Clinical ResearchEtanercept for active Crohn's disease: A randomized, double-blind, placebo-controlled trial☆,☆☆,★
Section snippets
Selection of patients
The study was performed between September 1999 and May 2000. Eligible patients were at least 12 years of age and had moderately to severely active Crohn's disease, as defined by a score of 220 to 450 on the Crohn's Disease Activity Index (CDAI).26
Eligible patients had Crohn's disease confirmed by radiologic, endoscopic, or histologic criteria. The following patients were not eligible: those with an ileostomy or colostomy; those immediately in need of surgery for active gastrointestinal
Results
A total of 49 patients were screened, of whom 43 were randomized. Of the 43 randomized patients, 20 received placebo and 23 received etanercept. All 43 patients had at least 1 efficacy evaluation and are thus included in the intention-to-treat population. The baseline characteristics of the 2 groups of patients were similar (Table 1).Variable Placebo (n = 20) Etanercept (n = 23) Sex (M/F) 10/10 16/7 Age at entry Median 39.3 37.4 Range 22-60 20-69 Weight (kg) Median 75.3
Discussion
We found etanercept, when prescribed at 25 mg subcutaneously twice weekly, was not effective for inducing a clinical response at 4 weeks in patients with moderately to severely active Crohn's disease, using a decrease in baseline CDAI score of ≥70 points or a CDAI score <150 points as the definition of response. This lack of efficacy was supported by the lack of efficacy for any of the secondary endpoints including clinical response at 2 or 8 weeks, clinical remission at 2, 4, or 8 weeks,
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Address requests for reprints to: William J. Sandborn, M.D., Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905. e-mail: [email protected]; fax: (507) 266-0335.
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Supported by a research grant from Immunex Corporation, Seattle, Washington.
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William Sandborn is a consultant for Immunex. William Sandborn, Stephen Hanauer, Seymour Katz, Michael Safdi, Douglas Wolf, Richard Baerg, William Tremaine, Therese Johnson, Nancy Diehl, and Alan Zinsmeister have all received research support from Immunex. None of the authors have participated in continuing medical education events or speakers bureaus for Immunex.