Vedolizumab does not increase CDI Risk in IBD Patients

A recent study published in Saudi Pharmaceutical Journal found that the use of biologic therapy like vedolizumab or anti-TNF does not appear to impact the risk of Clostridium difficile infection (CDI).

In recent years, various studies have indicated a rising occurrence, recurrence, and severity of CDI. Notably, patients who have inflammatory Bowel Disease (IBD) and contract CDI tend to face a higher level of health risks and mortality compared to individuals with CDI who do not have IBD. The study conducted by Abdulaziz and team aimed to assess the CDI risk in IBD patients using vedolizumab when compared with alternative therapies.

This retrospective cohort study involved the inclusion of 684 patients who had confirmed IBD. These patients were divided into three groups: 228 were on vedolizumab treatment, 228 were on anti-TNF treatment, and 228 were receiving 5-Aminosalicylates acid therapy. The enrollment of these patients took place between January 2009 and August 2019, at a specialized IBD center located at McMaster University Medical Centre (MUMC) in Hamilton, Ontario, Canada.

The primary objective of this study was to determine the time it took for IBD patients, receiving different treatments, to develop Clostridium difficile infection (CDI). Secondary objectives included examining the rates of CDI and assessing the connection between baseline variables and the risk of developing CDI.

The key findings of this study:

There was no significant difference in the time it took for CDI to develop among the three treatment groups, as indicated by a log-rank p-value of 0.37.

CDI occurred in a total of 16 patients, accounting for 2.3% of the cases.

Specifically, four patients (1.75%) belonged to the vedolizumab group, another four patients (1.75%) were in the anti-TNF group, and eight patients (3.5%) were part of the 5-ASA group.

Upon analysis using the Cox proportional hazards (PH) model, several risk factors for CDI emerged, including current smoking, older age, and concurrent use of immunomodulators, after adjusting for other variables. Importantly, vedolizumab treatment was not associated with an increased risk of CDI in this model.

Reference:

Saad Alshahrani, A., Mohammad, D., attieh Alzahrani, M., & Narula, N. (2023). Vedolizumab does not increase risk of clostridium difficile infection in patients with inflammatory bowel disease using vedolizumab: A retrospective cohort study. In Saudi Pharmaceutical Journal (Vol. 31, Issue 9, p. 101736). Elsevier BV. https://doi.org/10.1016/j.jsps.2023.101736