Review of Long-Term Data on Ozanimod's Low Infection Risk, Favorable Safety Profile
In this video, Amit Bar-Or, MD, FRCPC, discusses new long-term data that show a favorable safety profile over time with the use of ozanimod among patients with relapsing forms of multiple sclerosis (transcript below).
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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.
Ozanimod, or Zeposia, is a sphingosine 1-phosphate receptor modulator, which is selective to the S1P receptor-1 and 5, approved for relapsing multiple sclerosis based on a clinical trial program that involved 2 phase 3 trials, the RADIANCE and SUNBEAM, and identified that compared to interferon beta-1a, that ozanimod essentially did not increase the risk of infections. That was in the context of the standard length of clinical trials.
But the open-label extensions have provided considerably more follow-up data, and today we'll be focusing on what the long-term extension data and the longer-term follow up may teach us about the infection rates seen with ozanimod.
The most important findings were that, with the long-term extension data, tere was no suggestion of an increased rate of infections with ozanimod, and to put that into perspective, the phase 3 trial clinical program involved a group of individuals, 882 participants, who were followed for approximately an average of 18 months, whereas the extension data includes a cohort of individuals of whom 90% were still represented from the phase 3 trials entering what was called the DAYBREAK open-label extension study
And there, we’re looking at approximately 32-month average follow-ups, almost twice as long, and whereas there were about 1300 patient-years of data from the phase 3 clinical trial program, we're now looking at data from over 7000 patient-years. And the good news was that with this longer-term duration and open-label extension, there were essentially no issues in terms of changes and rates of infection and certainly nothing in the way of serious infections.
They were similar to what was seen in the up to 24-month exposure in the phase 3 clinical trials. In particular, there were no serious opportunistic infections reported with ozanimod at the dose cutoff used in the studies, and there was also no association between absolute lymphocyte count, which is often a question that is raised, and the risk of serious or opportunistic infections.