OREANDA-NEWS. Takeda Pharmaceuticals Company Limited [TSE: 4502], (“Takeda”) today announced that data highlighting the efficacy and safety 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 2015 American College of Gastroenterology (ACG) Annual Scientific Meeting in Honolulu, Hawaii, held on October 16-21, and during the United European Gastroenterology Week (UEGW) annual meeting, which takes place in Barcelona, Spain from October 24-28.

Eleven Takeda-sponsored posters, as well as one oral presentation entitled ‘Efficacy of Vedolizumab Maintenance Therapy with and without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2 (Feagan, Siegel, Melmed, et al.), will be featured during the ACG meeting. Data presented during the UEGW meeting will highlight findings from an analysis of the cost-effectiveness of vedolizumab as a treatment for UC compared with conventional therapy in the United Kingdom, as well as results from a multinational survey investigating indicators of suboptimal therapy among UC and CD patients treated with tumor necrosis factor antagonists (TNF-?).

“At Takeda we strongly believe in the importance of supporting patients around the world with innovative treatment options, and this is why we remain committed to excellence in our scientific exploration of vedolizumab,” said Dr. Michael Smyth, Global Brand Medical Director, Gastroenterology, Takeda Pharmaceuticals. “The extensive study results being presented at these congresses demonstrate that vedolizumab is an important addition to the therapeutic options available for patients living with ulcerative colitis and Crohn’s disease.”

Vedolizumab was approved as a gut-selective humanized monoclonal antibody available in the European Union on May 27, 2014, under the trade name Entyvio® (vedolizumab). Entyvio is also available in the United States (U.S.) following U.S. Food and Drug Administration (FDA) approval on May 20, 2014. It is the first and only biologic therapy to be approved in the European Union, as well as in the U.S., 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 abstracts presented at ACG is as follows:

On Sunday 18 October

  • Abstract # P378: Corticosteroid Dose Reduction in Ulcerative Colitis Patients Treated with Vedolizumab During the GEMINI 1 Trial (Loftus, Siegel, Panaccione, et al)
    • This data is also being presented at UEGW 2015 (see abstract # P0372)
  • Abstract # P377: Corticosteroid Dose Reduction with Vedolizumab Treatment of Crohn’s Disease During the GEMINI 2 Trial (Loftus, Siegel, Panaccione, et al)
    • This data is also being presented at UEGW 2015 (see abstract # P0371)
  • Abstract # P373: Characteristics of Patients with Ulcerative Colitis initiating Vedolizumab Therapy in Real-World Clinical Practice (Reynolds, Alam, O’Hara, et al)
  • Abstract # P374: Characteristics Of Patients with Crohn’s Disease initiating Vedolizumab Therapy in Real-World Clinical Practice (Reynolds, Alam, O’Hara, et al)
  • Abstract # P379: Regional Variation in Quality of Care for Inflammatory Bowel Disease in the United States (Rubin, Patel, Shi, et al)
  • Abstract # P380: Epidemiology of Inflammatory Bowel Disease (IBD) and use of Biologic Therapy in the United States (US): A Retrospective Claims Database Study (Rubin, Patel, Shi, et al)
  • Abstract # P383: Indicators of Suboptimal Biologic Therapy in Patients with Ulcerative Colitis or Crohn's Disease in the United States (Mody, Patel, Rubin)
  • Abstract # P382: Characteristics of Patients Treated with Vedolizumab for Inflammatory Bowel Disease in the United States (Chastek, Patel, Mody)

On Monday 19 October

  • Abstract # P1069: Defining Remission using Patient-Reported Outcome Components of the Crohn’s Disease Activity Index: Post Hoc analyses of Vedolizumab Data from the GEMINI 2 Study (Sandborn, Vermeire, Sands, et al)
    • This data is also being presented at UEGW 2015 (see abstract # P1578)

On Tuesday 20 October

  • (Oral Presentation)Abstract # 021: Efficacy of Vedolizumab Maintenance Therapy with and without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2 (Feagan, Siegel, Melmed, et al)
    • This data is also being presented at UEGW 2015 (see abstract # OP052)
  • Abstract # P1769: Vedolizumab Exposure in Pregnancy: Outcomes from Clinical Studies in Ulcerative Colitis and Crohn's Disease (Mahadevan, Dubinsky, Vermeire, et al)
  • Abstract # P1764: Efficacy and Safety of Vedolizumab with Advancing Age in Patients with Crohn's Disease: Results from the GEMINI 2 Study (Yajnik, Khan, Dubinsky, et al)

The following presentations will be held during UEGW:

On Monday 26 October

  • Abstract # P0346: Indicators of Suboptimal Therapy among Crohn’s Disease Patients treated with Tumor Necrosis Factor Antagonists: Results from a Multinational Study (Armuzzi, Lindsay, Mody, et al)

On Tuesday 27 October

  • Abstract # P0963: A Multinational Study to Determine Indicators of Suboptimal Therapy among Ulcerative Colitis Patients treated with Tumor Necrosis Factor Antagonists (Lindsay, Gisbert, Mody, et al)

On Wednesday 28 October

  • Abstract # P1589: Cost-Effectiveness of Vedolizumab Compared with Infliximab, Adalimumab, and Golimumab for treatment of Moderately-to-Severely Active Ulcerative Colitis in the United Kingdom (Wilson, Kerrigan, Smyth, et al)
  • Abstract # P1590: Cost-Effectiveness of Vedolizumab Compared with Conventional Therapy for Treatment Of Moderately-to-Severely Active Ulcerative Colitis in the United Kingdom (Wilson, Kerrigan, Smyth, et al)