New analyses support the effectiveness and safety of Entyvio (vedolizumab)

Takeda Pharmaceutical Company Limited, ("Takeda") announced the presentation of eight real-world analyses supporting the effectiveness and safety of Entyvio (vedolizumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). The data were presented at the 2017 Digestive Disease Week (DDW) annual scientific meeting in Chicago, Illinois. Two analyses of real-world data from the U.S. VICTORY (Vedolizumab for Health OuTComes in InflammatORY Bowel Diseases) consortium support findings from the pivotal GEMINI clinical trial program demonstrating the efficacy of Entyvio.

A cohort analysis (abstract #1853) from the VICTORY consortium concerning predictors of clinical and endoscopic response examined mucosal healing, clinical response and remission and steroid-free response and remission in 180 patients with moderately to severely active UC treated with vedolizumab. Clinical response and remission were based on the physician global assessment score, a 5- or 6-point scoring system used to assess disease severity. In this large, multi-center cohort, a substantial proportion of patients achieved either mucosal healing defined as a Mayo endoscopic subscore of 0 or 1 (77 percent), clinical remission (51 percent) or steroid-free remission (41 percent) 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," said Parambir Dulai, M.D., Research Fellow, University of California San Diego, and Lead Investigator of the VICTORY consortium analyses.

An additional analysis (abstract #1785) from the VICTORY consortium examined the rates and predictors of progression to surgery and the proportion of patients with inflammatory bowel disease (IBD) requiring surgery 6 or 12 months after vedolizumab induction in 742 patients (UC=306, CD=436). Investigators observed trends toward a decline in surgical rates over time depending on when vedolizumab was initiated over a two year period. The reasons for these observations are unknown, and further prospective studies are required to characterize these findings.

"Real-world evidence plays an important role in helping healthcare 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," said Professor William Sandborn, M.D., Chief, Division of Gastroenterology, University of California San Diego.

The VICTORY consortium is a collaboration of 10 leading IBD centers from across the U.S. and represents the first large, well-characterized cohort of patients taking Entyvio in a real-world setting in the U.S. Patients included in the consortium were identified at each site through electronic medical record searches, review of clinical records, and/or queries of infusion center records. Approximately 900 UC and CD patients are now included in the consortium database, which was started when Entyvio was launched in the U.S. in 2014.