Gastroenterology

Gastroenterology

Volume 121, Issue 5, November 2001, Pages 1088-1094
Gastroenterology

Clinical Research
Etanercept for active Crohn's disease: A randomized, double-blind, placebo-controlled trial,☆☆,

https://doi.org/10.1053/gast.2001.28674Get rights and content

Abstract

Background & Aims: We evaluated etanercept, a human soluble tumor necrosis factor receptor: Fc fusion protein, for the treatment of active Crohn's disease. Methods: Forty-three patients with moderate to severe Crohn's disease were enrolled in an 8-week placebo-controlled trial. Patients were randomized to subcutaneous etanercept 25 mg or placebo twice weekly. The primary outcome measure was clinical response at week 4, defined as a decrease in the baseline Crohn's Disease Activity Index score ≥70 points or a Crohn's Disease Activity Index score <150 points. Results: At week 4, 39% of etanercept-treated patients had clinical response as compared with 45% of placebo-treated patients (P = 0.763). The frequency of common adverse events including headache, new injection site reaction, asthenia, abdominal pain, Crohn's disease–related anemia, and skin disorders was similar in both groups. Likewise, the frequency of severe or serious adverse events was similar in both groups. Conclusions: Subcutaneous etanercept at a dose of 25 mg twice weekly is safe, but not effective, for the treatment of patients with moderate to severe Crohn's disease. The dose of etanercept administered in this study is that approved for rheumatoid arthritis. Higher doses or more frequent dosing may be required to attain a response in patients with active Crohn's disease.

GASTROENTEROLOGY 2001;121:1088-1094

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).

. Baseline characteristics of the patients

VariablePlacebo (n = 20)Etanercept (n = 23)
Sex (M/F)10/1016/7
Age at entry
 Median39.337.4
 Range22-6020-69
Weight (kg)
 Median75.3

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.

    ☆☆

    Supported by a research grant from Immunex Corporation, Seattle, Washington.

    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.

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