Takeda Presents Real-World Clinical Effectiveness and Safety Results of Vedolizumab (ENTYVIO®) and Ustekinumab as First-Line Biologic Treatment for Crohn’s Disease
TORONTO, ON — Takeda Canada Inc. (“Takeda”) announces results from the EVOLVE Expansion study, which evaluated the safety and efficacy of vedolizumab (ENTYVIO®), a gut-selective α4β7-integrin inhibitor and ustekinumab (UST), an IL-12/23 p40 inhibitor, as first-line biologic treatment for patients with Crohn’s disease (CD). The data were presented as an oral presentation at Digestive Disease Week® (DDW) 2023 in Chicago, IL.1
“Vedolizumab is the only gut selective advanced therapy for the treatment of IBD. In this real-world comparative effectiveness study, we observe similar rates of clinical remission at 6 and 12 months after initiating first-line vedolizumab or ustekinumab therapy,” said Dr. Brian Bressler, Director of the Advanced IBD Training Program and Clinical Associate Professor of Medicine at the University of British Columbia. “These data are important for patients and providers, further supporting the use of vedolizumab as a first-line biologic treatment in Crohn’s disease.”
The EVOLVE Expansion study (NCT05056441) was a multicenter, observational, retrospective cohort study involving 623 biologic-naïve adult patients with CD who initiated treatment with vedolizumab or UST across 31 sites in Australia, Belgium, or Switzerland from 2016 to 2021.
For the primary outcome measure of cumulative rates of clinical remission over 36 months, similar effectiveness was reported for vedolizumab and UST cohorts (88.3%, 88.5%; p=0.67 respectively).2,3
Similar serious adverse event (including serious infections) occurred for the vedolizumab and UST treated patients (10.1%, 9.8%, respectively). There were no significant differences in the risk of CD exacerbations and CD-related surgeries between the two treatment cohorts.
“We are committed to ongoing investment in research and development and driven to continually seek ways to improve quality of life for patients with IBD,” said Jefferson Tea, Vice-President Medical & Scientific Affairs, Takeda, Canada. “With over one million years of patient experience with vedolizumab globally, studies like this EVOLVE Expansion Study help bolster real-world clinical evidence aimed to optimize outcomes and improve the quality of life for patients living with Crohn’s Disease.”
Data were collected from treatment initiation to chart abstraction, death, or loss to follow-up, whichever came first. The time to event analysis was conducted using the Kaplan-Meier method and cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were estimated over 12, 24 and 36 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations and CD-related surgeries were also evaluated. Inverse probability of treatment weighing was used to balance demographic and clinical characteristics across treatment groups.2
About Crohn’s disease and Ulcerative colitis
Inflammatory bowel disease (IBD) – the main forms of IBD being Crohn’s disease and ulcerative colitis – causes chronic inflammation of the gastrointestinal (GI) tract which impacts food digestion, nutrition absorption and waste elimination.4 IBD has been labelled Canada’s “national disease” due to Canada having among the highest rates in the world.5 More than 300,000 Canadians live with this disease for which there is currently no cure.6 The exact causes of UC and CD are not entirely understood, though they are believed to result from an interaction between genes and the body’s immune system, with environmental factors possibly playing a role.7
About Vedolizumab (ENTYVIO®)
Vedolizumab is a gut-selective biologic approved by Health Canada in both intravenous (IV) and subcutaneous (SC) formulations. It’s approved for the treatment of adults with moderately to severely active, ulcerative colitis (UC) for patients who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a tumor necrosis factor‐alpha (TNFα) antagonist, and Crohn’s disease (CD), for patients who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a tumour necrosis factor-alpha (TNFα) antagonist, or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.8
Vedolizumab has been granted marketing authorization in over 70 countries, including Canada, the United States and European Union, with more than 1,000,000 patient years of exposure to date.9
About Takeda Canada Inc.
Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: takeda.com/en-ca.
Takeda Canada Inc.
ClinicalTrials.gov. ENTYVIO® Real-World Outcomes in Bio-naïve Crohn’s Disease Patients in Belgium, Australia, and Switzerland: An EVOLVE Observational Expansion Study. Accessed April 24, 2023, at: https://beta.clinicaltrials.gov/study/NCT05056441.
Ferrante M, Christensen B, Bressler B, et al. Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naïve Patients with Crohn’s Disease: Results from the Evolve Expansion Study. Presented at the Digestive Disease Week® (DDW) 2023 in Chicago, IL.
M Ferrante, B Christensen, B Bressler, N Brett, M Bassel, P Kamble, S Adsul, L Gianchetti, M Scharl, P636 Real-world clinical effectiveness and safety of vedolizumab and ustekinumab in biologic-naïve patients with Crohn’s disease: Results from the EVOLVE Expansion study, Journal of Crohn’s and Colitis, Volume 17, Issue Supplement_1, February 2023, Pages i768–i769, https://doi.org/10.1093/ecco-jcc/jjac190.0766
Crohn’s and Colitis Canada. About Crohn’s and Colitis. Accessed April 24, at: http://www.crohnsandcolitis.ca/About-Crohn-s-Colitis/What-are-Crohns-and-Colitis.
Media Planet, Digestive Wellness Supplement, Tackling the burden of ulcerative colitis. Accessed, April 24 2023 at: http://www.personalhealthnews.ca/prevention-and-treatment/tackling-the-burden-of-ulcerative-colitis.
Crohn’s and Colitis Canada. 2018 Impact of Inflammatory Bowel Disease in Canada. Accessed April 24, 2023, at: https://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report.
Crohn’s and Colitis Foundation of America, The Facts about Inflammatory Bowel Disease, page 5, accessed March 2019, at: http://www.ccfa.org/assets/pdfs/updatedibdfactbook.pdf
Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, July 2022, p. 4. Available at: https://assets-dam.takeda.com/raw/upload/v1662721781/legacy-dotcom/siteassets/en-ca/home/what-we-do/our-medicines/product monographs/entyvio/ENTYVIO-PM-EN.pdf
Takeda data on file (VV-SUP-116025): Vedolizumab patient exposure from Marketing Experience May 2022.
Original source here.