C difficile Infection Not Linked to Use of Vedolizumab vs Anti-TNF-α Drugs for Ulcerative Colitis

Investigators assessed whether vedolizumab use is associated with an increased risk for Clostridioides difficile infection vs anti-TNF-α agents in patients with ulcerative colitis.

The following article is a part of conference coverage from the Advances in Inflammatory Bowel Diseases 2021 Annual Meeting , held from December 9 to 11, 2021. The team at Gastroenterology Advisor will be reporting on the latest news and research conducted by leading experts in gastroenterology. Check back for more from AIBD 2021.


Vedolizumab is not associated with an increased risk for Clostridioides difficile infection (CDI) compared with use of anti-tumor necrosis factor-alpha (TNF-α) agents in patients with ulcerative colitis (UC), after controlling for disease severity, according to research presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2021 Annual Meeting, held from December 9 to 11, 2021, in Orlando, Florida and virtually.

The retrospective cohort study included adult patients with UC who initiated infliximab, adalimumab, or vedolizumab use from June 1, 2014, to December 31, 2020, from a large academic health system. Patients who had Crohn disease, indeterminate colitis, previous biologic exposure, prior colectomy, and non-UC indications for biologics were excluded. The participants were followed until CDI, colectomy, biologic discontinuation or switch, or last gastroenterology encounter through August 1, 2021.

The primary outcome was the time from biologic initiation to first CDI, which was defined as a positive stool Clostridioides difficile (C difficile) toxin or toxigenic C difficile polymerase chain reaction (PCR) test result with associated CDI antibiotic prescriptions. Secondary outcomes included CDI-related hospitalization, colectomy, or death within 30 days of CDI.

The primary exposure was vedolizumab compared with anti-TNF-α therapy. Other independent variables included demographics and UC history and severity. Logistic regression was used to calculate propensity scores of vedolizumab vs anti-TNF-α agents regarding age, sex, Caucasian race, body mass index (BMI), disease duration, current systemic corticosteroid use, UC-related hospitalization within previous 12 months, last Mayo endoscopic subscore, Montreal classification of disease extent, albumin, and malignancy history.

A total of 805 patients with UC who initiated use of either vedolizumab (n=195) or anti-TNF-α agents (n=610) were included. Patients who used vedolizumab were older and less frequently received systemic corticosteroids or had UC-related hospitalization within 12 months before biologic initiation.

Participants had a total of 43 CDIs in more than 1436 patient-years of follow-up. CDI and CDI hospitalization occurred less frequently in patients who used vedolizumab compared with those who used anti-TNF-α agents (CDI: 1.0% vs 6.7%, respectively; P =.001; CDI hospitalization: 1.0% vs 3.8%, respectively; P =.042 by log-rank test).

No differences were observed in colectomies, deaths, or exposure to antibiotics or corticosteroids in the follow-up or within 30 days preceding CDI. A lower hazard for CDI for vedolizumab use vs anti-TNF-α agent use (hazard ratio [HR], 0.17; 95% CI, 0.04-0.71) was observed in the unadjusted Cox analysis. The multivariable inverse probability of treatment-weighted Cox model showed no difference in hazard for CDI for vedolizumab vs anti-TNF-α agents (HR, 0.33; 95% CI, 0.05-2.03) or immunomodulator exposure (HR, 1.01; 95% CI, 0.41-2.40).

Pre-biologic CDI was associated with an increased hazard for CDI (HR, 5.95; 95% CI, 2.93-12.09). In participants who had CDI, 17 of 43 (39.5%) had pre-biologic CDI a median of 227 days (IQR, 160-550 days) before CDI.

“We hope that these findings will reassure UC providers considering vedolizumab as a first-line biologic agent in the context of gastrointestinal infectious risks,” the study authors concluded.

Visit Gastroenterology Advisor’s meetings section for complete coverage of AIBD 2021.



Dalal R, Mitri J, Goodrick H, et al. Comparative risk of Clostridioides difficile infection in vedolizumab vs anti-TNFa agents in biologic-naïve patients with ulcerative colitis. Presented at: AIBD 2021 Annual Meeting; December 9-11, 2021; Orlando, FL and virtual. Abstract P074.