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

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.

Figures

Figure 1

Mean BASDAI scores during long-term adalimumab treatment. Data are observed values for completers. Refer to Tables 4 or 6 for number of patients at each time point. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measures the severity of fatigue, spinal and peripheral joint pain, localized tenderness, and morning stiffness in patients with ankylosing spondylitis. BASDAI scores range from 0 to 10, with lower scores indicating less severe disease activity.

Figure 2

Mean BASFI scores during long-term adalimumab treatment. Data are observed values for completers. Refer to Tables 4, 5, or 6 for number of patients at each time point. The Bath Ankylosing Spondylitis Functional Index (BASFI) measures the degree of functional limitation in patients with ankylosing spondylitis. BASFI scores range from 0 to 10, with a lower score indicating less functional limitation.

Figure 3

Mean SF-36 PCS scores during long-term adalimumab treatment. Data are observed values for completers. Refer to Tables 4, 5, or 6 for number of patients at each time point. The Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) is a composite score of four physical functioning domains of the SF-36: Physical Functioning, Role–Physical, Bodily Pain, and General Health. Greater scores indicate better health status.