NeuroSpeak: finally the EMA gives update on DMF

Finally the EMA has an opinion on DMF-related lymphopaenia. Thank you. #MSBlog #NeuroSpeak

"The following is the provisional update from the EMA regarding dimethyl fumarate or DMF (Tecfidera)."


Having reviewed the available information on the risk of PML, EMA has recommended the following to minimise this risk with Tecfidera:

"For how long? Biogen's data states that if you don't develop lymphopaenia in the first year you are unlikely to do so; why then do we need to continue 3-monthly monitoring indefinitely?"

"I don't agree with this cut-off. Why? There have been two cases of PML in patients with psoriasis on fumarates who developed PML with a lymphocyte count above 0.5, but below 0.8. This is why I will stick to 0.8 as my cut-off. However, I suspect JCV-serostatus may play a role here. If you are JCV-ve the risk of PML will be low."

"This is stating the obvious."

"No comment!"

"No comment!"

"No advice on treating PML? This may be an indication for a donor lymphocyte transplant from a MHC identical donor who is JCV+ve. What these patients need is a robust and quick cytotoxic CD8+ lymphocyte response against JCV infected cells so that they can recover from their PML. The latter is an experiment waiting to happen."

"Good point. As I have said before if you switch from other immunosuppressive drugs you are likely to take some risk with you. PML is a complex process with the virus needing to mutate and acquire several mutations. The latter are unlikely to unwind on switching therapies."

EMA Update on Tecfidera from Gavin Giovannoni

CoI: multiple

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