DEERFIELD, Ill., /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc., ("Takeda") today announced the presentation of new long-term efficacy real-world data analyses for Entyvio® (vedolizumab) at ACG 2018 in Philadelphia, PA. Studies of note include a retrospective multicentre cohort study of biologic-naïve adults with ulcerative colitis (UC) and Crohn's disease (CD), two systematic reviews and meta-analyses of real-world treatment persistence and mucosal healing, and a time-trend analysis of Entyvio utilization and outcomes across the United States (U.S.). A total of 10 Entyvio abstracts were accepted for presentation at the meeting.
The retrospective cohort study included 249 patients (UC: 166; CD: 83) with no prior exposure to biologic drugs for the treatment of UC or CD who initiated Entyvio treatment. Cumulative probability of clinical outcomes and treatment persistence were analyzed by Kaplan Meier method. At 18 months, 78.6% of UC and 74.8% of CD patients persisted on Entyvio treatment, and at 24 months, 76.9% of UC and 74.8% of CD patients persisted. High rates of treatment persistence (≥75%), clinical response, clinical remission and mucosal healing are observed in bio-naïve Entyvio patients after 18 months.
The abstract featuring a systematic review of treatment persistence showed similar trends in persistence rates. This meta-analysis identified 16 studies that reported Entyvio persistence or discontinuation rates in UC and CD patients. At 12 months, approximately three-quarters and nearly two-thirds of UC and CD patients, respectively, persisted with Entyvio treatment despite utilization in largely biologic-refractory patients. Higher Entyvio persistence was seen in bio-naïve patients. These results will need to be confirmed with a larger cohort.
"Treatment persistence rates are important indicators of the long-term effectiveness and tolerability of a therapy, and these results suggest positive patient response with Entyvio among those who had not previously taken a biologic," said Karen Lasch, M.D., Medical Head, GI Specialty, U.S. Medical Office, Takeda. "The high rates of treatment persistence, clinical response and remission observed with Entyvio in real-world settings are important considerations for physicians as they evaluate biologic options and when to prescribe them for patients with ulcerative colitis and Crohn's disease."
The mucosal healing systematic review analysed 26 studies that reported mucosal healing and/or endoscopic improvement rates in patients with moderate to severe CD taking Entyvio. The most common definition of mucosal healing was the absence of all ulcers and/or erosions. Twenty-six percent of CD patients at six months and 37 percent at 12 months achieved mucosal healing with Entyvio, despite utilization in largely bio-refractory patients. Higher mucosal healing rates were observed in patients naïve to biologic therapy.
An additional Takeda-sponsored poster presented at ACG includes a time trend analysis examining outcomes associated with shifts in Entyvio utilization across the U.S. The analysis included a comparison of real-world outcomes from Entyvio treatment during the first 12 months following its U.S. availability in May 2014 versus the subsequent 24 months. Results showed a shift in positioning Entyvio during the past three years toward use in less refractory patients with a more pronounced shift toward earlier use in the treatment paradigm in UC compared to CD. The shift was also accompanied by lower rates of IBD-related hospitalization and surgery for UC. A significant shift in IBD-related hospitalizations and surgery was not observed for CD. Further studies are needed to understand if earlier use in CD impacts disease-related complications.
"The cumulative real-world evidence presented at ACG this year further supports the long-term effectiveness of Entyvio for patients with moderate to severe ulcerative colitis or Crohn's disease, particularly as a first-line biologic treatment option in bio-naïve patients" said Uthra Sundaram, SVP, Specialty Business Unit, Takeda. "Takeda is committed to supporting the GI community through scientific exchange and improving patient outcomes, and we are pleased to present this new information about the only biologic with a gut-selective mechanism of action for treatment of moderate to severe ulcerative colitis and Crohn's disease at ACG."
Takeda's Commitment to Gastroenterology
Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda's presence in emerging markets, are currently fueling the growth of Takeda. Around 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda's partners in health care in more than 70 countries.
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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.
