This study was conducted in two parts to assess the clinical efficacy of etoricoxib (MK-0663) in patients with rheumatoid arthritis (RA) following withdrawal of prestudy NSAIDs and demonstration of flare based on preset criteria.

Part I compared placebo (n=123) to MK-0663 at doses 10 mg (n=78), 60 mg (n=126), 90 mg (n=134) and 120 mg (n=120), once daily for 8 weeks. At the conclusion of 8 weeks, all patients were given the opportunity to enter part II. Part II compared an active comparator, diclofenac, 50 mg tid (n=130) to MK-0663 at doses 60 mg (n=99), 90 mg (n=190), and 120 mg (n=110) once daily for 44 weeks. Stable doses of concomitant DMARDs were allowed.

At the conclusion of part I, clinical improvement, assessed by Patient and Investigator Global Assessment of Disease Activity, was observed in patients receiving either 90 mg or 120 mg of MK-0663. Approximate mean change ±SE was similar in both treatment groups and was as follows; -40mm for Patient Global Assessment (100 mm VAS); -1.3 for Investigator Global Assessment (0-4 Likert); -16 tender joints (total of 68); and -8 swollen joints (total of 66). The clinical improvement in Patient and Investigator Global Assessments in these two dosing groups was consistently maintained throughout the second part of the study and was similar to that observed in the group of patients receiving diclofenac. The long-term frequency of adverse events was similar in all 4 treatment groups, with a slightly higher incidence occurring in patients receiving 120 mg MK-0663. These data indicate that etoricoxib, at doses 90 mg and 120 mg once daily, is similar in terms of safety and efficacy to diclofenac for the treatment of RA.

Editorial Comment: Similar to the other selective COX-2 inhibitors, etoricoxib appears well tolerated and equally efficacious when compared with the older non-selective NSAIDs. When available, it will be a welcome addition to the choices of rofecoxib and celecoxib.

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