Takeda Presents 17 Abstracts at the 2016 Advances in Inflammatory Bowel Diseases (AIBD) Annual Conference

Data to feature additional insights into vedolizumab and elements of inflammatory bowel disease (IBD)

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 Crohn’s & Colitis Foundation of America’s 2016 Advances in Inflammatory Bowel Diseases (AIBD) annual conference, held in Orlando, Florida on December 8-10.

Seventeen Takeda-sponsored posters will be presented during the AIBD meeting, focused on a variety of topics important to the IBD community, including real-world data about vedolizumab treatment.

“As we continue our ongoing investigation and characterization of vedolizumab in clinical practice, we are able to provide additional insights that add to the growing body of scientific evidence supporting the full potential of this important compound,” said Karen Lasch, U.S. medical director, Gastroenterology, Takeda Pharmaceuticals. “We are pleased to have this opportunity to further engage with the professional community at AIBD and share additional data, as we work toward our common goal of improving the lives of patients living with ulcerative colitis and Crohn’s disease.”

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.

A full list of the 17 Takeda-sponsored abstracts accepted for presentation at the 2016 AIBD Annual Conference is as follows:

• Abstract: Project Sonar: Patient Engagement Reduced Relative Risk and Cost of Care in an Attributed Cohort of Patients with Crohn's Disease (Kosinski L, Baum C, Brill J, et al)
• Abstract: Mucosal Healing with Vedolizumab in Ulcerative Colitis and Crohn’s disease: Outcomes from the VICTORY Consortium (Kochhar G, Parikh M, Chaudrey K, et al)
• Abstract: Real-world Effectiveness of Vedolizumab as Induction Therapy in Inflammatory Bowel Disease: A Meta-analysis (Schreiber S, Dignass A, Peyrin-Biroulet L, et al)
• Abstract: A Retrospective UK Chart Review of Early Vedolizumab (Entyvio®) Experience: Real World Treatment, Effectiveness and Safety in Inflammatory Bowel Disease (REVIVE) (Cummings F, Gaya DR, Irving P, et al)
• Abstract: Validated Prediction Model for Clinical Remission with Vedolizumab in Crohn's Disease: Post Hoc Analysis of GEMINI II Clinical Trial (Dulai PS, Boland BS, Singh S, et al)
• Abstract: Corticosteroid Use in Patients with Crohn’s Disease Initiating Vedolizumab in the Real-world Setting (Sands BE, Khalid JM, Barocas M, Raluy-Callado M, Merinopoulou E)
• Abstract: Treatment Patterns of Vedolizumab and Anti-TNF-α Use among Patients with UC and CD in Germany: A Multicenter Retrospective Chart Review (Ehehalt R, Schubert S, Stein D, et al)
• Abstract: Impact of Dose Escalation with Anti-TNFs on Healthcare Resource Utilization Among Patients with Crohn’s Disease (Gisbert JP, Patel H, Nguyen GC, et al)
• Abstract: Cancer Incidence among Elderly Inflammatory Bowel Disease Patients: A Retrospective Database Analysis (Khan N, Unniachan S, Vallarino C, Lasch K, Lissoos T, Luo M)
• Abstract: Economic Impact of Infusion Administration Time Billing for Vedolizumab and Infliximab for Ulcerative Colitis and Crohn’s Disease: Health Plan Perspective (Kumar V, Null K, Cameron A, Lissoos T, Luo M)
• Abstract: Comparing Productivity between Patients on Vedolizumab and Infliximab Patients Using Infusion Administration Billing in the United States (Null K, Kumar V, Cameron A, Lissoos T, Luo M)
• Abstract: Assessing Risk Factors Predicting Loss of Response to Vedolizumab in Ulcerative Colitis and Crohn’s Disease: Outcomes from the VICTORY Consortium (Shmidt E, Winters AC, Katta LG, et al)
• Abstract: Hospitalisations, Flares, and Corticosteroid Use Outcomes in Biologic-naïve Patients with Ulcerative Colitis and Crohn’s Disease Initiating Vedolizumab (Alam N, Raluy-Callado M, Donaldson R, Kaviya A, Khalid JM)
• Abstract: A Description of Joint-Related Events in Patients Receiving Vedolizumab from Clinical and Post-Marketing Safety Experience (Ungaro R, Blake A, Bhayat F, Lasch K, Palo W, Colombel JF)
• Abstract: Assessing Factors Impacting Risk of Cancer among Elderly Patients with Inflammatory Bowel Disease: Findings from a Claims Database Study (Khan N, Unniachan S, Vallarino C, Lasch K, Lissoos T, Luo M)
• Abstract: Vedolizumab Use in Patients with IBD Undergoing Surgery: A Summary from Clinical Trials and Post-Marketing Experience (Shen B, Blake A, Lasch K, Palo W, Smyth M, Bhayat F)
• Abstract: Quantification of the Hypothetical Risk of Progressive Multifocal Leukoencephalopathy with Vedolizumab Treatment in Patients with Ulcerative Colitis and Crohn’s Disease (Xu J, Card T, Shick J, Palo W, Liang H, Bhayat F)

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 ≥3% and ≥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.

Takeda’s Commitment to Gastroenterology 
Takeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the company’s dedication to innovation continues to evolve and have a lasting impact. Beginning in the 1990’s Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors. Since that time, Takeda’s global capabilities have expanded into the specialty care market in gastroenterology and biologics with a focus on ulcerative colitis and Crohn’s disease. Takeda's expertise also remains focused on therapeutic agents that work to reduce the production of acid in the stomach, and options for the treatment of chronic idiopathic constipation, irritable bowel syndrome with constipation and opioid-induced constipation. Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.

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.

Contacts:

Linda Calandra
Takeda Pharmaceuticals U.S.A., Inc.
TEL: 224-554-4321
[email protected]