Effectiveness and Safety of Vedolizumab and Infliximab in Biologic-naive Patients with Crohn's Disease: Results from the EVOLVE Study

Overview

Journal Eur J Gastroenterol Hepatol

Specialty Gastroenterology

Date 2024 Jan 5

PMID 38179874

Authors

Gerassimos J Mantzaris

Brian Bressler

Shashi Adsul

Michelle Luo

Chris Colby

Neil R Brett

Sumit Saha

Pravin Kamble

Song Wang

Andres Yarur

Affiliations

Soon will be listed here.

Abstract

Objectives: This study compared the real-world effectiveness and safety of α 4 β 7 -integrin inhibitor vedolizumab and anti-tumor necrosis factor alpha (anti-TNFα) inhibitor infliximab in biologic-naive patients with Crohn's disease (CD).

Methods: EVOLVE was a retrospective, multicenter, medical chart review of biologic-naive adults with inflammatory bowel disease receiving vedolizumab or anti-TNFα treatment as first-line biologics in Canada, Greece, and the USA. Twelve-month outcomes were analyzed in vedolizumab- or infliximab-treated patients with moderate-to-severe CD (and subgroups with complicated and noncomplicated CD) including cumulative rates of clinical response, clinical remission, and mucosal healing, and incidence rates of serious adverse events (SAEs) and serious infections (SIs). Inverse probability weighting (IPW) was used to account for baseline differences between treatment groups.

Results: Data were analyzed from 167 patients. In the IPW dataset (99 vedolizumab-treated and 63 infliximab-treated), adjusted 12-month clinical remission rates were 73.1% and 55.2%, respectively ( P = 0.31). Overall, effectiveness rates were similar across treatment and complicated/noncomplicated disease subgroups. Adjusted 12-month incidence rates (first occurrence/1000 person-years) of SAEs for vedolizumab vs. infliximab: 43.6 vs. 200.9 [hazard ratio (HR) 0.36 (0.09-1.54)]; SIs: 10.8 vs. 96.0 [HR 0.08 (<0.01-2.64)]. AE incidence was significantly lower in vedolizumab- vs. infliximab-treated patients for complicated [131.6 vs. 732.2; HR 0.19 (0.05-0.65)] and noncomplicated [276.3 vs. 494.8; HR 0.59 (0.35-0.99)] disease subgroups.

Conclusion: These real-world data on first-line biologics show no differences in 12-month effectiveness outcomes for vedolizumab- vs. infliximab-treated biologic-naive patients with CD. Vedolizumab may have a more favorable safety profile vs. infliximab in patients with complicated and noncomplicated disease.

References

McLean L, Shea-Donohue T, Cross R . Vedolizumab for the treatment of ulcerative colitis and Crohn's disease. Immunotherapy. 2012; 4(9):883-98. PMC: 3557917. DOI: 10.2217/imt.12.85. View

Kumar A, Cole A, Segal J, Smith P, Limdi J . A review of the therapeutic management of Crohn's disease. Therap Adv Gastroenterol. 2022; 15:17562848221078456. PMC: 8859667. DOI: 10.1177/17562848221078456. View

Gomollon F, Dignass A, Annese V, Tilg H, Van Assche G, Lindsay J . 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management. J Crohns Colitis. 2016; 11(1):3-25. DOI: 10.1093/ecco-jcc/jjw168. View

Le Berre C, Peyrin-Biroulet L . Selecting End Points for Disease-Modification Trials in Inflammatory Bowel Disease: the SPIRIT Consensus From the IOIBD. Gastroenterology. 2021; 160(5):1452-1460.e21. DOI: 10.1053/j.gastro.2020.10.065. View

Ben-Horin S, Chowers Y . Review article: loss of response to anti-TNF treatments in Crohn's disease. Aliment Pharmacol Ther. 2011; 33(9):987-95. DOI: 10.1111/j.1365-2036.2011.04612.x. View

Sands B, Feagan B, Rutgeerts P, Colombel J, Sandborn W, Sy R . Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014; 147(3):618-627.e3. DOI: 10.1053/j.gastro.2014.05.008. View

Wyant T, Fedyk E, Abhyankar B . An Overview of the Mechanism of Action of the Monoclonal Antibody Vedolizumab. J Crohns Colitis. 2016; 10(12):1437-1444. DOI: 10.1093/ecco-jcc/jjw092. View

Torres J, Bonovas S, Doherty G, Kucharzik T, Gisbert J, Raine T . ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. 2019; 14(1):4-22. DOI: 10.1093/ecco-jcc/jjz180. View

Bisgaard T, Allin K, Keefer L, Ananthakrishnan A, Jess T . Depression and anxiety in inflammatory bowel disease: epidemiology, mechanisms and treatment. Nat Rev Gastroenterol Hepatol. 2022; 19(11):717-726. DOI: 10.1038/s41575-022-00634-6. View

10.

Singh S, Proctor D, Scott F, Falck-Ytter Y, Feuerstein J . AGA Technical Review on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021; 160(7):2512-2556.e9. PMC: 8986997. DOI: 10.1053/j.gastro.2021.04.023. View

11.

Hahn G, Golovics P, Wetwittayakhlang P, Al Khoury A, Bessissow T, Lakatos P . Is There a Best First Line Biological/Small Molecule in IBD: Are We Ready for Sequencing?. Biomedicines. 2022; 10(4). PMC: 9026422. DOI: 10.3390/biomedicines10040749. View

12.

Torres J, Mehandru S, Colombel J, Peyrin-Biroulet L . Crohn's disease. Lancet. 2016; 389(10080):1741-1755. DOI: 10.1016/S0140-6736(16)31711-1. View

13.

Bressler B, Yarur A, Silverberg M, Bassel M, Bellaguarda E, Fourment C . 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; 15(10):1694-1706. PMC: 8495488. DOI: 10.1093/ecco-jcc/jjab058. View

14.

Hernan M, Brumback B, Robins J . Marginal structural models to estimate the causal effect of zidovudine on the survival of HIV-positive men. Epidemiology. 2000; 11(5):561-70. DOI: 10.1097/00001648-200009000-00012. View

15.

Singh S, Fumery M, Sandborn W, Murad M . Systematic review and network meta-analysis: first- and second-line biologic therapies for moderate-severe Crohn's disease. Aliment Pharmacol Ther. 2018; 48(4):394-409. DOI: 10.1111/apt.14852. View

16.

Lichtenstein G, Feagan B, Cohen R, Salzberg B, Safdi M, Popp Jr J . Infliximab for Crohn's Disease: More Than 13 Years of Real-world Experience. Inflamm Bowel Dis. 2018; 24(3):490-501. PMC: 6176880. DOI: 10.1093/ibd/izx072. View

17.

Ko Y, Paramsothy S, Yau Y, Leong R . Superior treatment persistence with ustekinumab in Crohn's disease and vedolizumab in ulcerative colitis compared with anti-TNF biological agents: real-world registry data from the Persistence Australian National IBD Cohort (PANIC) study. Aliment Pharmacol Ther. 2021; 54(3):292-301. DOI: 10.1111/apt.16436. View

18.

Atreya R, Neurath M, Siegmund B . Personalizing Treatment in IBD: Hype or Reality in 2020? Can We Predict Response to Anti-TNF?. Front Med (Lausanne). 2020; 7:517. PMC: 7492550. DOI: 10.3389/fmed.2020.00517. View

19.

Neurath M . Targeting immune cell circuits and trafficking in inflammatory bowel disease. Nat Immunol. 2019; 20(8):970-979. DOI: 10.1038/s41590-019-0415-0. View

20.

Bohm M, Xu R, Zhang Y, Varma S, Fischer M, Kochhar G . Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn's disease. Aliment Pharmacol Ther. 2020; 52(4):669-681. PMC: 7496810. DOI: 10.1111/apt.15921. View