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 tumour necrosis factor α inhibitor.
Methods: Patients were randomised equally to placebo, CP-690,550 5, 15 or 30 mg twice daily for 6 weeks, with 6 weeks’ follow-up. The patient’s assessment of arthritis pain (pain), patient’s assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 (SF-36) were recorded.
Results: At week 6, significantly more patients in the CP-690,550 5, 15 and 30 mg twice-daily 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.
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▸ An additional figure and table are published online only at http://ard.bmj.com/content/vol69/issue2
Disclosure: Some data from this study have previously been reported in poster format at the European League Against Rheumatism 2007 meeting.
Funding This research was sponsored by Pfizer Inc.
Competing interests BJB, MPF, DG, BW and SHZ are all employees of Pfizer and, as such, may be eligible to receive stock options. JMK and FCB were paid consultants to Pfizer in connection with this study.
Ethics approval The study was approved by the institutional review boards and/or independent ethics committees at each of the investigational centres participating in the study.
Patient consent Patient consent received.
JHC is now located at Novartis Pharmaceuticals, Florham Park, New Jersey, USA.
Provenance and Peer review Not commissioned; externally peer reviewed.