Takeda reports positive Phase IIIb results for vedolizumab

11th March 2019 (Last Updated March 11th, 2019 00:00)

Takeda Pharmaceutical has reported positive results from the Phase IIIb head-to-head VARSITY clinical trial of gut-selective biologic vedolizumab (Entyvio) for the treatment of moderately to severely active ulcerative colitis (UC).

Takeda reports positive Phase IIIb results for vedolizumab
Vedolizumab IV is approved for adults with moderately to severely active ulcerative colitis and Crohn’s disease. Credit: RicHard-59.

Takeda Pharmaceutical has reported positive results from the Phase IIIb head-to-head VARSITY clinical trial of gut-selective biologic vedolizumab (Entyvio) for the treatment of moderately to severely active ulcerative colitis (UC).

Data showed statistically significant rates of clinical remission with vedolizumab, compared to subcutaneous (SC) adalimumab (Humira), at week 52.

In addition, 39.7% of the patients treated with vedolizumab experienced mucosal healing, compared to 27.7% treated with adalimumab.

Vedolizumab is a humanised monoclonal antibody that specifically targets alpha4beta7 integrin and inhibits its binding to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).

The alpha4beta7 integrin is found on a subset of circulating white blood cells, which are known to be involved in mediating the inflammatory process in UC and Crohn’s disease (CD).

"VARSITY provides invaluable knowledge to help inform physicians’ treatment decisions when initiating biologic therapy."

Vedolizumab’s inhibition of alpha4beta7 integrin is expected to prevent certain white blood cells from infiltrating gut tissues.

The intravenous (IV) formulation of the drug is approved for adults with moderately to severely active UC and CD, who experienced an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

The randomised, double-blind, double-dummy, multi-centre, active-controlled VARSITY trial is designed to assess the safety and efficacy of vedolizumab IV compared to adalimumab SC at week 52 in 769 patients with moderately to severely active UC.

Participants in the vedolizumab arm had a lower rate of overall adverse events and serious adverse events over 52 weeks than those treated with adalimumab.

Takeda Pharmaceutical executive medical director Jeff Bornstein said: “As the first clinical study to directly compare the efficacy and safety of two commonly used biologic therapies in patients with ulcerative colitis, VARSITY provides invaluable knowledge to help inform physicians’ treatment decisions when initiating biologic therapy.

“This is also the first time we have seen a direct comparison between two medicines with distinct modes of action in ulcerative colitis, the gut-selective anti-alpha4beta7 integrin vedolizumab and the anti-TNFα adalimumab.”

Vedolizumab IV has marketing authorisation in more than 60 countries, including the US.