Improvement in quality of life with infliximab induction and maintenance therapy in patients with moderate-to-severe psoriasis: a randomized controlled trial
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.
Document Type: Research Article
Affiliations: 1: Department of Dermatology, University of Zurich Medical School, Zurich, Switzerland 2: Probity Research, Waterloo, Ontario, Canada 3: Hôpital L'Archet, Nice, France 4: Centocor, Inc., Malvern, PA, U.S.A. 5: The Dermatology Centre, Hope Hospital, The University of Manchester, Manchester M6 8HD, U.K.
Publication date: 01 June 2006