Scheduled infliximab monotherapy to prevent recurrence of Crohn's disease following ileocolic or ileal resection: A 3-year prospective randomized open trial
Article first published online: 13 NOV 2011
Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 18, Issue 9, pages 1617–1623, September 2012
How to Cite
Yoshida, K., Fukunaga, K., Ikeuchi, H., Kamikozuru, K., Hida, N., Ohda, Y., Yokoyama, Y., Iimuro, M., Takeda, N., Kato, K., Kikuyama, R., Nagase, K., Hori, K., Nakamura, S., Miwa, H. and Matsumoto, T. (2012), Scheduled infliximab monotherapy to prevent recurrence of Crohn's disease following ileocolic or ileal resection: A 3-year prospective randomized open trial. Inflamm Bowel Dis, 18: 1617–1623. doi: 10.1002/ibd.21928
- Issue published online: 9 AUG 2012
- Article first published online: 13 NOV 2011
- Manuscript Accepted: 23 SEP 2011
- Manuscript Received: 20 SEP 2011
- Health and Labour Sciences Research
- Japan Ministry of Health
- Labour and Welfare
- Crohn's disease;
- anti-TNF α antibody;
- infliximab monotherapy;
- postoperative Crohn's disease recurrence
Infliximab (IFX) is effective for remission induction and maintenance of Crohn's disease (CD). This trial assessed the efficacy of scheduled maintenance IFX monotherapy to prevent postoperative CD recurrence.
Thirty-one CD patients who had ileocolic resection within the past 4 weeks were randomly assigned to scheduled IFX at 5 mg/kg intravenously every 8 weeks for 36 months (n = 15) or without IFX (control, n = 16). All patients were treated without immunomodulator or corticosteroid following surgery. The primary and secondary endpoints were remission rates at 12 and 36 months, defined as CD Activity Index (CDAI) ≤150, an International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score <2, and C-reactive protein (CRP) <0.3 mg/dL. Additionally, endoscopic recurrences at 12 and 36 months were evaluated.
At 12 and 36 months, 100%, and 93.3% of patients in the IFX group were in remission (IOIBD <2), respectively vs. 68.8% and 56.3% in the control arm (P < 0.03). Similarly, 86.7% and 86.7% of patients in the IFX group maintained serological remission (CRP <0.3 mg/dL) vs. 37.5% and 37.5% in the control arm (P < 0.02). Further, the IFX group achieved higher endoscopic remission at 12 months, 78.6% vs. 18.8% (P = 0.004). However, in the Kaplan–Meier survival analysis the CDAI scores between the two arms were not significantly different either at 12 or at 36 months. No adverse event (AE) was observed.
An early intervention with IFX monotherapy should prevent clinical, serological, and endoscopic CD recurrence following ileocolic resection. Thiopurine naivety and eliminating the initial loading dose of IFX might minimize serious AEs. (Inflamm Bowel Dis 2012)