Real-World Data Support Safety, Efficacy of Vedolizumab for Inflammatory Bowel Diseases

Eight real world analyses presented at the 2017 Digestive Disease Week annual scientific meeting further support the safety and efficacy of vedolizumab (Entyvio) for the treatment of adults with moderate-to-severe ulcerative colitis (UC) and Crohn’s disease.

Additionally, 2 analyses of real-world data from the US VICTORY consortium support findings from the pivotal GEMINI clinical trial that demonstrated the efficacy of vedolizumab, according to a press release.

Vedolizumab is designed to bind to the alpha4beta7 integrin to prevent the white blood cells from entering the inflamed gut tissue, resulting in decreased inflammation.

In a cohort analysis from the VICTORY consortium, investigators examined mucosal healing, clinical response and remission, and steroid-free response and remission in 180 patients with moderate-to-severe UC who were treated with vedolizumab.

The results of the large, multi-center cohort showed that 77% of patients achieved mucosal healing, 51% achieved clinical remission, and 41% achieved steroid-free remission by 12 months in routine practice.

“The real-world evidence from the VICTORY consortium supports the data observed in the pivotal GEMINI clinical trial program, further demonstrating the effectiveness of vedolizumab,” Parambir Dulai, MD, research fellow, University of California San Diego, and lead investigator of the VICTORY consortium analyses, said in a release.

In a different analysis from the VICTORY consortium, investigators examined the rates and predictors of progression to surgery, as well as the number of patients with inflammatory bowel disease (IBD) who required surgery 6 or 12 months after induction of vedolizumab in 742 patients.

The results of the analysis showed that over time, there was a decline in surgical rates dependent on when vedolizumab was initiated over a 2-year period.

“Real-world evidence plays an important role in helping health care providers evaluate a therapy’s effectiveness and safety in routine medical practice against clinical trial results, and the VICTORY consortium provides valuable clinical knowledge for the IBD community,” Professor William Sandborn, MD, chief, Division of Gastroenterology, University of California San Diego, said in a release.

The VICTORY consortium is the first large, well-characterized cohort of patients receiving vedolizumab in a real-world setting.