Takeda's Entyvio Superior to Humira in Ulcerative Colitis

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Japan’s Takeda Pharmaceutical presented more data from its Phase IIIb head-to-head VARSITY clinical trial of Entyvio compared to AbbVies Humira in ulcerative colitis. The results show that Entyvio is superior to Humira in treating the disease.

The study evaluated Entyvio (vedolizumab) compared to Humira (adalimumab) in patients with moderately to severely active ulcerative colitis (UC). In March, the VARSITY trial showed that Entyvio was superior to Humira in achieving clinical remission at week 52. The new exploratory data indicated that a larger proportion of patients receiving Entyvio had a clinical response at week 14 compared to those receiving Humira, 67.1% compared to 45.9%, respectively. The differences between the treatment groups were observed as early as week six, favoring Entyvio.

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The company presented the data in a Distinguished Abstract Plenary Lecture Presentation at the 2019 Digestive Disease Week (DDW) annual scientific meeting held in San Diego.

Entyvio is a gut-selective biologic approved as an intravenous (IV) formulation. A humanized monoclonal antibody, it is engineered to antagonize the alpha4beta7 integrin, which inhibits the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1).

Entyvio was approved by the U.S. Food and Drug Administration (FDA) in May 2014. It has been approved for adult ulcerative colitis and adult Crohn’s disease.

The company also presented additional exploratory data on the absence of active histologic disease. Histologic disease activity was an endpoint that evaluated the amount of microscopic gut inflammation. This occurs when inflammation is lower than a pre-defined severity threshold.

In the VARSITY trial, consistent data was observed with Entyvio with both the Geboes Score and Robarts Histopathology Index.

“Exploratory data from the VARSITY study suggests that more patients experienced early symptomatic response and improvement of microscopic intestinal inflammation with vedolizumab as compared to adalimumab,” stated Bruce E. Sands, primary investigator of the VARSITY study and chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Icahn School of Medicine at Mount Sinai in New York. “In clinical practice there is a need to balance early symptomatic improvement alongside the longer-term treatment goal of helping patients to achieve clinical remission, making these findings important to physicians.”

VARSITY is a Phase IIIb, randomized, double-blind, multi-center, active-controlled trial. It is designed to evaluate the efficacy and safety of the intravenous formulation of Entyvio compared to the subcutaneous (SC) dosing of Humira at 52 weeks in patients with moderately to severely active ulcerative colitis. The trial randomized 769 patients, with 383 receiving Entyvio and 386 receiving Humira. All of the patients previously had inadequate response or loss of response or intolerance to corticosteroids, immunomodulators or one tumor necrosis factor-alpha-antagonist other than Humira before being enrolled.

Patients received Entyvio IV 300 mg and placebo SC or Humira SC 160 mg and placebo IV.

At week 52, 31.3% of patients receiving the IV Entyvio hit the primary endpoint of clinical remission compared to 22.5% in patients receiving Humira SC. Also, 39.7% of patients receiving Entyvio hit the secondary endpoint of mucosal healing at week 52 compared to 2.7% of the Humira group.

The FDA is currently evaluating Takeda’s application for Entyvio’s subcutaneous formulation.

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