Effects of alefacept on health-related quality of life in patients with psoriasis: Results from a randomized, placebo-controlled phase II trial
Introduction: Chronic plaque psoriasis has a profound impact on patient quality of life (QOL), including adverse psychosocial effects, impaired daily activities, anxiety, and depression.
Objective: To assess health-related QOL in a randomized phase II trial of alefacept (human LFA-3/IgG1 fusion protein), a selective immunomodulator for psoriasis.
Study design: Multicenter, randomized, placebo-controlled, double-blind trial.
Methods: 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®1 Health Survey) and dermatology-specific (Dermatology Life Quality Index [DLQI] and Dermatology Quality Of Life Scales [DQOLS]) QOL surveys at each study visit.
Results: 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 ?50% or a ?75% reduction in Psoriasis Area and Severity Index (PASI) reported similar improvement in QOL, which was significantly greater than that of other patients.
Conclusions: 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.