Improvement in quality of life with infliximab induction and maintenance therapy in patients with moderate-to-severe psoriasis: A randomized controlled trial

Background: Psoriasis has a well-documented, markedly negative effect on patient quality of life. Objectives: To evaluate the impact of long-term infliximab maintenance therapy on health-related quality of life (HRQoL) in patients with psoriasis. Methods: The Dermatology Life Quality Index (DLQI) and 36-item Short Form Health Survey (SF-36) were administered as part of the pivotal double-blind, placebo-controlled efficacy and safety EXPRESS study of infliximab in chronic plaque psoriasis. In total, 378 patients with moderate-to-severe psoriasis were enrolled at 32 centres in Europe and Canada. Patients were randomized to receive either placebo or infliximab 5 mg kg -1 induction at weeks 0, 2 and 6 followed by maintenance every 8 weeks; placebo patients crossed over at week 24 to receive the infliximab induction and maintenance regimen. Results: At week 10, infliximab-treated patients had significantly greater improvement in DLQI scores (P <0.001) and SF-36 physical and mental component summary scores (P <0.001) than placebo-treated patients. Significant improvement (P <0.001) was also seen in all eight SF-36 subscales, and was greatest for the 'Bodily Pain' and 'Social Functioning' scales. Significant improvement in HRQoL persisted with maintenance infliximab treatment at week 24 (P <0.001), with patients achieving a Psoriasis Area and Severity Index score of 0 reporting the greatest benefit. Treatment-related HRQoL improvement remained substantial at week 50. Conclusions: Infliximab induction and maintenance regimens resulted in rapid, substantial, sustained and clinically meaningful improvement in both dermatology-specific and general quality of life indices in patients with psoriasis, with total clearance resulting in maximum improvement. © 2006 British Association of Dermatologists.