Abstract
Background: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD). Objective: To assess the long-term safety and efficacy of dupilumab in patients with AD. Methods: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. Results: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life. Limitations: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks. Conclusion: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.
| Original language | English |
|---|---|
| Journal | Journal of the American Academy of Dermatology |
| Volume | 82 |
| Issue number | 2 |
| Pages (from-to) | 377-388 |
| Number of pages | 12 |
| ISSN | 0190-9622 |
| DOIs | |
| Publication status | Published - 02.2020 |
Funding
Supported by Sanofi and Regeneron Pharmaceuticals, Inc. Medical writing and editorial assistance were funded by Sanofi and Regeneron Pharmaceuticals.Disclosure: Dr Deleuran provides research support, has consulting/advisory board agreements, and/or has received honoraria for lecturing from AbbVie, Eli Lilly, Galapagos, LEO Pharma, Meda, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals, and Sanofi Genzyme. Dr Tha?i has received honoraria for participation on ad boards, as a speaker, and for consultancy from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dignity, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, LEO Pharma, Morphosis, Merck Sharp & Dohme, Novartis, Pfizer, Sandoz-Hexal, Pfizer, Regeneron Pharmaceuticals, Sanofi, and UCB and has received research grants from Celgene and Novartis. Dr Beck serves as a consultant/advisory board member for AbbVie, Boehringer Ingelheim, Eli Lilly, Menlo Therapeutics, Novan, Realm Therapeutics, Regeneron Pharmaceuticals, and Sanofi Genzyme and is a clinical study investigator for AbbVie, Regeneron Pharmaceuticals, and Realm Therapeutics. Dr de Bruin-Weller is a principal investigator and advisory board member for AbbVie; is an advisory board member for Eli Lilly; is a principal investigator for LEO Pharma; is a principal investigator and advisory board member for Pfizer; is a principal investigator, provides research support, has received honoraria for lecturing, and is an advisory board member and consultant for Regeneron Pharmaceuticals and Sanofi Genzyme; and is an advisory board member for UCB. Dr Blauvelt is a scientific advisor and clinical study investigator for AbbVie, Aclaris, Akros, Allergan, Almirall, Amgen, Arena, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, LEO Pharma, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron Pharmaceuticals, Revance, Sandoz, Sanofi Genzyme, Sienna Biopharmaceuticals, Sun Pharma, UCB, Valeant, and Vidac and is a paid speaker for Janssen, Regeneron Pharmaceuticals, and Sanofi Genzyme. Dr Forman has received consulting fees from AbbVie, Cellceutix, Galderma, and Psoria-Light; lecture fees from AbbVie and Novartis; and grant support from AstraZeneca, Eli Lilly, Incyte, Janssen, Novartis, Promius, Regeneron Pharmaceuticals, Pfizer, and Valeant. Dr Bissonnette is a consultant for and/or has received grants/research support from AbbVie, Aquinox Pharma, Arcutis Antiobix, Asana, Astellas, Boehringer Ingelheim, Brickell Biotech, Dermavant, Dermira, Dignity Sciences, Eli Lilly, Galderma, Glenmark, GlaxoSmithKline-Stiefel, Hoffman-La Roche, Kiniksa, Incyte, LEO Pharma, Neokera, Pfizer, Ralexar, Regeneron Pharmaceuticals, Sanofi Genzyme, and Vitae and is a shareholder of Innovaderm Research. Dr Reich is an advisor and/or paid speaker and/or investigator for AbbVie, Affibody, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Covagen, Forward Pharma, Fresenius Medical Care, GlaxoSmithKline, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Eli Lilly, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron Pharmaceuticals, Samsung Bioepis, Sanofi, Takeda, UCB, Valeant, and XenoPort. Dr Soong has received research funding from 3M, Aimmune, AstraZeneca, Circassia, Genentech, Galderma, Glenmark, LEO Pharma, Menlo Therapeutics, Novartis, Optinose, Pfizer, Regeneron Pharmaceuticals, Ralexar, Roche, Sanofi, Stallergenes, and Teva; has received speaking fees from AstraZeneca, Circassia, Optinose, Roche-Genentech, GlaxoSmithKline, Sanofi, Regeneron Pharmaceuticals, and Teva; and has received consulting fees from AbbVie, ALK, AstraZeneca, Regeneron Pharmaceuticals, Stallergenes, and Teva. Dr Hussain is an investigator for Regeneron Pharmaceuticals and Shire. Dr Foley has received honoraria and/or research grants and/or has served as an investigator and/or advisory board member for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Celtaxsys, Cutanea, Dermira, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Sanofi, Sun Pharma, UCB Pharma, and Valeant. Dr Hide has received research funding, consulting fees, and/or speaking fees from GlaxoSmithKline, Kaken Pharmaceutical, Kyowa Hakko Kirin, Mitsubishi-Tanabe, Merck Sharp & Dohme, Taiho Pharmaceutical, Teikoku Seiyaku, and Sanofi. Dr Bouaziz has received speaking fees from Novartis; consulting fees from Eli Lilly and Neovacs; a research grant from Therakos; and a travel grant from AbbVie, Janssen, and Sanofi. Dr Gelfand has received consulting fees/honoraria from AbbVie, Coherus, Janssen Biologics (formerly Centocor), Merck, Novartis, Valeant, and Pfizer; receives research grants (to the Trustees of the University of Pennsylvania) from AbbVie, Eli Lilly, Janssen, Novartis, Regeneron Pharmaceuticals, Sanofi, and Pfizer; has done continuing medical education work related to Lilly and AbbVie; and is a co-patent holder of resiquimod for treatment of cutaneous T-cell lymphoma. Dr Sher serves on the advisory board of and as speaker for Aimmune, Optinose, Regeneron Pharmaceuticals, and Sanofi and does research for Aimmune, DBV, Galderma, GlaxoSmithKline, Optinose, Pfizer, Regeneron Pharmaceuticals, Sanofi, Teva, and Watson. Dr Schuttelaar has received honoraria for participation on advisory boards for Sanofi Genzyme and has participated in clinical trials with AbbVie, Novartis, and Sanofi Genzyme. Dr Akinlade, Dr Ardeleanu, Dr Chen, Dr Davis, Dr Gadkari, Dr Graham, Dr Rajadhyaksha, and Dr Wang are employees and shareholders of Regeneron Pharmaceuticals, Inc. Drs Eckert, Pirozzi, and Staudinger are employees of and may hold stock and/or stock options in Regeneron Pharmaceuticals.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
