RWD on safety of vedolizumab in biologic-naïve individuals with ulcerative colitis and Crohn’s disease
Takeda Pharmaceutical Company (Tokyo, Japan) has presented retrospective, real-world data (RWD), in line with current clinical evidence, investigating the safety of vedolizumab in biologic-naïve individuals with moderate to severe ulcerative colitis or Crohn’s disease.
Takeda Pharmaceutical Company (Tokyo, Japan) has presented results from their retrospective, chart review study — entitled EVOLVE — at the United European Gastroenterology Week 2019 (19—23 October, Barcelona, Spain). The real-world study investigated the likelihood of serious adverse events and infections associated with vedolizumab and anti-TNF-α biologic drugs in biologic-naïve patients with moderate to severe ulcerative colitis or Crohn’s disease.
Frequently asked questions:
In EVOLVE, RWD on 1095 ulcerative colitis and Crohn’s disease patients were analyzed to determine the incidence rates of serious adverse events or infections resulting from vedolizumab or anti-TNF-α administration.
598 patients received vedolizumab and 497 were treated with anti-TNFα therapies — including adalimumab, infliximab, golimumab or certolizumab pegol.
Cox proportional hazards models were employed to adjust for patients’ baseline characteristics and allow comparison of adverse event and infection incidence rates between cohorts.
For both patient cohorts — those with ulcerative colitis or Crohn’s disease — the adverse event and infection incidence rates were estimated to be lower amongst vedolizumab-receiving patients compared with anti-TNF-α-treated patients.
Michelle Luo, Head of Global Outcomes Research — Gastroenterology at Takeda, commented: “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.”
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How does vedolizumab work?
Vedolizumab is a gut-selective, monoclonal antibody biologic that targets a specific integrin protein found on white blood cells — cells that are overproduced in patients with ulcerative colitis or Crohn’s disease.
What is ulcerative colitis?
Ulcerative Colitis is one of the two main forms of inflammatory bowel disease; it manifests in inflammation and ulceration of the inner lining of the colon and rectum.