Phase 2a randomized clinical trial of dupilumab (anti‐IL‐4Rα) for alopecia areata patients
| Autor: | Mark Lebwohl, Emma Guttman-Yassky, Giselle Singer, Jason E. Hawkes, Yael Renert-Yuval, Jennifer Bares, Margot Chima, Patricia Gilleaudeau, Sandra Garcet, Ana B. Pavel, James G. Krueger, Mary Sullivan-Whalen |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Treatment response biology business.industry Immunology Atopic dermatitis Alopecia areata Immunoglobulin E Placebo medicine.disease Gastroenterology Dupilumab Article law.invention Randomized controlled trial law Internal medicine Concomitant biology.protein Immunology and Allergy Medicine business |
| Zdroj: | Allergy |
| ISSN: | 1398-9995 0105-4538 |
| Popis: | BACKGROUND Treatments for alopecia areata (AA) patients with extensive scalp hair loss are limited, and recent evidence supports a role for type 2 T-cell (Th2)-immune response in AA. Dupilumab, a monoclonal antibody inhibiting Th2 signaling, approved for type 2 diseases including atopic dermatitis, was evaluated in AA patients. METHODS Alopecia areata patients with and without concomitant atopic dermatitis were randomized 2:1 to receive weekly subcutaneous dupilumab (300 mg) or placebo for 24 weeks, followed by another 24-week dupilumab open-label phase. The primary outcome was change from baseline in the Severity of Alopecia Tool (SALT) score at week 24; secondary outcomes included a range of measures of hair regrowth. RESULTS Forty and 20 patients were assigned to the dupilumab and placebo arms, respectively. At week 24, disease worsening was documented in the placebo arm, with a least-squares mean change in the SALT score of -6.5 (95% confidence-interval [CI], -10.4 to -2.6), versus a change of 2.2 (95% CI, -0.6 to 4.94) in the dupilumab arm (p |
| Databáze: | OpenAIRE |
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