Evaluation of "top-down" treatment of early Crohn's disease by double balloon enteroscopy.

To assess "top-down" treatment for deep remission of early moderate to severe Crohn's disease (CD) by double balloon enteroscopy. 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. 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. Top-down treatment with infliximab and azathioprine, as compared with corticosteroid and azathioprine, results in higher rates of earlier deep remission in early CD.