title: Rifaximin-extended intestinal release induces remission in patients with moderately active Crohn's disease.
abstract: OBJECTIVE
  Bacteria might be involved in the development and persistence of inflammation in patients with Crohn's disease (CD), and antibiotics could be used in therapy. We performed a clinical phase 2 trial to determine whether a gastroresistant formulation of rifaximin (extended intestinal release [EIR]) induced remission in patients with moderately active CD.
  
  
  METHODS
  We performed a multicenter, randomized, double-blind trial of the efficacy and safety of 400, 800, and 1200 mg rifaximin-EIR, given twice daily to 402 patients with moderately active CD for 12 weeks. Data from patients given rifaximin-EIR were compared with those from individuals given placebo, and collected during a 12-week follow-up period. The primary end point was remission (Crohn's Disease Activity Index <150) at the end of the treatment period.
  
  
  RESULTS
  At the end of the 12-week treatment period, 62% of patients who received the 800-mg dosage of rifaximin-EIR (61 of 98) were in remission, compared with 43% of patients who received placebo (43 of 101) (P = .005). A difference was maintained throughout the 12-week follow-up period (45% [40 of 89] vs 29% [28 of 98]; P = .02). Remission was achieved by 54% (56 of 104) and 47% (47 of 99) of the patients given the 400-mg and 1200-mg dosages of rifaximin-EIR, respectively; these rates did not differ from those of placebo. Patients given the 400-mg and 800-mg dosages of rifaximin-EIR had low rates of withdrawal from the study because of adverse events; rates were significantly higher among patients given the 1200-mg dosage (16% [16 of 99]).
  
  
  CONCLUSIONS
  Administration of 800 mg rifaximin-EIR twice daily for 12 weeks induced remission with few adverse events in patients with moderately active CD.
authors.affiliation: Gastroenterology Unit, San Camillo Forlanini Hospital, Rome, Italy. prantera@tin.it
authors.forename: Cosimo
authors.initials: C
authors.lastname: Prantera
authors.forename: Herbert
authors.initials: H
authors.lastname: Lochs
authors.forename: Maria
authors.initials: M
authors.lastname: Grimaldi
authors.forename: Silvio
authors.initials: S
authors.lastname: Danese
authors.forename: Maria Lia
authors.initials: ML
authors.lastname: Scribano
authors.forename: Paolo
authors.initials: P
authors.lastname: Gionchetti
mesh_terms: D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002626:Chemistry, Pharmaceutical; D016009:Chi-Square Distribution; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007557:Israel; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012074:Remission Induction; D012294:Rifamycins / Q000008:administration & dosage* / Q000009:adverse effects; D000078262:Rifaximin; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D003692:Delayed-Action Preparations; D005765:Gastrointestinal Agents; D012294:Rifamycins; D000078262:Rifaximin