Deerfield, IL, October 17, 2016 –Today, Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”), announced data highlighting the effectiveness and safety profile 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 2016 American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nevada. Eleven Takeda-sponsored posters, including several vedolizumab studies featuring real-world data, as well as treatment persistence and post-marketing safety data, are being presented during the meeting.
A presentation entitled ‘Systematic Literature Review of Real World Effectiveness and Safety of Vedolizumab in Adult Ulcerative Colitis and Crohn’s Disease Patients’ (Demuth D, Bovens S, Solaman A, Curtis R, O’Byrne S, Khalid JM) examined reports describing more than 7,700 patients with moderate-to-severely active UC or CD receiving treatment with vedolizumab. Investigators analyzed treatment benefit and safety profile with vedolizumab from their review of patients with moderately to severely active UC or CD. 1
“Findings from our comprehensive data review support previous clinical trial findings regarding remission rates and reductions in disease activity scores in many patients with moderate to severe UC and CD receiving treatment with vedolizumab,” explained study co-author and lead presenter Dirk Demuth, associate director, Global Outcomes Research, Takeda Development Centre Europe Ltd. “This systematic review offers us a unique perspective into the real-world impact of vedolizumab treatment for a large cross-section of patients, adding to the growing body of information about both the safety and effectiveness profile of vedolizumab as a treatment option for patients living with moderate to severe UC or CD.”
Additional real-world vedolizumab data will be presented at ACG, including poster presentations entitled ‘Patterns of Dose Escalation Amongst Patients with Ulcerative Colitis and Crohn’s Disease Treated with Vedolizumab vs. Infliximab in the United States’ (Khalid JM, Raluy-Callado M, Li Q, Luo M, Lasch K) and ‘Hospitalizations and Treatment Discontinuation Among Patients with Ulcerative Colitis and Crohn’s Disease Treated with Vedolizumab Compared with Infliximab’(Khalid JM, Raluy-Callado M, Alam N, Wang R). ,
Included among Takeda’s other vedolizumab presentations at ACG are two abstracts focusing on real-world treatment persistence, entitled ‘Real World Treatment Persistence with Vedolizumab in Patients with Ulcerative Colitis and Crohn’s Disease: A Retrospective Claims Analysis in the U.S.’ (Null KD, Visaria J, Demuth D, et al.) and ‘Real-World Treatment Persistence with Vedolizumab in Crohn’s Disease and Ulcerative Colitis Patients in the United States (US): A Retrospective Analysis Using the Optum Research Database’ (Demuth D, Patel H, Chastek B, Lee B, Khalid JM, Null KD).
“We are pleased to contribute to the ongoing study of vedolizumab and have this opportunity to share findings from a dynamic selection of real-world studies, offering insights into the use of vedolizumab,” said Karen Lasch, U.S. medical director, Gastroenterology, Takeda Pharmaceuticals, and co-author of two vedolizumab abstracts accepted for presentation at ACG. “Since Takeda launched vedolizumab more than two years ago in the U.S., we continue to build upon the outcomes of our clinical trials with real world evidence supporting the importance of this treatment option for the UC and CD communities.”
Vedolizumab is approved as a humanized monoclonal antibody under the trade name Entyvio® (vedolizumab). It is the first and only biologic therapy to be approved 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 posters presented at the 2016 ACG Annual Scientific Meeting is as follows:
Monday, October 17
• Poster 1188: Examining Patient Decision-Making Surrounding Biologic Therapies in Inflammatory Bowel Disease: Insights from a Conjoint Analysis Survey (Almario CV, Keller M, Mosadeghi S, et al.)
• Poster 1136: Vedolizumab Efficacy Exposure Response Relationship for Ulcerative Colitis Patients (GEMINI I) Based on Causal Inference Analysis (Osterman M, Gastonguay MR, Lasch K, et al.)
• Poster 1187: Post-marketing Safety Experience with Vedolizumab: Skin Reactions (Psoriasiform and Eczematous) (Bhayat F, England D, Blake A)
• Poster 1144: Systematic Literature Review of Real World Effectiveness and Safety of Vedolizumab in Adult Ulcerative Colitis and Crohn’s Disease Patients (Demuth D, Bovens S, Solaman A, Curtis R, O’Byrne S, Khalid JM)
Tuesday, October 18
• Poster 1915: Real-World Treatment Persistence with Vedolizumab in Patients with Ulcerative Colitis and Crohn’s Disease: A Retrospective Claims Analysis in the U.S. (Null KD, Visaria J, Demuth D, et al.)
• Poster 1917: Assessing Administration and Billing of Vedolizumab and Infliximab Across IBD Sites of Care (Null K, Cameron A, Kumar VM, Lissoos T, Luo M)
• Poster 1890: Post-marketing Safety Experience with Vedolizumab: Malignancy (Bhayat F, Blake A)
• Poster 1918: Real World Treatment Persistence with Vedolizumab in Crohn’s Disease and Ulcerative Colitis Patients in the United States (US): A Retrospective Analysis Using the Optum Research Database (Demuth D, Patel H, Chastek B, Lee B, Khalid JM, Null KD)
• Poster 1897: Patterns of Dose Escalation Amongst Patients with Ulcerative Colitis and Crohn’s Disease Treated with Vedolizumab vs. Infliximab in the United States (US) (Khalid JM, Raluy-Callado M, Li Q, Luo M, Lasch K)
• Poster 1898: Hospitalizations and Treatment Discontinuation Among Patients with Ulcerative Colitis and Crohn’s Disease Treated with Vedolizumab Compared with Infliximab (Khalid JM, Raluy-Callado M, Alam N, Wang R)
• Poster 1896: Predictors of Non-response or Loss of Response to Tumor Necrosis Factor Antagonist Therapies in Inflammatory Bowel Disease (Khalid JM, Peyrin-Biroulet L, Armuzzi A, 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.6 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.
