Alefacept for severe alopecia areata: a randomized, double-blind, placebo-controlled study.

Author(s): Strober BE, Menon K, McMichael A, Hordinsky M, Krueger G, Panko J, Siu K, Lustgarten JL, Ross EK, Shapiro J

Affiliation(s): Department of Dermatology, New York University Medical Center, 550 First Ave, TCH-158, New York, NY 10016, USA. strober@nyc.rr.com

Publication date & source: 2009-11, Arch Dermatol., 145(11):1262-6.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To assess the efficacy of alefacept for the treatment of severe alopecia areata (AA). DESIGN: Multicenter, double-blind, randomized, placebo-controlled clinical trial. SETTING: Academic departments of dermatology in the United States. PARTICIPANTS: Forty-five individuals with chronic and severe AA affecting 50% to 95% of the scalp hair and resistant to previous therapies. Intervention Alefacept, a US Food and Drug Administration-approved T-cell biologic inhibitor for the treatment of moderate to severe plaque psoriasis. Main Outcome Measure Improved Severity of Alopecia Tool (SALT) score over 24 weeks. RESULTS: Participants receiving alefacept for 12 consecutive weeks demonstrated no statistically significant improvement in AA when compared with a well-matched placebo-receiving group (P = .70). Conclusion Alefacept is ineffective for the treatment of severe AA.