April 23–25, 2021
Join Amgen at AAD VMX 2021 for the latest information and education in dermatology.
Below is a selection of Amgen-sponsored presentations.
Improvements and Response Achievement in PASI Subscale Domains for Head Scaling and Erythema in Apremilast-Treated Patients With Moderate to Severe Plaque Psoriasis of the Scalp: Results From the STYLE Study
Kim Papp, MD, PhD1,2; Abby Van Voorhees, MD3; Linda Stein Gold, MD4; Mark Lebwohl, MD5; Bruce Strober, MD, PhD6,7; Zuoshun Zhang, PhD8; Yao Wang, MD8
1Probity Medical Research, Waterloo, Ontario, Canada; 2K Papp Clinical Research, Waterloo, Ontario, Canada; 3Eastern Virginia Medical School, Norfolk, VA, USA; 4Henry Ford Health System, West Bloomfield, MI, USA; 5Icahn School of Medicine at Mount Sinai, New York, NY, USA; 6Yale University, New Haven, CT, USA; 7Central Connecticut Dermatology, Cromwell, CT, USA; 8Amgen Inc., Thousand Oaks, CA, USA
Objectives: To evaluate the changes in PASI subscale domains for head scaling and head erythema through 16 weeks in patients with moderate-to-severe plaque psoriasis of the scalp receiving apremilast.
To determine the proportion of patients achieving response in head scaling and head erythema domains through 16 weeks in patients with moderate-to-severe psoriasis of the scalp receiving apremilast.
Background: Up to 80% of patients with psoriasis have scalp involvement. Apremilast 30 mg BID (APR) demonstrated efficacy in the phase 3 STYLE study of moderate-to-severe scalp psoriasis. We report a post hoc analysis of the head scaling and head erythema PASI subscale domains.
Methods: Patients with moderate-to-severe plaque psoriasis (PASI ≥12, BSA ≥10%, sPGA ≥3) and moderate-to-severe scalp psoriasis (baseline Scalp PGA score ≥3, psoriasis-involved scalp surface area ≥20%) with inadequate response/intolerance to ≥1 topical therapy were randomized to double-blind treatment with APR or placebo (PBO) for 16 weeks.
Results: Baseline mean (SD) PASI head scaling scores were 2.8 (0.7) for APR (n=201) and PBO (n=102); head erythema scores were 2.9 (0.6) and 2.8 (0.6). Significantly greater mean percentage changes from baseline were observed at Week 16 with APR vs. PBO in head scaling (APR: −52.2 [95% CI: −57.9, −46.4] vs. PBO: −26.9 [95% CI: −34.4, −19.4]) and head erythema scores (APR: −53.1 [95% CI: −59.1, −47.2] vs. PBO: −25.0 [95% CI: −32.0, −17.9]). Improvements were observed as early as Week 2. Significantly more APR vs. PBO patients achieved Week 16 responses (score of 0 [none] or 1 [slight]) on head scaling (55.4% [95% CI: 47.5, 63.0] vs. 31.0% [95% CI: 21.3, 42.0]; P=0.0002) and erythema (55.4% [95% CI: 47.5, 63.0] vs. 23.8% [95% CI: 15.2, 34.3]; P<0.0001).
Conclusions: Patients with moderate-to-severe scalp psoriasis had greater improvements in PASI subscale scores (head scaling, head erythema); greater proportions of patients achieved head scaling and erythema responses with APR vs. PBO.
Disclosures
KP: AbbVie, Allergan, Amgen, Anacor, Astellas, Baxalta, Biogen-Idec, Boehringer Ingelheim, BMS, Celgene Corporation, Dermira, Dow Pharma, Eli Lilly, Galderma, Genentech, Glenmark, GSK, Janssen, Kyowa Hakko Kirin, LEO Pharma, MedImmune, Merck, Merck Serono, Mylan, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis, Stiefel, Takeda, UCB, Valeant – grant/research support.
AVV: AbbVie, Celgene, and Lilly – investigator; AbbVie, Allergan, AstraZeneca, Celgene, Dermira, Merck, Novartis, Pfizer, UCB, and Valeant – advisor and/or consultant.
LSG: Celgene Corporation, LEO Pharma, Novartis, Pfizer, and Stiefel/GlaxoSmithKline – investigator and/or consultant.
ML: Mount Sinai (which receives funds from Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Janssen/Johnson & Johnson, Kadmon, MedImmune/AstraZeneca, Novartis, Pfizer, and ViDac).
BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Boehringer Ingelheim, Bristol-Myers-Squibb, Celgene, Dermavant, Dermira, Equillium, Janssen, Leo, Eli Lilly, Meiji Seika Pharma, Mindera, Novartis, Pfizer, GlaxoSmithKline, UCB Pharma, Sun Pharma, Ortho Dermatologics, Regeneron, Sanofi-Genzyme; Speaker: AbbVie, Amgen, Eli Lilly, Janssen, Ortho Dermatologics; Scientific Director (consulting fee): Corrona Psoriasis Registry; Investigator: Dermavant, AbbVie, Corrona Psoriasis Registry, Dermira, Cara, Novartis, AbbVie.
ZZ & YW: Amgen, Inc. – employment; Celgene Corporation – employment at the time of study conduct.