Research article

Physical function, disease activity, and health-related quality-of-life outcomes after 3 years of adalimumab treatment in patients with ankylosing spondylitis

Désirée M van der Heijde¹ , Dennis A Revicki² , Katherine L Gooch³ , Robert L Wong⁴ , Hartmut Kupper⁵ , Neesha Harnam² , Chris Thompson² and Joachim Sieper⁶ for the ATLAS Study Group

¹  Department of Rheumatology, Leiden University Medical Center, Leiden, PO Box 9600, 2300 RC Leiden, The Netherlands

²  Center for Health Outcomes Research, United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, Maryland, 20814, USA

³  Global Health Economics and Outcomes Research, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, Illinois, 60064, USA

⁴  Formerly Abbott Immunology, Abbott Laboratories, 300 Interpace Parkway, Parsippany, New Jersey, 07054, USA

⁵  Abbott GmbH & Co. KG, Knollstrasse 50, Ludwigshafen, 67061, Germany

⁶  Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin, and German Rheumatism Research Center, Hindenburgdamm 30, Berlin, 12200, Germany

author email corresponding author email

Arthritis Research & Therapy 2009, 11:R124doi:10.1186/ar2790

Published:	17 August 2009

Abstract

Introduction

We evaluated the three-year impact of adalimumab on patient-reported physical function and health-related quality-of-life (HRQOL) outcomes in patients with active ankylosing spondylitis (AS).

Methods

The Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) is an ongoing five-year study that included an initial 24-week, randomized, placebo-controlled, double-blind period, followed by open-label extension treatment with adalimumab. Clinical and HRQOL data collected for up to three years from ATLAS were used for these analyses. Patients were randomized to receive adalimumab 40 mg or placebo by subcutaneous injection every other week. Physical function was assessed by the Bath AS Functional Index (BASFI), as well as by the Short Form 36 (SF-36) Health Survey Physical Component Summary (PCS) and Physical Function subscale scores. HRQOL was assessed using the AS Quality of Life (ASQOL) questionnaire. Disease activity was assessed by the Bath AS Disease Activity Index (BASDAI).

Results

Of 315 patients enrolled in ATLAS, 288 (91%) participated in an open-label adalimumab treatment extension and 82% provided three-year outcome data. During the 24-week double-blind phase, adalimumab-treated patients experienced significant improvement compared with placebo-treated patients in the BASDAI (P < 0.001), BASFI (P < 0.001), ASQOL (P < 0.001), and both the SF-36 PCS (P < 0.001) and Physical Function subscale (P < 0.001) scores, but not the SF-36 Mental Component Summary score (P = 0.181) and Mental Health subscale scores (P = 0.551). Mean changes from baseline through three years of adalimumab treatment were statistically significant for the BASDAI (change score: -3.9, P < 0.001), BASFI (change score: -29.6, P < 0.001), SF-36 PCS (change score: 11.6, P < 0.001), and Physical Function (change score: 23.3, P < 0.001). Comparable results were observed for the other SF-36 scores and for the ASQOL (all P < 0.001).

Conclusions

Adalimumab significantly improved disease activity, patient-reported physical function, and HRQOL. These benefits were maintained over three years of treatment in patients with AS.

Trial registration

ClinicalTrials.gov NCT00085644.