In the Phase III VARSITY trial, Entyvio (vedolizumab) was found to be superior to Humira (adalimumab) in achieving statistically significant clinical remission at week 52 in patients with moderately to severely active ulcerative colitis.

According to the data, 31.3% of patients receiving intravenous (IV) vedolizumab achieved the primary endpoint of clinical remission compared to 22.5% of those treated with subcutaneous (SC) adalimumab at week 52.

Treatment with vedolizumab was also linked with significantly higher rates of mucosal healing compared to patients treated with adalimumab (39.7% vs 27.7%), though a "non-significant difference in favour of adalimumab" was observed in the percentage of patients using oral corticosteroids at baseline who discontinued corticosteroids and were in clinical remission at week 52, Takeda noted.

The study was not powered to compare safety, but showed that, over the 52 treatment period, patients given vedolizumab had numerically lower rates of overall adverse events (62.7%) than patients treated with adalimumab (69.2%), infections (33.5% versus 43.5%, respectively) and serious adverse events (11.0% versus 13.7%, respectively).

"As the first biologic head-to-head trial in inflammatory bowel disease, VARSITY provides compelling data for the superiority of vedolizumab (Entyvio, an anti-integrin) in achieving clinical remission and mucosal healing over adalimumab, an anti-TNF therapy, in ulcerative colitis," said Professor Simon Travis, consultant gastroenterologist at Oxford University Hospitals NHS Foundation Trust.

"The goals of treatment for ulcerative colitis are to achieve clinical remission and mucosal healing. This landmark study raises the question of the optimal biologic for first-line therapy in patients with moderate to severely active ulcerative colitis and will challenge current practice.

"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," added Jeff Bornstein, executive medical director, Takeda.

"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."