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, vol. 132, no. 7, pp. 2313-2319, doi: 10.1053/j.gastro.2007.03.031.

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Title Two-year combination antibiotic therapy with clarithromycin, rifabutin, and clofazimine for Crohn's disease
Author(s) Selby, Warwick
Pavli, Paul
Crotty, BrendanORCID iD for 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
Journal name Gastroenterology
Volume number 132
Issue number 7
Start page 2313
End page 2319
Publisher Elsevier Science
Place of publication New York, N.Y.
Publication date 2007-06
ISSN 0016-5085
Summary 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.
Language eng
DOI 10.1053/j.gastro.2007.03.031
Field of Research 110307 Gastroenterology and Hepatology
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C1.1 Refereed article in a scholarly journal
Copyright notice ©2007, AGA Institute Published by Elsevier Inc.
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