The rationale for treating lupus nephritis with novel therapies such as belimumab and voclosporin.
Ronald van Vollenhoven, Prof. PhD: Some of these trials are also specific for lupus nephritis, and we didn’t talk about it much because that’s a different situation. Belimumab, which has been around for a long time, was only very recently approved for lupus nephritis, but it did seem to work very well in the clinical trial. We’re also going to have to experience it in practice and see, how do we use it, how does it work? In the United States, you have another new drug for lupus nephritis specifically, right?
Fotios Koumpouras, MD, FACR: That’s right. It’s called voclosporin. It’s an old calcineurin inhibitor that has been repurposed and studied in lupus nephritis. It was initially developed for the transplant space but didn’t move forward there. But it’s a calcineurin inhibitor that’s got very good pharmacokinetics, so it can be used safely at a wide dose range in most patients with varying levels of kidney disease. It showed a very potent effect in reducing proteinuria rapidly, I think at 3 months. It’s a very promising therapy used in combination with mycophenolate, which is what the study was after typical induction, to get patients in remission. I looked at that trial deeply, and I calculated a number needed to treat. The number needed to treat for voclosporin, to get them to the primary end point of 500 mg, was 5 patients.
Ronald van Vollenhoven, Prof. PhD: Which is very respectable, right?
Fotios Koumpouras, MD, FACR: I think it’s very respectable. For lupus nephritis, we were expecting 30% of patients to get some kind of complete response.
Ronald van Vollenhoven, Prof. PhD: Yeah, it’s true.
Fotios Koumpouras, MD, FACR: What do you think? Are your patients in Amsterdam able to tolerate mycophenolate well at these doses? I’m curious.
Ronald van Vollenhoven, Prof. PhD: Some are, some aren’t. It’s very variable. If you take all the patients, we can still have confidence in prescribing mycophenolate, but we do have to warn the patients that some can’t tolerate it. In part, it’s because of subjective tolerability issues or patient experience—nausea, gastrointestinal adverse effects. Then there’s the monitoring required and the cytopenia toxicity, which can occur rarely. You have to know these things about mycophenolate before you start using it. It’s a tricky drug, but it can work very well for some patients.
Transcripts Edited for Clarity