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/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.