Objectives To determine the efficacy and safety profile of rofecoxib 25 mg and 50 mg versus placebo and naproxen in patients with RA.
Methods 1058 RA patients were randomised in a double-blind fashion to: placebo (n = 299), rofecoxib 25 mg (n = 315), 50 mg (n = 297), or naproxen 1000 mg (given as 500 mg bid; n = 147). Eligible patients were chronic NSAID users and demonstrated a clinical worsening or flare upon withdrawal of prestudy NSAID(s). Efficacy assessments included all components of the ACR core set. Four endpoints were prespecified as primary: the patient and investigator global assessments of disease activity and counts of tender and swollen joints. The proportion of patients meeting the ACR20 criteria, patient assessment of pain, and a modified HAQ score were key secondary measurements. Safety was assessed based on adverse experience reporting by investigators (particularly discontinuations due to adverse experiences [AEs]) and routine laboratory and vital sign measurements.
Results After 12 weeks, patients receiving rofecoxib 25 mg, 50 mg, and naproxen showed similar improvements compared with placebo: a 3 to 4- joint reduction in the number of tender joints; a 1-joint reduction in the number of swollen joints; a 7 to 10 mm improvement on the patient global assessment (1 -100 mm VAS) and a 0.3 to 0.4-unit reduction on the investigator global assessment (0 to 4 Likert scale). All improvements were statistically significant (p < 0.05) versus placebo, except naproxen on swollen joint count. For key secondary measurements, all three active treatments showed a >10% difference (p < 0.05) versus placebo for the proportion of patients meeting the ACR20 criteria. All active treatments showed a significant difference from placebo, consistent with improvement, for the modified HAQ and the patient assessment of pain. No statistically significant differences were noted between 25 mg and 50 mg rofecoxib or between naproxen and either rofecoxib group for any efficacy measurement. Fewer patients discontinued due to AEs in the rofecoxib 25 mg group (3.8%) compared with the other active treatment groups (~8%) and placebo (4.7%).
Conclusion Overall, improvements with 25 mg rofecoxib were similar to those with 50 mg rofeocixb and naproxen but with improved tolerability, supporting the use of 25 mg rofecoxib for treating the signs and symptoms of RA in adults.
This study was supported by a grant from Merck and Co., Inc.
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