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

Abstract

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.