P362. Retrospective comparison of the efficacy of anti-TNF agents in isolation or combined with azathioprine in prevention of early postoperative endoscopic recurrence in Crohn's disease from the MULTIPER database
Y. Suzuki1, P.G. Kotze2, A. Spinelli3,4, R. Saad-Hossne5, A. Yamada1, M. Sacchi3, F. Teixeira6, I. Albuquerque7, I. Barcelos2, R. Silva2, L. Kotze8, M. Olandoski9, S. Danese10, T. Yamamoto11, 1Toho University - Sakura Medical Center, Internal Medicine, Chiba, Japan, 2Cajuru University Hospital - Catholic University of Parana, Colorectal Surgery Unit, Curitiba, Brazil, 3Humanitas Research Hospital, Medical Biotechnologies and Translational Medicine, Milano, Italy, 4Humanitas Research Hospital, IBD Surgery Unit, Milano, Italy, 5São Paulo State University, Digestive Surgery Department, Botucatu, Brazil, 6Gastrosaude, Colorectal Surgery, Marilia, Brazil, 7Heliopolis Hospital, IBD unit, São Paulo, Brazil, 8Cajuru University Hospital - Catholic University of Parana, Gastroenterology, Curitiba, Brazil, 9Catholic University of Paraná, Statistics, Curitiba, Brazil, 10Humanitas Research Hospital, IBD Unit - Gastroenterology, Milano, Italy, 11Yokkaichi Social Insurance Hospital, IBD Unit, Yokkaichi, Japan
Early postoperative endoscopic recurrence (EPER) occurs in nearly 80% of the patients one year after ileocecal resection in Crohn's disease (CD) patients. Biological agents showed to reduce the rates of EPER in comparison with conventional therapy, in prospective trials. The aim of this study was to evaluate if the superiority of the combination therapy (anti-TNF agents and azathioprine or 6-mercaptopurine - 6-MP) in comparison with monotherapy with biologics, in terms of EPER rates after ileocecal resection in CD, could be confirmed in a multicentric retrospective analysis.
The MULTIPER (Multicenter International Postoperative Endoscopic Recurrence) database is a retrospective analysis of EPER rates in CD patients after ileocecal resection, from 7 referral centres from 3 different countries. All consecutive patients that were submitted to ileocecal resections and had colonoscopies performed up to 12 months after surgery between 2008 and 2012 were included in the analysis. Patients with conventional therapy after surgery were excluded. Recurrence was defined by Rutgeerts' score equal or greater than i2. The patients under postoperative biological therapy were allocated in two groups: monotherapy and combination therapy with azathioprine or 6-MP. The EPER rates were compared between the two groups. Statystical analysis was performed by Fischer and chi-square tests (qualitative variables), and by Student's t test and Mann–Whitney test (quantitavive variables), with p < 0.05 considered significant.
Initially, 231 patients were analyzed (63 excluded, for missing data and having the first postoperative colonoscopy longer than 12 months). From the 168 patients in the database, 96 had anti-TNF agents after resection (59 in the monotherapy and 37 on the combotherapy group) and were included in this analysis. The groups were homogeneous regarding age (p = 0.150), gender (p = 0.830), previous resections (p = 0.284) and the type of anti-TNF agent used (Adalimumab or Infliximab, p = 0.521). There was a longer disease duration in the combotherapy in comparison with the monotherapy group (108 vs. 64 months, p = 0.030). EPER was detected in 13/59 (22.03%) patients in the monotherapy group versus 12/37 (32.43%) in the combotherapy group (p = 0.340).
In this retrospective analysis from the MULTIPER database, combination therapy with biologics associated with azathioprine or 6-MP showed comparable outcomes in terms of preventing EPER after ileocecal resection compared to biologics alone, probably due to more severe disease activity in the first group. Wider prospective data are needed to better elucidate the role of a plausible synergistic effect between immunomodulators and biological agents in the postoperative setting.