Rifaximin-Extended Intestinal Release Induces Remission in Patients With Moderately Active Crohns Disease

Gastroenterology, 02/29/2012

Administration of 800 mg rifaximin–extended intestinal release (EIR) twice daily for 12 weeks induced remission with few adverse events in patients with moderately active Crohn's disease (CD).

Methods

  • The authors 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]).

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