Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis

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  • Lisa A. Beck, University of Rochester
  • ,
  • Diamant Thaçi, University of Lübeck
  • ,
  • Mette Deleuran
  • Andrew Blauvelt, Oregon Medical Research Center
  • ,
  • Robert Bissonnette, Innovaderm Research
  • ,
  • Marjolein de Bruin-Weller, Utrecht University
  • ,
  • Michihiro Hide, Hiroshima University
  • ,
  • Lawrence Sher, Peninsula Research Associates
  • ,
  • Iftikhar Hussain, Vital Prospects Clinical Research Institute
  • ,
  • Zhen Chen, Regeneron Pharmaceuticals, Inc.
  • ,
  • Faisal A. Khokhar, Regeneron Pharmaceuticals, Inc.
  • ,
  • Bethany Beazley, Regeneron Pharmaceuticals, Inc.
  • ,
  • Marcella Ruddy, Regeneron Pharmaceuticals, Inc.
  • ,
  • Naimish Patel, Sanofi-Aventis
  • ,
  • Neil M.H. Graham, Regeneron Pharmaceuticals, Inc.
  • ,
  • Marius Ardeleanu, Regeneron Pharmaceuticals, Inc.
  • ,
  • Brad Shumel, Regeneron Pharmaceuticals, Inc.

Background: Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment. Objective: The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD. Methods: This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety. Results: Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, − 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, − 65.4%) at week 148. Limitations: No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose. Conclusion: These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD. Trial Registration: ClinicalTrials.gov: NCT01949311. Video abstract: [MediaObject not available: see fulltext.]

OriginalsprogEngelsk
TidsskriftAmerican Journal of Clinical Dermatology
Vol/bind21
Nummer4
Sider (fra-til)567-577
ISSN1175-0561
DOI
StatusUdgivet - aug. 2020

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