Effects of alefacept on health-related quality of life in patients with psoriasis: results from a randomized, placebo-controlled phase II trial.

Abstract

Chronic plaque psoriasis has a profound impact on patient quality of life (QOL), including adverse psychosocial effects, impaired daily activities, anxiety, and depression. To assess health-related QOL in a randomized phase II trial of alefacept (human LFA-3/IgG(1) fusion protein), a selective immunomodulator for psoriasis. Multicenter, randomized, placebo-controlled, double-blind trial. 229 patients with moderate to severe psoriasis were randomized to alefacept (0.025, 0.075, or 0.150 mg/kg) or placebo by 30-second intravenous bolus once weekly for 12 weeks and followed for 12 additional weeks. Patients completed a general (SF-36) Health Survey) and dermatology-specific (Dermatology Life Quality Index [DLQI] and Dermatology Quality Of Life Scales [DQOLS]) QOL surveys at each study visit. Patients treated with alefacept had significantly greater improvements on dermatology-specific QOL scales compared with patients receiving placebo (p < 0.05). Patients who achieved a >or=50% or a >or=75% reduction in Psoriasis Area and Severity Index (PASI) reported similar improvement in QOL, which was significantly greater than that of other patients. The clinical effect of alefacept on psoriasis is associated with an improvement in patients' QOL. Among patients with moderate to severe psoriasis, an improvement in PASI of 50% or more is associated with better QOL scores.