On Saturday, Takeda released data from its Phase IIIb head-to-head study that showed Entyvio, a gut-selective biologic, was superior to the anti-tumor necrosis factor-alpha (anti-TNFα) Humira in achieving clinical remission in patients with moderately to severely active ulcerative colitis after 52 weeks. Takeda said data from the VARSITY trial showed 31.3 percent of patients who received Entyvio intravenously achieved the primary endpoint of clinical remission compared to 22.5 percent of Humira patients after 52 weeks. Takeda said the difference between the two outcomes was statistically significant.
Bruce Sands, the primary investigator of the VARSITY study and head of gastroenterology at Mount Sinai Hospital in New York, said the results of the study addresses “critical questions concerning the selection of biologic therapy in ulcerative colitis.” The goal of treating the disorder is to achieve clinical remission and mucosal healing. The results show that Takeda’s Entyvio is the medication better suited for that goal, he said.
In addition to besting Humira in the study, Takeda said data showed treatment with Entyvio was associated with significantly higher rates of mucosal healing after one year of treatment. At 52 weeks, 39.7 percent of patients who received Entyvio achieved mucosal healing compared to 27.7 percent treated with Humira. Takeda did note that a non-statistically significant difference in favor of Humira was seen in the percentage of patients using oral corticosteroids at baseline who discontinued corticosteroids and were in clinical remission at week 52. The results were announced as an oral presentation at the 14th Congress of the European Crohn’s and Colitis Organization in Denmark.
The VARSITY study was not designed to compare safety between the two blockbuster treatments, but Takeda said patients on Entyvio reported slightly lower adverse events than those treated with Humira, 62.7 percent compared to 69.2 percent respectively. There was also a lower rate of infections in favor of Entyvio, 33.5 percent compared to 43.5 percent.
Jeff Bornstein, executive medical director of Takeda, said the VARSITY study is the first to directly compare the efficacy and safety of two commonly used biologic therapies in patients with ulcerative colitis. UC is a chronic, relapsing, remitting, inflammatory condition of the gastrointestinal tract that is often progressive in nature. Ulcerative colitis commonly presents with symptoms of abdominal discomfort and loose bowel movements, including blood or pus. The VARSITY study is the first to provide “invaluable knowledge to help inform physicians’ treatment decisions when initiating biologic therapy,” Bornstein said in a statement.
“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 (Entyvio) and the anti-TNFα adalimumab (Humira). 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,” he said.
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