Hee Seok Moon

doi:10.5217/ir.2025.00300

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Editorial IBD The efficacy of ustekinumab in the management of perianal fistulizing Crohn’s disease: Hee Seok Moon; Intestinal Research 2026;24(1):1-2.
DOI: https://doi.org/10.5217/ir.2025.00300
Published online: January 28, 2026

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea

Correspondence to Hee Seok Moon, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chungnam National University College of Medicine, 266 Munhwa-ro, Jung-gu, Daejeon 35015, Korea. E-mail: mhs1357@cnuh.co.kr

• Received: November 28, 2025 • Revised: January 9, 2026 • Accepted: January 11, 2026

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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REFERENCES

See the article "Comparative effectiveness of ustekinumab versus infliximab in the management of perianal fistulizing Crohn's disease: a retrospective study in China" on page 52.

Crohn’s disease (CD) is a chronic inflammatory disease of the gastrointestinal tract that can lead to progressive bowel damage and disability. Due to the transmural nature of CD, fistulas, abscesses, and strictures frequently complicate the disease course. In particular, perianal fistulizing lesions in CD are strongly linked to more aggressive disease behavior and a poorer prognosis [1]. CD is considered multifactorial, with the microbiota and other environmental factors triggering inappropriate activation of the mucosal immune system in genetically susceptible hosts. A key pathogenic feature is the inflammatory infiltrate, which is characterized by the Th1/Th17 response with production of various proinflammatory cytokines (tumor necrosis factor [TNF]-α, interferon-γ, interleukin [IL]-1, IL-6, IL-12, and IL-23) along with impaired regulatory T-cell activity. Perianal fistulizing disease affects approximately 5% to 40% of patients during the course of their CD and is the initial manifestation of CD in approximately 10% of patients. For most patients with fistulizing disease, multidisciplinary care from both gastroenterology and colorectal surgery is necessary. Anti-TNF agents are among the most effective therapies to induce and maintain remission in CD. Although three agents (infliximab [IFX], adalimumab, and certolizumab pegol) are approved, IFX is the only advanced therapy with a dedicated randomized controlled trial to show efficacy for the treatment of perianal disease [2,3]. It is recommended in the European Crohn’s and Colitis Organisation guidelines as a first-line medical therapy following adequate drainage of complex perianal fistulas [4]. Ustekinumab (UST; an anti-IL-12/23 p40 monoclonal antibody) is a therapy that targets alternative pathways to anti-TNF agents in the CD treatment. This drug appears to have fewer serious side effects and lower immunogenicity without the need for combination therapy with an immunomodulator. Induction (UNITI-1 and UNITI-2) and maintenance trials have suggested that UST was effective for treating moderate to severe CD [5-7]. However, the role of UST in treating perianal CD remains limited. Recently, data from subgroup analyses from induction and maintenance trials suggested that UST resulted in some benefit for patients with perianal fistula [8]. Until now, there have been few studies on whether UST is useful in Asian patients with perianal CD. In this issue of Intestinal Research, Chen et al. [9] presented a study comparing UST with IFX to determine whether it is useful in patients with perianal fistulizing CD. Although this study is retrospective in nature and includes a relatively small number of patients, this study demonstrates the effectiveness of UST in treating perianal fistula of CD patients naive to biological agents in a real-world setting, particularly in Asian patients with perianal CD. A key finding of this study is the comparison of the efficacy of UST and IFX as the first-line biologic used in the treatment of perianal fistulizing CD. Compared with IFX, UST exhibited significantly higher rates of treatment success (89.8% vs. 50.0%; P<0.001) and intestinal clinical response (85.7% vs. 68.8%; P=0.048). UST was shown to be as effective as IFX in terms of fistula remission, fistula response, fistula closure, intestinal clinical remission, endoscopic remission, and endoscopic response. The rates of disease relapse and operation in the IFX group were higher as compared to the UST group during follow-up. Regarding safety, infection was the most common adverse event and there was no statistical difference in both groups. Therefore, in terms of safety issues, UST was found to be comparable to IFX. This finding shows that UST may serve as a promising alternative to IFX for the first-line biologic treatment of perianal fistulizing CD but there are several limitations to this study. It was a single- center study with a relatively small sample size and retrospective design and a recent web-based survey conducted in Asia reported that Asian experts still overwhelmingly prefer anti-TNF agents as first-line treatment [10]. To overcome these limitations, larger prospective long-term comparative studies are thought to be necessary.

NOTES

Funding Source

The author received no financial support for the research, authorship, and/or publication of this article.

Conflict of Interest

Moon HS is an editorial board member of the journal but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.

Data Availability Statement

Not applicable.

Author Contributions

Writing and approval of the final manuscript: Moon HS.

REFERENCES

1. Zhan W, Bai X, Yang H, Qian J. Perianal fistulizing lesions of Crohn’s disease are associated with long-term behavior and its transition: a Chinese cohort study. Intest Res 2024;22:484–495.Article PubMed PMC PDF
2. Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn’s disease. N Engl J Med 1999;340:1398–1405.Article PubMed
3. Sands BE, Anderson FH, Bernstein CN, et al. Infliximab maintenance therapy for fistulizing Crohn’s disease. N Engl J Med 2004;350:876–885.Article PubMed
4. Torres J, Bonovas S, Doherty G, et al. ECCO guidelines on therapeutics in Crohn’s disease: medical treatment. J Crohns Colitis 2020;14:4–22.PubMed
5. Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2016;375:1946–1960.Article PubMed
6. Sands BE, Irving PM, Hoops T, et al. Ustekinumab versus adalimumab for induction and maintenance therapy in biologicnaive patients with moderately to severely active Crohn’s disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet 2022;399:2200–2211.PubMed
7. Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn’s disease. Cochrane Database Syst Rev 2025;5–CD007572.Article
8. Chapuis-Biron C, Kirchgesner J, Pariente B, et al. Ustekinumab for perianal Crohn’s disease: the BioLAP multicenter study from the GETAID. Am J Gastroenterol 2020;115:1812–1820.Article PubMed
9. Chen M, Chen Z, Lin J, et al. Comparative effectiveness of ustekinumab versus infliximab in the management of perianal fistulizing Crohn’s disease: a retrospective study in China. Intest Res 2026;24:52–63.Article PubMed PDF
10. Song EM, Na SY, Hong SN, Ng SC, Hisamatsu T, Ye BD. Treatment of inflammatory bowel disease-Asian perspectives: the results of a multinational web-based survey in the 8th Asian Organization for Crohn’s and Colitis meeting. Intest Res 2023;21:339–352.Article PubMed PMC PDF

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The efficacy of ustekinumab in the management of perianal fistulizing Crohn’s disease

Intest Res. 2026;24(1):1-2. Published online January 28, 2026

DOI: https://doi.org/10.5217/ir.2025.00300

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