VISIONARY 2-Year eGFR Data in IgA Nephropathy

This is, I think, really reassuring, um, as we think about, you know, how we're gonna treat these patients going forward.

And I think one of the other questions that comes up is, you know, what happens to immunoglobulin levels? And maybe, Dana, you could comment on was there a cutoff of, um, IgG levels for patients that were enrolled in this trial?

So they did have-- Uh, I think their IgG level had to be over six hundred at study entry.

We did track immunoglobulin levels, all three immunoglobulin levels, A, G, and M.

Uh, that data will be reported, um, soon.

We did not have it in time for the GlomCon presentation.

But, uh, as importantly, to look at adverse events in the context of low immunoglobulin levels, uh, if any.

And so we will share that data pretty soon.

Uh, because to your point, it is important, again, as we modulate these B cells to keep an eye on the immunoglobulin levels.

Absolutely.

And, I mean, you know, as we think about monitoring these patients in, in-

Yeah

... you know, the real world, and we have these conversations at meetings-

Exactly

... you know, when, uh, do we need to be concerned? And, you know, is there a time point that we might need to hold drug? Or if they're not having infections, can we continue? I think those are the sorts of, you know, real world things that nephrologists are going to grapple with now that, um, the drug's available in some parts of the world, and hopefully will become available in other parts of the world soon.

Um, one of the other things, Dana, that I was wondering, so I know Uh, you may not have this data yet, but have you guys looked at or have you- are you planning on looking at, um, subgroups of UPCR less than two grams? So we know that patients in this trial entered at, say, 0.75 grams per gram, I believe, or greater than one gram per day on a 24-hour urine collection.

Is that something you guys will be looking at in the patients who, you know, were at lower grades of proteinuria and, and how they might compare?

Yeah, absolutely.

I think we need to slice and dice this data the best we can, and all these kind of post-hoc analyses would be helpful, again, for clinicians to get- give them, uh, guidance.

We, you know, would wanna look at people that achieve also proteinuria outcomes set forth by the guidelines.

We talked about the eGFR high bar, but they set also a very high proteinuria bar to try to get people to less than 0.5 gram per day or less than 0.3 if we can, which, um, a- again, not many people can get to that level.

And what would that mean in the future, uh, in the context of a stable eGFR? Uh, I mean, I don't know.

Um, I know Brendan challenged me to that question when we were in, in Maui, and it is hard to believe that residual proteinuria would not have any impact.

I mean, I'm still a little bit nervous leaving people proteinuria, even if their eGFR is stable.

I think we'll need longer term data, and some of it will come from the open label extension, uh, hopefully.