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Background & AimsFew prospective data are available to support the clinical relevance of mucosal healing in patients with Crohn's disease. This study examined whether complete healing, determined by endoscopy, predicts a better outcome in Crohn's disease. MethodsOne-hundred thirty-three newly diagnosed and treatment-naïve Crohn's disease patients were given either a combination of immunosuppressive therapy (azathioprine) and 3 infusions of infliximab or treatment with conventional corticosteroids. Patients given azathioprine were given repeated doses of infliximab for relapses, patients given corticosteroids were given azathioprine in cases of corticosteroid dependency and infliximab only if azathioprine failed. A representative subset of 49 patients from the initially randomized cohort underwent ileocolonoscopy after 2 years of therapy. Correlation analysis was performed between different clinical parameters including endoscopic activity (Simple Endoscopic Score) and clinical outcome 2 years after this endoscopic examination. Data were available from 46 patients 3 and 4 years after therapy began. ResultsComplete mucosal healing, defined as a simple endoscopic score of 0 after 2 years of therapy, was the only factor that predicted sustained, steroid-free remission 3 and 4 years after therapy was initiated; it was observed in 17 of 24 patients (70.8%) vs 6 of 22 patients with lesions detected by endoscopy (27.3%, Simple Endoscopic Score >0) (P = .036; odds ratio = 4.352; 95% confidence interval, 1.10−17.220). Fifteen of 17 patients with mucosal healing at year 2 maintained in remission without further infliximab infusions during years 3 and 4 (P = .032; odds ratio = 4.883; 95% confidence interval, 1.144−20.844). ConclusionsComplete mucosal healing in patients with early-stage Crohn's disease is associated with significantly higher steroid-free remission rates 4 years after therapy began. Abbreviations used in this paper: CD, Crohn's disease, CDAI, Crohn's Disease Activity Index, CIS, combined immunosuppressive treatment, CM, conventional management, SES-CD, Simple Endoscopic Score, TNF, tumor necrosis factor ⁎ H.–Hartziekenhuis Roeselare–Menen vzw, Roeselare, Belgium ‡ University Hospital Gasthuisberg, Leuven, Belgium § Ziekenhuis Oost–Limburg, Genk, Belgium ∥ Groeninge Ziekenhuis, Kortrijk, Belgium ¶ Ghent University, University Hospital, Belgium # Academic Medical Centre, Amsterdam, The Netherlands ⁎⁎ Leiden University Medical Centre, Leiden, The Netherlands ‡‡ Imelda GI Clinical Research Centre, Bonheiden, Belgium
View this article's video abstract at www.gastrojournal.org This article has an accompanying continuing medical education activity on page e10. Learning Objective: Upon completion of reading this article, successful learners will be able to interpret the concept of mucosal healing in Crohn's disease, as well as identify patients that would benefit from an endoscopic evaluation and integrate the endoscopic findings as a prognostic marker in the management of Crohn's disease patients. Conflicts of interest This study was sponsored by Centocor B.V. This study is a follow-up of an earlier published investigator initiated trial. Although this study was sponsored by an unrestricted grant from Centocor B.V., the authors are fully responsible for its content and the sponsor did not participate in the design or the analysis of the data. These authors disclose the following: Dr Baert received a research grant to conduct this trial from Centocor. Prof De Vos received research support from Schering Plough and UCB. The remaining authors disclose no conflicts. PII: S0016-5085(09)01751-X doi:10.1053/j.gastro.2009.09.056 © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
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ABSTRACT
Mucosal Healing Predicts Sustained Clinical Remission in Patients With Early-Stage Crohn's Disease