Tofacitinib in older patients with ulcerative colitis: balancing efficacy and safety

Yoon Suk Jung

doi:10.5217/ir.2026.00070

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Editorial IBD Tofacitinib in older patients with ulcerative colitis: balancing efficacy and safety: Yoon Suk Jung; Intestinal Research 2026;24(2):193-194.
DOI: https://doi.org/10.5217/ir.2026.00070
Published online: April 29, 2026

Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea

Correspondence to Yoon Suk Jung, Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea. E-mail: ys810.jung@samsung.com

• Received: March 2, 2026 • Accepted: March 17, 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 "Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a post hoc analysis of safety and effectiveness in older (≥65 years) and younger (<65 years) patients" on page 214.

Inflammatory bowel disease (IBD) is most commonly diagnosed in young adults, but diagnoses in older individuals have increased with population aging [1]. In rapidly aging countries such as Japan and Korea, the epidemiology of ulcerative colitis (UC) is evolving accordingly [1]. As the number of older patients with IBD increases, clinicians are increasingly confronted with a familiar dilemma: how to balance treatment efficacy with safety in older patients with a higher burden of comorbidities and a higher risk of infection. In this issue of Intestinal Research, Matsuoka et al. [2] provide timely real-world data from a large Japanese post-marketing surveillance (PMS) study evaluating the safety and efficacy of tofacitinib in patients with UC, stratified by age ( ≥ 65 years vs. <65 years).

Tofacitinib, an oral Janus kinase inhibitor, has demonstrated efficacy in patients with moderate-to-severe UC [3,4]. However, concerns regarding the safety of Janus kinase inhibitors—particularly following the findings of the ORAL Surveillance study in patients with rheumatoid arthritis—have heightened calls for caution, especially in older individuals and those with cardiovascular risk factors [5]. Against this backdrop, this age-stratified PMS analysis provides important clinical insights. Several key findings warrant particular attention.

The most clinically relevant difference between age groups was the higher incidence of herpes zoster and serious infections among older patients. Notably, the incidence rates of both herpes zoster and serious infections peaked within the first 15 weeks of therapy in both age groups, suggesting that the early phase of treatment may represent a particularly vulnerable period. These findings support the notion that age itself is an independent risk factor for opportunistic infections in IBD [6]. Whether the higher infection rates observed early after treatment initiation reflect the higher induction dose, residual immunologic effects of prior biologics, concomitant corticosteroid use, or intrinsic immunosenescence remains uncertain. The lack of detailed reporting on concomitant corticosteroid exposure represents a limitation of the study, given its well-established association with infection risk [7]. This study demonstrates that proactive risk-mitigation strategies, including vaccination (particularly against zoster) are essential when administering tofacitinib to elderly patients with UC.

Reassuringly, no clear excess of cardiovascular events or malignancy emerged in older patients during the 60-week observation period. Notably, no cardiovascular events were reported in the ≥ 65 group, despite a substantially higher baseline prevalence of cardiovascular comorbidities. However, the relatively short follow-up and limited number of older patients (n=212) preclude definitive conclusions.

An encouraging finding from this study is that clinical remission rates through week 60 were generally comparable across age groups. Although the PMS design and the use of the partial Mayo score limit direct comparisons, the data suggest that advanced age does not reduce the therapeutic potential of tofacitinib.

This study emphasizes that effective treatment should not be withheld solely because of advanced age. Tofacitinib remains a viable therapeutic option for older patients with UC requiring advanced therapy. However, age should still be considered in risk stratification. Clinicians should consider the following in older patients: carefully assessing underlying infectious and cardiovascular risks, optimizing vaccinations before initiating treatment, minimizing concomitant corticosteroid use, and closely monitoring during the initial induction period.

The study by Matsuoka et al. [2] provides valuable real-world data in a field with limited evidence, yet several questions remain to be addressed. Future studies should investigate long-term safety of tofacitinib beyond 60 weeks, dose-specific risks, and comparative effectiveness versus other advanced therapies in elderly patients. As therapeutic options for UC continue to expand [8], the challenge is no longer whether older patients can be treated effectively, but how they can be treated safely and judiciously. This PMS analysis brings us one step closer to achieving this goal.

NOTES

Funding Source

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

Conflict of Interest

Jung YS 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: Jung YS.

REFERENCES

1. Yoon J, Kim D, Kim YS. Elderly-onset inflammatory bowel disease in Asia: clinical characteristics and therapeutic strategies. Intest Res 2025;23:430–442.Article PubMed PMC PDF
2. Matsuoka K, Yamamoto T, Matsuura M, et al. Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a post hoc analysis of safety and effectiveness in older (≥65 years) and younger (<65 years) patients. Intest Res 2026;24:214–224.Article PubMed PDF
3. Shimizu H, Aonuma Y, Hibiya S, et al. Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study. Intest Res 2024;22:369–377.Article PubMed PMC PDF
4. Ikenouchi M, Fukui H, Yagi S, et al. Propensity score-matched real-world comparative treatment outcomes of Janus kinase inhibitors for ulcerative colitis in patients with and without prior exposure to anti-tumor necrosis factor α antibody. Intest Res 2025;23:464–474.Article PubMed PMC PDF
5. Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med 2022;386:316–326.Article PubMed
6. Matsuoka K, Inoue T, Tsuchiya H, Nagano K, Iwahori T. Association between oral corticosteroid starting dose and the incidence of pneumonia in Japanese patients with ulcerative colitis: a nation-wide claims database study. Intest Res 2024;22:319–335.Article PubMed PMC PDF
7. Kim DH, Kang SB. Herpes zoster infection in patients with inflammatory bowel disease. Korean J Intern Med 2025;40:347–356.Article PubMed PMC PDF
8. Yen HH, Wu JF, Wang HY, et al. Management of ulcerative colitis in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease updated in 2023. Intest Res 2024;22:213–249.Article PubMed PMC PDF

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