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Comparative Safety of Advanced Therapies in Patients with Ulcerative Colitis: An Administrative Claims-based Study
Dhruv Ahuja1,2, Claudia Dziegielewski1, Kuan-Hung Yeh3
1Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, USA.
The American Journal of Gastroenterology
|October 22, 2025
Summary
Advanced therapies like anti-interleukins and Janus kinase (JAK) inhibitors show a lower risk of serious infections in ulcerative colitis (UC) patients. These treatments may offer benefits, particularly for those previously treated with tumor necrosis factor-α (TNF) antagonists.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
- Advanced therapies are increasingly used for UC management.
- Comparative safety data for these advanced therapies are crucial.
Purpose of the Study:
- To compare the safety profiles of different advanced therapies in UC patients.
- To evaluate the risk of serious infections, venous thromboembolism (VTE), and major adverse cardiovascular events (MACE).
Main Methods:
- Retrospective cohort study using administrative claims data (OptumLabs® Data Warehouse).
- Identified UC patients initiating treatment with TNF antagonists, anti-integrins, anti-interleukins, JAK inhibitors, or S1PR modulators (2016-2022).
- Used inverse probability weighting (IPW) to adjust for confounding factors and competing risks.
Main Results:
- Included 9,430 UC patients across various advanced therapy groups.
- Anti-interleukins and JAK inhibitors were associated with a lower risk of serious infections compared to TNF antagonists.
- Incidence of VTE and MACE was low and did not significantly differ across treatment groups.
Conclusions:
- Anti-interleukins and JAK inhibitors demonstrate a reduced risk of serious infections in UC patients.
- These agents may provide a net benefit, especially in patients with prior TNF antagonist exposure.
- Real-world data support the safety and potential advantages of specific advanced therapies in UC.
Keywords:
Inflammatory bowel diseaseadverse drug reactionsbenefit-risk assessmentpharmacovigilanceulcerative colitisMore Related Videos
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