Retrospective Real-World Comparative Analysis Highlights Safety of Vedolizumab and Anti-TNFα Therapies in Biologic-Naïve Patients with Ulcerative Colitis or Crohn’s Disease
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced results from a retrospective chart review study (EVOLVE), which investigated the likelihood of serious adverse events and serious infections with vedolizumab and anti-tumor necrosis factor-alpha (anti-TNFα) therapies in biologic-naïve patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD) in real-world clinical practice. These data were announced in an oral presentation at UEG Week 2019, held in Barcelona, Spain.
Data from over 1,000 biologic-naïve patients with UC or CD receiving vedolizumab or an anti-TNFα therapy (adalimumab, infliximab, golimumab, or certolizumab pegol) were collected, with the incidence rate (per 100 person-years) for serious adverse events and serious infections estimated per cohort. The incidence rates for the first occurrence of a serious adverse event (vedolizumab: 4.6 [3.5-6.8]; anti-TNFα: 10.3 [9.5-14.9]) and serious infections (vedolizumab: 1.4 [0.8-2.5]; anti-TNFα: 2.6 [1.7-4.3]) were estimated to be lower with vedolizumab treatment.1 Also, gastrointestinal infections were estimated to be lower in vedolizumab-treated vs. anti-TNFα-treated patients (1.1% vs. 4.3%, respectively, p<0.01).1 Similar trends were observed when results were segmented by UC and CD.1*
“While retrospective chart reviews have limitations and are not conclusive, real-world evidence can enhance our understanding of the performance of treatments in clinical practice, providing valuable information to assist physicians in the selection of appropriate therapy for patients. Sharing the latest real-world evidence, such as the EVOLVE study, with scientific and clinical communities, forms an integral part of Takeda’s ongoing commitment towards improving patient care,” said Michelle Luo, PhD, Head of Global Outcomes Research-Gastroenterology, Takeda.
The EVOLVE study is one of nine Takeda vedolizumab abstracts accepted for presentation at the annual UEG Week congress, with new data being presented from clinical studies that assess the efficacy and safety of vedolizumab, as well as new evaluations to understand the role of clinical decision support tools in the management of inflammatory bowel disease.
* Data revised following abstract acceptance
About the EVOLVE Study
The EVOLVE study was a retrospective chart review of real-world data in biologic-naïve patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD) treated with vedolizumab or anti-tumor necrosis factor-alpha (anti-TNFα) therapies. Patients had initiated treatment with vedolizumab or anti-TNFα therapies (adalimumab, infliximab, golimumab, or certolizumab pegol) between May 2014 and March 2018 and were followed for ≥six months. Evidence was collected from 1,095 biologic-naïve patients from 42 sites in Canada, Greece and the United States; 598 were treated with vedolizumab (UC=380; CD=218), and 497 were treated with anti-TNFα therapies (UC=224; CD=273).1 A Cox proportional hazards model adjusted for baseline patient characteristics was used to compare incidence rates between treatment cohorts.2