Comparison of the Efficacy and Safety of Ketoprofen Plaster and Diclofenac Plaster for Osteoarthritis-Related Knee Pain: A Multicenter, Randomized, Active-Controlled, Open-Label, Parallel-Group, Phase III Clinical Trial.

ABSTRACT

PURPOSE: To compare the efficacy and safety of ketoprofen plasters and diclofenac plasters after 3 weeks of administration in patients with osteoarthritis-related knee pain. METHODS: This multicenter, randomized, active-controlled, open-label, parallel-group, noninferiority phase III study randomized 236 adults with osteoarthritis-related knee pain for 3 weeks with ketoprofen plaster 30 mg twice daily (n = 118) or diclofenac plaster 15 mg once daily (n = 118). The primary efficacy end point was the mean change from baseline to week 3 in the mean knee pain intensity score during walking, as measured by a 100-mm visual analog scale with a predefined noninferiority margin of 10.0 mm. Secondary end points included changes in knee pain intensity score during walking (weeks 1 and 2) and at rest (weeks 1, 2, and 3), Knee Injury and Osteoarthritis Outcome Score, Patient Global Impression of Improvement scale assessments, and frequency of rescue medication use after 2 and 3 weeks of treatment. FINDINGS: A total of 223 patients (115 in the ketoprofen group and 108 in the diclofenac group) were included in the per-protocol analysis. After 3 weeks of treatment, the least squares mean change from baseline in knee pain intensity scores during walking was -35.9 (95% CI, -39.7 to -32.2) in the ketoprofen group and -31.7 (95% CI, -35.5 to -27.9) in the diclofenac group, with noninferiority found (least squares mean difference, -4.2; 95% CI, -9.6 to 1.1). Ketoprofen significantly (P < 0.05) reduced the pain intensity score at rest after 2 and 3 weeks of treatment compared with diclofenac. No statistically significant difference was found between the groups in terms of changes in pain intensity score during walking at weeks 1, 2, and 3. The mean Patient Global Impression of Improvement score was statistically significant (P < 0.001) in favor of ketoprofen after 2 and 3 weeks of treatment. In addition, the Knee Injury and Osteoarthritis Outcome Score improved in both groups, and no statistically significant difference was found between the groups in terms of frequency of rescue medication use. The overall adverse event profile of the groups was similar, and no difference was found in skin reaction rates between the 2 groups. IMPLICATIONS Ketoprofen plasters can be effectively and safely administered to patients with osteoarthritis-related knee pain.