Eric L Simpson1, Abhijit Gadkari2, Margitta Worm3, Weily Soong4, Andrew Blauvelt5, Laurent Eckert6, Richard Wu2, Marius Ardeleanu2, Neil M H Graham2, Gianluca Pirozzi7, E Rand Sutherland8, Vera Mastey2. 1. Department of Dermatology, Oregon Health and Science University, Portland, Oregon. Electronic address: simpsone@ohsu.edu. 2. Regeneron Pharmaceuticals Inc, Tarrytown, New York. 3. Department of Dermatology and Allergy, Charité University, Berlin, Germany. 4. Alabama Allergy and Asthma Center, Birmingham, Alabama. 5. Oregon Medical Research Center, Portland, Oregon. 6. Sanofi, Paris, France. 7. Sanofi, Bridgewater, New Jersey. 8. Sanofi, Cambridge, Massachusetts.
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.
RCT Entities:
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.
Authors: Maria C Schneeweiss; Richard Wyss; Kristyn Chin; Joseph F Merola; Jonathan I Silverberg; Arash Mostaghimi; Sebastian Schneeweiss Journal: Dermatitis Date: 2022-02-15 Impact factor: 4.867
Authors: Lawrence F Eichenfield; April Armstrong; Emma Guttman-Yassky; Peter A Lio; Chi-Chang Chen; Dionne M Hines; Catherine B McGuiness; Sohini Ganguli; Dimittri Delevry; Debra Sierka; Usha G Mallya Journal: Dermatol Ther (Heidelb) Date: 2022-05-11