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Upfront tofacitinib in patients with biological-naïve ulcerative colitis - An Indian multicentric experience
Suprabhat Giri1, Sukanya Bhrugumalla1, Abhishek Kamuni1
1Department of Gastroenterology, Nizam's Institute of Medical Sciences, Hyderabad, 500 082, India.
Tofacitinib effectively treats moderate to severe ulcerative colitis (UC) in biologic-naïve Indian patients. This study shows upfront tofacitinib is a viable option, though further research is needed.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
- Tofacitinib, a Janus Kinase inhibitor, is approved for moderate to severe UC, typically after biologic therapy failure.
- Limited data exists on tofacitinib's efficacy in patients who have not previously used biologics.
Purpose of the Study:
- To evaluate the safety and effectiveness of tofacitinib in biologic-naïve Indian patients with moderate to severe UC.
- To identify predictors of treatment response in this population.
Main Methods:
- Retrospective study of 47 biologic-naïve UC patients from six Indian tertiary care centers.
- Patients received tofacitinib between September 2020 and September 2022.
- Clinical remission and response assessed using the partial Mayo score at weeks 8, 16, and 24.
Main Results:
- At 8 weeks, 70.2% achieved clinical remission; baseline serum albumin predicted this response.
- By 24 weeks, 59.6% remained in remission, with 29.8% discontinuing tofacitinib due to failure or adverse events.
- Adverse events occurred in 21.2%, including infections like tuberculosis and CMV colitis.
Conclusions:
- Upfront tofacitinib demonstrates effectiveness in biologic-naïve Indian patients with moderate to severe UC.
- Baseline serum albumin is a significant predictor of early remission.
- Further randomized controlled trials are necessary to confirm these findings.
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