title: Evaluation of "top-down" treatment of early Crohn's disease by double balloon enteroscopy.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Top-down treatment with infliximab and azathioprine, as compared with corticosteroid and azathioprine, results in higher rates of earlier deep remission in early CD.
authors.affiliation: 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.
authors.forename: Rong
authors.initials: R
authors.lastname: Fan
authors.affiliation: 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.
authors.forename: Jie
authors.initials: J
authors.lastname: Zhong
authors.affiliation: 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.
authors.forename: Zheng-Ting
authors.initials: ZT
authors.lastname: Wang
authors.affiliation: 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.
authors.forename: Shu-Yi
authors.initials: SY
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Jie
authors.initials: J
authors.lastname: Zhou
authors.affiliation: 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.
authors.forename: Yong-Hua
authors.initials: YH
authors.lastname: Tang
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D001379:Azathioprine / Q000008:administration & dosage; D003424:Crohn Disease / Q000188:drug therapy* / Q000473:pathology*; D058582:Double-Balloon Enteroscopy; D004359:Drug Therapy, Combination; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D000069285:Infliximab; D008297:Male; D011237:Predictive Value of Tests; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab; D001379:Azathioprine; D011241:Prednisone
keywords: Crohn’s disease; Deep remission; Double balloon enteroscopy; Mucosal healing; Top-down treatment