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
<u><b><i></i></b><b><i>Background:</i></b></u> Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials.<u><b><i>Objective:</i></b></u> Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.15% in AD.<u><b><i>Methods:</i></b></u> 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).<u><b><i>Results:</i></b></u> 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).<u><b><i>Conclusion:</i></b></u> 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.
Authors
- Melinda Gooderham (ORCID: https://orcid.org/0000-0001-8926-0113)
- Kim Papp (ORCID: https://orcid.org/0000-0001-9557-3642)
- Jonathan I. Silverberg (ORCID: https://orcid.org/0000-0003-3686-7805)
- Robert Higham
- Emma Guttman‐Yassky (ORCID: https://orcid.org/0000-0002-9363-324X)
- Patrick Burnett (ORCID: https://orcid.org/0000-0002-7123-9161)
- Vimal H. Prajapati (ORCID: https://orcid.org/0000-0002-8315-2522)
- Hwanhee Hong (ORCID: https://orcid.org/0000-0002-3736-6327)
- Melissa S. Seal
- Lawrence F. Eichenfield (ORCID: https://orcid.org/0000-0002-2760-0474)
- Diane T. Hanna (ORCID: https://orcid.org/0000-0003-1162-9341)
- Seth Forman (ORCID: https://orcid.org/0000-0001-5800-1856)
- Adelaide A. Hebert (ORCID: https://orcid.org/0000-0002-9167-5729)
- S. Snyder (ORCID: https://orcid.org/0000-0001-8610-8423)
- Mercedes E. González (ORCID: https://orcid.org/0000-0001-8346-8298)
- Eric L. Simpson (ORCID: https://orcid.org/0000-0002-8793-7087)
- David H. Chu (ORCID: https://orcid.org/0000-0001-7797-3829)
- David R. Berk
- David Krupa
- Erin Almaraz
Institutions
- University of British Columbia (CA)
- Oregon Health & Science University (US)
- University of Calgary (CA)
- University of Toronto (CA)
- George Washington University (US)
- Queen's University (CA)
- University of California San Diego (US)
- Rady Children's Hospital-San Diego (US)
- Probity Medical Research (CA)
- MemorialCare Health System (US)
- Atara Biotherapeutics (United States) (US)
- Digital Research Alliance of Canada
- The University of Texas Health Science Center at Houston (US)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- Dermatitis
- Published
- 2025-01-10
- DOI
- https://doi.org/10.1089/derm.2024.0418
- Citations
- 7
- Primary Topic
- Dermatology and Skin Diseases
- Type
- article
- Field-Weighted Citation Impact
- 14.03