Takeda Pharmaceuticals issued the following announcement on Feb. 6.
Takeda Pharmaceuticals, U.S.A., Inc. ("Takeda") announced the publication of a study utilizing a novel simulation model to predict treatment response in patients with moderately to severely active ulcerative colitis (UC) and help better understand optimal treatment positioning. The study, titled "Assessing the Optimal Position for Vedolizumab in the Treatment of Ulcerative Colitis: A Simulation Model," was published on January 18, 2018 in Inflammatory Bowel Diseases.
Over the last two decades there have been significant advances in the medical management of UC with the development of multiple therapeutic options. As more options become available uncertainty has developed regarding where each should be incorporated into a complex treatment paradigm. There are currently limited data comparing treatment algorithms incorporating sequential therapies. For this study researchers employed state-of-the-art simulation modeling to compare multiple treatment scenarios using the evidence currently available. Scenarios evaluated included the use of Entyvio® (vedolizumab) as a first-line biologic therapy for a steroid-dependent patient with moderately to severely active UC.
"In the absence of clinical trials comparing treatment algorithms for ulcerative colitis, analyses like this simulation provide tools for helping the clinical community determine the best ways to incorporate specific therapies into practice," said Frank I. Scott, M.D., MSCE, Assistant Professor of Medicine, University of Colorado School of Medicine. "The resulting data help provide valuable insights for healthcare providers evaluating the sequence of therapies for certain patients with ulcerative colitis early in the treatment algorithm."
"Takeda is committed to supporting the GI community by developing innovative disease management tools that aim to help inform patient treatment," said Karen Lasch, M.D., Medical Head, GI Specialty, U.S. Medical Office, Takeda. "The innovative modeling used in this study provides valuable information that can help healthcare professionals make informed treatment decisions when evaluating the increasingly complex treatment paradigm for ulcerative colitis."
Using a Markov model designed to simulate real-world situations based on previous clinical trial data, investigators assessed the optimal positioning for initiating Entyvio therapy based on the case of a 35-year-old male with moderately to severely active UC who was dependent on steroids and had not previously received immunomodulators or biologic therapy. The model compared four treatment scenarios over the course of one year, incorporating Entyvio in different positions within a typical step-up therapy treatment paradigm for patients dependent on steroids: prior to initiating azathioprine, prior to combination therapy with infliximab and azathioprine, prior to combination therapy with adalimumab and azathioprine, and as last-line therapy after combination therapy with adalimumab prior to a colectomy. Primary analyses included simulating 100 trials of 100,000 patients with outcomes assessed in terms of quality-adjusted life years.
The authors concluded that the results of the model simulation support the use of Entyvio as an initial steroid-sparing biologic therapy in steroid-dependent patients with UC. Clinical trials are needed to directly compare sequential treatment algorithms. Complete results from the study can be found on the publication website here: https://academic.oup.com/ibdjournal/article/24/2/286/4816945.
Vedolizumab is approved as a humanized monoclonal antibody and is available in the United States (U.S.) under the trade name Entyvio® (vedolizumab). It is the first and only biologic therapy to be approved in the U.S. simultaneously for the treatment of adults with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha antagonist.
Original source can be found here.
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