DustyKat
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Takeda Pharmaceuticals International GmbH ("Takeda") have announced that new data from GEMINI LTS (Long-Term Safety), a Phase 3, ongoing, open-label extension study of Entyvio® (vedolizumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) will be presented as oral presentations during the 21st United European Gastroenterology Week (UEGW) in Vienna, Austria.
Two of the abstracts demonstrate that the efficacy observed in vedolizumab Phase 3 induction and maintenance trials of 52 weeks was maintained over the course of an additional 52 weeks of open label follow up.
Patients who completed or withdrew early from the double-blind, randomized, placebo-controlled maintenance studies GEMINI 1 and 2 were eligible to enrol in GEMINI LTS. Patients included in the Efficacy Population (GEMINI completers) received vedolizumab 300 mg IV doses every four weeks (Q4W).* Of the UC patients who completed GEMINI 1 and enrolled in GEMINI LTS, 66 percent were in clinical remission at week 52 and 73 percent were in clinical remission at week 104. In addition, 79 percent had clinical response at week 52 and 80 percent had clinical response at week 104.
Of the CD patients who completed GEMINI 2 and enrolled in GEMINI LTS, 57 percent were in clinical remission at week 52 and 61 percent were in clinical remission at week 104. In addition, 81 percent had clinical response at week 52 and 74 percent had clinical response at week 104. Although open-label, these data add to the evidence bank of vedolizumab, supporting the positive findings of the pivotal Phase 3 GEMINI 1 and 2 studies, which assessed the efficacy and safety of adult patients with moderately to severely active UC and CD, respectively, over 52 weeks.
"Ulcerative colitis and Crohn's disease are chronic diseases that can have a serious impact on patients. As physicians, our aim is to help patients achieve and maintain disease remission," said Prof. Dr. Severine Vermeire, University Hospitals Leuven, Belgium. "Current findings from the long-term extension study add to the evidence bank of vedolizumab as a long-term treatment option for people with ulcerative colitis and Crohn's disease."
Vedolizumab is a gut-selective humanized monoclonal antibody that has recently been made available in the United States and the European Union, and has also received approval in Australia, under the trade name Entyvio® (vedolizumab). It is the first and only biologic therapy to be approved in the European Union 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.
http://www.medicalnewstoday.com/releases/283466.php
Two of the abstracts demonstrate that the efficacy observed in vedolizumab Phase 3 induction and maintenance trials of 52 weeks was maintained over the course of an additional 52 weeks of open label follow up.
Patients who completed or withdrew early from the double-blind, randomized, placebo-controlled maintenance studies GEMINI 1 and 2 were eligible to enrol in GEMINI LTS. Patients included in the Efficacy Population (GEMINI completers) received vedolizumab 300 mg IV doses every four weeks (Q4W).* Of the UC patients who completed GEMINI 1 and enrolled in GEMINI LTS, 66 percent were in clinical remission at week 52 and 73 percent were in clinical remission at week 104. In addition, 79 percent had clinical response at week 52 and 80 percent had clinical response at week 104.
Of the CD patients who completed GEMINI 2 and enrolled in GEMINI LTS, 57 percent were in clinical remission at week 52 and 61 percent were in clinical remission at week 104. In addition, 81 percent had clinical response at week 52 and 74 percent had clinical response at week 104. Although open-label, these data add to the evidence bank of vedolizumab, supporting the positive findings of the pivotal Phase 3 GEMINI 1 and 2 studies, which assessed the efficacy and safety of adult patients with moderately to severely active UC and CD, respectively, over 52 weeks.
"Ulcerative colitis and Crohn's disease are chronic diseases that can have a serious impact on patients. As physicians, our aim is to help patients achieve and maintain disease remission," said Prof. Dr. Severine Vermeire, University Hospitals Leuven, Belgium. "Current findings from the long-term extension study add to the evidence bank of vedolizumab as a long-term treatment option for people with ulcerative colitis and Crohn's disease."
Vedolizumab is a gut-selective humanized monoclonal antibody that has recently been made available in the United States and the European Union, and has also received approval in Australia, under the trade name Entyvio® (vedolizumab). It is the first and only biologic therapy to be approved in the European Union 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.
http://www.medicalnewstoday.com/releases/283466.php
