Alimentary TractEndoscopic and histological healing with infliximab anti–tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial☆,☆☆
Section snippets
Materials and methods
Thirty patients with active refractory Crohn's disease were enrolled in an international randomized controlled trial comparing 5, 10, and 20 mg/kg infliximab with placebo as a single 2-hour infusion at four European centers (Leuven, Belgium; Amsterdam and Leiden, The Netherlands; and Leeds, England). To be eligible for the study, patients had to have had Crohn's disease for at least 6 months, with Crohn's Disease Activity Index (CDAI) scores between 220 and 400. Patients were excluded from the
Results
The patient and disease characteristics of the four treatment groups are shown in Table 1.
Empty Cell Empty Cell Infliximab Empty Cell Placebo 5mg/kg 10 mg/kg 20 mg/kg All cA2 No. of patients 8 7 7 8 22 Sex (M/F) 3/5
¾
¾ 3/5 9/13 Age (yr)a 34.4 ± 9.8 30.1 ± 5.0 30.7 ± 8.7 33.1 ± 7.8 31.4 ± 7.1 Concomitant medication Azathioprine 3/8 3/7 1/7 5/8 9/22 Steroids 5/8 4/7 3/7 4/8 11/22 aMean ± SEM.
Discussion
Therapeutic options in refractory Crohn's disease are limited. Although the widespread use of azathioprine and 6-mercaptopurine has dramatically reduced the number of intractable cases, patients not responding to this therapy often become dependent on corticosteroids and eventually have to undergo debilitating surgical resections.14, 15, 16, 17, 18 The advent of immune-targeted therapy opens a wide range of new therapeutic possibilities, the most convincing clinical results to date having been
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Address requests for reprints to: Geert D'Haens, M.D., Ph.D., Department of Internal Medicine, University Hospital Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium. e-mail: [email protected]; fax: (32) 16-3488-58.
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Supported in part by Centocor, Inc., Malvern, Pennsylvania.