Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

Brian Bressler, Andres Yarur, Mark S. Silverberg, Marielle Bassel, Emanuelle Bellaguarda, Chris Fourment, Anthie Gatopoulou, Pantelis Karatzas, Uri Kopylov, George Michalopoulos, Spyridon Michopoulos, Udayakumar Navaneethan, David T. Rubin, Jesse Siffledeen, Andrew Singh, Konstantinos Soufleris, Dara Stein, Dirk Demuth, Gerassimos J. Mantzaris

Research output: Contribution to journalArticlepeer-review


Background and Aims: This study aimed to compare real-world clinical effectiveness and safety of vedolizumab, an α4β7-integrin inhibitor, and anti-tumour necrosis factor-α [anti-TNFα] agents in biologic-naïve ulcerative colitis [UC] and Crohn's disease [CD] patients. Methods: This was a 24-month retrospective medical chart study in adult UC and CD patients treated with vedolizumab or anti-TNFα in Canada, Greece and the USA. Inverse probability weighting was used to account for differences between groups. 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]. Secondary outcomes included cumulative rates of treatment persistence [patients who did not discontinue index treatment during follow-up] and dose escalation and incidence rates of disease exacerbations and disease-related surgeries. Adjusted analyses were performed using inverse probability weighting. Results: A total of 1095 patients [604 UC, 491 CD] were included. By 24 months, rates of clinical effectiveness were similar between groups, but 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 vs anti-TNFα patients. Rates of treatment persistence [p < 0.01] by 24 months were higher in vedolizumab patients with UC. Incidence rates of disease exacerbations were lower in vedolizumab patients with UC (HR = 0.58 [0.45-0.76]). Other outcomes did not significantly differ between groups. Conclusion: 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 favourable safety profile.

Original languageEnglish
Pages (from-to)1694-1706
Number of pages13
JournalJournal of Crohn's and Colitis
Issue number10
StatePublished - 1 Oct 2021
Externally publishedYes


  • Vedolizumab
  • biologic-naïve
  • real-world effectiveness


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