Stephen Krieger, MD, spoke about the phase 3b NOVA study (NCT03689972) data presented at AAN 2022 on natalizumab (Tysabri; Biogen) dosing regimens.
Stephen Krieger, MD: At the American Academy of Neurology Annual Meeting this year, John Foley, MD, presented outcomes from the NOVA study, which was looking at extended interval dosing with natalizumab. The goal here is to try to maintain the efficacy of natalizumab, building on the idea that extending out the dosing could decrease PML [progressive multifocal leukoencephalopathy] risk. This project has been going on for a couple of years, and it allows us to try to personalize the dosing a little bit to optimize the risk-benefit ratio.
It's an interesting set of outcomes that Foley presented. For the most part, Q6 week dosing was just as effective efficacious as Q4-week dosing in terms of relapse outcomes and new MRI lesions. But there were a few outlier patients that had extensive inflammatory disease activity. And there was also a patient that did develop PML in the study. So, in a trial that's looking to try to minimize risk of PML, and show that we can ensure the continued efficacy of the drug, there were these outliers.
I think it's, on the whole, reassuring that Q6-week dosing of natalizumab will be effective. But I think it points out that we need to keep vigilant for rare things. We need to keep on the lookout for MS rebound. And, of course, for anyone on natalizumab—even on extended interval dosing—we have to be vigilant for PML. The risk is never zero, rare things do happen. I want to give credit to Foley and to Biogen for being very clear in how they communicated those outcomes even, though they make it a little bit more complicated perhaps.
Transcript edited for clarity.