VIDEO: Entyvio post-marketing safety data consistent with previous clinical trials
ORLANDO — Four-year post-marketing data appeared to demonstrate a favorable safety profile of Entyvio in patients with Crohn’s disease and ulcerative colitis that was consistent with what had been established in previous clinical trials, according to study results presented at Advances in IBD 2018.
“The good news for patients and providers with Crohn’s disease and ulcerative colitis is that the 4-year global safety database results from the manufacturer for vedolizumab have been very encouraging with no higher than expected reports of infections, serious infections, neoplasms, or opportunistic infections,” Russell D. Cohen, MD, director of the Inflammatory Bowel Disease Center at University of Chicago Medicine, told Healio Gastroenterology and Liver Disease.
However, Cohen said that there are some limitations to the results and that it is important to notice that the adverse events were voluntarily reported to the manufacturer.
“As a result, this may not exactly reflect real life and it’s more likely that people are going to report more serious events to the manufacturer than mild ones,” he said. “From the clinical trials with this agent, and our knowledge of the mechanism of action, it was not believed that there would be any higher risks of infections or neoplasms or any other particular types of reactions. And we were hoping that the 4-year data would support this contention.”
Cohen RD, et al. Poster 014. Presented at: Advances in Inflammatory Bowel Diseases; Dec. 13-15, 2018; Orlando.
Disclosures: Cohen reports serving as a consultant and investigator for Takeda.