Abstract
IntroductionWe 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).MethodsThe 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).ResultsOf 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).ConclusionsAdalimumab significantly improved disease activity, patient-reported physical function, and HRQOL. These benefits were maintained over three years of treatment in patients with AS.Trial registrationClinicalTrials.gov NCT00085644.
Highlights
We evaluated the three-year impact of adalimumab on patient-reported physical function and healthrelated quality-of-life (HRQOL) outcomes in patients with active ankylosing spondylitis (AS)
During the 24week double-blind phase, adalimumab-treated patients experienced significant improvement compared with placebotreated patients in the Bath AS Disease Activity Index (BASDAI) (P < 0.001), Bath AS Functional Index (BASFI) (P < 0.001), AS Quality of Life Questionnaire (ASQOL) (P < 0.001), and both the Short Form 36 (SF-36) Physical Component Summary (PCS) (P < 0.001) and Physical Function subscale (P < 0.001) scores, but not the Short Form 36 (SF36) 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, BASFI, SF-36 PCS, and Physical Function
Summary
We evaluated the three-year impact of adalimumab on patient-reported physical function and healthrelated quality-of-life (HRQOL) outcomes in patients with active ankylosing spondylitis (AS). Symptoms of AS include pain, joint stiffness, and the loss of spinal mobility These clinical symptoms and the subsequent disease progression result in substantial functional limitations and impairment of health-related quality of life (HRQOL) [2,3,4,5]. Many AS studies have used the SF-36 [8,9,10,11,12,13,14,15,16,17,18,19], whereas use of the ASQOL has been somewhat limited [9,16,20,21] These measures have demonstrated HRQOL impairment and loss of physical functioning for patients with AS, compared with the general population. At least one other study reported statistically lesser baseline SF-36 scores for all eight SF-36 domains, especially those pertaining to physical function, for patients with AS compared with the US general population [22]
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