Original articleSerious Infections and Mortality in Association With Therapies for Crohn’s Disease: TREAT Registry
Section snippets
Study Design
The TREAT Registry is a prospective, observational, multicenter, long-term registry of North American patients with CD. The registry was initiated in 1999 to evaluate the clinical safety outcomes of various treatment regimens, including infliximab, in the management of CD. Approximately 350 gastroenterologists from both community-based and academic practice settings were each to enroll up to 150 patients for a target enrollment of at least 5000 patients. Most physicians were identified from the
Results
Through August 2004, 6290 CD patients from 212 centers were enrolled from both community (82%) and academic (18%) centers. Most patients were female (58%) and Caucasian (89%), with an average age of 43 ± 14.7 years. The population was distributed almost equally between those who had been treated with infliximab (N = 3179, 50.5%) and those who had not. More than 85% of patients treated with infliximab had received at least 2 infusions. Among patients who received infliximab, a median of 5
Discussion
This is the first report from the TREAT Registry, a large, prospective, observational research program designed to address the long-term safety of medications, including infliximab, for the treatment of CD. After adjustment for confounding factors including disease severity and the use of other medications, the risk for serious infection or death with infliximab use was similar to that observed with the use of conventional immunomodulators, and was not higher than the overall incidence of
Conclusions
Because CD is a chronic, potentially debilitating disease requiring ongoing treatment, physicians must consider the benefit/risk profiles of all therapies. Data from the TREAT Registry indicate that the risks for serious infection and death associated with infliximab are similar to those of conventional immunomodulators over 2 years of follow-up evaluation. Possible factors implicated with a significantly increased risk for serious infections include the use of prednisone, the use of narcotic
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- 1
Gary R. Lichtenstein has received honorarium and research funding from Centocor, the manufacturers of infliximab; honorarium from Prometheus; honorarium from Salix, the manufacturers of azathioprine; and honorarium from Astra Zeneca, the manufacturers of Budesonide.
- 2
Michelle L. Pritchard is employed by Ovatich Research Group, a company that receives funding from Centocor Inc.
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William J. Sandler has received research support and is a Consultant for Centocor, and has participated in CME events indirectly sponsored by Centocor.
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Bruce A. Salzberg is on the Speakers Bureau for Centocor.
- 5
Robert H. Diamond is employed by Centocor.
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Donny M. Chen is a Consultant for Centocor.
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Russell D. Cohen has received research grants and is a consultant for Centocor, and is a stockholder in Johnson Johnson.