Patients with moderate to severely active ulcerative colitis reported clinical improvements with up to 3 years of treatment with Entyvio, according to interim data from the GEMINI Long-Term Safety trial presented at the European Crohn’s and Colitis Organization’s Congress.
“Interim findings revealed very encouraging levels of remission for patients with ulcerative colitis with approximately 3 years of treatment and also provided valuable insights about how treatment history may impact treatment success,” Edward V. Loftus, Jr., MD, professor of medicine and gastroenterology at the Mayo Clinic in Rochester, Minn., said in a press release. “Achieving long-term remission is the treatment goal for all patients living with inflammatory bowel diseases, so it is essential that studies like this are conducted to help us understand the long-term efficacy and safety of the treatment options we prescribe.”
Edward V. Loftus, Jr.
Entyvio (vedolizumab, Takeda) is a gut-selective humanized monoclonal antibody that targets the alpha-4/beta-7 integrin, which was shown to be effective in treating UC in the GEMINI 1 study.
In GEMINI 1, researchers randomly assigned patients to two doses of vedolizumab or placebo during induction. Researchers then randomly assigned responders at week 6 to maintenance therapy every 8 weeks or every 4 weeks or to placebo. GEMINI LTS is an ongoing open-label extension study comprising 894 UC patients.
At the time of the analysis, 73 patients with moderately to severely active UC had completed 152 weeks of cumulative vedolizumab therapy. Among those who received vedolizumab every 8 weeks, 53% achieved remission, and among those who received vedolizumab every 4 weeks, 39% achieved remission. Patients who were anti–tumor necrosis factor naive had higher remission rates (8-week treatment group, 57%; 4-week treatment group, 43%) compared with those who were previously exposed to anti-TNF (8-week group, 48%; 4-week group, 29%).
Included in a total of 12 Takeda-sponsored abstracts on vedolizumab accepted for presentation at ECCO, was another retrospective analysis of individuals enrolled in GEMINI LTS, which demonstrated mucosal healing in patients with Crohn’s disease or UC after long-term treatment, according to the press release. Researchers evaluated data from 82 colonoscopies performed after a median of 2.7 years in 23 patients with CD and 39 with UC who received over a year of vedolizumab maintenance treatment every 4 weeks. Complete mucosal healing occurred in 44% of the CD colonoscopies and partial healing occurred in 38%. For UC colonoscopies, 54% achieved endoscopic healing with a Mayo score of 0 and 20% achieved healing with a score of 1.
“The pivotal phase 3 GEMINI clinical trial program was the largest ever conducted simultaneously in ulcerative colitis and Crohn's disease, and continues to yield a great depth of information around the safety and efficacy of vedolizumab,” Michael Smyth, MD, global brand medical director, gastroenterology, Takeda, said in the press release. – by Adam Leitenberger
Loftus EV Jr, et al. Abstract DOP051. Presented at: ECCO Congress; March 16-19, 2016. Amsterdam.
Disclosure: Healio Gastroenterology was unable to confirm Loftus’ relevant financial disclosures at the time of publication. Please see the ECCO disclosures database for all other researchers’ relevant financial disclosures. Smyth is employed by Takeda.