Takeda has announced results from Phase IIIb head-to-head study of two biologic therapies, Entyvio (vedolizumab) and adalimumab, the generic of AbbVie’s Humira, in which Entyvio achieved statistically significant clinical remission in patients with moderately to severely active ulcerative colitis at week 52.
Results from the Varsity study showed that 31.3% of patients receiving intravenous Entyvio achieved the primary endpoint of clinical remission, compared to 22.5% receiving subcutaneous adalimumab.
Entyvio was associated with significantly higher rates of mucosal healing at week 52, as well as lower rates of adverse events, compared to adalimumab.
Takeda executive medical director Jeff Bornstein said: “As the first prospective 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.
“This is an exciting time in the landscape of ulcerative colitis treatment, as head to-head clinical data has not previously been available to guide treatment decisions around biologic therapies.”
The results were announced over the weekend at the 14th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Copenhagen, Denmark.
Entyvio is a humanised monoclonal antibody designed to specifically antagonise the alpha4beta7 integrin. This integrin is expressed on circulating white blood cells shown to play a role in ulcerative colitis and Crohn’s disease, and so by inhibiting the integrin, Entyvio may limit the ability of these white blood cells to infiltrate gut tissues.
The drug has already been approved for patients with moderate to severe ulcerative colitis and Crohn’s Disease who have had an inadequate response, a decline in response or were intolerant to conventional therapy of a tumour necrosis factor-alpha antagonist, such as adalimumab.
AbbVie’s European patent for Humira expired in October 2018, leading to several biosimilars being launched by various global pharmaceutical companies.
Some companies signed licensing agreements with AbbVie to sell Humira biosimilars at various points in 2023 in the US in exchange for royalties.