Rofecoxib shows consistent efficacy in osteoarthritis clinical trials, regardless of specific patient demographic and disease factors

Objective. To evaluate the efficacy of rofecoxib (Vioxx(TM)) in subpopulati ons of patients with osteoarthritis (OA) identified by demographic or basel ine disease characteristics, or varied OA involvement. Methods. Data were combined from three 6-week double blind trials in patien ts with OA of the knee or hip. All trials contained placebo. 12.5 mg rofeco xib, and 25 mg rofecoxib arms (the only trials to date containing all 3 tre atments). Analyses were performed on subgroups categorized according to the following baseline demographics and disease characteristics [age, sex, hei ght, weight, body mass index, American Rheumatism Association (ARA) functio nal class, joint tenderness, joint stiffness, Western Ontario-McMaster Univ ersity OA Index (WOMAC) functional subscale. unilateral/bilateral joint inv olvement, number of joint groups involved]. Three primary endpoints - Pain Walking on Flat Surface (WOMAC), Patient Global Assessment of Response to T herapy, and Investigator Global Assessment of Disease Status - were analyze d. The global assessments. which provided data on overall aspects of OA, re gardless of affected joint, were used to assess effects among patients with one, 2, 3, or 4 joint groups affected (from among the following: interphal angeal/first carpal-metacarpal joint, spine, hip, or knee). Results. Data from 1501 patients were included. No consistent treatment-by- subgroup interaction was observed with all 3 primary endpoints for patients taking placebo or 12.5 or 25 mg rofecoxib. Rofecoxib showed generally cons istent efficacy across subgroups of patients identified by sex, race, age, OA location(s), prior OA therapy, baseline study joint tenderness or swelli ng (patients with knee OA only), and ARA functional class level. Conclusion. In this combined analysis, no specific factor predicted a diffe rential treatment effect to rofecoxib.