title: Two-year-outcomes analysis of Crohn's disease treated with rifabutin and macrolide antibiotics.
abstract: Fifty-two patients with severe Crohn's disease were enrolled in this study. Six (11.5%) were intolerant of the medication and had to be excluded. The remaining 46 patients were treated with rifabutin in combination with a macrolide antibiotic (clarithromycin or azithromycin). Patients 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 steroids when treatment was established. A reduction in the Harvey-Bradshaw 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 measured 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). When subsets of the study population were analysed, patients with pan-intestinal disease achieved better remission at 2 years than did those with less extensive involvement (P = 0.04, Mann-Whitney U-test). No difference in treatment response by age, disease duration, the presence of granulomas on histology, or the occurrence of drug-induced side-effects, was observed. These data suggest that treatment with rifabutin and clarithromycin or azithromycin may result in a substantial clinical improvement in Crohn's disease and justify the conduct of a randomized controlled trial.
authors.affiliation: University Department of Surgery, St George's Hospital Medical School, London, UK.
authors.forename: G P
authors.initials: GP
authors.lastname: Gui
authors.forename: P R
authors.initials: PR
authors.lastname: Thomas
authors.forename: M L
authors.initials: ML
authors.lastname: Tizard
authors.forename: J
authors.initials: J
authors.lastname: Lake
authors.forename: J D
authors.initials: JD
authors.lastname: Sanderson
authors.forename: J
authors.initials: J
authors.lastname: Hermon-Taylor
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000032:analysis; D017291:Clarithromycin / Q000627:therapeutic use; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D016016:Proportional Hazards Models; D012074:Remission Induction; D017828:Rifabutin / Q000627:therapeutic use*; D012709:Serum Albumin / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D012709:Serum Albumin; D017828:Rifabutin; D002097:C-Reactive Protein; D017291:Clarithromycin