Aaron E. Miller, MD


October 15, 2013

In This Article

Cardiac Risk and Relapse Rates

Another concern about fingolimod has been the cardiac risk factors after the first dose. Several presentations at this meeting give us reassurance about that. The incidence of first-dose bradycardia is very low, and an initial monitoring period of 6 hours is generally recommended, although some patients need extended monitoring. It turns out, in these multiple presentations, that less than 4% of patients need prolonged monitoring, and no serious cardiac events occurred in any of these rather large real-world settings.

Finally, the relapse information with fingolimod continues to be very good. The initial pivotal phase 3 trial (FREEDOMS)[1] showed a reduction of 50%-55% in the relapse rate, and this seems to be holding up in the extension trials. Additional work presented by Omar Khan[2] looked at the relapse reduction in black patients. It is important to note that black patients, although they have a lower incidence of multiple sclerosis, tend to have more severe multiple sclerosis. It was clear in this subset of the FREEDOMS trial that blacks responded to fingolimod, but their annualized relapse rate reduction in that trial was 29% compared with 50%-55% in the trial overall. The take-home message from ECTRIMS is that the real-world use of fingolimod has been a positive experience in the sense that the results and the safety profile have been very similar to what occurred during the pivotal phase 3 trials, and we are learning better and safer ways to put patients on fingolimod after they have been on natalizumab.


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