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GEMINI LTS Study: No New Safety Concerns for Vedolizumab in IBD
Long-term use of vedolizumab (Entyvio) is safe for the treatment of ulcerative colitis (UC) and Crohn disease (CD), according to final results from GEMINI long-term safety (LTS), a multinational, multicenter, open-label, phase 3 study. The final results were presented at Digestive Disease Week.
The study included 894 participants with UC and 1349 with CD who received intravenous vedolizumab, 300 mg every 4 weeks, after completing or withdrawing from a prior phase 2 study or one of the GEMINI phase 3 studies. Some enrolled as vedolizumab-naïve de novo participants.
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The participants had previously received at least 1 conventional therapy, such as corticosteroids or immunomodulators. Vedolizumab treatment was planned to last 9 years.
In all, 93% of the participants with UC and 96% of the participants with CD experienced an adverse event, the most common of which were exacerbations of UC (36%) and CD (35%). Nasopharyngitis occurred in 28% of those with UC and in 25% with CD.
Serious adverse events, the most common being disease exacerbations, were experienced by 31% of the participants with UC and by 41% of those with CD.
Overall, 15% of the those with UC and 17% of those with CD discontinued vedolizumab treatment due to adverse events. Exacerbation of UC (9%) and CD (8%) were the most commonly cited reasons for discontinuation.
The researchers observed no new trends for infections, malignancies, infusion-related reactions, or hepatic events, as well as no cases of progressive multifocal leukoencephalopathy.
The participants who received vedolizumab throughout the entire study had a sustained long-term clinical response. This evaluation of efficacy is limited, however, due to loss of patients to follow-up, according to the study authors.
“The final GEMINI LTS results provide evidence that vedolizumab has a safety profile suitable for long-term treatment of UC and CD,” the study authors concluded. “In this carefully monitored population receiving vedolizumab in a clinical trial setting, there continue to be no unexpected or new safety concerns.”
—Colleen Murphy
Reference:
Loftus EV, Colombel JF, Feagan BG, et al. Long-term safety of vedolizumab in ulcerative colitis and Chron’s disease: final results from the GEMINI LTS study. Presented at: Digestive Disease Week; May 18-21; San Diego, CA. https://www.gastrojournal.org/article/S0016-5085(19)37244-0/fulltext. Accessed May 24, 2019.
