Original articleAlimentary tractPatients Enrolled in Randomized Controlled Trials Do Not Represent the Inflammatory Bowel Disease Patient Population
Section snippets
Study Population and Data Collection
We performed a retrospective chart review of consecutive adult IBD patients with moderate–severe disease activity presenting to the Mount Sinai Medical Center for an escalation or adjustment of their medical therapy from January 2008 to June 2009. Moderate–severe disease activity was defined as a Harvey–Bradshaw Index (HBI) score between 8 and 16 for CD and a Mayo UC disease activity index score between 6 and 12 for UC.7, 15 Patients with indeterminate colitis, suspected but not established
Patient Characteristics
Two hundred six patients with moderate–severe IBD met enrollment criteria during the 18-month study period. Of the 125 CD patients, 34% of patients (n = 43) would have qualified for enrollment into at least 1 of the 7 included RCTs. Trial eligibility for the RCTs for infliximab, adalimumab, certolizumab pegol, and natalizumab ranged from 8% for the SONIC trial to 27% for the CHARM and PRECISE1 trials. Only 25% of the UC patients (n = 21) would have qualified for enrollment into the ACT trial.
Discussion
The biologics are among the most prescribed medications for symptomatic IBD patients. The evidence supporting their increasing utilization is largely based from RCT data. However, our study suggests that IBD patients enrolled in the major RCTs of the FDA-approved biological agents might not be completely representative of patients encountered during routine clinical practice where anti-TNF therapy is often considered as the next step of management. Compared with the patients enrolled in the
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This article has an accompanying continuing medical education activity on page e78. Learning Objectives—At the end of this activity, the successful learner will be able to identify the potential limitations of clinical trial data when translated to a real-world clinical practice.
Conflicts of interest These authors disclose the following: Asher Kornbluth has served on the Advisory board for Igen/Biodec, Abbott, Elan, and Centocor; provided research support for Abbott and Centocor; and has been on the Speaker's Bureau for Abbott and Centocor. Corey A. Siegel has been on the Consultant/Advisory board for Abbott, Elan, UCB; CME lecturer for Abbott and Janssen; and received research funding from Abbott. Thomas Ullman has been a Consultant for Abbott, UCB, and Centocor. The remaining author discloses no conflicts.