Rare Disease Report

Takeda Releases New Data Proving Effectiveness of Vedolizumab in UC and Crohn's Disease

FEBRUARY 20, 2018
Mathew Shanley
At the 13th Congress of European Crohn’s and Colitis Organization (ECCO) in Vienna, Austria last week, Takeda Pharmaceutical Company Limited released new real-world data evaluating the comparative effectiveness of Entyvio (vedolizumab) and tumor necrosis factor-alpha (TNFα)-antagonist in patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

UC and CD are two of the most common forms of inflammatory bowel disease (IBD). Both are chronic, relapsing, remitting, inflammatory, progressive conditions of the gastrointestinal (GI) tract. Vedolizumab is a gut-selective immunosuppressive biologic and humanized monoclonal antibody that is being developed to specifically antagonize the alpha4beta7 integrin. With this target, the drug is designed to inhibit the binding of alpha4beta7 ingegrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1) and fibronectin, but not vascular cell adhesion molecule 1 (VCAM-1).

By inhibiting alpha4beta7 integrin, vedolizumab has the potential to limit the ability of some white blood cells to permeate gut tissues.

Analyses conducted by the VICTORY (Vedolizumab Health OuTComes in InflammatORY Bowel Diseases) Consortium observed that patients with UC treated with Entyvio compared to TNFα-antagonist therapy had statistically significant higher 12-month cumulative rates of mucosal healing and clinical remission and numerically higher steroid-free clinical remission rates. In CD, results reported statistically significant higher 12-month cumulative rates of mucosal healing and numerically higher rates of clinical remission and steroid-free clinical remission compared to TNFα-antagonist.

The VICTORY Consortium is a collaboration of 12 leading IBD centers from across the U.S. and represents the first large, well-characterized cohort of patients being administered vedolizumab in a real-world setting in the U.S.

"These data from the VICTORY Consortium highlight the effectiveness of Entyvio in achieving mucosal healing and clinical remission in the real-world, and support the use of Entyvio as a first-line biologic therapy," said Professor William Sandborn, M.D., Chief, Division of Gastroenterology, University of California San Diego in a press release. "While additional research is needed to confirm these findings, these are important comparative effectiveness analyses of real-world data involving Entyvio and TNFα-antagonist therapy, which further aid our understanding of biologic therapy in clinical practice."

Entyvio was launched in the U.S. in 2014, and as of the data presentation, more than 1,700 UC and CD patients have been included in the consortium database. 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.

Also presented by Takeda at ECCO were clinical data from the Phase 3b open-label prospective multicenter study (VERSIFY), evaluating the efficacy of Entyvio on complete mucosal healing, endoscopic remission, and endoscopic response.

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