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Upfront tofacitinib in patients with biological-naïve ulcerative colitis – An Indian multicentric experience

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Indian Journal of Gastroenterology Aims and scope Submit manuscript

Abstract

Objectives

Tofacitinib is a Janus Kinase inhibitor used for treating moderate to severe ulcerative colitis (UC), mainly after the failure of biological therapy. There is a paucity of data on the outcome of tofacitinib in biological-naïve UC patients. The present study was aimed at analyzing the safety and efficacy of tofacitinib in biological-naïve Indian patients with UC.

Methods

The present study retrospectively evaluated consecutive patients with biological-naïve moderate-to-severe active UC from six tertiary care centers in India receiving tofacitinib from September 2020 to September 2022. Clinical remission or response assessment was based on partial Mayo score (PMS) calculated at baseline and weeks eight, 16 and 24.

Results

Total 47 cases (57.4% male, median age: 32 years) were included. After eight weeks of therapy, 33 (70.2%) achieved clinical remission and eight (17.0%) had a primary failure. The baseline serum albumin at treatment initiation was the only independent predictor of remission at eight weeks (Odds ratio: 11.560, 95% CI: 1.478 – 90.404), but not at 16 weeks. By 24 weeks, 59.6% (28/47) of the patients were in remission and 29.8% (14/47) had stopped tofacitinib either due to failure (27.6%) or adverse events (AEs) (2.1%). Among the 47 patients, 10 (21.2%) cases developed AEs during follow-up, including two tuberculosis (4.2%), one cytomegalovirus (CMV) colitis (2.1%) and one herpes zoster (2.1%). Four patients with infection required temporary drug discontinuations. One required permanent discontinuation (mania).

Conclusion

Upfront tofacitinib is effective in biologic-naïve Indian patients with moderate-severe UC. Further randomized studies are required to validate the study findings.

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Authors and Affiliations

  1. Department of Gastroenterology, Nizam’s Institute of Medical Sciences, Hyderabad, 500 082, India

    Suprabhat Giri, Sukanya Bhrugumalla & Abhishek Kamuni

  2. Department of Gastroenterology, Institute of Medical Sciences and SUM Hospital, Bhubaneswar, 751 003, India

    Debakanta Mishra & Girish Kumar Pati

  3. Department of Gastroenterology, PACE Hospital, Hyderabad, 500 081, India

    Dhiraj Agrawal & Govind Verma

  4. Department of Gastroenterology, Lokmanya Tilak Municipal General Hospital and Medical College, Mumbai, 400 022, India

    Rohit Wagh, Shamshersingh Chauhan & Meghraj Ingle

  5. Department of Gastroenterology, Topiwala National Medical College and BYL Nair Hospital, Mumbai, 400 008, India

    Sanjay Chandnani, Shubham Jain & Pravin M. Rathi

  6. Department of Gastroenterology, Seth GS Medical College and KEM Hospital, 9th Floor, New OPD Building, Parel, Mumbai, 400 012, India

    Akash Shukla & Aditya Kale

Authors
  1. Suprabhat Giri
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  2. Sukanya Bhrugumalla
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  4. Debakanta Mishra
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Contributions

Conceptualization: SG, AK; Data curation: SG, AK, DM, DA, RW, SsC, SC, SJ, AbK; Formal analysis: SG, AbK, AK; Funding acquisition: N/A; Investigation: SG, AbK, DM, DA, RW, SsC, SC, SJ, AK; Methodology: SG, SB, GKP, GV, MI, PMR, AS, AK; Project administration: SB, GKP, GV, MI, PMR, AS; Resources: SB, GKP, GV, MI, PMR, AS; Software: SG; Supervision: SG, SB, GKP, GV, MI, PMR, AS, AK; Validation: SB, GKP, GV, MI, PMR, AS; Visualization: SG; Roles/Writing—original draft: SG, AdK; Writing—review and editing: SG, SB, AK, DM, GKP, DA, GV, RW, SsC, MI, SC, SJ, PMR, AS, AK.

Corresponding author

Correspondence to Aditya Kale.

Ethics declarations

Conflict of interest

SG, SB, AbK, DM, GKP, DA, GV, RW, SsC, MI, SC, SJ, PMR, AS and AK declare that they have no conflict of interest.

Ethics statement

The study was performed conforming to the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.

Ethical approval

Taken from respective Institutional Ethical Committees.

Ethical clearance was taken from IEC of respective centers.

Coordinating center: Nizam's Institute of Medical Sciences: EC/NIMS/4157/2023.

Other centers:

Lokmanya Tilak Municipal General Hospital and Medical College: IEC/26/23.

Seth GS Medical College and KEM Hospital: EC/OA-70/2023.

The other three centers received an exemption from the IEC due to the study’s retrospective nature, with a sample size of less than five from each center and only written informed consent was taken from the participants.

Financial disclosures

No funds, grants or other support were received.

Disclaimer

The authors are solely responsible for the data and the contents of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members, the Indian Society of Gastroenterology or the printer/publishers are responsible for the results/findings and content of this article.

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Giri, S., Bhrugumalla, S., Kamuni, A. et al. Upfront tofacitinib in patients with biological-naïve ulcerative colitis – An Indian multicentric experience. Indian J Gastroenterol 43, 237–243 (2024). https://doi.org/10.1007/s12664-023-01434-9

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  • DOI: https://doi.org/10.1007/s12664-023-01434-9

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