Objectives: The objective of this study was to assess the humanistic impact of ankylosing spondylitis (AS), and compare the effect of etanercept 50 mg once-weekly (QW), etanercept 25 mg twice-weekly (BIW) and placebo on patient-reported outcomes (PROs).
Methods: In a 12-week, double-blind, placebo-controlled multicenter study, 356 patients with active AS received etanercept 50 mg QW, etanercept 25 mg BIW or placebo (3:3:1 randomization, respectively). PROs were assessed using Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Activity Index fatigue item, EuroQOL-5D (EQ-5D) utility, EQ-5D visual analog scale and the Medical Outcomes Short Form Questionnaire (SF-36) scores at baseline and at regular intervals. Mean changes from baseline in PROs were analysed using analysis of covariance to assess differences between etanercept and placebo, or between the two etanercept groups.
Results: Consistent with earlier reports, AS was associated with quality of life (QOL) impairment and functional limitations, similar to or worse than cancer, congestive heart failure, diabetes or depression. Treatment with etanercept 50 mg QW or 25 mg BIW significantly improved QOL and functional status compared with placebo. High proportions of patients achieved clinically meaningful improvements in all PRO measures, including physical function, fatigue, pain, psychosocial domains and general health status. Improvements were similar with the two etanercept dose regimens.
Conclusions: The more convenient etanercept 50 mg QW dose regimen significantly improves function and QOL in patients with AS, similarly to the standard dosing of 25 mg BIW, supporting its use for AS therapy.