Objectives: To determine the efficacy of CP-690,550 in improving pain, function, and health status in patients with moderate to severe active rheumatoid arthritis (RA) and an inadequate response to methotrexate or a TNF-α inhibitor.
Methods: Patients were randomized equally to placebo, CP 690,550 5, 15, or 30 mg BID for 6 weeks, with 6 weeks' follow-up. Patient's Assessment of Arthritis Pain (Pain), Patient's Assessment of Disease Activity, HAQ-DI, and SF-36 were recorded.
Results: At Week 6, significantly more patients in the CP-690,550 5, 15, and 30 mg BID groups experienced a 50% improvement in pain compared with placebo (44%, 66%, 78%, and 14%, respectively), clinically meaningful reductions in HAQ-DI (≥0.3 units) [57%, 75%, 76%, and 36%, respectively], and clinically meaningful improvements in SF-36 domains and physical and mental components.
Conclusions: CP-690,550 was efficacious in improving the pain, function, and health status of patients with RA, from Week 1 to Week 6.