Takeda’s key growth product Entyvio has outperformed AbbVie’s Humira in a trial in ulcerative colitis (UC), said to be the first head-to-head comparison of biologic drugs for the condition.
The VARSITY study pitted anti-integrin antibody Entyvio (vedolizumab) against Humira (adalimumab) – an anti-TNF drug and the biggest-selling medicine in the world – in patients at the more severe end of the UC spectrum and will “challenge current practice,” according to one of its investigators.
After a year, 31.3% of patients treated with intravenous Entyvio, given every two months after a lead-in period, were in remission from the inflammatory bowel disease. That compared to 22.5% of the arm who received Humira every other week, according to the results, which were resented over the weekend at the European Crohn’s and Colitis Organisation (ECCO) conference in Copenhagen, Denmark.
Treatment with Entyvio also achieved higher rates of mucosal healing after a year than Humira, at 39.7% versus 27.7%, respectively, and there was a trend towards reduced use of corticosteroids among patients on Takeda’s drug.
“The goals of treatment for ulcerative colitis are to achieve clinical remission and mucosal healing,” said Prof Simon Travis, consultant gastroenterologist at Oxford University Hospitals NHS Foundation Trust. “This landmark study raises the question of the optimal biologic for first-line therapy in patients with moderate to severely active ulcerative colitis.”
Entyvio is an important growth product for Takeda as it is bearing the brunt of losing patent protection in the US for its big-selling multiple myeloma drug Velcade (bortezomib). Sales of Entyvio for UC and Crohn’s disease rose around a third to $550m in its fiscal third quarter, offsetting an 11% Velcade decline with the help of follow-up myeloma drug Ninlaro (ixazomib) which grew 35%.
Takeda’s patent cliff and a weak near-term pipeline were the main drivers for its $63bn takeover of Shire, which completed in January, but the company also needs its home-grown drugs to deliver sales growth, particularly as it integrates the two businesses.
“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,” said Takeda’s medical director Jeff Bornstein.
“This is also the first time we have seen a direct comparison between two medicines with distinct modes of action in ulcerative colitis.”
Takeda is also developing a subcutaneous formulation of Entyvio that has reached phase 3 and like Humira could be given every two weeks, and is also testing the drug in new indications such as graft-versus-host disease (GVHD).