Gilenia, generic fingolimod, is a new treatment for multiple sclerosis. It is taken orally and has shown significant efficacy in studies so far, perhaps even better than the existing therapy of interferon.
That said, it has also shown concerning side effects that may limit how it is used.
What is multiple sclerosis?
Multiple Sclerosis (MS) is a neurodegenerative disease that gets worse with time. Basically, it is caused by your immune system attacking your nervous system.
This damage can cause symptoms that include difficulty moving, loss of sensation and weakness. As the damage builds up, the symptoms get worse.
There is no real cure for MS currently. Therapies that slow the progress of the disease or alleviate symptoms exist but are very limited in what they can do.
How does Gilenia work?
Gilenia works by acting as a type of modulator to the sphingosine-1 phosphate (S1P) receptor. This receptor is part of a pathway that leads to immune cells called lymphocytes leaving lymph nodes and possibly causing damage to the nervous system.
By disrupting this pathway, Gilenia might reduce the immune response, and so reduce the damage to the body.
Beyond regulating how your immune system works, Gilenia may also, in theory, help part of your nervous system regenerate and protect it from further harm – to some degree. While this is theoretically possible, it is yet to be determined whether it happens.
How well does it work?
Gilenia works fairly well. There have been at least two major studies so far that have shown it reduces the number of relapses from MS and certain measures of disease by at least 50% compared to those who didn’t get Gilenia.
One study was of 1292 patients with MS of the relapsing-remitting course and lasted for 12 months. There, participants either got Gilenia at 1.25mg or 0.5mg per day as opposed to getting interferon, the standard treatment.
80% of those on Gilenia at 1.25mg had no relapse and 83% of those on Gilenia at 0.5mg had no relapse. This is compared to 69% of those on interferon who had no relapse. Additionally, Gilenia was better at reducing the amount of new or enlarged lesions.
What are the concerns?
Because Gilenia works by interfering with the immune system, there is a very significant possibility for serious side effects. In the studies so far, two people have died from an immune related side effect like herpes simplex virus.
Gilenia may increase your risk of developing cancer and can cause other serious side effects like macular edema.
What are the benefits?
Gilenia may work better than the current therapy. It can also be taken orally instead of by injection.
1) Oral fingolimod was more effective than intramuscular interferon for relapsing–remitting multiple sclerosis
2) Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis
3) The Impact of Fingolimod (FTY720) in Neuroimmunologic Diseases