Takeda highlights safety, efficacy of vedolizumab for UC and CD at ACG Annual Scientific Meeting

Takeda Pharmaceuticals, U.S.A., Inc. ("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.

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 BG, Siegel CA, Melmed GY, et al.), will be featured during the ACG meeting.

"We are pleased with how physicians and patients have received vedolizumab in the U.S., and we are committed to continued scientific exploration of this compound to support the GI community," said Karen Lasch, M.D., Executive Medical Director- GI Medical Affairs, U.S. Region, Takeda Pharmaceuticals. "At ACG, we have the opportunity to engage in valuable discussions, and this scientific exchange helps us focus on supporting UC and CD patients."

Vedolizumab was approved as a humanized monoclonal antibody available in the United States (U.S.), under the trade name Entyvio^® (vedolizumab). It is the first and only biologic therapy to be approved 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 the 2015 American College of Gastroenterology (ACG) Annual Scientific Meeting is as follows:

On Sunday 18 October

• Abstract: Corticosteroid Dose Reduction in Ulcerative Colitis Patients Treated with Vedolizumab During the GEMINI 1 Trial (Loftus EV, Siegel CA, Panaccione R, et al.)
• Abstract: Corticosteroid Dose Reduction with Vedolizumab Treatment of Crohn's Disease During the GEMINI 2 Trial (Loftus EV, Siegel CA, Panaccione R, et al.)
• Abstract: Characteristics of Patients with Ulcerative Colitis initiating Vedolizumab Therapy in Real-World Clinical Practice (Reynolds M, Alam N, O'Hara D, Smyth MDL, Khalid JM)
• Abstract: Characteristics Of Patients with Crohn's Disease initiating Vedolizumab Therapy in Real-World Clinical Practice (Reynolds M, Alam N, O'Hara D, Smyth MDL, Khalid JM)
• Abstract: Regional Variation in Quality of Care for Inflammatory Bowel Disease in the United States (Rubin DT, Patel H, Shi S, Mody R)
• Abstract: Epidemiology of Inflammatory Bowel Disease (IBD) and Use of Biologic Therapy in the United States (US): A Retrospective Claims Database Study (Rubin DT, Patel H, Shi S, Mody R)
• Abstract: Indicators of Suboptimal Biologic Therapy in Patients with Ulcerative Colitis or Crohn's Disease in the United States (Mody R, Patel H, Rubin DT)
• Abstract: Characteristics of Patients Treated with Vedolizumab for Inflammatory Bowel Disease in the United States (Chastek B, Patel H, Mody R)

On Monday 19 October

• Abstract: 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 WJ, Vermeire S, Sands BE, et al.)

On Tuesday 20 October

• (Oral Presentation) Abstract: Efficacy of Vedolizumab Maintenance Therapy with and without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2 (Feagan BG, Siegel CA, Melmed GY, et al.)
• Abstract: Vedolizumab Exposure in Pregnancy: Outcomes from Clinical Studies in Ulcerative Colitis and Crohn's Disease (Mahadevan U, Dubinsky M, Vermeire S, Abhyankar B, Lasch K)
• Abstract: Efficacy and Safety of Vedolizumab with Advancing Age in Patients with Crohn's Disease: Results from the GEMINI 2 Study (Yajnik V, Khan N, Dubinsky M, et al.)