Nipocalimab Benefits Hold Up at 2 Years in Teens With Myasthenia Gravis

— Long-term Vibrance-MG data showed sustained efficacy with no new safety concerns

Two-year results from the phase III Vibrance-MG studyopens in a new tab or window presented at the American Association of Neuromuscular & Electrodiagnostic Medicineopens in a new tab or window annual meeting showed that the benefits of nipocalimab (Imaavy) were sustained in adolescents with generalized myasthenia gravis with no new safety concerns emerging during longer-term treatment.

In this exclusive MedPage Today video, Jonathan Strober, MD, of University of California San Francisco Benioff Children's Hospital, discusses the updated findings, including sustained improvements in measures of disease severity and the potential for reducing steroid use.

Following is a transcript of his remarks:

We've all been very excited about the results. What the drug [nipocalimab] does is it helps lower the antibody levels in the blood. So myasthenia being an autoimmune condition, being led by the abnormal antibodies that are causing the problems between the muscle and the nerve, and so this is just one way of trying to help fix that problem in these patients.

And so what we found is that there was a decrease in the antibody levels in the patients. Luckily, it's not a significant enough drop that the immunity is really affected. So it's pretty well tolerated by most patients. And then we looked at how it actually affected them functionally. So just because we're lowering the antibodies doesn't mean that we're actually going to make a difference in their disease. But it did show that over time, pretty quickly, there was a decrease in the two scales that we look at, the QMG, which is the Quantitative Myasthenia Gravis scale and the MG-ADL, which is activities of daily living scale.

And so there was significant reduction in those numbers, so improvement in patients' lives. And then that is what we saw initially, and then we now are seeing that that is being continued to be carried out over the 2-year period.

The other thing that was super positive about this, so a lot of times when we see these patients, we treat them with steroids, which are awful and horrible and terrible, but they kind of help get the disease under control pretty quickly. And so we always look for what we call steroid-sparing agents, like how do we get them off steroids? And then the patients in the study, most of them were able to actually reduce their dose or even come off steroids completely, which was really nice too.

Pediatrics is an odd one compared to adults. Stuff that you get when you're an adult typically stays with you for adulthood. In pediatrics, we know that there can be a higher rate of remission for a lot of these patients. You do see remission in some adults, but I'm definitely looking forward to the younger data because the kids that start things before puberty, often as puberty goes through, things change. But because a lot of these patients were towards the later end of adolescence and therefore the question is always, can this be something that we're going to be able to continue through adulthood as we transfer them over to the adult side?

And right now it's looking like yes, even if they need to be on it for years, it still works for them, and at low risk. Like I said earlier, the concern is always when you're affecting the immune system, is there higher risk of infection? And while there are some infections, it's probably some of the more common side effects that we see here, there weren't any real significant ones that made people have to stop taking the drug completely. I think there was one patient who stopped it for a little bit, but then was able to restart on it.