Observational Study
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World J Gastroenterol. Oct 21, 2014; 20(39): 14479-14487
Published online Oct 21, 2014. doi: 10.3748/wjg.v20.i39.14479
Evaluation of “top-down” treatment of early Crohn’s disease by double balloon enteroscopy
Rong Fan, Jie Zhong, Zheng-Ting Wang, Shu-Yi Li, Jie Zhou, Yong-Hua Tang
Rong Fan, Jie Zhong, Zheng-Ting Wang, Shu-Yi Li, Jie Zhou, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
Yong-Hua Tang, Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
Author contributions: Fan R contributed partially to conception and design of the study, collection, analysis and interpretation of the data, and drafting of the article; Zhong J contributed to design of the study and endoscopic evaluation and revised the article critically for important intellectual content; Wang ZT participated in design of the study; Zhou J participated in collection of the data; Li SY participated in collection and analysis of the data; Tang YH contributed to radiologic evaluation.
Correspondence to: Jie Zhong, MD, PhD, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 Ruijin Er Road, Shanghai 200025, China. jimmyzj64@medmail.com.cn
Telephone: +86-21-64370045 Fax: +86-21-64315951
Received: November 10, 2013
Revised: March 16, 2014
Accepted: June 20, 2014
Published online: October 21, 2014
Processing time: 344 Days and 2.5 Hours
Abstract

AIM: To assess “top-down” treatment for deep remission of early moderate to severe Crohn’s disease (CD) by double balloon enteroscopy.

METHODS: Patients with early active moderate to severe ileocolonic CD received either infusion of infliximab 5 mg/kg at weeks 0, 2, 6, 14, 22 and 30 with azathioprine from week 6 onwards (Group I), or prednisone from week 0 as induction therapy with azathioprine from week 6 onwards (Group II). Endoscopic evaluation was performed at weeks 0, 30, 54 and 102 by double balloon enteroscopy. The primary endpoints were deep remission rates at weeks 30, 54 and 102. Secondary endpoints included the time to achieve clinical remission, clinical remission rates at weeks 2, 6, 14, 22, 30, 54 and 102, and improvement of Crohn’s Disease Endoscopic Index of Severity scores at weeks 30 and 54 relative to baseline. Intention-to-treat analyses of the endpoints were performed.

RESULTS: Seventy-seven patients were enrolled, with 38 in Group I and 39 in Group II. By week 30, deep remission rates were 44.7% and 17.9% in Groups I and II, respectively (P = 0.011). The median time to clinical remission was longer for patients in Group II (14.2 wk) than for patients in Group I (6.8 wk, P = 0.009). More patients in Group I were in clinical remission than in Group II at weeks 2, 6, 22 and 30 (2 wk: 26.3% vs 2.6%; 6 wk: 65.8% vs 28.2%; 22 wk: 71.1% vs 46.2%; 30 wk: 68.4% vs 43.6%, P < 0.05). The rates of clinical remission and deep remission were greater at weeks 54 and 102 in Group I, but the differences were insignificant.

CONCLUSION: Top-down treatment with infliximab and azathioprine, as compared with corticosteroid and azathioprine, results in higher rates of earlier deep remission in early CD.

Keywords: Crohn’s disease; Top-down treatment; Deep remission; Double balloon enteroscopy; Mucosal healing

Core tip: We assessed the outcome of “top-down” treatment in terms of deep remission in treatment-naïve patients with early Crohn’s disease (CD) with small bowel involvement. This study is believed to be the first designed with deep remission as the primary endpoint. Furthermore, mucosal healing was assessed by double balloon enteroscopy for the first time in patients with CD treated with biologic agents. We excluded patients with luminal fibrostenotic or abdominal fistulizing CD in screening, resulting in encouraging deep remission rates at week 30. These results may have implications in the treatment of CD.