Deerfield, IL, November 9, 2017 – Takeda Pharmaceuticals, U.S.A., Inc. (“Takeda”), today announced the presentation of GEMINI I post-hoc data evaluating deep remission with Entyvio® (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC). The poster was selected as a “Poster of Distinction” for presentation at the 2017 Advances in Inflammatory Bowel Diseases (AIBD) annual conference, held in Orlando, Florida, November 9-11. The analysis sought to explore the association of Entyvio versus placebo across four definitions of deep remission.
As treatment options become available for inflammatory bowel disease (IBD), treatment goals are evolving beyond the control of symptoms toward control of objectively-measured gastrointestinal inflammation. Deep remission, generally defined as a composite of symptom control and endoscopic improvement, may be a possible target. A standard definition of deep remission has not yet been determined. Additional studies evaluating the ability of individual therapies to achieve deep remission for patients are needed to make this a realistic target.
“Deep remission as a new treatment goal that can go beyond the control of symptoms to include sustained control of inflammation is important for both patients and providers,” said William Sandborn, M.D., Chief, Division of Gastroenterology, University of California San Diego. “This new post-hoc analysis provides insight for physicians as treatment goals evolve and new therapies become available.”
The analysis being presented at AIBD, titled “Relationship between Vedolizumab Concentrations and Deep Remission in Patients with Moderately-to-Severely Active Ulcerative Colitis: A GEMINI 1 Post-Hoc Analysis,” (Sandborn W, Colombel JF, Panaccione R, et al.) evaluated four different criteria sets for deep remission in patients at week 52 of treatment with Entyvio. The criteria assessed combinations of endoscopic improvement and symptomatic remission/improvement, that included rectal bleeding and stool frequency, across varying degrees of stringency. The deep remission rates were then analyzed against Entyvio trough serum concentrations to determine if there was a correlation.
“We are pleased that this poster was recognized as a ‘Poster of Distinction’ by AIBD. Takeda is committed to investigating important therapeutic targets like deep remission in order to help the GI community determine what goals might be important for patients with the increasing number of treatment options available for IBD,” said Karen Lasch, M.D., Medical Head, GI Specialty, U.S. Medical Office, Takeda. “As deep remission becomes an important and realistic treatment goal, Takeda will continue to explore this area.”
Two encore presentations of GEMINI post-hoc analyses evaluating early symptomatic improvement with Entyvio for patients with moderately to severely active UC or Crohn’s disease (CD) will also be shared at the conference. For a full list of poster titles and authors, visit http://advancesinibd.com/aibd_downloads/2017-ibd-abstract-titles.pdf.
About Entyvio® (vedolizumab)
Vedolizumab is a prescription medicine approved for adults with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). In people with UC and CD, there’s an increased number of inflammatory white blood cells entering the mucosal lining of the bowel. The presence of these inflammatory cells can lead to the symptoms most commonly seen in people who have UC or CD. Vedolizumab is designed to reduce this inflammation by blocking the movement of the white blood cells into the inflamed gut tissue. Mucosal addressin cell adhesion molecule 1 (MAdCAM-1) is preferentially expressed on the endothelial lining of blood vessels in the lymphoid tissue of the bowel. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. Vedolizumab specifically binds to the alpha4beta7 integrin and blocks its interaction with MAdCAM-1, therefore inhibiting the white blood cells from entering the inflamed gut tissue, thus decreasing inflammation.
About the GEMINI Studies
The safety and efficacy of Entyvio® is supported by the results of the GEMINI clinical trial program. These Phase 3 studies involved 2,400 individuals with ulcerative colitis (UC) or Crohn’s disease (CD) who were recruited from nearly 40 countries.
The GEMINI program consists of four studies – a placebo-controlled study of vedolizumab induction and maintenance treatment in patients with moderately to severely active UC (GEMINI I), a placebo-controlled study of vedolizumab induction and maintenance treatment in patients with moderately to severely active CD (GEMINI II), a placebo-controlled study of vedolizumab induction in patients with moderately to severely active CD (GEMINI III) and an open-label long-term safety study of vedolizumab in patients with either CD or UC (GEMINI long-term safety). For GEMINI I, the primary endpoint of the induction phase was clinical response (defined as reduction in complete Mayo score of ≥3 points and ≥30% from baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point) at 6 weeks, and the primary endpoint of the maintenance phase was clinical remission (defined as complete Mayo score of ≤2 points and no individual subscore >1 point) at week 52.
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.
About Ulcerative Colitis and Crohn’s Disease
Ulcerative colitis (UC) and Crohn’s disease (CD) are two of the most common forms of inflammatory bowel disease (IBD). Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal (GI) tract that are often progressive in nature. UC only involves the large intestine as opposed to CD which can affect any part of the GI tract from mouth to anus. CD can also affect the entire thickness of the bowel wall, while UC only involves the innermost lining of the large intestine. UC often presents with symptoms of abdominal discomfort, loose bowel movements, including blood or pus. CD commonly presents with symptoms of abdominal pain, diarrhea and weight loss. The cause of UC or CD is not fully understood, however recent research suggests hereditary, genetics, environmental factors and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to UC or CD.
Takeda’s Commitment to Gastroenterology
Takeda is driven to improving the lives of patients with GI diseases through innovative medicines, dedicated patient disease management support and the evolution of the healthcare environment. Takeda is leading in gastroenterology through the delivery of innovative medicines. With more than 25 years of experience in this area, our broad approach to treating many diseases that impact the GI system and our global network of collaborators, Takeda aims to advance how patients manage their disease.
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
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Takeda’s growth is being fuelled by products, especially in oncology and gastroenterology, as well as its presence in emerging markets. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.
Takeda Pharmaceuticals U.S.A., Inc.
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