The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis

J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14.

Abstract

Background: Safety and efficacy of up to 3 courses of alefacept intramuscular (IM) in the treatment of chronic plaque psoriasis have been demonstrated in earlier trials.

Objective: We sought to determine the safety and efficacy of up to 5 courses of alefacept IM in treating plaque psoriasis.

Methods: A standard treatment course was defined as 15 mg of alefacept IM once weekly for 12 weeks, followed by 12 weeks of treatment-free observation. Patients with chronic plaque psoriasis, who had previously received alefacept IM, received up to 3 additional courses (A, B, and C). Efficacy was evaluated by Physician Global Assessment.

Results: Safety profiles were similar to those for a single course of treatment. There were no cumulative adverse effects. At 2 weeks postdosing, 16%, 22%, and 19% of patients were rated clear or almost clear by Physician Global Assessment in courses A, B, and C, respectively, with 35%, 42%, and 42% achieving this response at any time during these courses. Patients who achieved clear or almost clear at 2 weeks postdosing remained so for a median duration of 214 and 126 days after courses A and B, respectively.

Limitations: This was an extension study and therefore contained no control group.

Conclusions: Up to 5 courses of alefacept IM may provide extended treatment-free, symptom-free periods in responders while maintaining the safety profile.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Alefacept
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / pharmacology
  • Drug Administration Schedule
  • Female
  • Humans
  • Injections, Intramuscular
  • Lymphocyte Count
  • Male
  • Middle Aged
  • Psoriasis / drug therapy*
  • Psoriasis / pathology
  • Recombinant Fusion Proteins / administration & dosage*
  • Recombinant Fusion Proteins / adverse effects
  • Recombinant Fusion Proteins / pharmacology
  • Remission Induction

Substances

  • Dermatologic Agents
  • Recombinant Fusion Proteins
  • Alefacept