Among IBD Patients, Treatment with Immunomodulators or Biologics Not Tied to Higher Risk of Major CV Events: Study
France: In a Medicare population with inflammatory bowel disease (IBD), treatment with immunomodulators or biologics was not associated with a higher risk of major cardiovascular events (such as heart attack or stroke) compared to 5-aminosalicylic acid, suggesting cardiovascular safety of these advanced therapies. However, regarding infection risk, advanced therapy comparisons showed that JAK inhibitors carried the highest risk of serious infections, while ustekinumab demonstrated the lowest risk among the studied agents.
A large nationwide cohort study published in Clinical Gastroenterology and Hepatology by Anaïs Bertrand and colleagues from Hôpital Bicêtre provides important real-world insights into infection risks associated with commonly used therapies in IBD. The study evaluated the safety of biologics and Janus kinase inhibitors (JAK inhibitors) in comparison with conventional treatments such as aminosalicylates.
Using French national healthcare data, the investigators analyzed 309,025 treatment initiations among 219,229 patients aged over 15 years between 2014 and 2024. The therapies assessed included vedolizumab, ustekinumab, JAK inhibitors, anti-TNF agents, and aminosalicylates. The median patient age was 41 years, with women accounting for just over half of the cohort, and nearly 45% diagnosed with Crohn’s disease. Over a median follow-up of one year, more than 15,000 serious infections were recorded.
The researchers reported the following findings:
- Compared with aminosalicylates, the risk of serious infection differed across therapies.
- JAK inhibitors were associated with the highest risk of serious infections.
- Vedolizumab and anti-TNF agents showed intermediate levels of risk.
- Ustekinumab had a risk profile closest to that of aminosalicylates.
- When compared with anti-TNF therapies, ustekinumab was associated with a lower risk of infection.
- Vedolizumab and JAK inhibitors showed higher infection risks relative to anti-TNF agents.
- Distinct infection patterns were observed with different treatments.
- Anti-TNF therapies were more commonly associated with mycobacterial infections.
- JAK inhibitors were more strongly linked to herpesvirus infections.
- Anti-TNF agents and vedolizumab were frequently associated with infections of the skin, upper respiratory tract, and central nervous system.
- Concomitant use of corticosteroids more than doubled the risk of serious infections.
- Use of thiopurines or methotrexate was associated with a modest but significant increase in infection risk.
These findings were consistent across different types of IBD, reinforcing the robustness of the results. The authors used advanced statistical techniques, including propensity score weighting, to minimize bias and better account for differences in patient characteristics and treatment indications.
Overall, the study highlights meaningful differences in infection risk across IBD therapies. While newer agents are widely used for disease control, their safety profiles vary, underscoring the need for individualized treatment decisions. The relatively lower risk observed with ustekinumab and the elevated risk with JAK inhibitors may help guide clinicians when balancing efficacy and safety, particularly in patients at higher risk for infections.
Reference:
Bertrand, A., Amiot, A., Martin, A., Carbonnel, F., & Meyer, A. (2026). Serious infection in inflammatory bowel diseases patients treated with vedolizumab, ustekinumab, JAK inhibitors, anti-TNF or aminosalicylates. Clinical Gastroenterology and Hepatology. https://doi.org/10.1016/j.cgh.2026.04.015
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