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

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.

Keywords: Colitis, ulcerative; Guideline; Inflammatory bowel disease; Management.

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.