 to oral placebo, deucravacitinib 6mg once daily, or apremilast 30mg twice daily. Patients could then enroll in the POETYK LTE (NCT04036435) trial and receive open-label deucravacitinib 6mg once daily.

Results: A total of 1,221 patients were enrolled in the POETYK LTE trial and received one or more doses of deucravacitinib. Cumulative exposures in person-years from randomization in POETYK PSO-1 or PSO-2 and the LTE trial were 2,166.9 and 2,482.0 for efficacy and safety analyses, respectively. At enrollment in the POETYK LTE trial, response rates for 75-percent or greater reduction from baseline in Psoriasis Area and Severity Index (PASI75) and static Physician’s Global Assessment (PGA) score of zero (clear) or one (almost clear) with a two-point or greater improvement from baseline (sPGA 0/1) were 65.1 and 50.9 percent, respectively, and were maintained for up to two years after initial randomization (Week 48 of POETYK LTE—PASI75: 75.7%; sPGA 0/1: 56.4% [as observed]). Exposure-adjusted incidence rates per 100 person-years for adverse events were similar in the controlled period (Weeks 0–52) of POETYK PSO-1 and PSO-2 and during the cumulative POETYK PSO-1, PSO-2, and LTE trial period (229.2 [controlled period] vs. 154.4 [cumulative period]), serious adverse events (5.7 vs. 6.1), discontinuations (4.4 vs. 2.8), deaths (0.2 vs. 0.4), herpes zoster (0.9 vs. 0.7), malignancies (1.0 vs. 0.9), major adverse cardiovascular events (0.3 vs. 0.4), and venous thromboembolism (0.1 vs. 0.1).

Conclusion: Deucravacitinib demonstrated persistent efficacy and consistent safety profiles for up to two years after initial randomization in the POETYK PSO-1, PSO-2, and LTE trials.

Funding/financial disclosures: This study was sponsored by Bristol Myers Squibb. Writing and editorial assistance was provided by Lisa Feder, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.

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. HS: Clinical investigator: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, LEO Pharma, Novartis, and Sun Pharma. SI: Grants and personal fees: AbbVie, Eisai, Janssen, Kyowa Kirin, Leo Pharma, Maruho, Sun Pharma, Taiho Yakuhin, Tanabe Mitsubishi, and Torii Yakuhin; personal fees: Amgen (Celgene), Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Novartis, and UCB. JCS: Advisory board member/consultant: AbbVie, Leo Pharma, Novartis, Pierre-Fabre, Sanofi Genzyme, and Trevi; speaker: AbbVie, Eli Lilly, Janssen-Cilag, Leo Pharma, Novartis, and Sanofi Genzyme; Investigator: AbbVie, Amgen, Bristol Myers Squibb, Galapagos, Galderma, Incyte, InfraRX, Janssen-Cilag, Manlo Therapeutics, Merck, Novartis, Pfizer, Regeneron, UCB, and Trevi. AB: Speaker (with honoraria): AbbVie, Bristol Myers Squibb, Eli Lilly, Pfizer, Regeneron, and Sanofi; 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, CTI BioPharma, Dermavant, EcoR1, Eli Lilly, Escient, Evelo Biosciences, Evommune, Forte Biosciences, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Lipidio, Merck, Nektar, Novartis, Pfizer, 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 (clinical study funds received by institution): AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly, Evelo Biosciences, Evommune, Galderma, Incyte, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB, and Ventyx Biosciences. LS: Consultant, paid investigator, and/or speaker: AbbVie, Amgen, Anacor, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Bristol Myers Squibb, Boehringer Ingelheim, Botanix, Celgene, Dermira, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Hexima, Janssen, LEO Pharma, Mayne, Medimmune, Merck, Merck-Serono, Novartis, Otsuka, Pfizer, Phosphagenics, Photon MD, Regeneron, Roche, Samumed, Sanofi Genzyme, SHR Pharmacy, Sun Pharma ANZ, Trius, UCB, and Zai Lab. EC, JT, and SB: Employees and shareholders: Bristol Myers Squibb. AB: Contractor (through functional service provider Cytel): Bristol Myers Squibb. AM: Advisory board: Abbott Labs, Amgen, Boehringer Ingelheim, Janssen Biotech, LEO Pharma; consultant: Abbott Labs, Amgen, Eli Lilly, Janssen Biotech, LEO Pharma, Novartis, Sun Pharma, and UCB; honoraria: Abbott Labs, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen Biotech, LEO Pharma, Novartis, Sun Pharma, and UCB; investigator: Abbott Labs, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Biotech, LEO Pharma, Merck, Novartis, Sun Pharma, and UCB; research grants: Abbott Labs, Amgen, Boehringer Ingelheim, Celgene, Janssen Biotech, LEO Pharma, Merck, and Sun Pharma; speaker: Abbott Labs, Amgen, Janssen Biotech, LEO Pharma, Sun Pharma, and UCB.

Seborrheic Dermatitis

Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a Phase III trial: assessment of pruritus

Presenters: Andrew Blauvelt,1 Zoe D. Draelos,2 Melinda Gooderham,3 Edward Lain,4 Angela Y. Moore,5 Kim A. Papp,6 Matthew Zirwas,7 David Krupa,8 Patrick Burnett,8 David R. Berk,8 David H. Chu8

Affiliations: 1Oregon Medical Research Center, Portland, OR; 2Dermatology Consulting Services, High Point, NC; 3SKiN Centre for Dermatology, Probity Medical Research and Queen’s University, Peterborough, ON, Canada; 4Sanova Dermatology, Austin, TX; 5Arlington Research Center, Arlington, TX, and Baylor University Medical Center, Dallas, TX; 6Probity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada; 7Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley, OH; 8Arcutis Biotherapeutics, Inc., Westlake Village, CA

Introduction: Itch is a major complaint among patients with seborrheic dermatitis (SD). Roflumilast is a selective, nonsteroidal, highly potent phosphodiesterase 4 inhibitor under investigation as a once-daily foam for treatment of SD.

Methods: This Phase III, randomized, parallel-group, double-blind, vehicle-controlled trial (NCT04973228) was conducted in patients aged nine years or older with at least moderate SD affecting scalp and/or non-scalp areas. Patients were randomized 2:1 to apply once-daily roflumilast foam 0.3% (n=304) or vehicle (n=153) for eight weeks. The primary efficacy endpoint was Investigator’s Global Assessment (IGA) success (clear/almost clear plus ≥2-grade improvement from baseline) at Week 8. Secondary efficacy endpoints included Worst Itch Numeric Rating Scale (WI-NRS), which was completed daily by patients. Safety and local tolerability were also evaluated.

Results: Overall, significantly more roflumilast-treated patients than vehicle-treated patients achieved IGA success (79.5% vs. 58.0%; p<0.0001) and IGA status of clear (50.6% vs. 27.7%; p<0.0001) at Week 8. Significantly greater percentages of roflumilast-treated patients, compared to vehicle-treated patients, had four-point or greater improvement on WI-NRS at Weeks 2 (32.7% vs. 15.5%; p=0.0016), 4 (47.6% vs. 29.1%; p=0.0007), and 8 (62.8% vs. 40.6%; p=0.0001). Greater improvement in itch was observed among roflumilast-treated patients as early as 48 hours after the first application (mean percent change from baseline: –27.87% vs. –13.11%; nominal p=0.0024). Local tolerability and safety were favorable.

Conclusion: Once-daily roflumilast foam provided improvement across multiple efficacy endpoints, including rapid itch improvement, while demonstrating favorable safety and tolerability.

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

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