Long-Term Safety and Efficacy with Roflumilast Cream 0.15% in Patients Aged ≥6 Years with Atopic Dermatitis: A Phase 3 Open-Label Extension Trial

Eric L. Simpson, From the Oregon Health & Science University, Portland, OR, USA.
Lawrence F. Eichenfield, Departments of Dermatology and Pediatrics, Rady's Children's Hospital-San Diego, University of California San Diego, La Jolla, CA, USA.
Kim A. Papp, Probity Medical Research and Alliance Clinical Trials, Waterloo, Canada.
Seth B. Forman, ForCare Medical Center, Tampa, FL, USA.
Adelaide A. Hebert, UTHealth McGovern Medical School, Houston, TX, USA.
Mercedes E. Gonzalez, Pediatric Skin Research, LLC Miami, FL, USA.
Melinda J. Gooderham, SKiN Centre for Dermatology, Probity Medical Research, and Queen's University, Peterborough, Canada.
H Chih-Ho Hong, Probity Medical Research and Department of Dermatology and Skin Science, University of British Columbia, Surrey, BC, Canada.
Vimal H. Prajapati, Probity Medical Research, Dermatology Research Institute, Skin Health & Wellness Centre, and University of Calgary, Calgary, Canada.
Emma Guttman-Yassky, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Jonathan I. Silverberg, Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Melissa S. Seal, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
David Krupa, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Erin Almaraz, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Diane Hanna, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Patrick Burnett, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Scott Snyder, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
David H. Chu, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Robert C. Higham, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
David R. Berk, Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.

Document Type

Journal Article

Publication Date

1-10-2025

Journal

Dermatitis : contact, atopic, occupational, drug

DOI

10.1089/derm.2024.0418

Abstract

Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials. Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.15% in AD. In this open-label extension (OLE) trial (INTEGUMENT-OLE; NCT04804605), patients aged ≥6 years who completed one of the 4-week phase 3 trials applied roflumilast for up to 52 weeks. After 4 weeks of once-daily application, patients who achieved Validated Investigator Global Assessment for AD (vIGA-AD) of clear (0) switched to twice-weekly (BIW) application to normal-appearing flare-prone areas (proactive treatment). Among 657 patients treated, 36.7% reported adverse events, including 4.7% that were treatment related. Application site pain and stinging/burning that caused definite discomfort at any visit were reported for 0.5% and 0.4%-2.1% of patients, respectively. Patients who achieved vIGA-AD 0 and switched to proactive BIW application maintained vIGA-AD 0/1 (almost clear) for a median of 281 days (Kaplan-Meier estimate). Roflumilast cream 0.15% was well tolerated for up to 56 weeks. BIW application to normal-appearing flare-prone sites maintained improvement in AD signs and symptoms, showing that proactive treatment represents an alternative to the current standard practice of reactive treatment.

Department

Dermatology

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