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

Arch Dermatol. 2009 Nov;145(11):1262-6. doi: 10.1001/archdermatol.2009.264.

Abstract

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Academic Medical Centers
  • Adolescent
  • Adult
  • Aged
  • Alefacept
  • Alopecia Areata / diagnosis*
  • Alopecia Areata / drug therapy*
  • Dermatologic Agents / administration & dosage*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Injections, Intramuscular
  • Male
  • Middle Aged
  • New York City
  • Probability
  • Recombinant Fusion Proteins / administration & dosage*
  • Risk Assessment
  • Severity of Illness Index
  • Statistics, Nonparametric
  • Treatment Outcome
  • Young Adult

Substances

  • Dermatologic Agents
  • Recombinant Fusion Proteins
  • Alefacept