2-YEAR-OUTCOMES ANALYSIS OF CROHNS-DISEASE TREATED WITH RIFABUTIN ANDMACROLIDE ANTIBIOTICS

Fifty-two patients with severe Crohn's disease were enrolled in this s tudy. Six (11.5%) were intolerant of the medication and had to be excl uded. The remaining 46 patients were treated with rifabutin in combina tion with a macrolide antibiotic (clarithromycin or azithromycin). Pat ients were treated for a mean of 18.7 (range 6-35) months and followed up for 25.1 (range 7-41) months. Of the 19 patients who were steroid dependent at the start of this study, only two continued to require st eroids when treatment was established. A reduction in the Harvey-Brads haw Crohn's disease activity index occurred after 6 months' treatment (P = 0.004, paired Wilcoxon test) and was maintained at 24 months (P < 0.001). An improvement in inflammatory parameters was observed as mea sured by a reduction in erythrocyte sedimentation rate (P = 0.009) and C-reactive protein (P = 0.03) at 18 months compared with pretreatment levels, and an increase in serum albumin at 12 months (P = 0.04). Whe n subsets of the study population were analysed, patients with pan-int estinal disease achieved better remission at 2 years than did those wi th less extensive involvement (P = 0.04, Mann-Whitney U-test). No diff erence in treatment response by age, disease duration, the presence of granulomas on histology, or the occurrence of drug-induced side-effec ts, was observed. These data suggest that treatment with rifabutin and clarithromycin or azithromycin may result in a substantial clinical i mprovement in Crohn's disease and justify the conduct of a randomized controlled trial.