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GEMINI: Entyvio safe in long-term IBD study
SAN DIEGO — Entyvio therapy is safe for the long-term treatment of Crohn’s disease and ulcerative colitis, according to the final results of the GEMINI trial, presented at Digestive Disease Week.
“This is the longest study of continuous vedolizumab (Entyvio, Takeda) exposure to date,” Edward V. Loftus, Jr., MD, of the Mayo Clinic in Rochester, Minnesota, said in his presentation. “This looked at both safety and efficacy of vedolizumab for both UC and Crohn’s disease, and this is the final analysis of that data.”
The GEMINI trial comprised 894 patients with UC and 1,349 with CD who participated in a planned treatment duration of 9 years. All patients received at least one prior conventional therapy.
Researchers observed adverse events in 93% of patients with UC, the most frequent of which was exacerbations (28%). Adverse events were reported in 96% of patients with CD, with the most common being nasopharyngitis (25%).
Investigators observed serious adverse events in 31% of patients with UC and 41% of patients with CD. Exacerbations were the most frequent events in both groups (13% in UC, 17% in CD).
Exacerbations were also the most common reason for discontinuation of the drug, with 9% in UC and 8% in CD. Overall, 15% of patients with UC discontinued due to severe adverse events compared with 17% of patients with CD.
Loftus and colleagues did not observe any new trends for infections, malignancies, infusion-related reactions or hepatic events. There were no new cases of progressive multifocal leukoencephalopathy. Ten patients died during the study (4 in UC, 6 in CD).
Although an expected patient loss to follow-up limited the study’s efficacy analysis, researchers found that patients who continued vedolizumab therapy throughout the entire study were able to maintain clinical response.
“Vedolizumab was safe and well-tolerated for long-term IBD treatment,” Loftus said. “The patients who stayed in the study continued to see favorable clinical outcomes, and these final data are consistent with what is previously known about the safety of vedolizumab.” – by Alex Young
Reference:
Loftus EV, et al. Abstract 835. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.
Disclosures: Loftus reports financial ties to AbbVie, Amgen, Celgene, Genentech, Gilead, Janssen, Pfizer, Seres, Takeda and UCB. Please see the meeting disclosure index for all other authors’ relevant financial disclosures.
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The main thing with the GEMINI study is that we have more than 2,000 patients who were treated long-term with Entyvio (vedolizumab, Takeda) in both ulcerative colitis and Crohn's disease.
Vedolizumab continues to show long-term efficacy, and although we don’t have direct head-to-head comparisons, the persistence on therapy with vedolizumab looks to be somewhat better than in trials of the TNF inhibitors.
It’s not a direct comparison, but there are several reasons why vedolizumab may work longer than TNF inhibitors. One instance is that vedolizumab has a different mechanism of action.
A second reason is that the half-life of vedolizumab is longer than the half-life of the TNF inhibitors, so there is also apparent less immunogenicity or less development of anti-drug antibodies. Those reasons may explain the apparent, and I emphasize apparent, better, long-term efficacy.
We’re not seeing new or unexpected side effects and in particular, in both cases, progressive multifocal leukoencephalopathy (PML), which we did not anticipate seeing because the mechanism of action is very different from the mechanism of action in tirofiban, although both are anti-integrins but nevertheless the FDA did put a warning against PML and to date we have not seen it in the IBD population.