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)
| Autor: | Andrew Blauvelt, Laurent Eckert, Marius Ardeleanu, Neil M.H. Graham, Vera Mastey, Abhijit Gadkari, Weily Soong, Eric L. Simpson, Richard Wu, Gianluca Pirozzi, E. Rand Sutherland, Margitta Worm |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Injections Subcutaneous Dermatology Hospital Anxiety and Depression Scale Placebo Antibodies Monoclonal Humanized Risk Assessment Severity of Illness Index Drug Administration Schedule Dermatitis Atopic 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine Severity of illness medicine Humans 030212 general & internal medicine SCORAD Patient Reported Outcome Measures medicine.diagnostic_test Dose-Response Relationship Drug business.industry Minimal clinically important difference Antibodies Monoclonal Dermatology Life Quality Index Middle Aged Dupilumab Treatment Outcome Patient Satisfaction Physical therapy Quality of Life Patient-reported outcome Female business Follow-Up Studies |
| Zdroj: | Journal of the American Academy of Dermatology. 75(3) |
| ISSN: | 1097-6787 |
| Popis: | Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies.We sought to evaluate dupilumab treatment on patient-reported outcomes in adults with moderate to severe AD.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.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.There are potential cultural differences affecting patient-reported outcome responses. Outcomes were secondary or exploratory end points.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. |
| Databáze: | OpenAIRE |
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