Objectives Celecoxib, a specific cyclooxygenase (COX)-2 inhibitor, has been shown to improve the signs and symptoms of RA. Because of the safety and tolerability of this agent, celecoxib administration is more sustainable, potentially producing long-term decreases in disease activity.
Methods The ability of celecoxib to induce responses at the ACR20, ACR50, and ACR70 levels was determined in a pooled analysis of two placebo- and active-comparator controlled trials. In addition, radiographic data from a long-term open label safety trial were analysed for the effect of celecoxib on radiographic evidence of disease progression using the Sharp score and Sharp count. Dose titration was allowed during this trial.
Results Celecoxib induced significant improvement compared to placebo at the ACR20, ACR50, and ACR70 levels at 12 weeks during the controlled trials (see Table 1 for% of responders, *p < 0.05 vs placebo). Prior to entry to the long-term open label trial, the average changes in the Sharp score and count were 2.76 (95% confidence interval [CI] 0.68–4.84) units/year and 1.15 (95% CI 0.10–2.19) units/year. After entry, the average changes in the Sharp score and count were 1.72 (95% CI 1.04–2.39) units/year and 0.63 (0.40–0.87) units/year, with an average duration of follow-up of approximately 1 year.
Conclusion Combined with the safety and tolerability data derived from recent studies, these data suggest that celecoxib has the potential to modify disease activity in RA with long-term use in addition to providing symptomatic benefits over shorter durations.
Sponsored by Pharmacia Corporation and Pfizer, Inc.
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