• Mette Deleuran, Diamant Thaçi, Lisa A Beck, Marjolein de Bruin-Weller, Andrew Blauvelt, Seth Forman, Robert Bissonnette, Kristian Reich, Weily Soong, Iftikhar Hussain, Peter Foley, Michihiro Hide, Jean-David Bouaziz, Joel M Gelfand, Lawrence Sher, Marie L A Schuttelaar, Chen Wang, Zhen Chen, Bolanle Akinlade, Abhijit Gadkari, Laurent Eckert, John D Davis, Manoj Rajadhyaksha, Heribert Staudinger, GrahamNeil M HNMHRegeneron Pharmaceuticals, Inc, Tarrytown, New York., Gianluca Pirozzi, and Marius Ardeleanu.
• Aarhus University Hospital, Aarhus, Denmark. Electronic address: mettdele@rm.dk.
• J. Am. Acad. Dermatol. 2020 Feb 1; 82 (2): 377-388.

BackgroundSignificant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD).ObjectiveTo assess the long-term safety and efficacy of dupilumab in patients with AD.MethodsThis 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.ResultsOf 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.LimitationsLack 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.ConclusionThe safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

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