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, Lawrence F. Eichenfield, Kim Papp, Seth Forman, Adelaide A. Hebert, Mercedes E. González, Melinda Gooderham, Hwanhee Hong, Vimal H. Prajapati, Emma Guttman‐Yassky, Jonathan I. Silverberg, Melissa S. Seal, David Krupa, Erin Almaraz, Diane Hanna, Patrick Burnett, Scott Snyder, David H. Chu, Robert Higham, David R. Berk
Abstract
Abstract: Background: Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials. Objective: Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.15% in AD. Methods: 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). Results: 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). Conclusion: 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.