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Physical function, disease activity, and health-related quality-of-life outcomes after 3 years of adalimumab treatment in patients with ankylosing spondylitis
Arthritis Research & Therapy, 08/21/09
van der Heijde DM et al. – In this study adalimumab significantly improved disease activity, patient-reported physical function, and health-related quality-of-life (HRQOL) in patients with ankylosing spondylitis (AS); these benefits were maintained over 3 years of treatment.
Methods- An evaluation of 3-year impact of adalimumab on patient-reported physical function and HRQOL outcomes in pts with active AS
- ATLAS is an ongoing 5-yr study that included an initial 24-wk randomized period, followed by open-label extension treatment with adalimumab
- Clinical and HRQOL data collected for up to 3 yrs from ATLAS were used for these analyses
- Pts were randomized to receive adalimumab 40 mg or placebo by sc injection every other wk
- Physical function was assessed by BASFI and SF-36, Health Survey PCS, and Physical Function subscale scores
- HRQOL was assessed using the AS Quality of Life (ASQOL) questionnaire
- Disease activity was assessed by BASDAI
- 315 pts; 91% participated in an open-label adalimumab treatment extension and 82% provided 3-yr outcome data
- During the 24-wk double-blind phase, adalimumab-treated pts experienced:
- Improvement in the BASDAI, BASFI, ASQOL, and both the SF-36 PCS, and Physical Function subscale scores
- No improvement in the SF-36 Mental Component Summary score, and Mental Health subscale scores
- Mean changes from baseline through 3 yrs of adalimumab treatment were significant for the BASDAI, BASFI, SF-36 PCS, and Physical Function
- Comparable results were observed for other SF-36 scores and for the ASQOL
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