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Korean clinical practice guidelines on biologics for moderate to severe Crohn’s disease: Seong-Joon Koh, Sung Noh Hong, Soo-Kyung Park, Byong Duk Ye, Kyeong Ok Kim, Jeong Eun Shin, Yong Sik Yoon, Hong Sub Lee, Sung Hoon Jung, Miyoung Choi, Soo-Young Na, Chang Hwan Choi, Joo Sung Kim, on behalf of the IBD Research Group of the Korean Association for the Study of Intestinal Diseases; Intest Res 2023;21(1):43-60. Published online October 18, 2022; DOI: https://doi.org/10.5217/ir.2022.00029

Crohn’s disease (CD) is a relapsing and progressive condition characterized by diarrhea, abdominal pain, weight loss, and hematochezia that results in serious complications such as perforations, fistulas, and abscesses. Various medications, interventions, and surgical treatments have been used to treat CD. The Korean guidelines for CD management were distributed in 2012 and revised in 2017 by the Inflammatory Bowel Disease (IBD) Research Group of the Korean Association for the Study of Intestinal Diseases. Substantial progress in mucosal immunologic research has elucidated the pathophysiology of IBD, leading to development of biological agents for treatment of CD. The first developed biologic agent, tumor necrosis factor-α agents, were shown to be efficacious in CD, heralding a new era in management of CD. Subsequently, vedolizumab, a monoclonal antibody against integrin α4β7, and ustekinumab, a human monoclonal antibody that inhibits the common p40 subunit of interleukin-12 and interleukin-23, were both approved for clinical use and are efficacious and safe for both induction and maintenance of remission in moderate-to-severe CD patients. Moreover, a recent study showed the non-inferiority of CT-P13, an infliximab biosimilar, compared with infliximab in CD patients. The third Korean guidelines for CD management provide updated information regarding treatment of moderate-to-severe CD patients with biologic agents.

Citations

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Inflammatory bowel diseases

Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases: Sang Hyoung Park, Jae Cheol Park, Milan Lukas, Martin Kolar, Edward V. Loftus, Jr; Intest Res 2020;18(1):34-44. Published online January 30, 2020; DOI: https://doi.org/10.5217/ir.2019.09147

Abstract PDF PubReader ePub

The inflammatory bowel diseases (IBD), which consist of Crohn’s disease and ulcerative colitis, are chronic, incurable immunemediated inflammatory disorders of the intestine. As IBD incidence continues to increase globally and its mortality is low, prevalent cases of IBD are rapidly increasing, thereby leading to a substantial increase in health care costs. Although the introduction of biologic agents for IBD management has revolutionized the armamentarium of IBD therapy, the high cost of this therapy is concerning. With the expirations of patents for existing biologic agents (originals), biosimilars with cheaper costs have been highlighted in the field of IBD. Despite concerns regarding their short- and long-term efficacy, safety, immunogenicity, and interchangeability, increasing evidence via prospective observations and phase III or IV clinical trials, which aim to prove the “biosimilarity” of biosimilars to originals, has partly confirmed their efficacy, safety, and interchangeability. Additionally, although patients and physicians are reluctant to use biosimilars, a positive budget impact has been reported owing to their use in different countries. In the near future, multiple biosimilars with lower costs, and efficacy and safety profile similar to originals, could be used to treat IBD; thus, further consideration and knowledge dissemination are warranted in this new era of biosimilars.

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