New reviews using real-world data support safety profile of ENTYVIO® (vedolizumab) in ulcerative colitis or Crohn's disease

Meta-analyses provide comprehensive view of real-world data and further understanding of
this important treatment option

OAKVILLE, ON, Nov. 1, 2017 /CNW/ - Two new reviews of data from multiple sources of real-world information support the safety profile seen in clinical studies of ENTYVIO^® (vedolizumab) in treating people living with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). The new real-world data with the first and only gut selective treatment for UC and CD were presented today at the 25th United European Gastroenterology (UEG) Week in Barcelona, Spain.

"It is a responsible, patient-centred approach to follow up the essential clinical trial data required for regulatory approval of a treatment such as ENTYVIO^® by providing valid data from real-world clinical practice settings. These analyses are particularly important because they are a reflection of the reality that treating physicians and patients experience with ENTYVIO^®," said Chatrick Paul, General Manager of Takeda Canada Inc.

The first study was a systematic review and combined analysis of real-world outcomes screening 218 published studies from publications and conference abstracts from May 1, 2014 to January 10, 2017, and examined safety events reported after use of ENTYVIO^® in patients with UC or CD. A total of 33 studies reported data on 2,857 ENTYVIO^®-treated patients (CD: 1532; UC: 829) over an ENTYVIO^® exposure or follow-up period ranging from 0.5 to 18 months. Total adverse event (AE) rates in ENTYVIO^®-treated patients were reported for infections, serious AEs and serious infections and were consistent with previous clinical trial results in patients with moderate to severe UC or CD, thus supporting the long-term safety profile of ENTYVIO^® in clinical practice.^1,2

"Having real-world data that support the safety of a treatment allows physicians to make even more informed decisions about the management of a disease. More often than not, having access to this type of data validates what is happening in our practice," said Dr. John Marshall, Chief of Service for Gastroenterology at Hamilton Health Sciences in Hamilton, Ontario. "In this case it is reassuring to have the already strong safety profile of ENTYVIO^® supported by thorough real-world data."

The second review presented in Barcelona was a U.S-specific analysis assessing the real-world use of immunosuppressives (IM) across a total of 567 patients which also provide information on the safety profile of ENTYVIO^®. Of the 567 patients (58.6% female; 41.4% male), 68.4% had CD and 31.6% had UC. The mean age at index was 44 and on average, patients initiated ENTYVIO^® 4.5 years following their initial diagnosis. The findings report, in real-world clinical practice, that the majority of patients with a history of IM use did not use IM therapy after initiating ENTYVIO^®.  Of the 54.6% of patients with a history of IM therapy, 61.0% did not use IM during maintenance treatment with ENTYVIO^® during follow-up. Of the 45.4% of patients without a history of IM use, 87.0% did not initiate IM therapy during ENTYVIO^® follow-up. In this analysis, lower rates of healthcare resource utilization were observed among patients without a history of IM use.³

ENTYVIO^® is Takeda Canada's innovative biologic treatment for the two most common types of inflammatory bowel disease (IBD), CD and UC.⁴ ENTYVIO^® was the 2016 winner of the prestigious Prix Galien Canada - Innovative Product Award, recognizing its unique mode of action and ability to offer an efficacious gut-selective treatment option for patients living with moderate to severe UC or CD.⁴

Patients who are prescribed ENTYVIO^® are fully supported with information, reimbursement assistance and convenient infusion clinics through Takeda's patient support program YOURVANTAGE™.

About ulcerative colitis and Crohn's disease
Ulcerative colitis (UC) and Crohn's disease (CD) are the two most common forms of inflammatory bowel disease (IBD).⁵ Approximately 233,000 Canadians are living with UC and CD. More than 10,000 new cases are diagnosed each year, typically in patients in their 20s, though it can be diagnosed at any age, including in children.⁶ IBD has been labelled Canada's "national disease" due to Canada having among the highest rates in the world.⁷ UC causes the tissue of the large intestine (including the colon and rectum) to become inflamed, form sores and bleed easily. Along with symptoms of abdominal pain, cramping, diarrhea, nausea and vomiting, UC can cause severe complications including intestinal bleeding and bowel obstructions. CD may involve inflammation in different parts of the gastrointestinal (GI) tract in different people; however, it most commonly affects the lower part of the small intestine (the ileum) where it joins the beginning of the colon.⁸ Sometimes a portion of the bowel needs to be surgically removed to bring patients relief.⁸ The exact causes of UC and CD are not entirely understood, though they are believed to result from an interaction between genes and the body's immune system, with environmental factors possibly playing a role.⁹

About ENTYVIO^®
ENTYVIO^® is approved by Health Canada for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNFα antagonist.¹⁰ ENTYVIO^® is also indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a tumor necrosis factor-alpha (TNFα) antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.¹⁰

Canadian researchers played a pivotal role in the treatment's early discovery and development. Researcher Dr. Andrew Lazarovits of London, Ontario, developed a first potential molecule for this type of therapy while working in Boston but passed away in 1999 at age 44.¹¹ His work was taken up by others, resulting in the development of vedolizumab and eventually international clinical trials financed by Takeda which were led by Dr. Feagan in London, Ontario. The treatment was first used on an ulcerative colitis patient at University Hospital in London¹² and Dr. Feagan was the lead author of the publication of the trial results in The New England Journal of Medicine in 2013.¹³

Takeda's Commitment to Gastroenterology
More than 70 million people worldwide are impacted by gastrointestinal (GI) diseases, which can be complex, debilitating and life-changing.¹⁴ 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 in areas associated with high unmet needs, such as inflammatory bowel disease, GI acid-related diseases and GI motility disorders. Our GI research & development team is also exploring solutions in celiac disease and nonalcoholic steatohepatitis (NASH), as well as scientific advancements through microbiome therapies. 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
Located in Osaka, Japan, 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. Additional information about Takeda is available at takeda.com.

Takeda Canada, located in Oakville, Ontario, is the Canadian sales and marketing organization of Takeda Pharmaceutical Company Limited. Takeda Canada is transforming to become an agile specialty pharmaceutical company, focusing on gastroenterology and oncology, while continuing to meet a number of important primary care needs. Additional information about Takeda Canada is available at takedacanada.com.

ENTYVIO^® is a registered trademark of Millennium Pharmaceuticals, Inc. and used under licence by Takeda Canada Inc.
YOURVANTAGE™ is a trademark of Takeda Canada

REFERENCES
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¹ Schreiber S, et al. Real world safety of vedolizumab in inflammatory bowel disease: a meta-analysis. United European Gastroenterology (UEG) Week 2017. Poster #P1696

² Colombel JF et al. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut 2017; 66:839

³ Raluy-Callado M, et al. Real-world use of immunosuppressives among patients with inflammatory bowel disease treated with vedolizumab. United European Gastroenterology (UEG) Week 2017. Poster #P1028.

⁴ Crohn's and Colitis Canada, Newly Diagnosed; accessed October 25, 2017, at: http://www.crohnsandcolitis.ca/Living-with-Crohn-s-Colitis/Diagnostic-recent

⁵ Crohn's and Colitis Canada, Newly Diagnosed; accessed October 25, 2017, at: http://www.crohnsandcolitis.ca/Living-with-Crohn-s-Colitis/Diagnostic-recent

⁶ Crohn's and Colitis Canada, The Impact of IBD Report, Who is affected; accessed October 25, 2017, at: http://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report

⁷ Media Planet, Digestive Wellness Supplement, Tackling the burden of ulcerative colitis, March 2015, accessed October 25, 2017, at: http://www.personalhealthnews.ca/prevention-and-treatment/tackling-the-burden-of-ulcerative-colitis

⁸ Crohn's and Colitis Canada, The impact of inflammatory bowel disease in Canada, 2012 final report, page 17, 20 and 22 accessed October 25, 2017, at: http://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report

⁹ Crohn's and Colitis Foundation of America, The Facts about Inflammatory Bowel Disease, page 5, accessed October 25, 2017, at: http://www.ccfa.org/assets/pdfs/updatedibdfactbook.pdf

¹⁰ Takeda Canada Inc., ENTYVIO^® (vedolizumab) Product Monograph, November 11, 2016, p. 3., and Health Canada Notice of Compliance information. Available at: http://www.takedacanada.com/entyviopm/~/media/countries/ca/files/product%20pdfs/entyviopm_eng_2016nov11.pdf, accessed October 25, 2017.

¹¹ Feagan BG et al, Treatment of Active Crohn's Disease With MLN0002, a Humanized Antibody to the α4β7 Integrin, Clinical Gastroenterology and Hepatology, 2008; 6:12, 1370–1377, accessed October 25, 2017, at: http://www.cghjournal.org/article/S1542-3565%2808%2900617-4/abstract and Sher J, Approval being sought for new treatment for Crohn's and colitis, The London Free Press, Aug. 21, 2013, accessed October 25, 2017, at: http://www.lfpress.com/2013/08/21/approval-being-sought-for-new-treatment-for-crohns-and-colitis

¹² Sher J, Approval being sought for new treatment for Crohn's and colitis, The London Free Press, Aug. 21, 2013, accessed October 25, 2017, at: http://www.lfpress.com/2013/08/21/approval-being-sought-for-new-treatment-for-crohns-and-colitis

¹³ Feagan BG et al, Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis, N Engl J Med 2013; 369:699-710, August 22, 2013, accessed October 25, 2017, at: http://www.nejm.org/doi/full/10.1056/NEJMoa1215734

¹⁴ Digestive Health. University of Miami Hospital. http://umiamihospital.com/service-lines/digestive-health, accessed October 25, 2017.

SOURCE Takeda Canada Inc.

For further information: Media contact: Natacha Raphael, Corporate Communications, Takeda Canada Inc., Tel: [phone], [email protected]