An overview of fumarates available as treatment for relapsing multiple sclerosis and recommendations for counseling and caring for patients on these therapies.
Patricia Melville, RN, MSN, NP-C, MSCN: As with the S1Ps [sphingosine-1-phosphates], we have several fumarates that are now available on the market. The first one, dimethyl fumarate, was approved in 2012-2013. It’s now available through a generic formulation, which has created all sorts of havoc with our patients. I don’t know what all your experiences have been, but we get phone calls all the time with patients telling us that their pharmacy is now sending them the generic, and they didn’t give permission for the generic to arrive, etc. There is now another version of a fumarate that came about a year or two ago called diroximel fumarate. They took the molecule of dimethyl fumarate. They were able to manipulate it by adding a nitrogen dioxide compound to it, and they were able to get this approved through an FDA program where they were able to use efficacy and clinical safety data from the dimethyl fumarate trial. This is called Vumerity. They’ve done head-to-head studies with dimethyl fumarate versus diroximel fumarate; by manipulating that molecule, they were able to improve tolerability, there’s less in the way of GI [gastrointestinal] adverse effects. They measured this through a self-report scale that looked at the number of days that patients were affected by GI symptoms. And patients taking diroximel fumarate were less effected by GI symptoms than those taking dimethyl fumarate. There was not as much of a benefit shown in the flushing, but frankly, the primary outcome for that study, the EVOLVE study, was primarily looking at GI adverse effects.
There’s now been a new player on the market in the fumarate category, and this is monomethyl fumarate, which is more of a pure form, if you will, of the fumarate. Both dimethyl fumarate and diroximel fumarate undergo esterase conversion, and they turn into monomethyl fumarate. We now have a pure form of that, a monomethyl fumarate called Bafiertam, which came onto the market about a year or so ago. This is a purer form of the other 2 fumarates. The company that makes this has put out a press release, again about a year or so ago, indicating that this was going to be much cheaper for patients than the other 2 fumarates that are on the market. I have not seen that come to fruition yet. I haven’t had patients come to me to tell me that the insurance is requiring them to switch to Bafiertam, but I suspect that this might be something coming down the road.
In all 3 of these cases, the patients are titrated. They work their way up in the case of dimethyl fumarate and Bafiertam to 1 pill twice a day. And the case of diroximel fumarate, it’s 2 pills twice a day. There have been some concerns about adherence with these medications because they are BID [twice a day] dosing. This is something that, again, you need to have a really very open and honest dialogue with your patients to see if indeed they are taking the medication. If they believe they can comply with a BID dosing schedule, discussing things like taking the medication with food is something that is going to be an important part of your planning. And then of course there is onboarding blood work that needs to be done. And then periodically, while they’re on the medication, you’re going to be monitoring them with a CBC [complete blood count], particularly looking at lymphocyte count, and LFTs [liver function tests].
Amy Perrin Ross, APN, MSN, CNRN, MSCN:Thank you all so much. I would like to thank this wonderful panel, Christen Kutz, Stephanie Agrella, Bryan Walker, and Patricia Melville for this wonderful discussion. I’d like to thank you, as an audience, for watching NeurologyLive® Peer Exchange. If you enjoyed the content, I suggest that you subscribe to the NeurologyLive® newsletters to receive information about upcoming Peer Exchange segments and other content available to you. Thank you all so much.
Transcript edited for clarity.