Transcript
Announcer:
This is Living Rheum on ReachMD. On this episode, we’ll learn about emerging therapies and clinical trial progress for Sjögren's disease from Dr. Nancy Carteron. She’s a Health Sciences Clinical Professor at the University of California Berkeley School of Optometry and a Co-Investigator of the Accelerating Medicines Partnership Autoimmune and Immune-Mediated Diseases Program. Here’s Dr. Carteron now.
Dr. Carteron:
After a lot of advocacy from patient groups, the Sjögren’s Foundation, clinicians who've seen Sjögren’s, and working with pharmaceutical companies over 15 years, we're now at the point where we at least have this outcome measure that's been met by two clinical development programs. And that data was presented at the American College of Rheumatology last year.
There's one for a product called ianalumab, which is a B-cell targeting agent that the FDA is currently reviewing the package of, and it could be any day now that we hear whether they're going to approve it or not. And then there's another product that's also B-cell targeted with another mechanism that was developed in China. And it's now approved in China for Sjögren’s, as well as for lupus and rheumatoid arthritis. But there's another company that's taken over that licensure to develop it in the rest of the world. And so there's another phase three trial in the United States and other countries looking at that product as well.
There's no labeled product, except in China now, for systemic manifestations of Sjögren’s anywhere. And I think that's been such a hurdle in clinicians' awareness about the severity of the whole spectrum: the fact that they've had to rely on using off-label drugs, which is even harder in the US now to get approved through our insurance structure.
If and when—but hopefully soon—we get a labeled indication for the systemic manifestations of Sjögren’s, I think that will be a real game changer, both for physicians' education and interest and for patients. Then we'll have to figure out who's best to use it, but that's a good place to be.
And right behind them are a number of other companies that have products in development that are targeting different pathways in the immune system in Sjögren’s. We know that it involves a wide spectrum. So I think there's going to be the opportunity to really begin to tease apart things that have been life-altering for patients, like the fatigue. That fatigue component may be more modifiable by agents that target interferon pathways, for example, as opposed to the B-cell pathway. But I think, intuitively, we certainly would expect that by targeting the B-cell pathway, those patients will be less likely to develop some of the more severe manifestations of Sjögren’s, like lymphoma, maybe even some of the neuropathies, and certain kinds of lung disease that patients have.
Announcer:
You just heard Dr. Nancy Carteron talking about the drug development pipeline for Sjögren's disease. To access this and other episodes in our series, visit Living Rheum on ReachMD.com, where you can Be Part of the Knowledge. Thanks for listening!
