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A Randomized, Double-blind, Placebo-Controlled Study

Bruce E. Strober, MD, PhD; Kavita Menon, MD; Amy McMichael, MD; Maria Hordinsky, MD; Gerald Krueger, MD; Jackie Panko, MD; Kimberly Siu, MD; Jonathan L. Lustgarten, PhD; Elizabeth K. Ross, MD; Jerry Shapiro, MD

Arch Dermatol. 2009;145(11):1262-1266.

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.

Author Affiliations: Departments of Dermatology, New York University School of Medicine, New York (Drs Strober, Menon, Siu, and Shapiro), Wake Forest University, Winston-Salem, North Carolina (Dr McMichael), University of Minnesota, Minneapolis (Dr Hordinsky), University of Utah, Salt Lake City (Drs Krueger and Panko), Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania (Dr Lustgarten), Dermatology and Laser Center NW, Bellingham, Washington (Dr Ross), and Dermatology and Skin Science, University of British Columbia, Vancouver, Canada (Dr Shapiro).

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