Jung Won Lee; Yoo Min Han

doi:10.5217/ir.2025.00117

Articles

Page Path: HOME > Intest Res > Volume 23(3); 2025 > Article

Editorial Assessing tuberculosis risk in Crohn’s disease patients receiving biologic therapies: real-world insights from Japan: Jung Won Lee¹, Yoo Min Han^2,3; Intestinal Research 2025;23(3):231-232.
DOI: https://doi.org/10.5217/ir.2025.00117
Published online: July 29, 2025

¹Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea

²Department of Internal Medicine and Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, Korea

³Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea

Correspondence to Yoo Min Han, Internal Medicine, Department of Internal Medicine and Healthcare Research Institute, Seoul National University Hospital Healthcare System Gangnam Center, 39th floor, GFC building, 152 Teheran-ro, Gangnam-gu, Seoul 06236, Korea. E-mail: umminy@naver.com

• Received: June 25, 2025 • Revised: July 2, 2025 • Accepted: July 13, 2025

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.

prev next

1,359 Views
29 Download

Full Article

Download PDF

NOTES
REFERENCES

See the article "Tuberculosis risk in patients with Crohn’s disease on biologics: a retrospective analysis of the Japanese Medical Claims Database" on page 309.

In the past 20 years, advances in therapy have significantly improved the management of inflammatory bowel disease, allowing for better achievement of remission [1]. While these new treatment strategies, including biologic agents, are effective in alleviating symptoms and modifying disease progression, their strong immunosuppressive action poses a risk for opportunistic infections [2]. Among these opportunistic infections, tuberculosis (TB) is one of the most clinically significant concerns [3].

In the current issue of Intestinal Research, Fujimoto et al. [4] reported valuable real-world evidence on the risk of TB in Crohn’s disease (CD) patients receiving biologic therapies in Japan using a large-scale medical claims database. According to this study, tumor necrosis factor alpha (TNF-α) inhibitors were associated with increased risk of active TB development (hazard ratio 3.66). However, no TB cases were observed among the patients with ustekinumab (UST) and vedolizumab (VDZ) during the follow-up period. It is consistent with previous results from Western and Asian studies [5,6].

Since the incidence of TB is influenced not only by the intrinsic risk of the biologic agent but also by the regional prevalence of TB, this study is meaningful in that it evaluates TB risk using a large-scale, population-based database representative of the Japanese population. This large sample size allows the capture of rare events such as TB, which remains a critical concern in immunosuppressed populations. Importantly, the authors employed a time-dependent Cox proportional hazard model to better reflect the real-world timing of biologic initiation and TB onset, enhancing the validity of the observed associations.

Despite these strengths, several considerations should be taken into account when interpreting the results of this study. As the authors noted, the database lacks clinical variables, such as tuberculin skin test and interferon-gamma release assay. To address this limitation, they attempted to exclude patients who received isoniazid monotherapy, thereby removing cases with latent TB infection undergoing prophylaxis. However, according to the previous study [7], the risk of TB reactivation remains even among patients who receive prophylactic therapy upon initiation of biologic agents. Therefore, an accurate evaluation of TB risk requires more detailed analyses including latent TB infection patients with prophylaxis [8]. Furthermore, comprehensive data such as regimen and duration of TB prophylaxis and the methods used for TB surveillance would also be helpful.

In summary, this study offers important real-world evidence that TNF-α inhibitors increase the risk of active TB in Japanese CD patients. This study reinforces the importance of TB risk assessment prior to initiating TNF-α inhibitors [9]. It also highlights the potential utility of alternative agents like UST and VDZ in patients at high risk for active TB or those with latent TB. Nevertheless, firm conclusions about the comparative safety of newer biologics must await further prospective, registry-based evaluations because UST/VDZ have had shorter periods of availability and relatively fewer users in this dataset. Continued pharmacovigilance and individualized treatment approaches remain essential in the evolving landscape of CD management.

NOTES

Funding Source

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

Conflict of Interest

Han YM 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

Conceptualization: Han YM. Writing - original draft: all authors Writing - review & editing: all authors. Approval of final manuscript: all authors

REFERENCES

1. Ananthakrishnan AN. Precision medicine in inflammatory bowel diseases. Intest Res 2024;22:8–14.Article PubMed PMC PDF
2. Viget N, Vernier-Massouille G, Salmon-Ceron D, Yazdanpanah Y, Colombel JF. Opportunistic infections in patients with inflammatory bowel disease: prevention and diagnosis. Gut 2008;57:549–558.Article PubMed
3. Bonovas S, Fiorino G, Allocca M, et al. Biologic therapies and risk of infection and malignancy in patients with inflammatory bowel disease: a systematic review and network meta-analysis. Clin Gastroenterol Hepatol 2016;14:1385–1397.Article PubMed
4. Fujimoto K, Hosomi S, Kobayashi Y, et al. Tuberculosis risk in patients with Crohn’s disease on biologics: a retrospective analysis of the Japanese Medical Claims Database. Intest Res 2025;23:309–317.Article PubMed PDF
5. Lee CK, Wong SHV, Lui G, et al. A prospective study to monitor for tuberculosis during anti-tumour necrosis factor therapy in patients with inflammatory bowel disease and immune-mediated inflammatory diseases. J Crohns Colitis 2018;12:954–962.Article PubMed
6. Fehily SR, Al-Ani AH, Abdelmalak J, et al. Review article: latent tuberculosis in patients with inflammatory bowel diseases receiving immunosuppression-risks, screening, diagnosis and management. Aliment Pharmacol Ther 2022;56:6–27.Article PubMed PMC PDF
7. Kim J, Im JP, Yim JJ, et al. Clinical features and outcomes of tuberculosis in inflammatory bowel disease patients treated with anti-tumor necrosis factor therapy. Korean J Gastroenterol 2020;75:29–38.Article PubMed PMC PDF
8. Alrajhi S, Germain P, Martel M, et al. Concordance between tuberculin skin test and interferon-gamma release assay for latent tuberculosis screening in inflammatory bowel disease. Intest Res 2020;18:306–314.Article PubMed PMC PDF
9. Jun YK, Koh SJ, Myung DS, et al. Infectious complications in patients with inflammatory bowel disease in Asia: the results of a multinational web-based survey in the 8th Asian Organization for Crohn’s and Colitis meeting. Intest Res 2023;21:353–362.Article PubMed PMC PDF

Figure & Data

REFERENCES

Citations

Citations to this article as recorded by

PubReader
ePub Link

Cite

CITE: export Copy Download Format; Close

Download Citation

Download a citation file in RIS format that can be imported by all major citation management software, including EndNote, ProCite, RefWorks, and Reference Manager.

Format:

RIS — For EndNote, ProCite, RefWorks, and most other reference management software
BibTeX — For JabRef, BibDesk, and other BibTeX-specific software

Include:

Citation for the content below
Citation and abstract for the content below

Assessing tuberculosis risk in Crohn’s disease patients receiving biologic therapies: real-world insights from Japan

Intest Res. 2025;23(3):231-232. Published online July 29, 2025

DOI: https://doi.org/10.5217/ir.2025.00117

XML Download

Assessing tuberculosis risk in Crohn’s disease patients receiving biologic therapies: real-world insights from Japan