Additional Interim Data Supporting Long-Term Use of Vedolizumab in Patients with Ulcerative Colitis and Crohn's Disease Published in Journal of Crohn's and Colitis

Interim analyses shows clinical benefits with long-term vedolizumab treatment regardless of prior tumor necrosis factor (TNF)  antagonist exposure

OSAKA, Japan, Sept. 28, 2016 /PRNewswire/ -- Takeda Pharmaceutical Company Limited [TSE: 4502], ("Takeda") announced that two interim reports from the ongoing, open-label GEMINI long-term safety (LTS) study describing clinical data of long-term Entyvio (vedolizumab) treatment in patients with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD) have been published in the Journal of Crohn's & Colitis.

The data showed that patients with moderately to severely active UC experienced clinical and health-related quality of life (HRQL) improvements with continued vedolizumab treatment. For patients with moderately to severely active CD, the clinical benefits of vedolizumab continued with long-term treatment regardless of prior TNF antagonist exposure. UC and CD patients that entered the study after discontinuing prior eight-weekly maintenance dosing due to loss of clinical response, in GEMINI I and II respectively, could experience a beneficial effect with increasing dosing frequency to every four weeks.

GEMINI LTS is an ongoing, single-arm, open-label phase 3 extension study, with a primary objective of evaluating the safety profile of long-term vedolizumab treatment. Enrolled patients included those who completed or withdrew early from the double-blind, randomized, placebo-controlled phase 3 studies GEMINI I and II. The interim reports published today in the Journal of Crohn's & Colitis represent efficacy data collected from May 22, 2009 to June 27, 2013. Outcomes of clinical response, remission and HRQL were assessed for up to 152 weeks of treatment in the efficacy population.

"Given that ulcerative colitis and Crohn's are chronic diseases, it is imperative we evaluate a treatment's efficacy and safety over the long-term to assess its continued benefit for patients," Edward V. Loftus, MD, Professor of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. "These latest findings, reflecting continuous use of vedolizumab for up to three years, are encouraging and provide additional information about the potential benefit for vedolizumab as a long-term treatment option for people with ulcerative colitis and Crohn's disease."