Postoperative Therapy With Infliximab Prevents Long-term Crohn’s Disease Recurrence  Miguel Regueiro, Kevin E. Kip, Leonard Baidoo, Jason M. Swoger, Wolfgang Schraut  Clinical Gastroenterology and Hepatology  Volume 12, Issue 9, Pages 1494-1502.e1 (September 2014) DOI: 10.1016/j.cgh.2013.12.035 Copyright © 2014 AGA Institute Terms and Conditions

Figure 1 Long-term (>5 years) follow-up of patients initially randomized to infliximab or placebo. Recurrence is defined as endoscopic recurrence (i2, i3, i4). Remission is defined as endoscopic score of i0 or i1. Surgery is defined as intestinal resection for recurrent Crohn’s disease or complication of Crohn’s disease. All surgery patients had 1 intercurrent surgery during follow-up, except 1 of the infliximab patients who stopped infliximab had 2 surgeries and the 1 placebo patient who did not receive anti-TNF treatment had 2 surgeries. IFX, infliximab; PBO, placebo; RCT, randomized controlled trial. Clinical Gastroenterology and Hepatology 2014 12, 1494-1502.e1DOI: (10.1016/j.cgh.2013.12.035) Copyright © 2014 AGA Institute Terms and Conditions

Figure 2 Plot of days to endoscopic disease recurrence by initial random assignment to infliximab or placebo. The black-filled portion of each horizontal bar depicts number of days on infliximab therapy; the gray portion of each horizontal bar depicts number of days not on infliximab therapy. Clinical Gastroenterology and Hepatology 2014 12, 1494-1502.e1DOI: (10.1016/j.cgh.2013.12.035) Copyright © 2014 AGA Institute Terms and Conditions

Figure 3 Percentage of patients in remission (ileal score, i0 or i1) of Crohn’s disease at 5–8 years of endoscopic evaluation by use vs non-use of biologic therapy in the period that preceded endoscopic evaluation. Clinical Gastroenterology and Hepatology 2014 12, 1494-1502.e1DOI: (10.1016/j.cgh.2013.12.035) Copyright © 2014 AGA Institute Terms and Conditions

Figure 4 Colonoscopy-level analysis of rate of endoscopic disease recurrence (i2, i3, i4) stratified by use vs non-use of infliximab and by 6MP/AZA status overall and in absence of use of infliximab. The 6 colonoscopies with adalimumab or certolizumab were excluded. IFX, infliximab. Clinical Gastroenterology and Hepatology 2014 12, 1494-1502.e1DOI: (10.1016/j.cgh.2013.12.035) Copyright © 2014 AGA Institute Terms and Conditions

Figure 5 Plot of days to recurrent surgery by initial random assignment to infliximab or placebo. The black-filled portion of each horizontal bar depicts number of days on infliximab therapy; the gray portion of each horizontal bar depicts number of days not on infliximab therapy. Clinical Gastroenterology and Hepatology 2014 12, 1494-1502.e1DOI: (10.1016/j.cgh.2013.12.035) Copyright © 2014 AGA Institute Terms and Conditions

Figure 6 Crude rates of surgery during entire study period stratified by initial random assignment and cumulative time on infliximab therapy (<60% vs ≥60%). IFX, infliximab; pts, patients. Clinical Gastroenterology and Hepatology 2014 12, 1494-1502.e1DOI: (10.1016/j.cgh.2013.12.035) Copyright © 2014 AGA Institute Terms and Conditions

Supplementary Figure 1 Kaplan–Meier plot of surgery-free survival stratified by initial random assignment and cumulative time on infliximab therapy (<60% vs ≥60%). The highly divergent survival curves did not achieve statistical significance (P = .23), likely because of low statistical power. IFX, infliximab. Clinical Gastroenterology and Hepatology 2014 12, 1494-1502.e1DOI: (10.1016/j.cgh.2013.12.035) Copyright © 2014 AGA Institute Terms and Conditions