W1285 Infliximab Mono-Therapy Prevented Post Operative Recurrence of Crohn's Disease After Intestinal Resection: A Prospective Randomized Open Trial in Japanese Population

Abstract

BACKGROUND: Infliximab (IFX) has been widely used for remission induction and maintenance therapies of Crohn's disease (CD). In addition, a US group has reported that IFX prevented post operative recurrence in CD patients after having surgery (Regueiro M, et al., Gastroenterology 2009); however, there was no sufficent evidence that IFX could achieve this prevention when we has given IFX alone. We have hence conducted this study to prove or disprove that IFXmono-therapy might prevent post operative recurrence of CD in Japanese population. METHODS: A prospective open-labeled trial was conducted. Twenty-seven patients of CD, who had undergone intestinal resection within 4 weeks of surgery, were randomly assigned either with (IFX group; n=15) or without (Control; n=12) intravenous infusions of 5mg/kg IFX every 8weeks and continued for 12 months. They were absolutory naive of concomitant immunomodulators during their CD duration. Primary endpoint was the population of patients maintaining clinical remission, defined as≤150 in the CD activity index (CDAI), and endoscopic recurrence at 1 year was evaluated using Rutgeert's endoscopic score as secondary endpoint. RESULTS: After 12 months, 85.7% of patients in the IFX group have maintained clinical remission, whereas that of Control was 66.7%. Further, IFX achieved significant higher endoscopic remission ratio at 1 year (Figure). Concomitant therapies, including 5-ASA and enteral nutrition, were not different between these groups, and there was no patient taking steroid and thioprine during the study period. One patient in the IFX group was dropped out due to severe dyspnea at 3 months. COMMENTS AND CONCLUSIONS: Scheduled administration of IFX in every 8 weeks has been proven to prevent recurrences in CD patients after intestinal resective surgery without concomitant immunomodulators.