A PROSPECTIVE RANDOMIZED 13-WEEK STUDY EVALUATING THE EFFICACY OF LUMIRACOXIB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE

Background: Lumiracoxib (Prexige®) is a cyclooxygenase-2 (COX-2) selective inhibitor which has been developed for the treatment of osteoarthritis (OA), rheumatoid arthritis and acute pain.Objectives: The objective of this multicentre, randomized, double-blind study was to evaluate the clinical efficacy, safety and tolerability of lumiracoxib 200 and 400 mg od compared with placebo and celecoxib 200 mg od for the treatment of OA over 13 weeks.Methods: After a 3-7-day washout period for previous nonsteroidal anti-inflammatory drug (NSAID) therapy, 1600 patients with primary knee OA were randomized to receive lumiracoxib 200 mg od (n=462), lumiracoxib 400 mg od (n=463), celecoxib 200 mg od (n=444) or placebo (n=231) for 13 weeks. A visual analogue scale (VAS) pain intensity of ≥40 mm was required for study entry. Primary efficacy variables were: overall pain intensity (VAS) in the target knee, patient's global assessment of disease activity and the WOMAC© questionnaire (Pain subscale and Total index) at Week 13. Secondary variables included VAS pain at each visit, WOMAC© questionnaire (Total Index, and Pain, Difficulty in Performing Daily Activities [DPDA] and Stiffness subscale scores) and physicians global assessment of disease activity. Tolerability and safety were assessed.Results: Lumiracoxib showed significant improvements in all primary (table) and key secondary variables compared with placebo. Lumiracoxib 200 mg od demonstrated similar efficacy both in terms of improved overall pain intensity and functional status compared with celecoxib 200 mg od. Lumiracoxib 400 mg od demonstrated significantly superior efficacy in terms of OA pain intensity at Weeks 2 and 4, and similar efficacy at Weeks 8 and 13 compared with celecoxib 200 mg od. However, no statistically significant differences were observed between the two doses of lumiracoxib. Primary efficacy variables: Placebo–treatment differences at Week 13 Lumiracoxib Lumiracoxib Celecoxib 200 mg od 400 mg od 200 mg od (n=462) (n=463) (n=444) OA pain intensity in the target joint (VAS mm) 7.39** 8.83** 6.27* Patient's global assessment of disease activity (VAS mm) 8.55** 9.42** 7.12** WOMAC© Pain subscale score 1.27** 1.46** 1.13** WOMAC© Total score 7.38** 7.48** 5.97** *p<0.01; **p<0.001 vs placebo lt]0.01; **p<0.001 vs placeboThe overall incidence of adverse events (AEs), serious AEs and discontinuations due to AEs was similar among the groups.Conclusion: Lumiracoxib 200 mg od and 400 mg od demonstrated superior efficacy vs placebo in terms of pain relief and functional status in patients with knee OA. Lumiracoxib 200 mg od and 400 mg od exhibited comparable efficacy and tolerability profiles.Citation: , volume , supplement , year 2003, page Session: Osteoarthritis – Clinical aspects and treatment