Efficacy and safety of ketoprofen patch in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled study.

This study assessed the efficacy and safety of ketoprofen patch compared with placebo in patients who had rheumatoid arthritis and persistent wrist pain. Patients (N = 676)who had achieved systemic disease control with a disease-modifying antirheumatic drug and/or systemic corticosteroid, but still had persistent wrist pain, were randomized to a 2-week course of once-daily treatment with application of a 20-mg ketoprofen patch or a placebo patch to the wrist. The primary efficacy end point was the percent change from baseline to the end of treatment in the intensity of wrist pain scored by each patient on a 100-mm visual analog scale. The mean ± SD percent change on the pain intensity scale was significantly larger in patients treated with ketoprofen than in those receiving placebo (31.2% ± 30.3% [95% confidence interval: 28.0-34.4] vs 25.5% ± 31.2% [95% confidence interval: 22.1-28.8]; P = .020). However, the actual difference of the mean pain intensity scale between the 2 groups was small at the end of treatment. The frequency of adverse events was similar in both groups. The ketoprofen patch was more effective than placebo for relieving persistent local joint pain in patients with rheumatoid arthritis. The patch was also safe and well tolerated during the 2-week treatment period.