Clinical-alimentary tractA pilot randomized trial of a human anti-interleukin-6 receptor monoclonal antibody in active Crohn’s disease☆
Section snippets
Patients
Patients with CD, diagnosed in terms of history and radiologic or endoscopic intestinal appearance, who were at least 20 years of age were eligible for the study. Patients were to have a score on the Crohn’s Disease Activity Index (CDAI)8 ≥150, which indicates active CD, and abnormal serum levels of CRP. Patients were screened for eligibility at least 2 weeks before treatment. A total of 36 patients were screened, and all patients underwent randomization at 7 study centers in Japan between May
Patient characteristics
Thirty-six patients were randomly assigned to the M2W, M4W, or placebo group (Figure 1). Demographic data for the randomized patients are given in Table 1. There were no significant differences in age, sex, duration of disease, CDAI scores, or laboratory test values including CRP levels at baseline among the groups. All the patients had colonic disease with or without involvement of the small intestine. There were no significant differences in the number of the patients who had undergone
Discussion
Our study is the first randomized placebo-controlled trial of anti-IL-6R mAb MRA in the treatment of patients with active CD. Although this is a preliminary study, the results presented here show that the therapy with MRA for CD is safe and well tolerated and suggests a beneficial effect.
The clinical response rate of the M2W group was higher than that of the M4W group. The different response rate between the MRA groups might be attributable to a continuous suppression of acute-phase reactants
Acknowledgements
The authors wish to thank Paul Langman, Ph.D., for his valuable assistance with the preparation of the English version of this paper.
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Supported by Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.