ACTRIMS 2020 News Network: APLIOS Bioequivalence Study on Relapsing MS


Patricia K. Coyle, MD: There was an interesting late-breaking study on ofatumumab. Ofatumumab is a human anti-CD20 monoclonal antibody. It's given subq [subcutaneous] monthly, 20 mg. They give it weekly 3 times initially, and this is an anti-CD20 that lowers B-cell count. It lyses B cells. They actually looked at how quickly it lowered the B-cell count, which was very quickly. You're talking about within 2 or 3 weeks, and the B-cell count remained low throughout the course of treatment. In addition, it didn't seem to matter what part of your body was getting the subq injections, you had a very complete lowering of the B-cell count. They also did do an analysis of injection issues because this is going to be a subq home delivery, and the injection reactions seem to be very mild. They were most pronounced with the very first subq injection of the ofatumumab product and then didn't really seem very bad at all.

Ofatumumab is not yet approved, but it's going to be approved. It's going to give us an alternative high efficacy anti-CD20 that can be given at home subq. It's reassuring that you saw an excellent lowering of the B-cell count throughout. It is also somewhat reassuring that the subq injection seemed to be extremely well tolerated.

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