Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease after Ileocolonic Resection

Miguel Regueiro, Brian G. Feagan, Bin Zou, Jewel Johanns, Marion A. Blank, Marc Chevrier, Scott Plevy, John Popp, Freddy J. Cornillie, Milan Lukas, Silvio Danese, Paolo Gionchetti, Stephen B. Hanauer, Walter Reinisch, William J. Sandborn, Dario Sorrentino, Paul Rutgeerts, H. Debinski, T. Florin, D. Hetzel & 136 others I. Lawrance, G. Radford-Smith, A. Sloss, D. Sorrentino, S. Gassner, T. Haas, G. Reicht, W. Reinisch, M. Strasser, H. Vogelsang, P. Bossuyt, O. Dewit, G. D'Haens, D. Franchimont, E. Louis, S. Vermeire, C. N. Bernstein, R. Bourdages, N. Chiba, S. S. Dhalla, B. G. Feagan, R. N. Fedorak, J. R. Lachance, R. Panaccione, M. Ropeleski, B. Singh Salh, M. Lukas, J. F. Colombel, M. Allez, P. Desreumaux, J. L. Dupas, J. C. Grimaud, X. Hebuterne, D. Laharie, E. Lerebours, L. Peyrin-Biroulet, J. M. Reimund, S. Viennot, F. Zerbib, C. Antoni, R. Atreya, D. C. Baumgart, C. Berg, U. Boecker, G. Bramkamp, C. Bünning, R. Ehehalt, S. Howaldt, T. Kucharzik, H. G. Lamprecht, J. Mudter, J. C. Preiss, S. Schreiber, U. Seidler, I. Altorjay, J. Banai, P. L. Lakatos, M. Varga, A. Vincze, I. Avni-Biron, S. Fishman, G. M. Fraser, E. Goldin, D. Rachmilewitz, V. Annese, S. Ardizzone, L. Biancone, F. Bossa, S. Danese, W. Fries, P. Gionchetti, G. Maconi, G. Terrosu, P. Usai, G. R. D'Haens, R. B. Gearry, J. Hill, D. S. Rowbotham, M. Schultz, R. S. Stubbs, D. Wallace, R. S. Walmsley, J. Wyeth, E. Malecka-Panas, L. Paradowski, J. Regula, I. P. Beales, S. Campbell, A. B. Hawthorne, M. Parkes, S. P. Travis, J. P. Achkar, B. W. Behm, S. J. Bickston, K. J. Brown, M. V. Chiorean, Debra Helper, D. E. Elliott, D. Grunkmeier, J. W. Hamilton, S. B. Hanauer, J. S. Hanson, R. Hardi, D. J. Helper, H. Herfarth, P. D R Higgins, W. H. Holderman, R. Kottoor, M. D. Kreines, B. I. Leman, X. Li, E. V. Loftus, M. Noar, I. Oikonomou, J. Onken, K. A. Peterson, R. P. Phillips, C. W. Randall, M. Ricci, T. Ritter, D. T. Rubin, M. Safdi, W. J. Sandborn, L. Sauberman, E. Scherl, R. P. Schwarz, S. Sedghi, I. Shafran, C. A. Sninsky, I. Stein, J. Swoger, J. Vecchio, D. I. Weinberg, L. D. Wruble, V. Yajnik, Z. Younes

Research output: Contribution to journalArticle

66 Citations (Scopus)

Abstract

Background & Aims Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs after resection. We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence. Methods We evaluated the efficacy of infliximab in preventing postoperative recurrence of CD in 297 patients at 104 sites worldwide from November 2010 through May 2012. All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks. The primary end point was clinical recurrence, defined as a composite outcome consisting of a CD Activity Index score >200 and a ≥70-point increase from baseline, and endoscopic recurrence (Rutgeerts score ≥i2, determined by a central reader) or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary end point. Results A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9% vs 20.0%; absolute risk reduction [ARR] with infliximab, 7.1%; 95% confidence interval: -1.3% to 15.5%; P =.097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared with the placebo group (30.6% vs 60.0%; ARR with infliximab, 29.4%; 95% confidence interval: 18.6% to 40.2%; P <.001). Additionally, a significantly smaller proportion of patients in the infliximab group had endoscopic recurrence based only on Rutgeerts scores ≥i2 (22.4% vs 51.3%; ARR with infliximab, 28.9%; 95% confidence interval: 18.4% to 39.4%; P <.001). Patients previously treated with anti-tumor necrosis factor agents or those with more than 1 resection were at greater risk for clinical recurrence. The safety profile of infliximab was similar to that from previous reports. Conclusions Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. However, infliximab does reduce endoscopic recurrence. ClinicalTrials.gov ID NCT01190839.

Original languageEnglish (US)
Pages (from-to)1568-1578
Number of pages11
JournalGastroenterology
Volume150
Issue number7
DOIs
StatePublished - Jun 1 2016

Fingerprint

Crohn Disease
Recurrence
Numbers Needed To Treat
Placebos
Confidence Intervals
Infliximab
Random Allocation
Abscess
Fistula
Tumor Necrosis Factor-alpha
Safety

Keywords

  • Anti-TNF
  • CDAI
  • Inflammatory Bowel Disease
  • PREVENT

ASJC Scopus subject areas

  • Medicine(all)
  • Gastroenterology

Cite this

Regueiro, M., Feagan, B. G., Zou, B., Johanns, J., Blank, M. A., Chevrier, M., ... Younes, Z. (2016). Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease after Ileocolonic Resection. Gastroenterology, 150(7), 1568-1578. https://doi.org/10.1053/j.gastro.2016.02.072

Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease after Ileocolonic Resection. / Regueiro, Miguel; Feagan, Brian G.; Zou, Bin; Johanns, Jewel; Blank, Marion A.; Chevrier, Marc; Plevy, Scott; Popp, John; Cornillie, Freddy J.; Lukas, Milan; Danese, Silvio; Gionchetti, Paolo; Hanauer, Stephen B.; Reinisch, Walter; Sandborn, William J.; Sorrentino, Dario; Rutgeerts, Paul; Debinski, H.; Florin, T.; Hetzel, D.; Lawrance, I.; Radford-Smith, G.; Sloss, A.; Sorrentino, D.; Gassner, S.; Haas, T.; Reicht, G.; Reinisch, W.; Strasser, M.; Vogelsang, H.; Bossuyt, P.; Dewit, O.; D'Haens, G.; Franchimont, D.; Louis, E.; Vermeire, S.; Bernstein, C. N.; Bourdages, R.; Chiba, N.; Dhalla, S. S.; Feagan, B. G.; Fedorak, R. N.; Lachance, J. R.; Panaccione, R.; Ropeleski, M.; Singh Salh, B.; Lukas, M.; Colombel, J. F.; Allez, M.; Desreumaux, P.; Dupas, J. L.; Grimaud, J. C.; Hebuterne, X.; Laharie, D.; Lerebours, E.; Peyrin-Biroulet, L.; Reimund, J. M.; Viennot, S.; Zerbib, F.; Antoni, C.; Atreya, R.; Baumgart, D. C.; Berg, C.; Boecker, U.; Bramkamp, G.; Bünning, C.; Ehehalt, R.; Howaldt, S.; Kucharzik, T.; Lamprecht, H. G.; Mudter, J.; Preiss, J. C.; Schreiber, S.; Seidler, U.; Altorjay, I.; Banai, J.; Lakatos, P. L.; Varga, M.; Vincze, A.; Avni-Biron, I.; Fishman, S.; Fraser, G. M.; Goldin, E.; Rachmilewitz, D.; Annese, V.; Ardizzone, S.; Biancone, L.; Bossa, F.; Danese, S.; Fries, W.; Gionchetti, P.; Maconi, G.; Terrosu, G.; Usai, P.; D'Haens, G. R.; Gearry, R. B.; Hill, J.; Rowbotham, D. S.; Schultz, M.; Stubbs, R. S.; Wallace, D.; Walmsley, R. S.; Wyeth, J.; Malecka-Panas, E.; Paradowski, L.; Regula, J.; Beales, I. P.; Campbell, S.; Hawthorne, A. B.; Parkes, M.; Travis, S. P.; Achkar, J. P.; Behm, B. W.; Bickston, S. J.; Brown, K. J.; Chiorean, M. V.; Helper, Debra; Elliott, D. E.; Grunkmeier, D.; Hamilton, J. W.; Hanauer, S. B.; Hanson, J. S.; Hardi, R.; Helper, D. J.; Herfarth, H.; Higgins, P. D R; Holderman, W. H.; Kottoor, R.; Kreines, M. D.; Leman, B. I.; Li, X.; Loftus, E. V.; Noar, M.; Oikonomou, I.; Onken, J.; Peterson, K. A.; Phillips, R. P.; Randall, C. W.; Ricci, M.; Ritter, T.; Rubin, D. T.; Safdi, M.; Sandborn, W. J.; Sauberman, L.; Scherl, E.; Schwarz, R. P.; Sedghi, S.; Shafran, I.; Sninsky, C. A.; Stein, I.; Swoger, J.; Vecchio, J.; Weinberg, D. I.; Wruble, L. D.; Yajnik, V.; Younes, Z.

In: Gastroenterology, Vol. 150, No. 7, 01.06.2016, p. 1568-1578.

Research output: Contribution to journalArticle

Regueiro, M, Feagan, BG, Zou, B, Johanns, J, Blank, MA, Chevrier, M, Plevy, S, Popp, J, Cornillie, FJ, Lukas, M, Danese, S, Gionchetti, P, Hanauer, SB, Reinisch, W, Sandborn, WJ, Sorrentino, D, Rutgeerts, P, Debinski, H, Florin, T, Hetzel, D, Lawrance, I, Radford-Smith, G, Sloss, A, Sorrentino, D, Gassner, S, Haas, T, Reicht, G, Reinisch, W, Strasser, M, Vogelsang, H, Bossuyt, P, Dewit, O, D'Haens, G, Franchimont, D, Louis, E, Vermeire, S, Bernstein, CN, Bourdages, R, Chiba, N, Dhalla, SS, Feagan, BG, Fedorak, RN, Lachance, JR, Panaccione, R, Ropeleski, M, Singh Salh, B, Lukas, M, Colombel, JF, Allez, M, Desreumaux, P, Dupas, JL, Grimaud, JC, Hebuterne, X, Laharie, D, Lerebours, E, Peyrin-Biroulet, L, Reimund, JM, Viennot, S, Zerbib, F, Antoni, C, Atreya, R, Baumgart, DC, Berg, C, Boecker, U, Bramkamp, G, Bünning, C, Ehehalt, R, Howaldt, S, Kucharzik, T, Lamprecht, HG, Mudter, J, Preiss, JC, Schreiber, S, Seidler, U, Altorjay, I, Banai, J, Lakatos, PL, Varga, M, Vincze, A, Avni-Biron, I, Fishman, S, Fraser, GM, Goldin, E, Rachmilewitz, D, Annese, V, Ardizzone, S, Biancone, L, Bossa, F, Danese, S, Fries, W, Gionchetti, P, Maconi, G, Terrosu, G, Usai, P, D'Haens, GR, Gearry, RB, Hill, J, Rowbotham, DS, Schultz, M, Stubbs, RS, Wallace, D, Walmsley, RS, Wyeth, J, Malecka-Panas, E, Paradowski, L, Regula, J, Beales, IP, Campbell, S, Hawthorne, AB, Parkes, M, Travis, SP, Achkar, JP, Behm, BW, Bickston, SJ, Brown, KJ, Chiorean, MV, Helper, D, Elliott, DE, Grunkmeier, D, Hamilton, JW, Hanauer, SB, Hanson, JS, Hardi, R, Helper, DJ, Herfarth, H, Higgins, PDR, Holderman, WH, Kottoor, R, Kreines, MD, Leman, BI, Li, X, Loftus, EV, Noar, M, Oikonomou, I, Onken, J, Peterson, KA, Phillips, RP, Randall, CW, Ricci, M, Ritter, T, Rubin, DT, Safdi, M, Sandborn, WJ, Sauberman, L, Scherl, E, Schwarz, RP, Sedghi, S, Shafran, I, Sninsky, CA, Stein, I, Swoger, J, Vecchio, J, Weinberg, DI, Wruble, LD, Yajnik, V & Younes, Z 2016, 'Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease after Ileocolonic Resection', Gastroenterology, vol. 150, no. 7, pp. 1568-1578. https://doi.org/10.1053/j.gastro.2016.02.072
Regueiro, Miguel ; Feagan, Brian G. ; Zou, Bin ; Johanns, Jewel ; Blank, Marion A. ; Chevrier, Marc ; Plevy, Scott ; Popp, John ; Cornillie, Freddy J. ; Lukas, Milan ; Danese, Silvio ; Gionchetti, Paolo ; Hanauer, Stephen B. ; Reinisch, Walter ; Sandborn, William J. ; Sorrentino, Dario ; Rutgeerts, Paul ; Debinski, H. ; Florin, T. ; Hetzel, D. ; Lawrance, I. ; Radford-Smith, G. ; Sloss, A. ; Sorrentino, D. ; Gassner, S. ; Haas, T. ; Reicht, G. ; Reinisch, W. ; Strasser, M. ; Vogelsang, H. ; Bossuyt, P. ; Dewit, O. ; D'Haens, G. ; Franchimont, D. ; Louis, E. ; Vermeire, S. ; Bernstein, C. N. ; Bourdages, R. ; Chiba, N. ; Dhalla, S. S. ; Feagan, B. G. ; Fedorak, R. N. ; Lachance, J. R. ; Panaccione, R. ; Ropeleski, M. ; Singh Salh, B. ; Lukas, M. ; Colombel, J. F. ; Allez, M. ; Desreumaux, P. ; Dupas, J. L. ; Grimaud, J. C. ; Hebuterne, X. ; Laharie, D. ; Lerebours, E. ; Peyrin-Biroulet, L. ; Reimund, J. M. ; Viennot, S. ; Zerbib, F. ; Antoni, C. ; Atreya, R. ; Baumgart, D. C. ; Berg, C. ; Boecker, U. ; Bramkamp, G. ; Bünning, C. ; Ehehalt, R. ; Howaldt, S. ; Kucharzik, T. ; Lamprecht, H. G. ; Mudter, J. ; Preiss, J. C. ; Schreiber, S. ; Seidler, U. ; Altorjay, I. ; Banai, J. ; Lakatos, P. L. ; Varga, M. ; Vincze, A. ; Avni-Biron, I. ; Fishman, S. ; Fraser, G. M. ; Goldin, E. ; Rachmilewitz, D. ; Annese, V. ; Ardizzone, S. ; Biancone, L. ; Bossa, F. ; Danese, S. ; Fries, W. ; Gionchetti, P. ; Maconi, G. ; Terrosu, G. ; Usai, P. ; D'Haens, G. R. ; Gearry, R. B. ; Hill, J. ; Rowbotham, D. S. ; Schultz, M. ; Stubbs, R. S. ; Wallace, D. ; Walmsley, R. S. ; Wyeth, J. ; Malecka-Panas, E. ; Paradowski, L. ; Regula, J. ; Beales, I. P. ; Campbell, S. ; Hawthorne, A. B. ; Parkes, M. ; Travis, S. P. ; Achkar, J. P. ; Behm, B. W. ; Bickston, S. J. ; Brown, K. J. ; Chiorean, M. V. ; Helper, Debra ; Elliott, D. E. ; Grunkmeier, D. ; Hamilton, J. W. ; Hanauer, S. B. ; Hanson, J. S. ; Hardi, R. ; Helper, D. J. ; Herfarth, H. ; Higgins, P. D R ; Holderman, W. H. ; Kottoor, R. ; Kreines, M. D. ; Leman, B. I. ; Li, X. ; Loftus, E. V. ; Noar, M. ; Oikonomou, I. ; Onken, J. ; Peterson, K. A. ; Phillips, R. P. ; Randall, C. W. ; Ricci, M. ; Ritter, T. ; Rubin, D. T. ; Safdi, M. ; Sandborn, W. J. ; Sauberman, L. ; Scherl, E. ; Schwarz, R. P. ; Sedghi, S. ; Shafran, I. ; Sninsky, C. A. ; Stein, I. ; Swoger, J. ; Vecchio, J. ; Weinberg, D. I. ; Wruble, L. D. ; Yajnik, V. ; Younes, Z. / Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease after Ileocolonic Resection. In: Gastroenterology. 2016 ; Vol. 150, No. 7. pp. 1568-1578.
@article{166c20823dc84847a9842a2361a252cb,
title = "Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease after Ileocolonic Resection",
abstract = "Background & Aims Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs after resection. We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence. Methods We evaluated the efficacy of infliximab in preventing postoperative recurrence of CD in 297 patients at 104 sites worldwide from November 2010 through May 2012. All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks. The primary end point was clinical recurrence, defined as a composite outcome consisting of a CD Activity Index score >200 and a ≥70-point increase from baseline, and endoscopic recurrence (Rutgeerts score ≥i2, determined by a central reader) or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary end point. Results A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9{\%} vs 20.0{\%}; absolute risk reduction [ARR] with infliximab, 7.1{\%}; 95{\%} confidence interval: -1.3{\%} to 15.5{\%}; P =.097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared with the placebo group (30.6{\%} vs 60.0{\%}; ARR with infliximab, 29.4{\%}; 95{\%} confidence interval: 18.6{\%} to 40.2{\%}; P <.001). Additionally, a significantly smaller proportion of patients in the infliximab group had endoscopic recurrence based only on Rutgeerts scores ≥i2 (22.4{\%} vs 51.3{\%}; ARR with infliximab, 28.9{\%}; 95{\%} confidence interval: 18.4{\%} to 39.4{\%}; P <.001). Patients previously treated with anti-tumor necrosis factor agents or those with more than 1 resection were at greater risk for clinical recurrence. The safety profile of infliximab was similar to that from previous reports. Conclusions Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. However, infliximab does reduce endoscopic recurrence. ClinicalTrials.gov ID NCT01190839.",
keywords = "Anti-TNF, CDAI, Inflammatory Bowel Disease, PREVENT",
author = "Miguel Regueiro and Feagan, {Brian G.} and Bin Zou and Jewel Johanns and Blank, {Marion A.} and Marc Chevrier and Scott Plevy and John Popp and Cornillie, {Freddy J.} and Milan Lukas and Silvio Danese and Paolo Gionchetti and Hanauer, {Stephen B.} and Walter Reinisch and Sandborn, {William J.} and Dario Sorrentino and Paul Rutgeerts and H. Debinski and T. Florin and D. Hetzel and I. Lawrance and G. Radford-Smith and A. Sloss and D. Sorrentino and S. Gassner and T. Haas and G. Reicht and W. Reinisch and M. Strasser and H. Vogelsang and P. Bossuyt and O. Dewit and G. D'Haens and D. Franchimont and E. Louis and S. Vermeire and Bernstein, {C. N.} and R. Bourdages and N. Chiba and Dhalla, {S. S.} and Feagan, {B. G.} and Fedorak, {R. N.} and Lachance, {J. R.} and R. Panaccione and M. Ropeleski and {Singh Salh}, B. and M. Lukas and Colombel, {J. F.} and M. Allez and P. Desreumaux and Dupas, {J. L.} and Grimaud, {J. C.} and X. Hebuterne and D. Laharie and E. Lerebours and L. Peyrin-Biroulet and Reimund, {J. M.} and S. Viennot and F. Zerbib and C. Antoni and R. Atreya and Baumgart, {D. C.} and C. Berg and U. Boecker and G. Bramkamp and C. B{\"u}nning and R. Ehehalt and S. Howaldt and T. Kucharzik and Lamprecht, {H. G.} and J. Mudter and Preiss, {J. C.} and S. Schreiber and U. Seidler and I. Altorjay and J. Banai and Lakatos, {P. L.} and M. Varga and A. Vincze and I. Avni-Biron and S. Fishman and Fraser, {G. M.} and E. Goldin and D. Rachmilewitz and V. Annese and S. Ardizzone and L. Biancone and F. Bossa and S. Danese and W. Fries and P. Gionchetti and G. Maconi and G. Terrosu and P. Usai and D'Haens, {G. R.} and Gearry, {R. B.} and J. Hill and Rowbotham, {D. S.} and M. Schultz and Stubbs, {R. S.} and D. Wallace and Walmsley, {R. S.} and J. Wyeth and E. Malecka-Panas and L. Paradowski and J. Regula and Beales, {I. P.} and S. Campbell and Hawthorne, {A. B.} and M. Parkes and Travis, {S. P.} and Achkar, {J. P.} and Behm, {B. W.} and Bickston, {S. J.} and Brown, {K. J.} and Chiorean, {M. V.} and Debra Helper and Elliott, {D. E.} and D. Grunkmeier and Hamilton, {J. W.} and Hanauer, {S. B.} and Hanson, {J. S.} and R. Hardi and Helper, {D. J.} and H. Herfarth and Higgins, {P. D R} and Holderman, {W. H.} and R. Kottoor and Kreines, {M. D.} and Leman, {B. I.} and X. Li and Loftus, {E. V.} and M. Noar and I. Oikonomou and J. Onken and Peterson, {K. A.} and Phillips, {R. P.} and Randall, {C. W.} and M. Ricci and T. Ritter and Rubin, {D. T.} and M. Safdi and Sandborn, {W. J.} and L. Sauberman and E. Scherl and Schwarz, {R. P.} and S. Sedghi and I. Shafran and Sninsky, {C. A.} and I. Stein and J. Swoger and J. Vecchio and Weinberg, {D. I.} and Wruble, {L. D.} and V. Yajnik and Z. Younes",
year = "2016",
month = "6",
day = "1",
doi = "10.1053/j.gastro.2016.02.072",
language = "English (US)",
volume = "150",
pages = "1568--1578",
journal = "Gastroenterology",
issn = "0016-5085",
publisher = "W.B. Saunders Ltd",
number = "7",

}

TY - JOUR

T1 - Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease after Ileocolonic Resection

AU - Regueiro, Miguel

AU - Feagan, Brian G.

AU - Zou, Bin

AU - Johanns, Jewel

AU - Blank, Marion A.

AU - Chevrier, Marc

AU - Plevy, Scott

AU - Popp, John

AU - Cornillie, Freddy J.

AU - Lukas, Milan

AU - Danese, Silvio

AU - Gionchetti, Paolo

AU - Hanauer, Stephen B.

AU - Reinisch, Walter

AU - Sandborn, William J.

AU - Sorrentino, Dario

AU - Rutgeerts, Paul

AU - Debinski, H.

AU - Florin, T.

AU - Hetzel, D.

AU - Lawrance, I.

AU - Radford-Smith, G.

AU - Sloss, A.

AU - Sorrentino, D.

AU - Gassner, S.

AU - Haas, T.

AU - Reicht, G.

AU - Reinisch, W.

AU - Strasser, M.

AU - Vogelsang, H.

AU - Bossuyt, P.

AU - Dewit, O.

AU - D'Haens, G.

AU - Franchimont, D.

AU - Louis, E.

AU - Vermeire, S.

AU - Bernstein, C. N.

AU - Bourdages, R.

AU - Chiba, N.

AU - Dhalla, S. S.

AU - Feagan, B. G.

AU - Fedorak, R. N.

AU - Lachance, J. R.

AU - Panaccione, R.

AU - Ropeleski, M.

AU - Singh Salh, B.

AU - Lukas, M.

AU - Colombel, J. F.

AU - Allez, M.

AU - Desreumaux, P.

AU - Dupas, J. L.

AU - Grimaud, J. C.

AU - Hebuterne, X.

AU - Laharie, D.

AU - Lerebours, E.

AU - Peyrin-Biroulet, L.

AU - Reimund, J. M.

AU - Viennot, S.

AU - Zerbib, F.

AU - Antoni, C.

AU - Atreya, R.

AU - Baumgart, D. C.

AU - Berg, C.

AU - Boecker, U.

AU - Bramkamp, G.

AU - Bünning, C.

AU - Ehehalt, R.

AU - Howaldt, S.

AU - Kucharzik, T.

AU - Lamprecht, H. G.

AU - Mudter, J.

AU - Preiss, J. C.

AU - Schreiber, S.

AU - Seidler, U.

AU - Altorjay, I.

AU - Banai, J.

AU - Lakatos, P. L.

AU - Varga, M.

AU - Vincze, A.

AU - Avni-Biron, I.

AU - Fishman, S.

AU - Fraser, G. M.

AU - Goldin, E.

AU - Rachmilewitz, D.

AU - Annese, V.

AU - Ardizzone, S.

AU - Biancone, L.

AU - Bossa, F.

AU - Danese, S.

AU - Fries, W.

AU - Gionchetti, P.

AU - Maconi, G.

AU - Terrosu, G.

AU - Usai, P.

AU - D'Haens, G. R.

AU - Gearry, R. B.

AU - Hill, J.

AU - Rowbotham, D. S.

AU - Schultz, M.

AU - Stubbs, R. S.

AU - Wallace, D.

AU - Walmsley, R. S.

AU - Wyeth, J.

AU - Malecka-Panas, E.

AU - Paradowski, L.

AU - Regula, J.

AU - Beales, I. P.

AU - Campbell, S.

AU - Hawthorne, A. B.

AU - Parkes, M.

AU - Travis, S. P.

AU - Achkar, J. P.

AU - Behm, B. W.

AU - Bickston, S. J.

AU - Brown, K. J.

AU - Chiorean, M. V.

AU - Helper, Debra

AU - Elliott, D. E.

AU - Grunkmeier, D.

AU - Hamilton, J. W.

AU - Hanauer, S. B.

AU - Hanson, J. S.

AU - Hardi, R.

AU - Helper, D. J.

AU - Herfarth, H.

AU - Higgins, P. D R

AU - Holderman, W. H.

AU - Kottoor, R.

AU - Kreines, M. D.

AU - Leman, B. I.

AU - Li, X.

AU - Loftus, E. V.

AU - Noar, M.

AU - Oikonomou, I.

AU - Onken, J.

AU - Peterson, K. A.

AU - Phillips, R. P.

AU - Randall, C. W.

AU - Ricci, M.

AU - Ritter, T.

AU - Rubin, D. T.

AU - Safdi, M.

AU - Sandborn, W. J.

AU - Sauberman, L.

AU - Scherl, E.

AU - Schwarz, R. P.

AU - Sedghi, S.

AU - Shafran, I.

AU - Sninsky, C. A.

AU - Stein, I.

AU - Swoger, J.

AU - Vecchio, J.

AU - Weinberg, D. I.

AU - Wruble, L. D.

AU - Yajnik, V.

AU - Younes, Z.

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Background & Aims Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs after resection. We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence. Methods We evaluated the efficacy of infliximab in preventing postoperative recurrence of CD in 297 patients at 104 sites worldwide from November 2010 through May 2012. All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks. The primary end point was clinical recurrence, defined as a composite outcome consisting of a CD Activity Index score >200 and a ≥70-point increase from baseline, and endoscopic recurrence (Rutgeerts score ≥i2, determined by a central reader) or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary end point. Results A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9% vs 20.0%; absolute risk reduction [ARR] with infliximab, 7.1%; 95% confidence interval: -1.3% to 15.5%; P =.097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared with the placebo group (30.6% vs 60.0%; ARR with infliximab, 29.4%; 95% confidence interval: 18.6% to 40.2%; P <.001). Additionally, a significantly smaller proportion of patients in the infliximab group had endoscopic recurrence based only on Rutgeerts scores ≥i2 (22.4% vs 51.3%; ARR with infliximab, 28.9%; 95% confidence interval: 18.4% to 39.4%; P <.001). Patients previously treated with anti-tumor necrosis factor agents or those with more than 1 resection were at greater risk for clinical recurrence. The safety profile of infliximab was similar to that from previous reports. Conclusions Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. However, infliximab does reduce endoscopic recurrence. ClinicalTrials.gov ID NCT01190839.

AB - Background & Aims Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs after resection. We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence. Methods We evaluated the efficacy of infliximab in preventing postoperative recurrence of CD in 297 patients at 104 sites worldwide from November 2010 through May 2012. All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks. The primary end point was clinical recurrence, defined as a composite outcome consisting of a CD Activity Index score >200 and a ≥70-point increase from baseline, and endoscopic recurrence (Rutgeerts score ≥i2, determined by a central reader) or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary end point. Results A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9% vs 20.0%; absolute risk reduction [ARR] with infliximab, 7.1%; 95% confidence interval: -1.3% to 15.5%; P =.097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared with the placebo group (30.6% vs 60.0%; ARR with infliximab, 29.4%; 95% confidence interval: 18.6% to 40.2%; P <.001). Additionally, a significantly smaller proportion of patients in the infliximab group had endoscopic recurrence based only on Rutgeerts scores ≥i2 (22.4% vs 51.3%; ARR with infliximab, 28.9%; 95% confidence interval: 18.4% to 39.4%; P <.001). Patients previously treated with anti-tumor necrosis factor agents or those with more than 1 resection were at greater risk for clinical recurrence. The safety profile of infliximab was similar to that from previous reports. Conclusions Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. However, infliximab does reduce endoscopic recurrence. ClinicalTrials.gov ID NCT01190839.

KW - Anti-TNF

KW - CDAI

KW - Inflammatory Bowel Disease

KW - PREVENT

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U2 - 10.1053/j.gastro.2016.02.072

DO - 10.1053/j.gastro.2016.02.072

M3 - Article

VL - 150

SP - 1568

EP - 1578

JO - Gastroenterology

JF - Gastroenterology

SN - 0016-5085

IS - 7

ER -