Objective: To evaluate the effect of adalimumab on pain, fatigue, and stiffness in patients with active ankylosing spondylitis (AS).
Methods: The Adalimumab Trial Evaluating Long-Term Safety and Efficacy for Ankylosing Spondylitis (ATLAS) was an ongoing 5-year study that included an initial 24-week, randomized, placebo-controlled, double-blind period. Patients were randomized to adalimumab 40 mg or placebo by subcutaneous injection every other week. Pain was assessed by the bodily pain domain scores of the Medical Outcomes Study Short Form-36 Health Survey (SF-36) and also by total back pain and nocturnal pain using visual analog scales. Fatigue was measured by the SF-36 vitality domain and question 1 of the Bath AS Disease Activity Index (BASDAI). Morning stiffness was measured by the mean of BASDAI questions 5 and 6.
Results: Of 315 patients enrolled, 208 received adalimumab 40 mg and 107 received placebo. At Week 12, adalimumab-treated patients experienced significant improvement compared with placebo-treated patients in the SF-36 bodily pain score (p < 0.001), total back pain score (p < 0.001), nocturnal pain score (p < 0.001), fatigue (p < 0.01), and morning stiffness (p < 0.001). Pain, fatigue, and morning stiffness were significantly correlated (p < 0.001) with baseline values of patient-reported health-related quality of life (HRQOL), and physical function, and with improvements in these values at Week 12 by regression analysis. Treatment effects occurred rapidly (within 2 wks) and were maintained through 24 weeks of treatment.
Conclusion: Adalimumab significantly improved symptoms of pain, fatigue, and stiffness in patients with AS. Improved symptoms were associated with improved physical function and HRQOL.