Stephen Krieger, MD; Daniel Bandari, MD, MS; Bruce Hughes, MD; Mitzi Williams, MD; and Heidi Crayton, MD, examine the safety of sphingosine 1-phosphate receptor modulators for the treatment of multiple sclerosis.
Stephen Krieger, MD: Well, let’s conclude this portion by thinking about some long-term safety things relating to our newer medicines. One of the nice things about having had a class of drugs, S1Ps [sphingosine 1-phosphate receptors], for over a decade is we have a little bit of a comfort zone about the long-term safety. But we are now starting to get that with our second generation S1Ps, which are now the data from the pivotal trials that are maturing. We’re seeing a couple of years down the line to ensure that people remain safe on these drugs. We do want to treat for the long term. So there have been presentations of data on the SUNBEAM, RADIANCE, and DAYBREAK studies. These were the series from ozanimod.
We’ve had data now from these longer-term extensions for our newer S1P modulators. Have there been any safety issues that you’ve seen of concern Dr Hughes, either in the long-term extensions from the more selective S1Ps or in your practice using them for these past couple of years?
Bruce Hughes, MD: Yes. I’d say the answer is no to both and that this data is very reassuring when you look at the long-term data that more serious adverse events didn’t suddenly pop up after 3, 4, 5 years of treatment. And I think that’s what I’m seeing in clinical practice.
Heidi Crayton, MD: I totally agree with that. I think it’s comforting to see when long-term safety data mirrors what we saw in the original 2 years of clinical trials, and I would echo what Dr Bruce Hughes just mentioned. I really have not seen anything untoward in my clinical experience either long-term, which is reassuring.
Stephen Krieger, MD: Yeah. We’ve learned in our field, the idea of PML [progressive multifocal leukoencephalopathy] being a risk with natalizumab treatment wasn’t something that was really appreciated during the study. It was something that emerged after the studies that occurred during the trial, or in that cohort. I think these long-term extensions like the DAYBREAK series for ozanimod have the potential for revealing things. Anything that you’ve seen that is of concern to you?
Mitzi Williams, MD: Not so far. My experience has been similar to my colleagues that have mentioned things on the panel. I haven’t seen any additional safety concerns. And I think that, as you said, it’s something that we continue to monitor. One of the things that I always keep in the back of my mind is, how do safety and efficacy work in terms of the sequencing of therapies? As our treatment options become broader, I also think about when we begin to consider the de-escalation of therapy. How will these things potentially change over time? But so far, it’s been pretty similar to what’s been in the clinical trials.
Stephen Krieger, MD: Great.
Transcript edited for clarity