Takeda Pharmaceuticals International has reported new data from GEMINI LTS (long-term safety), an ongoing, open-label extension Phase III trial of Entyvio (vedolizumab) to treat adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD).
Vedolizumab is a gut-selective humanised monoclonal antibody that has recently been made available in the US and the EU, while it is also approved in Australia under the trade name Entyvio.
The company said that two of the abstracts show that the efficacy observed in vedolizumab Phase III induction and maintenance trials of 52 weeks, was maintained over the course of an additional 52 weeks of open label follow up.
The data from this trial will be presented during the 21st United European Gastroenterology Week (UEGW) in Vienna, Austria.
The Phase III GEMINI LTS trial will enrol patients who completed or withdrew early from the double-blind, randomised, placebo-controlled maintenance trials GEMINI 1 and 2.
According to the company, patients included in the Efficacy Population (GEMINI completers) received vedolizumab 300mg IV doses every four weeks (Q4W).
Of the UC patients who completed GEMINI 1 and enrolled in GEMINI LTS trial, 66% were in clinical remission at week 52, while 73% were in clinical remission at week 104.
Additionally, 79% patients had clinical response at week 52 and 80% had clinical response at week 104.
University Hospitals Leuven professor Severine Vermeire said: "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.
"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 the first and only biologic therapy to be approved in the EU 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 tumour necrosis factor-alpha antagonist.
Takeda Pharmaceuticals General Medicine vice-president Global Medical Head Michael Smyth said: "We are focused on the ongoing study of vedolizumab for ulcerative colitis and Crohn’s disease, with a goal of continuing to identify how we can further support the patient and professional communities.
"It is therefore encouraging to see initial data from the ongoing long-term extension study that explores the possible utility of vedolizumab Q4W dosing for some patients."