Faculty Collaboration Database

Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study. J Crohns Colitis 2021 Oct 07;15(10):1694-1706

Date

04/01/2021

Pubmed ID

33786600

Pubmed Central ID

PMC8495488

DOI

10.1093/ecco-jcc/jjab058

Scopus ID

2-s2.0-85109125286 (requires institutional sign-in at Scopus site)   66 Citations

Abstract

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.

Author List

Bressler B, Yarur A, Silverberg MS, Bassel M, Bellaguarda E, Fourment C, Gatopoulou A, Karatzas P, Kopylov U, Michalopoulos G, Michopoulos S, Navaneethan U, Rubin DT, Siffledeen J, Singh A, Soufleris K, Stein D, Demuth D, Mantzaris GJ

Author

Daniel J. Stein MD Director, Associate Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Antibodies, Monoclonal, Humanized
Cohort Studies
Female
Gastrointestinal Agents
Humans
Inflammatory Bowel Diseases
Male
Middle Aged
Remission Induction
Retrospective Studies
Tumor Necrosis Factor-alpha