Two-Year combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for Crohn's disease

Selby, Warwick, Pavli, Paul, Crotty, Brendan, Florin, Tim, Radford-Smith, Graham, Gibson, Peter, Mitchell, Brent, Connell, William, Read, Robert, Merrett, Michael, Ee, Hooi, Hetzel, David and Antibiotics in Crohn's Disease Study Group (2007) Two-Year combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for Crohn's disease. Gastroenterology, 132 7: 2313-2319. doi:10.1053/j.gastro.2007.03.031

Author Selby, Warwick
Pavli, Paul
Crotty, Brendan
Florin, Tim
Radford-Smith, Graham
Gibson, Peter
Mitchell, Brent
Connell, William
Read, Robert
Merrett, Michael
Ee, Hooi
Hetzel, David
Antibiotics in Crohn's Disease Study Group
Title Two-Year combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for Crohn's disease
Journal name Gastroenterology   Check publisher's open access policy
ISSN 0016-5085
Publication date 2007
Sub-type Article (original research)
DOI 10.1053/j.gastro.2007.03.031
Volume 132
Issue 7
Start page 2313
End page 2319
Total pages 7
Editor Tamburini, M.
Place of publication Maryland Heights, MO, United States
Publisher W.B. Saunders Co.
Collection year 2008
Language eng
Subject C1
320503 Clinical Pharmacology and Therapeutics
730107 Inherited diseases (incl. gene therapy)
Formatted abstract
Background & Aims: Mycobacterium avium subspecies paratuberculosis has been proposed as a cause of Crohn’s disease. We report a prospective, parallel, placebo-controlled, double-blind, randomized trial of 2 years of clarithromycin, rifabutin, and clofazimine in active Crohn’s disease, with a further year of follow-up. 

Methods: Two hundred thirteen patients were randomized to clarithromycin 750 mg/day, rifabutin 450 mg/day, clofazimine 50 mg/day or placebo, in addition to a 16-week tapering course of prednisolone. Those in remission (Crohn’s Disease Activity Index <150) at week 16 continued their study medications in the maintenance phase of the trial. Primary end points were the proportion of patients experiencing at least 1 relapse at 12, 24, and 36 months.

Results: At week 16, there were significantly more subjects in remission in the antibiotic arm (66%) than the placebo arm (50%; P = .02). Of 122 subjects entering the maintenance phase, 39% taking antibiotics experienced at least 1 relapse between weeks 16 and 52, compared with 56% taking placebo (P = .054). At week 104, the figures were 26% and 43%, respectively (P .14). During the following year, 59% of the antibiotic group and 50% of the placebo group relapsed (P = .54).

Conclusions: Using combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for up to 2 years, we did not find evidence of a sustained benefit. This finding does not support a significant role for Mycobacterium avium subspecies paratuberculosis in the pathogenesis of Crohn’s disease in the majority of patients. Short-term improvement was seen when this combination was added to corticosteroids, most likely because of nonspecific antibacterial effects. 
Q-Index Code C1
Q-Index Status Confirmed Code

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Created: Fri, 18 Apr 2008, 14:27:59 EST by Maree Knight on behalf of School of Medicine