Entyvio (vedolizumab) is safe and effective to treat adults with moderate-to-severe active ulcerative colitis (UC) and Crohn’s disease (CD).
Two analyses conducted by the U.S. VICTORY (Vedolizumab for Health OuTComes in InflammatORY Bowel Diseases) consortium, a partnership of 10 leading IBD centers from across the U.S.. support the efficacy of Entyvio. The consortium now includes in its database information from about 900 UC and CD patients taking Entyvio in a real-world setting in the U.S.
The efficacy of Entyvio is supported by findings from the pivotal GEMINI clinical trial program. Data from GEMINI Phase 3 trial, which started in May 2009 and is expected to be complete in July 2017, indicate that patients responding to long-term treatment with Entyvio exhibited clinical response and remission. Patients also improved their health-related quality of life. The study enrolled 146 patients with CD and 154 patients with UC who were part of the GEMINI II (NCT00783692) and GEMINI I (NCT00783718) studies. Also part of the program is the GEMINI III (NCT01224171) study, which enrolled about 416 patients with moderate-to-severe CD.
One of the analyses presented during the Digestive Disease Week meeting examined clinical response and remission, and steroid-free response and remission, in 180 patients with moderate-to-severe active UC treated with Entyvio. These outcomes were assessed on a five- or six-disease severity point scale and measured by doctors. The results showed that more patients had either mucosal healing as assessed by a Mayo score of zero or one (77%), clinical remission (51%) or steroid-free remission (41%) by 12 months in routine clinical practice. The Mayo score evaluates ulcerative colitis stage, based solely on endoscopic exploration.
“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, MD, research fellow, University of California San Diego, in a press release. Dulai is lead investigator of the VICTORY consortium analyses.
A second analysis looked at the rates and predictors of progression to surgery and the number of patients with inflammatory bowel disease (IBD) who needed to undergo surgery after six or 12 months of starting treatment with Entyvio. These parametres were examined in 742 patients, of which 306 had UC, and 436 had CD.
The researchers found that when patients began treatment with Entyvio over a two-year period, there was a decrease in the need for patients to undergo surgery.
“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 William Sandborn, MD, chief, Division of Gastroenterology, University of California San Diego.
During the conference, Takeda also was behind some studies regarding the safety and effecriveness of Entyvio. More information about the presentations can be found by visiting the conference full schedule. www.ddw.org/attendee-planning/online-planner.
Entyvio was approved by the U.S. Food and Drug Administration in 2014 for adults with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC).