Takeda Presents New Interim Phase 3 Maintenance Data that Support the Long-Term Efficacy of Vedolizumab in Patients with Ulcerative Colitis and Crohn's Disease

-- Interim Data Presented at United European Gastroenterology Week Annual Meeting also Highlights Dosing Frequency and Safety of Vedolizumab

ZURICH, Oct. 2, 2014 /PRNewswire/ -- Takeda Pharmaceuticals International GmbH ("Takeda") today announced that new data from GEMINI LTS (Long-Term Safety), a Phase 3, ongoing, open-label extension study of Entyvio^® (vedolizumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) will be presented as oral presentations during the 21^st United European Gastroenterology Week (UEGW) in Vienna, Austria.

Two of the abstracts demonstrate that the efficacy observed in vedolizumab Phase 3 induction and maintenance trials of 52 weeks was maintained over the course of an additional 52 weeks of open label follow up. 

Patients who completed or withdrew early from the double-blind, randomized, placebo-controlled maintenance studies GEMINI 1 and 2 were eligible to enroll in GEMINI LTS. Patients included in the Efficacy Population (GEMINI completers) received vedolizumab 300 mg IV doses every four weeks (Q4W).* Of the UC patients who completed GEMINI 1 and enrolled in GEMINI LTS, 66 percent were in clinical remission at week 52 and 73 percent were in clinical remission at week 104. In addition, 79 percent had clinical response at week 52 and 80 percent had clinical response at week 104.

Of the CD patients who completed GEMINI 2 and enrolled in GEMINI LTS, 57 percent were in clinical remission at week 52 and 61 percent were in clinical remission at week 104. In addition, 81 percent had clinical response at week 52 and 74 percent had clinical response at week 104. Although open-label, these data add to the evidence bank of vedolizumab, supporting the positive findings of the pivotal Phase 3 GEMINI 1 and 2 studies, which assessed the efficacy and safety of adult patients with moderately to severely active UC and CD, respectively, over 52 weeks.

"Ulcerative colitis and Crohn's disease are chronic diseases that can have a serious impact on patients. As physicians, our aim is to help patients achieve and maintain disease remission," said Prof. Dr. Severine Vermeire, University Hospitals Leuven, Belgium. "Current findings from the long-term extension study add to the evidence bank of vedolizumab as a long-term treatment option for people with ulcerative colitis and Crohn's disease."

Vedolizumab is a gut-selective humanized monoclonal antibody that has recently been made available in the United States and the European Union, and has also received approval in Australia, under the trade name Entyvio^® (vedolizumab). It is the first and only biologic therapy to be approved in the European Union 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.   

A third oral presentation presents data from patients who enrolled in GEMINI 1 and 2 and were randomized to vedolizumab 300 mg every eight weeks (Q8W) having initially responded during the induction phase, but later discontinued during the maintenance phase due to lack of efficacy, and were subsequently enrolled in GEMINI LTS. The open-label findings indicate that patients who lost response to Q8W dosing may have improvements in mean disease activity scores with an increase in dosing frequency to Q4W without an apparent increased risk for adverse events (AEs).

"We are focused on the ongoing study of vedolizumab for ulcerative colitis and Crohn's disease, with a goal of continuing to identify how we can further support the patient and professional communities," said Michael Smyth, VP Global Medical Head, General Medicine, Takeda Pharmaceuticals. "It is therefore encouraging to see initial data from the ongoing long-term extension study that explores the possible utility of vedolizumab Q4W dosing for some patients."

A fourth oral presentation at UEGW centers on the evaluation of infection rates in patients treated with vedolizumab alone or with concomitant corticosteroids (CSs) and/or immunosuppressants (IMs) in GEMINI 1 and 2. Initial pooled data show that the percentages of patients with individual infection AEs were similar between the two groups, except for nasopharyngitis, which was reported at higher rates in the vedolizumab arm. Percentages of patients with individual infection SAEs across all placebo subgroups were similar to, or nominally lower than, those across all vedolizumab subgroups. The data suggest that the reported AE rates were similar whether patients with UC or CD were taking vedolizumab with or without concomitant IM and/or CS therapy.

UC and CD are the two most common types of inflammatory bowel disease (IBD), affecting more than four million people worldwide, including approximately 2.2 million in Europe. Inflammation caused by CD can involve varying areas of the digestive tract, while UC impacts the colon and rectum. CD and UC can be both painful and debilitating, and may lead to serious complications.

* Vedolizumab is approved for 300 mg IV doses every eight weeks (Q8W), with an option to increase to 300 mg IV doses every four weeks (Q4W) for patients who experience a decrease in their response.

About ulcerative colitis and Crohn's disease
Ulcerative colitis (UC) and Crohn's disease (CD) are marked by inflammation in the GI tract. UC impacts the large intestine only, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is no known cause for UC or CD, although many researchers believe that the interaction between genes, the body's immune system, and environmental factors may play a role. The aim of UC and CD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.

About Entyvio^® (vedolizumab)
Vedolizumab, developed for the treatment of UC and CD, is a humanized monoclonal antibody that is designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1) and fibronectin, but not vascular cell adhesion molecule 1 (VCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in UC and CD. By inhibiting alpha4beta7, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.

About Takeda Pharmaceuticals International GmbH
Headquartered in Zurich as a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Osaka, Japan, the Company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus are central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.

Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.

Additional information about Takeda is available through its corporate website, www.takeda.com.