Clinical–alimentary tractTwo-Year Combination Antibiotic Therapy With Clarithromycin, Rifabutin, and Clofazimine for Crohn’s Disease
Section snippets
Subjects
Patients over 18 years of age diagnosed with Crohn’s disease according to standard criteria and active disease defined as Crohn’s Disease Activity Index (CDAI) ≥200 were enrolled at 20 centers around Australia. Patients with isolated upper gastrointestinal or isolated perianal disease or a stoma were excluded, as were those requiring intravenous corticosteroids at initial assessment and those thought likely to require surgery during the first 4 months of the study. Permitted medications
Subject Disposition and Induction Phase
Between September 1999 and September 2001, 213 patients were enrolled and randomized to receive either antibiotics (n = 102) or placebo (n = 111) (Figure 1). The characteristics of these 2 groups are shown in Table 1. There were no significant differences between them.
There were significantly more patients in the antibiotics arm who went on to the maintenance phase starting at 16 weeks (P = .02). Ninety-one subjects were withdrawn during the prednisolone-induction phase: 35 from the antibiotic
Discussion
This study was designed to show a 40% difference between treatment groups at 24 months, a realistic difference if prolonged combination of clarithromycin, rifabutin, and clofazimine antibiotic therapy was to have a clinically significant impact on Crohn’s disease. Although there was a short-term benefit of the antibiotics at 16 weeks additional to the effect of corticosteroid therapy, the study showed no prolonged advantage of the antibiotic combination either during the 2-year treatment phase
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Supported by Pharmacia, Pharmacia and Upjohn, and Pfizer Pty Ltd.
None of the authors has a conflict of interest.
The Antibiotics in Crohn’s Disease Study Group: Peter Bampton, Flinders Medical Centre, Adelaide; David Hetzel, Royal Adelaide Hospital, Adelaide; Tim Florin, Mater Health Services Adult Hospital, Brisbane; Graham Radford-Smith, Royal Brisbane Hospital, Brisbane; Peter Stephenson, Brisbane Gastroscopy and Colonoscopy, Brisbane; Paul Pavli, The Canberra Hospital, Canberra; Hugh Jackson, Royal Hobart Hospital, Hobart; Brent Mitchell, Launceston General Hospital, Launceston; William Connell, St. Vincent’s Hospital, Melbourne; Brendan Crotty, Austin Health, Melbourne; Peter Gibson, Royal Melbourne Hospital, Melbourne; Steven Kolt, Western Hospital, Melbourne; Michael Merrett, Frankston Hospital, Melbourne; Robert Batey, John Hunter Hospital, Newcastle; Brendan Collins, Royal Perth Hospital, Perth; Hooi Ee, Sir Charles Gairdner Hospital, Perth; Peter Katelaris, Concord Hospital, Sydney; Robert Read, Hornsby Ku-rin-gai Hospital, Sydney; Warwick Selby, Royal Prince Alfred Hospital, Sydney; and Nicholas Talley, Nepean Hospital, Sydney, Australia.