Journal of Clinical Trials
Open Access

Abstract

Efficacy of Early Adalimumab or Immunomodulator on Postoperative Remission Maintenance in Patients with Crohn's Disease: Randomized study

Akihiro Yamada, Hiroaki Iwashita , Shin-ichi Okazumi, Hidemasa Kikuchi, Yasuo Suzuki, Katsuyoshi Matsuoka

Background and Aim: This study aim was to clarify the efficacy of early adalimumab (ADA) and azathioprine (AZA) in Postoperative recurrence of Crohn’s disease (CD). Methods: In a 78-week single-center prospective study, patients with bowel resection were randomly assigned to ADA 160-80-40 mg subcutaneously (SC) or AZA 0.5-1.5 mg/kg/day. The primary endpoint was endoscopic remission at 18 months (Rutgeerts i0, i1 and Simple endoscopic score for CD (SES-CD) ≤ 4). Results: A total of 47 patients (median age 39.0 years, disease duration 9.5 years, 19.1% smokers, 44.6% previous resections) were recruited, 39 patients were received the study drugs. Endoscopic remission was confirmed in 5/16 patients in the AZA group (31.2%) and 7/12 patients in the ADA group (58.3%) (p=0.24) in the intention-to-treat population. In the per-protocol population (19 patients with evaluable images), remission was recorded in 3/9 (33.3%) patients in the AZA and 7/10 (70.0%) in the ADA group (p=0.17). Re-surgery rate was trend to higher in the AZA group (21.1%) than in the ADA group (0%) (p=0.10). Treatment was discontinued due to adverse events in 6 patients (15.3%), severe adverse events were significantly more frequent in the AZA group than in the ADA group (AZA, 25.0% vs ADA, 0%; p=0.04). Conclusions: Early ADA did not show statistically better efficacy than AZA for postoperative CD recurrence in this study, although safety profile of ADA is better. (UMIN000032485).

Published Date: 2020-03-18; Received Date: 2020-02-27