Vedolizumab Use Increases Risk of CDI Episodes for IBD Patients


The median exposure of vedolizumab was 1.93 years and lower incidence rates were found for infliximab or adalimumab.

Vedolizumab Use Increases Risk of CDI Episodes for IBD Patients

Helena Martinez-Lozano

Credit: Twitter

New data suggests certain drugs taken by patients with inflammatory bowel disease increase the risk of developing Clostridioides difficile infections (CDI).

A team, led by Helena Martinez-Lozano, Hospital General Universitario Gregorio Maranon, assessed whether vedolizumab increased the risk of CDI compared to other biologics, mainly anti-TNF and ustekinumab, in patients with IBD.

Patients With IBD

Patients with IBD are often at an increased risk of developing CDI and it has been suggested in the past that the biologics commonly used to treated IBD can also increase the risk of CDI. This could be especially true for vedolizumab because of its selective gut mechanism.

In the retrospective study, the investigators examined patients diagnosed with IBD who were treated with at least 1 biologic agent between 2015-2021 at a tertiary referral IBD center in Madrid.

The Drugs

The investigators looked at results infliximab, adalimumab, golimumab, and certolizumab.

They also assessed predictors of CDI development using a Cox proportional hazards model and calculated the CDI incidence rate for each treatment as the number of patients experiencing the CDI episode per 100 person-years of exposure.

The study included 603 patients with IBD, 159 of which had ulcerative colitis and 444 of which had Crohn’s disease. The mean age of the patient population was 42.5 years and 25.54% of the patients were smokers.

The median number of biologics administered was 2 and 301 patients were treated with infliximab, 346 with adalimumab, 26 with certolizumab, 38 with golimumab, 151 with ustekinumab, and 106 with vedolizumab.

Overall, there were 42 (6.97%) CDI episodes, 24 of which were from patients treated with anti-TNF, 8 were treated with ustekinumab, 8 were treated with vedolizumab, and 2 patients on other therapies.

After conducting a multivariable analysis, the investigators found vedolizumab treatment (hazards ratio [HR]: 2.17, 95% confidence interval [CI], 1.06- 4.44; P = 0.034) and shorter disease duration (HR, 0.92; 95% CI, 0.88-0.96; P = .0002) were associated with increased risk of developing CDI.

In addition, CDI incidence was highest in the vedolizumab group (3.04 per 100 person-years, 95% CI 1.31-5.99), followed by ustekinumab (2.42 100 person-years; 95% CI, 1.05-4.78).

The median exposure of vedolizumab was 1.93 years and lower incidence rates were found for infliximab (1.30 100 person-years, 95% CI 0.71-2.19) or adalimumab (0.65 100 person-years, 95% CI 0.28-1.28).

Infliximab had the longest exposure time with a median of 3.47 years. This was followed by adalimumab with a median of 3.33 years.

The majority of CDI episodes were non-severe (85.71%) and community-acquired (57.76%) and 14.29% (n = 6) of patients had CDI recurrence.

“Our results suggest that the use of vedolizumab may increase the risk of developing CDI in IBD patients on biologic therapy,” the authors wrote.

The data was presented during the 2023 Digestive Disease Week (DDW) in Chicago.


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