Postoperative anti-TNF-alpha monoclonal antibody maintenance therapy for Japanese patients with Crohn's disease

2018 Fiscal Year Final Research Report

• Project/Area Number: 15K10133
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Digestive surgery
• Research Institution: Nagoya University
• Principal Investigator: NAKAYAMA Goro 名古屋大学, 医学部附属病院, 講師 (90422782)
• Co-Investigator(Kenkyū-buntansha): 藤井 努 富山大学, 大学院医学薬学研究部(医学), 教授 (60566967) ; 小寺 泰弘 名古屋大学, 医学系研究科, 教授 (10345879)
• Project Period (FY): 2015-04-01 – 2019-03-31
• Keywords: クローン病 / 抗TNF-α抗体 / インフリキシマブ / アダリマブ

Outline of Final Research Achievements

The prevention of postoperative recurrence is a critical issue in surgery for Crohn’s disease (CD). The aim of this study was to investigate the efficacy and safety of planned postoperative anti-TNF-α therapy after surgery in Japanese patients with CD. Twenty-six patients with CD undergoing surgical resection were enrolled. All patients received postoperative anti-TNF-α, adalimumab (ADA), therapy within 2 weeks after surgery. The primary endpoint of this study was the incidence of endoscopic recurrence. Endoscopic recurrence was observed in 31% of patients 1 year after surgery. Univariate analyses show that preoperative ADA therapy was significantly associated with endoscopic recurrence. 17% of patients experienced clinical recurrence 1 year after surgery. Secondary surgery for recurrence was not required. Planned postoperative ADA therapy reduced the incidence of endoscopic and clinical recurrence after bowel resection of Japanese patients with CD.

Free Research Field

消化器外科学

Academic Significance and Societal Importance of the Research Achievements

クローン病の術後寛解維持療法としてアダリムマブの有効性を検討した国内初めての前方視的臨床研究であり，術後再発を抑制するための新たな治療戦略を示唆する成果であると考える．