Rofecoxib and early relapse of inflammatory bowel disease: an open-label trial

Background: The safety and efficacy of selective cyclo-oxygenase-2 inhibitors in inflammatory bowel disease are under investigation. Aim: To assess, in a prospective, open-label trial, the efficacy and safety of rofecoxib (12.5 mg/day) in inflammatory bowel disease patients and controls. Methods: The inflammatory bowel disease group included 45 inactive patients (25 Crohn's disease; 20 ulcerative colitis) with associated arthralgia. The control group included 30 dyspeptic patients. The efficacy and safety of rofecoxib were assessed in inflammatory bowel disease patients and controls before and after treatment (range, 3 days to 3 months). Results: In inflammatory bowel disease, nine of the 45 patients (20%) required rofecoxib withdrawal due to gastrointestinal symptoms inducing clinical relapse, which subsided on drug discontinuation. The percentage of patients requiring rofecoxib discontinuation was comparable in patients with Crohn's disease and ulcerative colitis (20% vs. 20%), but was higher in inflammatory bowel disease patients than in controls (20% vs. 3%; P < 0.001). In inflammatory bowel disease, arthralgia relief was reported by 32 patients (71%): complete relief by eight patients (18%) and partial relief by 24 (53%). Thirteen patients (29%) reported no benefit. A comparable percentage of inflammatory bowel disease patients and controls reported arthralgia relief (71% vs. 70%). Conclusions: Rofecoxib appears to control arthralgia in almost two-thirds of inflammatory bowel disease patients. Side-effects requiring drug discontinuation are observed, however, in almost one-quarter of patients.