First head-to-head biologic study in ulcerative colitis

Takeda announced further results from the VARSITY study, published in The New England Journal of Medicine, highlighting the benefit of its biologic for ulcerative colitis therapy vs the competitor.

The VARSITY study demonstrated the superiority of the gut-selective biologic vedolizumab (Entyvio) to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira) in achieving the primary endpoint of clinical remission at week 52 in patients with moderately to severely active ulcerative colitis (UC). Clinical remission rates at week 52 were superior with vedolizumab at 31.3% (n=120/383) versus 22.5% (n=87/386) with adalimumab (p=0.006).

In the secondary endpoints of the study, treatment with vedolizumab was associated with significantly higher percentages of mucosal healing at week 52 compared to patients treated with adalimumab (39.7% [n=152/383] vs. 27.7% [n=107/386]; p<0.001). Vedolizumab was not superior to adalimumab in the percentage of patients using oral corticosteroids at baseline who discontinued corticosteroids and were in clinical remission at week 52 (12.6% [n=14/111] vs. 21.8% [n=26/119]).

“In a chronic, debilitating condition like ulcerative colitis, it is essential that patients gain relief from the many different aspects of the disease,” said Dr. Bruce E. Sands, primary investigator of the VARSITY study and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at The Mount Sinai Hospital and the Icahn School of Medicine at Mount Sinai in New York. “The VARSITY results provide physicians with valuable insights to support their treatment decisions when initiating biologic therapy in patients with ulcerative colitis.”

“The VARSITY study, a first-of-its-kind comparison of two biologics in ulcerative colitis, shows the benefits vedolizumab treatment provides to patients versus adalimumab across efficacy outcomes, in addition to improvements in overall quality of life,” said Jeff Bornstein, M.D., Executive Medical Director, Takeda. “These data further support the use of vedolizumab as a first-line biologic therapy in ulcerative colitis.”

While the study was not powered to compare the safety of the two biologics, patients treated with vedolizumab (62.7%; n=240/383) had a lower percentage of overall adverse events over 52 weeks than patients treated with adalimumab (69.2%; n=267/386). The percentage of serious adverse events was also lower in vedolizumab-treated patients than adalimumab (11.0% [n=42/383] vs. 13.7% [n=53/386] respectively). The proportion of patients who discontinued treatment because of adverse events was similar in both groups.

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