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

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.