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
Department of Dermatology, University of California, San Francisco, California, USA.
J Am Acad Dermatol. 2008 Mar;58(3):395-402. doi: 10.1016/j.jaad.2007.10.645.
Alopecia areata (AA) is a T-cell-mediated autoimmune disease. Efalizumab is a T-cell-targeted therapy approved for the treatment of psoriasis.
To assess the efficacy and safety of efalizumab in the treatment of moderate-to-severe AA.
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.
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.
Numbers were too small for certain analyses.
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.
斑秃（AA）是一种由T细胞介导的自身免疫性疾病。依法利珠单抗是一种获批用于治疗银屑病的靶向T细胞疗法。
评估依法利珠单抗治疗中度至重度斑秃的疗效和安全性。
62名患者被纳入这项II期安慰剂对照试验。该试验包括三个为期12周的阶段——一个双盲治疗阶段、一个依法利珠单抗开放标签治疗阶段和一次安全性随访。
治疗组之间在12周或24周后的毛发再生百分比、生活质量指标或疾病严重程度生物学标志物变化方面无统计学差异。两组中毛发再生的有效率均约为8%（12周时）。依法利珠单抗耐受性良好。
某些分析的样本量过小。
在这个小样本的中度至重度斑秃患者队列中，为期3至6个月的依法利珠单抗试验在促进毛发再生方面无效。
