Takeda reports further results from VARSITY ulcerative colitis study

27th September 2019 (Last Updated December 23rd, 2019 08:26)

Takeda Pharmaceutical has reported further results from the VARSITY study, which indicated the gut-selective biologic vedolizumab (Entyvio) being superior to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira) for ulcerative colitis.

Takeda reports further results from VARSITY ulcerative colitis study
Chronic inactive ulcerative colitis in a resection specimen. Credit: CoRus13.

Takeda Pharmaceutical has reported further results from the VARSITY study, which indicated the gut-selective biologic vedolizumab (Entyvio) being superior to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira) for ulcerative colitis.

In patients suffering with moderately to severely active ulcerative colitis (UC), clinical remission rates at week 52 were found to be superior with vedolizumab at 31.3% as against 22.5% with adalimumab.

VARSITY, which had treated 769 patients, is a Phase 3b randomised, double-blind, double-dummy, multi-centre trial. It is evaluating the efficacy and safety of vedolizumab intravenous (IV) compared with adalimumab subcutaneous (SC) at week 52.

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

Furthermore, as the secondary endpoints of the study, patients treated with vedolizumab have shown higher percentages of mucosal healing at week 52 compared to those treated with adalimumab.

However, vedolizumab was not found to be superior to adalimumab in the percentage of patients using oral corticosteroids at baseline. Therefore, these patients discontinued corticosteroids and were in clinical remission at week 52.

The exploratory results for the median change in oral corticosteroid use from baseline to week 52 were -10.0 mg in the vedolizumab group as against -7.0 mg in the adalimumab group.

An exploratory analysis was also carried out to understand the impact of vedolizumab and adalimumab therapy on clinical response and absence of active histologic disease.

The exploratory analysis indicated that 67.1% of patients receiving vedolizumab achieved clinical response at week 14 as against 45.9% of patients treated with adalimumab.

Absence of active histologic disease, as defined by the Geboes Score and Robarts Histopathology Index, was achieved at week 52 in 33.4% and 42.3% of patients treated with vedolizumab respectively, as against 13.7% and 25.6% of patients treated with adalimumab respectively.

Takeda executive medical director Jeff Bornstein said: “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. These data further support the use of vedolizumab as a first-line biologic therapy in ulcerative colitis.”