Double‐blind, randomised, placebo‐controlled crossover trial to evaluate the clinical efficacy of rifaximin in patients with moderate to severe active Crohn's disease. Issue 5 (9th September 2020)

• Record Type: Journal Article
• Authors: Lee, Scott D.; Singla, Anand; Rulyak, Stephen J.; Clark‐Snustad, Kindra
• Is Part Of: GastroHep. Volume 2:Issue 5(2020)
• Page Start: 185
• Page End: 192
• Publication Date: 2020-09-09
• Subjects: antibiotics -- clinical response -- Crohn's disease -- Rifaximin; Gastroenterology -- Periodicals; Hepatology -- Periodicals; 616.33
• DOI: 10.1002/ygh2.416
• Languages: English
• ISSNs: 2689-3711

Abstract

Abstract: Background: Antibiotics have been used to treat luminal Crohn's disease with variable success. Rifaximin has a favourable safety profile given its limited systemic absorption and may improve clinical symptoms in patients with mild to moderate Crohn's disease. Response of moderate to severe luminal Crohn's disease to rifaximin therapy is unclear. We aimed to evaluate the clinical response to rifaximin treatment in patients with moderately to severely active Crohn's disease. Methods: Subjects with moderate to severe Crohn's disease (Crohn's disease activity index 250‐450) were randomised 1:1 to blinded rifaximin 550 mg PO BID or placebo for 8 weeks. Nonresponders to placebo received open label rifaximin 550 mg PO BID for 8 weeks. We assessed Crohn's disease activity index, Inflammatory Bowel Disease Questionnaire and biochemical markers prior to and after therapy. Adverse events were documented throughout the study and for 8 weeks after the last dose of study medication. Results: We randomised 28 subjects. After 8 weeks, 35.7% of subjects on rifaximin reported clinical response, compared to 7.1% on placebo ( P = 0.046). Ten nonresponders to placebo received open label rifaximin. After 8 weeks, 1 subject had clinical response and no subjects were in remission after crossover open label therapy. Adverse events were similar between groups. Conclusion: Rifaximin improves the clinical disease activity in patients with moderate to severe active Crohn's disease who have a significant disease burden and who have had prior exposure to one or more biologic therapies. Quality of life and biochemical assessments were numerically improved. No new safety concerns were identified.