Scheduled infliximab monotherapy to prevent recurrence of Crohns disease following ileocolic or ileal resection: A 3-year prospective randomized open trial
Inflammatory Bowel Disease, 04/20/2012
Yoshida K et al. – An early intervention with Infliximab (IFX) monotherapy should prevent clinical, serological, and endoscopic Crohn's disease (CD) recurrence following ileocolic resection. Thiopurine naivety and eliminating the initial loading dose of IFX might minimize serious adverse event (AE).Methods
- 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.