Objective: To study the functional status and health-related quality of life (HRQOL) of patients with rheumatoid arthritis (RA) after treatment with celecoxib, compared with placebo and naproxen.
Methods: This was a prospective, randomized, double-blind, parallel group trial conducted at 79 sites in the United States and Canada over a 12-week treatment period. Patients were randomly assigned to 5 groups: placebo, 100 mg twice a day of celecoxib, 200 mg twice a day of celecoxib, 400 mg twice a day of celecoxib, and 500 mg twice a day of naproxen. The Health Assessment Questionnaire (HAQ) disability index was used to measure functional status. The Medical Outcomes Study Short Form 36 (SF-36) was used to measure general HRQOL.
Results: Enrollees were 1,149 patients with diagnosed and active RA. At the end of the treatment period, patients in the 4 active treatment groups had significant improvement in both functional status and overall HRQOL in comparison with the placebo group. Patients in the twice-daily 100 mg celecoxib group significantly differed from placebo at weeks 2 and 6 on HAQ scores and at week 12 on 5 domains and both summary scores of the SF-36. Patients treated with twice-daily 200 mg celecoxib had significantly better functional status than placebo at all times of testing with the HAQ, and also had significantly better function than those treated with naproxen after 2 and 12 weeks of treatment. Patients in the twice-daily 200 mg and 400 mg celecoxib groups showed similar improvement in HRQOL as determined by the 8 domain scores and 2 summary scores of the SF-36.
Conclusion: Celecoxib was better than placebo and comparable with naproxen in improving functional status and overall HRQOL among RA patients.