Quality of life in plaque psoriasis patients treated with voclosporin: a Canadian phase III, randomized, multicenter, double-blind, placebo-controlled study.

BACKGROUND: Quality of life assessments are important in the evaluation of new therapies for psoriasis. OBJECTIVE: To determine the effect of voclosporin (VCS) treatment on quality of life in patients with psoriasis. PATIENTS AND METHODS: 451 plaque psoriasis patients with ≥  10% body surface area involvement were randomly assigned in a double-blind fashion to 1 of 4 treatment groups (placebo, VCS 0.2 mg kg(-1) BID, VCS 0.3 mg kg(-1) BID, and VCS 0.4 mg kg(-1) BID) for up to 12 weeks of treatment. Quality of life was assessed using the Dermatology Life Quality Index (DLQI) and the Psoriasis Disability Index (PDI). RESULTS: At 12 weeks, patients treated with VCS 0.4 mg kg(-1) BID had statistically significantly more favourable assessments than placebo-treated patients in all domains of the DLQI and the PDI. Patients treated with VCS 0.3 mg kg(-1) BID had statistically significant improvements in 5 of 10 domains of the DLQI and all domains of the PDI. Patients treated with VCS 0.2 mg kg(-1) BID had statistically significant improvements in 4 of 10 domains of the DLQI and 2 of 4 domains of the PDI. CONCLUSION: Treatment with VCS 0.4 mg kg(-1) BID significantly improves the quality of life of patients with psoriasis.