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. 2025 Feb 22;17(2):e79456.
doi: 10.7759/cureus.79456. eCollection 2025 Feb.

Real-World Experience With Tofacitinib in Steroid-Dependent Patients With Moderate-to-Severe Ulcerative Colitis on Immunomodulators

Rajendra Bhati  1   2 , Abhishek Yadav  2 , Bobby Mitrolia  2 , Vivek Saini  2 , Sunil K Dadhich  2 , Narendra Bhargava  2
Affiliations

Real-World Experience With Tofacitinib in Steroid-Dependent Patients With Moderate-to-Severe Ulcerative Colitis on Immunomodulators

Rajendra Bhati et al. Cureus. .

Abstract

Introduction: Patients with moderate-to-severe ulcerative colitis (UC) who are steroid-dependent despite being on immunomodulators pose significant clinical challenges. Currently, biologics therapy is the only option apart from considering surgery. Tofacitinib is an oral Janus kinase inhibitor used as a second-line therapy for patients with UC following the failure of biologics therapy. There is a lack of Indian data on the use of tofacitinib in biologically naïve patients with moderate-to-severe UC. Our study aimed to evaluate the efficacy and safety of tofacitinib in steroid-dependent patients with moderate-to-severe UC who were already on immunomodulators.

Materials and methods: An open-label, single-arm, prospective observational study was conducted on steroid-dependent UC patients from January 2021 to June 2023. All eligible patients received tofacitinib according to standard guidelines. Clinical response and remission were assessed at eight and 24 weeks.

Results: A total of 53 patients met the inclusion criteria, of whom 52.83% were male and 47.16% were female. The mean age was 40.35 years (SD ± 10.85 years). At eight weeks, 36 patients (67.92%) showed a clinical response, 19 (35.8%) achieved clinical remission, and 12 (22.64%) attained endoscopic remission. At 24 weeks, 35 patients (66.03%) achieved clinical remission (p<0.001), and 22 (41.50%) attained endoscopic remission (p=0.003). A total of 36 patients (68%) showed a clinical response, while 17 (32%) did not respond to tofacitinib at eight weeks. CRP and Mayo scores showed significant differences between responders and non-responders (p<0.001). Only two patients developed herpes zoster infection, both of whom were managed conservatively without requiring discontinuation of tofacitinib. No other adverse effects, such as thromboembolic events, were observed during the study period.

Conclusion: The oral small-molecule tofacitinib is an effective and safe treatment for moderate-to-severe UC that is steroid-dependent in patients already on immunomodulators.

Keywords: biologics agents; immunomodulators; inflammatory bowel disease (ibd); tofacitinib; ulcerative colitis (uc).

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Conflict of interest statement

Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Institutional Ethics Committee of Dr. Sampurnanand Medical College issued approval SNMC/IEC/IIP/2022/063. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

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