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Indications for belimumab, a monoclonal antibody, as therapy for patients with systemic lupus erythematosus.
Fotios Koumpouras, MD, FACR: Lots of new therapies have emerged for lupus. When I say lots, I mean 3. But 3 is a lot more than 0 over the last certain number of years.
Ronald van Vollenhoven, Prof. PhD: Very well put.
Fotios Koumpouras, MD, FACR: It’s exciting because these are therapies that have been developed for lupus, whereas many of the other drugs we use are repurposed for use in SLE [systemic lupus erythematosus]. What do you think is very exciting in treatment advances for SLE? We can start with general lupus.
Ronald van Vollenhoven, Prof. PhD: What’s exciting is how there are new treatments coming to the fore for lupus. As you said, that hasn’t happened for a long time. We’re seeing completely new therapies, but also very effective ways of using therapies that have been with us for a little while. There’s also a lot in the pipeline. We’re at a watershed in the history of lupus therapeutics. We’re a little different in Europe from the United States. We’ve had belimumab available for about 10 years. It was available for treating general lupus, meaning not lupus nephritis specifically but other manifestations of lupus. It has slowly but surely become a staple of treatment of lupus, a real drug that’s being used. It is a bit targeted on patients who have the serological activity, the anti-DNA, or the low complement to support the strength of the effectiveness.
For those patients where it works, we’re very happy also because it’s very well tolerated in the long term. This is a treatment that, if it helps the patient, is something they can live with. We’re interested in long-term consequences of the disease, which can be quite devastating. But then if you control disease, some drugs can have long-term consequences that aren’t great, especially glucocorticoids but also other drugs. With belimumab, the long-term data are very positive.
That’s been around, but we didn’t know all this until the data started coming in from long-term follow-up studies and additional analysis. We’re learning how to use that drug in better ways. You’re probably thinking it’s also been approved for lupus nephritis. But for general lupus, that’s the 1 drug that has been coming very much in its right.
The difference with the United States is that anifrolumab, which is new, has only very recently received approval from the European Medicines Agency. I don’t believe it’s even formally been ratified by the European Commission, but I could be wrong. In other words, we don’t have it available. We’re eagerly waiting and anticipating that we’ll start treating also some patients with that new drug.
Fotios Koumpouras, MD, FACR: That’s terrific. You’re right aobut belimumab, a brand-new drug that was developed for lupus. For those who may not know, belimumab is a monoclonal antibody that inhibits something called soluble BLyS, or BAFF, or B lymphocyte stimulator. This is a very important molecule in lupus because high levels of BLyS keep B-cell memory populations stagnant, so they don’t undergo apoptosis. The idea is that if you use a monoclonal antibody against BLyS, these cells can become inhibited and to go apoptosis and you have amelioration of symptoms. One issues with belimumab is delay to improvement, but I’ve been happy with its tolerance. It seems to have indication across disease spectrum, including nephritis, as you pointed out.
Transcript Edited for Clarity