Takeda Presents Vedolizumab Data at the 2015 American College of Gastroenterology (ACG) Annual Meeting

DEERFIELD, Ill., Oct. 19, 2015 /PRNewswire/ -- Takeda Pharmaceuticals, U.S.A., Inc. ("Takeda"), today announced that data highlighting the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), will be presented during the 2015 American College of Gastroenterology (ACG) Annual Scientific Meeting in Honolulu, Hawaii, held on October 16-21.

Eleven Takeda-sponsored posters, as well as one oral presentation entitled 'Efficacy of Vedolizumab Maintenance Therapy with and without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2' (Feagan BG, Siegel CA, Melmed GY, et al.), will be featured during the ACG meeting.

"We are pleased with how physicians and patients have received vedolizumab in the U.S., and we are committed to continued scientific exploration of this compound to support the GI community," said Karen Lasch, M.D., Executive Medical Director- GI Medical Affairs, U.S. Region, Takeda Pharmaceuticals. "At ACG, we have the opportunity to engage in valuable discussions, and this scientific exchange helps us focus on supporting UC and CD patients."

Vedolizumab was approved as a humanized monoclonal antibody 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.

A full list of Takeda-sponsored abstracts presented at the 2015 American College of Gastroenterology (ACG) Annual Scientific Meeting is as follows:

On Sunday 18 October

• Abstract: Corticosteroid Dose Reduction in Ulcerative Colitis Patients Treated with Vedolizumab During the GEMINI 1 Trial (Loftus EV, Siegel CA, Panaccione R, et al.)
• Abstract: Corticosteroid Dose Reduction with Vedolizumab Treatment of Crohn's Disease During the GEMINI 2 Trial (Loftus EV, Siegel CA, Panaccione R, et al.) 
• Abstract: Characteristics of Patients with Ulcerative Colitis initiating Vedolizumab Therapy in Real-World Clinical Practice (Reynolds M, Alam N, O'Hara D, Smyth MDL, Khalid JM)
• Abstract: Characteristics Of Patients with Crohn's Disease initiating Vedolizumab Therapy in Real-World Clinical Practice (Reynolds M, Alam N, O'Hara D, Smyth MDL, Khalid JM)
• Abstract: Regional Variation in Quality of Care for Inflammatory Bowel Disease in the United States (Rubin DT, Patel H, Shi S, Mody R)
• Abstract: Epidemiology of Inflammatory Bowel Disease (IBD) and Use of Biologic Therapy in the United States (US): A Retrospective Claims Database Study (Rubin DT, Patel H, Shi S, Mody R)
• Abstract: Indicators of Suboptimal Biologic Therapy in Patients with Ulcerative Colitis or Crohn's Disease in the United States (Mody R, Patel H, Rubin DT)
• Abstract: Characteristics of Patients Treated with Vedolizumab for Inflammatory Bowel Disease in the United States (Chastek B, Patel H, Mody R)

On Monday 19 October

• Abstract: Defining Remission using Patient-Reported Outcome Components of the Crohn's Disease Activity Index: Post Hoc Analyses of Vedolizumab Data from the GEMINI 2 Study (Sandborn WJ, Vermeire S, Sands BE, et al.)

On Tuesday 20 October

• (Oral Presentation) Abstract: Efficacy of Vedolizumab Maintenance Therapy with and without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2 (Feagan BG, Siegel CA, Melmed GY, et al.) 
• Abstract: Vedolizumab Exposure in Pregnancy: Outcomes from Clinical Studies in Ulcerative Colitis and Crohn's Disease (Mahadevan U, Dubinsky M, Vermeire S, Abhyankar B, Lasch K)
• Abstract: Efficacy and Safety of Vedolizumab with Advancing Age in Patients with Crohn's Disease: Results from the GEMINI 2 Study (Yajnik V, Khan N, Dubinsky M, et al.)

About Entyvio^® (vedolizumab)
Entyvio, an integrin receptor antagonist, is a humanized monoclonal antibody that specifically binds to the alpha4beta7 integrin and blocks the interaction of alpha4beta7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Entyvio does not bind to or inhibit function of the alpha4beta1 and alpha E beta 7 integrins and does not antagonize the interaction of alpha4 integrins with vascular cell adhesion molecule-1 (VCAM-1). The alpha4beta7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue. The interaction of the alpha4beta7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn's disease.

INDICATIONS: ENTYVIO (vedolizumab)

Adult Ulcerative Colitis (UC)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.

Adult Crohn's Disease (CD)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission.

IMPORTANT SAFETY INFORMATION

• ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
• Infusion-related reactions and hypersensitivity reactions including anaphylaxis have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
• Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
• Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
• There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
• Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
• Most common adverse reactions (incidence greater than or equal to 3% and greater than or equal to 1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Please see the accompanying full Prescribing Information including Medication Guide for ENTYVIO.

More information is available at www.ENTYVIOHCP.com and www.ENTYVIO.com

About Ulcerative Colitis and Crohn's Disease
Ulcerative colitis (UC) and Crohn's disease (CD) are marked by inflammation in the lining of the gastrointestinal tract. UC impacts the large intestine only, which includes the colon and the rectum, while CD can impact any part of the digestive tract, and predominantly affects the ileum. There is no known cause for UC and CD, although many researchers believe that the interaction between genes, the body's immune system, and environmental factors may play a role.

About Takeda Pharmaceuticals U.S.A., Inc.
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.

The company has a commercial presence covering around 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of R&D focus include central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.

Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE: 4502) 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. Additional information about Takeda is available through its corporate website, www.takeda.com.

SOURCE Takeda Pharmaceuticals, U.S.A., Inc.

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