Vedolizumab Shows Better Safety Profile Compared With Anti-Tumor Necrosis Factor-α in IBD

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Researchers compared the clinical effectiveness and safety profiles of vedolizumab and anti-TNFα agents in biologic-naïve adult patients with ulcerative colitis and Crohn disease.

First-line vedolizumab and anti-tumor necrosis factor-α (anti-TNFα) treatments yield similar rates of clinical effectiveness up to 2 years after treatment initiation in patients with inflammatory bowel disease (IBD). However, vedolizumab has a better safety profile compared with anti-TNFα treatments. These findings are based on the results of a 24-month retrospective chart review published in Journal of Crohns and Colitis.

Researchers compared the real-world clinical effectiveness and safety of vedolizumab and anti-TNFα agents in biologic-naïve adult patients with ulcerative colitis (UC) and Crohn disease (CD). This multi-center study consisted of 37 sites across 3 countries (United States, 15 sites; Canada, 13 sites; Greece, 9 sites). The investigators used inverse probability weighting to account for differences between the vedolizumab and anti-TNFα groups.

The eligibility period for initiating first-line biological vedolizumab or anti-TNFα treatment was from May 20, 2014 to July 31, 2017. Data abstraction occurred from September 21, 2017 to December 14, 2018. The primary outcomes were cumulative rates of clinical effectiveness (clinical response, clinical remission, mucosal healing) and incidence rates of serious adverse events (SAEs) and serious infections (SIs).

A total of 1095 patients (598 vedolizumab [380 UC, 218 CD] and 497 anti-TNFα [224 UC, 273 CD]) were included in the final dataset.

By 24 months, rates of clinical effectiveness were determined to be similar between the vedolizumab and anti-TNFα groups. The incidence rates of SAEs (hazard ratio [HR], 0.42 [0.28-0.62]) and SIs (HR, 0.40 [0.19-0.85]) were significantly lower in vedolizumab patients compared with anti-TNFα patients.

By 24 months, rates of treatment persistence were higher in vedolizumab patients with UC (P <.01). Incidence rates of disease exacerbations were found to be lower in vedolizumab patients with UC (HR, 0.58 [0.45-0.76]). Other outcomes did not significantly differ among the vedolizumab and anti-TNFα groups.   

Limitations of this study include its retrospective design and lack of individual comparisons between anti-TNFα treatments and vedolizumab. Additionally, certain factors may not have been measured, such as patient decisions and reimbursement. Further, in Greece, only vedolizumab patients were included in the study, thus establishing a comparative analysis limitation. Lastly, the composite biochemical marker was not considered a validated algorithm. 

According to the researchers, “In this-real-world setting, first-line biologic therapy in biologic-naïve patients with UC and CD demonstrated that vedolizumab and anti-TNFα treatments were equally effective at controlling disease symptoms, but vedolizumab has a more favorable safety profile.”

Disclosure: This research was supported by Takeda Pharmaceuticals Company Ltd. Please see the original reference for a full list of disclosures.


Bressler B, Yarur A, Silverberg MS, et al. Vedolizumab and anti-TNFα real-world outcomes in biologic-naïve inflammatory bowel disease patients: results from the EVOLVE study. J Crohns Colitis. Published online March 31, 2021. doi: 10.1093/ecco-jcc/jjab058