05/19/2019 | Press release | Distributed by Public on 05/19/2019 21:02
Takeda Pharmaceutical Company Limited (NYSE: TAK) today announced further results from the Phase 3b head-to-head VARSITY study, which demonstrated that the gut-selective biologic vedolizumab (Entyvio®) was superior to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira®) in achieving clinical remission* at week 52 in patients with moderately to severely active ulcerative colitis (UC).1 New exploratory data showed that a greater proportion of patients receiving vedolizumab intravenous (IV) achieved clinical response** at week 14 compared to those treated with adalimumab subcutaneous (SC), 67.1% vs. 45.9% respectively. A separation between the treatment groups was seen as early as week 6, favoring vedolizumab. These results were announced in a Distinguished Abstract Plenary Lecture Presentation at the 2019 Digestive Disease Week® (DDW) annual scientific meeting (May 18-21 in San Diego, CA), one of 18 Takeda sponsored vedolizumab abstracts accepted for presentation.2
Additional exploratory data on absence of active histologic disease were also presented at the meeting. Histologic disease activity is an endpoint assessing the degree of microscopic inflammation in the gut. Absence of active histologic disease is achieved when inflammation is less than a pre-defined severity threshold.2,3,4*** In the VARSITY study, consistent results were seen with vedolizumab treatment across both the Geboes Score (<3.2) and Robarts Histopathology Index (<5), with absence of active histologic disease achieved in 33.4% and 42.3% of patients treated with vedolizumab, respectively, compared with 13.7% and 25.6% of patients treated with adalimumab, respectively.2
'Exploratory data from the VARSITY study suggest that more patients experienced early symptomatic response and improvement of microscopic intestinal inflammation with vedolizumab as compared to adalimumab,' said Dr. Bruce E. Sands, primary investigator of the VARSITY study and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Mount Sinai Hospital and the Icahn School of Medicine at Mount Sinai in New York. 'In clinical practice there is a need to balance early symptomatic improvement alongside the longer-term treatment goal of helping patients to achieve clinical remission, making these findings important to physicians.'
'Patients benefit from clinical trials that advance our understanding of the disease. The VARSITY study, a first-of-its-kind comparison of two biologics in ulcerative colitis, provides valuable information that can help inform treatment decisions, while also increasing our understanding of how these treatments are working at a microscopic level,' said Jeff Bornstein, M.D., Executive Medical Director, Takeda. 'Data from the VARSITY study show consistent results for vedolizumab, supporting the use of this treatment as a first-line biologic therapy in ulcerative colitis.'