Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

DOI

  • Mette Deleuran
  • Diamant Thaçi, University of Luebeck
  • ,
  • Lisa A. Beck, University of Rochester
  • ,
  • Marjolein de Bruin-Weller, Utrecht University
  • ,
  • Andrew Blauvelt, Oregon Medical Research Center
  • ,
  • Seth Forman, Forman Dermatology and Skin Cancer Institute
  • ,
  • Robert Bissonnette, Innovaderm Research
  • ,
  • Kristian Reich, University Medical Center Hamburg-Eppendorf, Dermatologikum Berlin
  • ,
  • Weily Soong, Alabama Allergy & Asthma Center
  • ,
  • Iftikhar Hussain, Vital Prospects Clinical Research Institute
  • ,
  • Peter Foley, University of Melbourne
  • ,
  • Michihiro Hide, Hiroshima University
  • ,
  • Jean David Bouaziz, Hôpital Saint-Louis
  • ,
  • Joel M. Gelfand, University of Pennsylvania
  • ,
  • Lawrence Sher, Peninsula Research Associates
  • ,
  • Marie L.A. Schuttelaar, University of Groningen
  • ,
  • Chen Wang, Regeneron Pharmaceuticals, Inc.
  • ,
  • Zhen Chen, Regeneron Pharmaceuticals, Inc.
  • ,
  • Bolanle Akinlade, Regeneron Pharmaceuticals, Inc.
  • ,
  • Abhijit Gadkari, Regeneron Pharmaceuticals, Inc.
  • ,
  • Laurent Eckert, Rhône-Poulenc Rorer Central Research
  • ,
  • John D. Davis, Regeneron Pharmaceuticals, Inc.
  • ,
  • Manoj Rajadhyaksha, Regeneron Pharmaceuticals, Inc.
  • ,
  • Heribert Staudinger, Rhône-Poulenc Rorer Central Research
  • ,
  • Neil M.H. Graham, Regeneron Pharmaceuticals, Inc.
  • ,
  • Gianluca Pirozzi, Rhône-Poulenc Rorer Central Research
  • ,
  • Marius Ardeleanu, Regeneron Pharmaceuticals, Inc.

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.

OriginalsprogEngelsk
TidsskriftJournal of the American Academy of Dermatology
Vol/bind82
Nummer2
Sider (fra-til)377-388
Antal sider12
ISSN0190-9622
DOI
StatusUdgivet - 2020

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