Published in:
01-02-2003 | Original Research Article
Effects of Alefacept on Health-Related Quality of Life in Patients with Psoriasis
Results from a Randomized, Placebo-Controlled Phase II Trial
Published in: American Journal of Clinical Dermatology | Issue 2/2003
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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.