Takeda’s Entyvio outperforms AbbVie’s Humira in GI trial

The results are important to Takeda, as Entyvio (vedolizumab) is the centrepiece of its gastroenterology drug franchise, with sales of around $1.8 billion in the first nine months of the year.

With cheaper biosimilar versions of Humira already available in Europe, and in the US in 2023, it was important for Takeda to put some clear air between Entyvio and its biggest competitor in order to continue to grow or maintain its market share.

The data from the phase 3b head-to-head VARSITY study showed Takeda was superior to Humira in achieving statistically significant clinical remission in patients with moderate to severely active ulcerative colitis at week 52 based on a commonly used score.

Treatment with Entyvio was also associated with higher rates of mucosal healing at week 52 compared with Humira.

However, there was a numerical, non-significant difference in favour of Humira in the percentage of patients using oral corticosteroids at baseline, who went on to stop this therapy by week 52.

The study was not powered to compare safety, but patients treated with Entyvio had numerically lower rates of overall adverse events than patients treated with Humira, with numerically fewer infections and serious adverse events.

This was the first head-to-head trial of biologics in inflammatory bowel disease, and professor Simon Travis, consultant gastroenterologist at Oxford University Hospitals NHS Foundation Trust said the results provided "compelling data" for superiority of Entyvio over Humira in the key goals of clinical remission and mucosal healing.

Travis added: "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."

VARSITY is a phase 3b, randomised, double-blind, double-dummy, multi-centre, active-controlled study to evaluate the efficacy and safety of vedolizumab IV compared to adalimumab SC at week 52 in patients with moderate to severe active ulcerative colitis.

The study randomised 769 patients, to receive Entyvio (383 patients) or Humira (386 patients), all of whom had inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or one TNFα-antagonist other than Humira prior to being enrolled.

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