Low Infection Risk With Ozanimod: New Long-Term Safety Data at a Glance
In this video, Amit Bar-Or, MD, FRCPC, gives an overview of encouraging findings regarding the long-term safety of ozanimod for relapsing forms of multiple sclerosis.
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Amit Bar-Or, MD, FRCPC, is chief of the Division of Multiple Sclerosis and Related Disorders, and director of the Center for Neuroinflammation and Experimental Therapeutics at the University of Pennsylvania.
Hartung HP, Cree BAC, Selmaj KW, et al. Low rate of infections with long-term use of ozanimod in relapsing multiple sclerosis trials (1596). Neurology. 94(15 suppl.). https://n.neurology.org/content/94/15_Supplement/1596
Amit Bar-Or, MD, FRCPC: Hello, my name is Amit Bar-Or. I'm a neurologist and neuroimmunologist and chief of the Division of MS and Related Disorders at the University of Pennsylvania, where I also direct the Center for Neuroinflammation and Experimental Therapeutics. And today, we'll talk about ozanimod, or Zeposia, and results from long-term extension data, in particular in relation to infection rates.
There were no surprises, and in fact, the rates remained very low in keeping with what one would expect in the background population. Nothing additional in terms of concerning signals identified for serious infections or opportunistic infections now, with over 7000 patient years of follow-up on ozanimod, which overall is very reassuring and in keeping with the profile of this drug as having clear efficacy on relapsing multiple sclerosis, while being both very well-tolerated and with an excellent overall safety profile.
As far as the future, one would still be interested in continuing to follow patients in the context of ozanimod treatment. There may be an importance of understanding what happens in the context of COVID, of course, in the context of vaccinations, and that's going to be important to understand for any medicine including ozanimod in the post-COVID and COVID vaccine era.
Additional questions: there had been no concern raised in the context of pregnancies. Of course, one is advocating individuals avoid getting pregnant on any of the MS therapies, including ozanimod, but in some individuals who did get pregnant during treatment, there was no obvious additional risk associated, but one would like to see more such data over time.