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Rheumatology Advance Access originally published online on March 27, 2007
Rheumatology 2007 46(6):999-1004; doi:10.1093/rheumatology/kem069
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© 2007 The Author(s).
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Improvement in patient-reported outcomes for patients with ankylosing spondylitis treated with etanercept 50 mg once-weekly and 25 mg twice-weekly

J. Braun1, N. McHugh2, A. Singh3, J. S. Wajdula4 and R. Sato3

1Rheumatology Medical Center, Ruhrgebeit, Herne, Ruhr-University, Bochum, Germany, 2Royal National Hospital for Rheumatic Diseases, Upper Borough Walls, Bath, UK, 3Global Health Outcomes Assessment, Wyeth Research, Collegeville PA, USA and 4Medical Research, Wyeth Research, Collegeville, PA, USA.

Correspondence to: R. Sato, PhD, Wyeth Research, Global Health Outcomes Assessment, 500 Arcola Road, E-Dock, Çollegeville, PA 19426, USA. E-mail: SATOR2{at}wyeth.com


  Abstract

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.

KEY WORDS: Etanercept, Ankylosing spondylitis, Patient-reported outcomes, Quality of life

Submitted 21 December 2006; revised version accepted 22 February 2007.
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