The DOI matches its Crossref record; 45 of the 45 references it cites were found in a registry or an index.
Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn’s Disease After Ileocolonic Resection
Open accessAbstract
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.
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Citations
Cites
Development of a Crohn's Disease Activity Index
Best, W. R., Becktel, J. M., Singleton, J. W., & Kern, F. (1976) · Gastroenterology · doi:10.1016/s0016-5085(76)80163-1 · Cited by 3,152
Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study.
Best, W. R., Becktel, J. M., Singleton, J. W., & Kern, F. (1976) · PubMed · Cited by 3,147
Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease
Colombel, J. F., Sandborn, W. J., Reinisch, W., Mantzaris, G. J., Kornbluth, A., Rachmilewitz, D., Lichtiger, S., D'Haens, G., Diamond, R. H., Broussard, D. L., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0904492 · Cited by 3,143
Self-citationPredictability of the postoperative course of Crohn's disease
Rutgeerts, P., Geboes, K., Vantrappen, G., Beyls, J., Kerremans, R., & Hiele, M. (1990) · Gastroenterology · doi:10.1016/0016-5085(90)90613-6 · Cited by 1,820
Self-citationFrolkis, A. D., Dykeman, J., Negrón, M. E., deBruyn, J., Jette, N., Fiest, K. M., Frolkis, T., Barkema, H. W., Rioux, K. P., Panaccione, R., et al. (2013) · Gastroenterology · doi:10.1053/j.gastro.2013.07.041 · Cited by 892
Self-citationRutgeerts, P., Hiele, M., Geboes, K., Peeters, M., Penninckx, F., Aerts, R., & Kerremans, R. (1995) · Gastroenterology · doi:10.1016/0016-5085(95)90121-3 · Cited by 743
Self-citationCosnes, J., Nion-Larmurier, I., Beaugerie, L., Afchain, P., Tiret, E., & Gendre, J.-P. (2005) · Gut · doi:10.1136/gut.2004.045294 · Cited by 657
Crohn's disease management after intestinal resection: a randomised trial
De Cruz, P., Kamm, M. A., Hamilton, A. L., Ritchie, K. J., Krejany, E. O., Gorelik, A., Liew, D., Prideaux, L., Lawrance, I. C., Andrews, J. M., et al. (2015) · The Lancet · doi:10.1016/s0140-6736(14)61908-5 · Cited by 619
Self-citationHanauer, S. B., Wagner, C. L., Bala, M. V., Mayer, L., Travers, S., Diamond, R. H., Olson, A. D., Bao, W., & Rutgeerts, P. J. (2004) · Clinical Gastroenterology and Hepatology · doi:10.1016/s1542-3565(04)00238-1 · Cited by 608
Self-citationInfliximab Prevents Crohn's Disease Recurrence After Ileal Resection
Regueiro, M., Schraut, W., Baidoo, L., Kip, K. E., Sepulveda, A. R., Pesci, M., Harrison, J., & Plevy, S. E. (2009) · Gastroenterology · doi:10.1053/j.gastro.2008.10.051 · Cited by 601
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Lamb, C. A., Kennedy, N. A., Raine, T., Hendy, P. A., Smith, P. J., Limdi, J. K., Hayee, B., Lomer, M. C. E., Parkes, G. C., Selinger, C., et al. (2019) · Gut · doi:10.1136/gutjnl-2019-318484 · Cited by 2,346
Metadata
- Authors
- Regueiro, M., Feagan, B. G., Zou, B., Johanns, J., Blank, M. A., Chevrier, M., Plevy, S., Popp, J., Cornillie, F. J., Lukas, M., Danese, S., Gionchetti, P., Hanauer, S. B., Reinisch, W., Sandborn, W. J., 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, 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., DeVilliers, W. J. S., 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.
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2016-06
- Volume
- 150
- Issue
- 7
- Pages
- 1568-1578
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2290216613
- Cited by
- 339
- References
- 45
- FWCI
- 27.40
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Regueiro, M., Feagan, B. G., Zou, B., Johanns, J., Blank, M. A., Chevrier, M., Plevy, S., Popp, J., Cornillie, F. J., Lukas, M., Danese, S., Gionchetti, P., Hanauer, S. B., Reinisch, W., Sandborn, W. J., Sorrentino, D., Rutgeerts, P., Debinski, H., Florin, T., . . . Younes, Z. (2016). Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn’s Disease After Ileocolonic Resection. Gastroenterology. https://doi.org/10.1053/j.gastro.2016.02.072
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