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


CONCLUSIONS
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.
Roberts
Janet L
JL
Northwest Dermatology and Research Center, Portland, Oregon, USA. janetrobertsmd@gmail.com
Ortonne
Jean-Paul
JP
Tan
Jerry K L
JK
Jaracz
Eileen
E
Frankel
Ellen
E
D000368:Aged; D000077944:Alefacept; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D012074:Remission Induction
D003879:Dermatologic Agents; D011993:Recombinant Fusion Proteins; D000077944:Alefacept