Meta-Analysis Using Real-World Data Evaluates Safety Profile of Entyvio® (vedolizumab) in Patients with Moderate to Seve

OSAKA, Japan, November 1, 2017 /PRNewswire/ --

New meta-analysis provides a comprehensive view of real-world data and furthers understanding of Entyvio as an important treatment option for patients with ulcerative

colitis or Crohn's disease  

Takeda Pharmaceutical Company Limited ("Takeda") today announced the presentation of real-world evidence from two analyses evaluating the safety profile of Entyvio(R) (vedolizumab), during the 25th United European Gastroenterology (UEG) Week in Barcelona, Spain (October 28-November 1). It includes a systematic review and meta-analysis of real-world safety outcomes reported for Entyvio in ulcerative colitis (UC) or Crohn's disease (CD), as well as a database analysis of the real-world use of immunosuppressive (IM) therapy in people living with inflammatory bowel disease (IBD) who initiated Entyvio treatment in the U.S.

A systematic review and meta-analysis of real-world outcomes screening 218 published studies from MEDLINE-, Cochrane-, and EMBASE-indexed publications and conference abstracts from May 1, 2014-January 10, 2017 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: 1,532; UC: 829) over an Entyvio exposure/follow-up period ranging 0.5-18 months. In the meta-analysis, pooled adverse event (AE) rates in Entyvio-treated patients were reported for infections, serious AEs and serious infections. These reported rates were consistent with previous vedolizumab clinical trial results in patients with moderate to severe UC or CD and support the long-term safety profile of Entyvio in clinical practice.

"Real-world data furthers our understanding of the efficacy and safety signals we see in placebo-controlled registration trials, which have strict selection criteria and may not be illustrative of the patient population seen in clinical practice. A meta-analysis adds stability to such real-world observations, especially when based on very large patient numbers. In this case, vedolizumab real-world data were systematically collected and analyzed with the rates of serious infections, infusion-related reactions and malignancies consistent with data previously reported in clinical trials in patients with moderate to severe UC or CD," said Stefan Schreiber, M.D., Ph.D., Professor of Medicine and Gastroenterology, Translational Inflammation Research, Christian Albrechts University, Kiel, Germany.  

Results from a second U.S-specific analysis assessing the real-world use of immunosuppressives (IM) across a total of 567 patients, identified via The Explorys Universe database, 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 vedolizumab 4.5 years following their initial diagnosis. The findings report, in real-world clinical practice, of the 45.4% of patients without a history of IM therapy, 87% of patients treated with Entyvio were not on IM therapy during follow-up. Of the 54.6% of patients with a history of IM therapy, 61% of patients treated with Entyvio were not on IM during maintenance treatment during follow-up. In this analysis, lower rates of healthcare resource utilization were observed among patients without a history of IM use.

"These data provide additional insight on the usage patterns, long-term safety profile and outcomes of Entyvio use in real-world clinical practice," said Mona Khalid, Senior Director, Head of Evidence and Value Generation, Takeda Pharmaceuticals. "We look forward to the continued expansion of our body of knowledge on the safety profile of Entyvio treatment in ulcerative colitis and Crohn's disease, and are pleased to present these real-world results at the UEG Week in Barcelona."

In addition to these real-world analyses, other Takeda-sponsored posters presented at the UEG Week meeting include evaluations of post-marketing safety, risk factors for postoperative infection following lower gastrointestinal surgery, treatment discontinuation, flares and hospitalizations among biologic-naive IBD patients, as well as post-hoc analyses of GEMINI 1, a pivotal Phase 3 placebo-controlled study of Entyvio induction and maintenance treatment in patients with moderately to severely active UC. For a full list of poster titles and authors, visit http://www.ueg.eu/week/programme/scientific-programme.

About Entyvio(R) (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 (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 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 commonly 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.

Therapeutic Indications 

Ulcerative colitis 

Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFalpha) antagonist.

Crohn's disease 

Vedolizumab is 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 either conventional therapy or a tumor necrosis factor-alpha (TNFalpha) antagonist.

Important Safety Information 

Contraindications 

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and special precautions for use 

Vedolizumab should be administered by a healthcare professional equipped to manage hypersensitivity reactions including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use when administering vedolizumab. Observe all patients during infusion and until the infusion is complete.

Infusion-related reactions 

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