Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 259

New Exploratory Data from Varsity

Posted by fidest press agency su martedì, 21 maggio 2019

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) 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. 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.
VARSITY is a Phase 3b, randomized, double-blind, double-dummy, multi-center, active-controlled study to evaluate the efficacy and safety of vedolizumab intravenous (IV) compared to adalimumab subcutaneous (SC) at week 52 in patients with moderately to severely active ulcerative colitis. The study randomized 769 patients (vedolizumab n=383 or adalimumab n=386), all of whom had inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or one tumor necrosis factor-alpha (TNFα)-antagonist other than adalimumab prior to being enrolled. Patients were randomized into one of two treatment groups, vedolizumab IV 300 mg and placebo SC or adalimumab SC 160 mg and placebo IV. Dose escalation was not permitted in either treatment arm during the study.

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