Ulcerative Colitis Resource Center

Ulcerative Colitis Resource Center

Disclosures: The study was sponsored by Takeda. Loftus reports receiving financial support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Gilead, Janssen, Pfizer, Receptos, Robarts Clinical Trials, Takeda, and UCB; and consulting for AbbVie, Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion Healthcare, Celgene, Eli Lilly, Gilead, Genentech, Janssen, Pfizer, Takeda and UCB.
September 08, 2020
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GEMINI: Entyvio safety profile favorable in long-term use

Disclosures: The study was sponsored by Takeda. Loftus reports receiving financial support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Gilead, Janssen, Pfizer, Receptos, Robarts Clinical Trials, Takeda, and UCB; and consulting for AbbVie, Allergan, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion Healthcare, Celgene, Eli Lilly, Gilead, Genentech, Janssen, Pfizer, Takeda and UCB.
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The safety profile of Entyvio remained favorable through 8 years of use in patients with inflammatory bowel disease, according to results from the GEMINI long-term safety study.

Edward V. Loftus, MD, professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn., and colleagues wrote that previous research has shown that Entyvio (vedolizumab, Takeda) therapy was effective and well-tolerated up to 1 year in patients with ulcerative colitis or Crohn’s disease.

“The GEMINI long-term safety study continued assessment of patients treated in the GEMINI studies, in addition to enrolling vedolizumab-naive patients, with the primary goal of evaluating the long-term safety of vedolizumab in patients with UC or CD,” they wrote. “Interim analyses (based on 4 years of follow-up) demonstrated that long-term vedolizumab therapy was well-tolerated and also provided clinical and health-related quality of life benefits.”

The GEMINI long-term safety study comprised 894 patients with UC and 1,340 patients with CD who were either previously enrolled in other clinical trials or were naive to vedolizumab treatment. Researchers also assessed the drug’s efficacy as an exploratory endpoint.

Patients received 300 mg of vedolizumab every 4 weeks and had a median cumulative exposure of 42.4 months in UC and 31.5 months in CD.

Over the course of 8 years, 93% of patients with UC and 96% of patients with CD experienced adverse events. The most common adverse event was disease exacerbation, which was reported in 31% of patients with UC and 41% of patients with CD.

In UC, 31% of patients reported serious adverse events, while 41% of patients with CD reported serious adverse events. Discontinuation rates due to adverse events were 15% in UC and 17% in CD.

Of the 10 deaths reported during the study, local investigators considered just two to be drug-related. Investigators did not identify any new trends for infections, malignancies, infusion-related reactions or hepatic events, and found no cases of progressive multifocal leukoencephalopathy.

At 400 treatment weeks, 33% of patients with UC and 28% of patients with CD maintained clinical response.

“The final analysis of GEMINI long-term safety study comprehensively demonstrates that vedolizumab therapy has a safety and tolerability profile suitable for long-term treatment of patients with moderately to severely active UC or CD,” Loftus and colleagues wrote. “This is a key consideration in the management of IBD given that they are chronic conditions that typically require lifelong therapy.”