Intest Res.  2023 Jan;21(1):61-87. 10.5217/ir.2022.00007.

Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis

Affiliations
  • 1Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea
  • 2Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
  • 3Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
  • 4Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
  • 5Department of Gastroenterology and Inflammatory Bowel Disease Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 6Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea
  • 7Department of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
  • 8Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
  • 9Department of Gastroenterology, College of Medicine, Kyung Hee University, Seoul, Korea
  • 10Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 11Department of Surgery, Seoul National University College of Medicine, Seoul, Korea
  • 12Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
  • 13National Evidence-based Healthcare Collaborating Agency, Seoul, Korea

Abstract

Ulcerative colitis (UC), a relapsing-remitting chronic inflammatory bowel disease (IBD), has a variable natural course but potentially severe disease course. Since the development of anti-tumor necrosis factor (TNF) agents has changed the natural disease course of moderate-to-severe UC, therapeutic options for patients who failed conventional treatments are expanding rapidly. IBD clinical trials have demonstrated the potential efficacy and safety of novel biologics such as anti-integrin α4β7 and anti-interleukin-12/23 monoclonal antibodies and small molecules such as a Janus kinase inhibitor. Anti-TNF biosimilars also have been approved and are widely used in IBD patients. Wise drug choices should be made considering evidence-based efficacy and safety. However, the best position of these drugs remains several questions, with limited data from direct comparative trials. In addition, there are still concerns to be elucidated on the effect of therapeutic drug monitoring and combination therapy with immunomodulators. The appropriate treatment regimens in acute severe UC and the risk of perioperative use of biologics are unclear. As novel biologics and small molecules have been approved in Korea, we present the Korean guidelines for medical management of adult outpatients with moderate-to-severe UC and adult hospitalized patients with acute severe UC, focusing on biologics and small molecules.

Keyword

Colitis, ulcerative; Inflammatory bowel disease; Management; Guideline

Figure

  • Fig. 1. A flowchart of screening reference guidelines.

  • Fig. 2. Korean Food and Drug Administration (KFDA) approval and reimbursement guidelines for novel biologics and small molecules in patients with moderate-to-severe ulcerative colitis (UC). VDZ, vedolizumab; CD, Crohn’s disease; TFC, tofacitinib; UST, ustekinumab; SC, subcutaneous.


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