Safety and efficacy of alefacept in elderly patients and other special populations.
BACKGROUND
The safety of biologic agents for psoriasis treatment is of particular importance in patient groups at higher risk for adverse events. We assessed the safety and efficacy of alefacept in elderly, obese, and diabetic patients with moderate to severe chronic plaque psoriasis by integrating data from phase 2 and 3 clinical studies and their extensions.


METHODS
Ninety-nine elderly, 652 obese, and 122 diabetic patients received at least 1 course of alefacept. In each cohort, accidental injury, headache, and pharyngitis were among the most common adverse events; infections were primarily common colds; and malignancies were mostly skin carcinomas. No opportunistic infections were reported. Safety was maintained over repeated courses. The safety profile of alefacept in each cohort was consistent with that of the overall population; however, additional data are needed to confirm our findings in the elderly and diabetic subgroups in the later courses due to the limited sample sizes. In course 1, 24% to 33% of patients achieved 75% or greater improvement in Psoriasis Area and Severity Index (PASI) at any time, with further enhancement of benefit with subsequent courses (eg, course 3, 41% to 58%).


CONCLUSIONS
Alefacept was well-tolerated and effective in elderly, obese, and diabetic patients with psoriasis.
Gottlieb
Alice B
AB
UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ 08901-0019, USA. gottliab@umdnj.edu
Boehncke
Wolf-Henning
WH
Darif
Mohamed
M
D000367:Age Factors; D000368:Aged; D000077944:Alefacept; D002769:Cholelithiasis / Q000453:epidemiology; D002908:Chronic Disease; D015897:Comorbidity; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000453:epidemiology; D004334:Drug Administration Schedule; D006801:Humans; D007273:Injections, Intramuscular; D007275:Injections, Intravenous; D015337:Multicenter Studies as Topic; D009765:Obesity / Q000453:epidemiology; D011565:Psoriasis / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D003879:Dermatologic Agents; D011993:Recombinant Fusion Proteins; D000077944:Alefacept