Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD)

Eric Simpson, Abhijit Gadkari, Margitta Worm, Weily Soong, Andrew Blauvelt, Laurent Eckert, Richard Wu, Marius Ardeleanu, Neil M H Graham, Gianluca Pirozzi, E. Rand Sutherland, Vera Mastey

Research output: Contribution to journalArticle

75 Scopus citations

Abstract

Background: Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies. Objective: We sought to evaluate dupilumab treatment on patient-reported outcomes in adults with moderate to severe AD. Methods: Adults (N = 380) with moderate to severe AD inadequately controlled by topical medications were randomized to 16 weeks of double-blind, subcutaneous treatment with dupilumab 100 mg every 4 weeks, 200 mg every 2 weeks, 300 mg every 2 weeks, 300 mg once weekly, or placebo. Patient-reported outcomes included pruritus numeric rating scale; patient-reported sleep item on Scoring AD scale; Patient-Oriented Eczema Measure; Hospital Anxiety and Depression Scale; Dermatology Life Quality Index; and 5-dimension 3-level EuroQol. Results: Dupilumab reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on numeric rating scale (P <.0001 all doses, except 100 mg every 4 weeks . P <.05); improved sleep and health-related quality of life on Dermatology Life Quality Index and 5-dimension 3-level EuroQol (P <.05 all doses, except 100 mg every 4 weeks); and reduced anxiety and depression symptoms (P <.05 all doses). Dupilumab's effects appeared early and achieved clinically relevant improvements without significant safety concerns. Limitations: There are potential cultural differences affecting patient-reported outcome responses. Outcomes were secondary or exploratory end points. Conclusion: Dupilumab produced early and sustained patient-reported and clinically relevant improvements in sleep, mental health, and health-related quality of life; the two 300-mg dose regimens resulted in greatest benefits.

Original languageEnglish (US)
JournalJournal of the American Academy of Dermatology
DOIs
Publication statusAccepted/In press - 2016

    Fingerprint

Keywords

  • Adults
  • Atopic dermatitis
  • Disease burden
  • Dupilumab
  • Patient-reported outcomes
  • Pruritus
  • Quality of life

ASJC Scopus subject areas

  • Dermatology

Cite this