European and US researchers have collaborated to publish a useful summary of the clinical trials and current knowledge about the new oral medication for multiple sclerosis, fingolimod (Gilenya).
This drug, now approved in many countries including Australia, is increasingly being offered to people with relapsing-remitting MS.
This paper highlights its efficacy in relation to placebo in the two year long FREEDOMS trial, with 0.4 relapses per year for the placebo group and 0.18 per year for the fingolimod 0.5mg a day group, and a 30% reduced risk of progression of disability.
It also notes its superior performance to interferon B-1a (Avonex) in the one year long TRANSFORMS trial, with 0.33 relapses per year for the placebo group and 0.16 relapses per year for the fingolimod 0.5mg a day group; further, this study was extended for a year, with those taking the Avonex switched to fingolimod, and their annual relapse rate fell from 0.31 per year on the Avonex to 0.22 per year on the fingolimod.
The TRANSFORMS study however failed to show any effect on disability progression.
So the authors note that while fingolimod appears superior to both placebo and Avonex, it has been licensed in Europe only for highly active MS or for those not responding to first-line disease-modifying drugs like Avonex, Copaxone and so on.
The authors also highlight the risks, which are basically related to suppression of the immune response, leading to the potential for serious infections. They suggest that data support the contention that the two deaths from overwhelming herpes infections in the group taking fingolimod in the TRANSFORMS study may not have been by chance.
The real question they raise is will the benefits outweigh the risks when this drug is used long term, and indicate that we do not know the answer to this question, whereas we do know the safety profile of the established drugs. This paper is well worth reading for those considering this drug.