Journal of the American Academy of Dermatology · 2008
Subcutaneous efalizumab is not effective in the treatment of alopecia areata.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Price Vera H, Hordinsky Maria K, Olsen Elise A, Roberts Janet L, Siegfried Elaine C, Rafal Elyse S, Korman Neil J, Altrabulsi Basel, Leung Hoi M, Garovoy Marvin R, Caro Ivor, Whiting David A
Аннотация
BACKGROUND: Alopecia areata (AA) is a T-cell-mediated autoimmune disease. Efalizumab is a T-cell-targeted therapy approved for the treatment of psoriasis.
OBJECTIVE: To assess the efficacy and safety of efalizumab in the treatment of moderate-to-severe AA.
METHODS: Sixty-two patients were enrolled into this phase II, placebo-controlled trial. The trial consisted of three 12-week periods-a double-blind treatment period, an open-label efalizumab treatment period, and a safety follow-up.
RESULTS: There were no statistical differences between treatment groups in percent hair regrowth, quality-of-life measures, or changes in biologic markers of disease severity after 12 or 24 weeks. In both groups, there was an approximately 8% response rate for hair regrowth (at 12 weeks). Efalizumab was well tolerated.
LIMITATIONS: Numbers were too small for certain analyses.
CONCLUSION: A 3- to 6-month trial of efalizumab was not effective in promoting hair regrowth in this small cohort of patients with moderate-to-severe AA.
OBJECTIVE: To assess the efficacy and safety of efalizumab in the treatment of moderate-to-severe AA.
METHODS: Sixty-two patients were enrolled into this phase II, placebo-controlled trial. The trial consisted of three 12-week periods-a double-blind treatment period, an open-label efalizumab treatment period, and a safety follow-up.
RESULTS: There were no statistical differences between treatment groups in percent hair regrowth, quality-of-life measures, or changes in biologic markers of disease severity after 12 or 24 weeks. In both groups, there was an approximately 8% response rate for hair regrowth (at 12 weeks). Efalizumab was well tolerated.
LIMITATIONS: Numbers were too small for certain analyses.
CONCLUSION: A 3- to 6-month trial of efalizumab was not effective in promoting hair regrowth in this small cohort of patients with moderate-to-severe AA.