A to Z of MS Fingolimod (Gilenya)

Gilenya (brand name). During development the drug was known as FTY720.

Fingolimod is a disease modifying drug for relapsing remitting multiple sclerosis. It is also undergoing trials as a potential treatment for primary progressive MS.

Fingolimod is licensed for people with rapidly evolving severe relapsing remitting MS (two or more relapses a year), and as a second line treatment for people whose MS remains active despite treatment with one of the beta interferon drugs or glatiramer acetate.

In August 2011, NICE issued a draft recommendation that fingolimod was not a cost effective treatment for the NHS to provide in England and Wales. Following a round of consultation, this recommendation was confirmed in December 2011. A second consultation took place with a final decision is expected in April 2012 (see the NICE website).

Fingolimod research

A six month, phase II controlled clinical trial of fingolimod involving 255 people with relapsing remitting MS found inflammation measured on MRI scans was significantly reduced in treatment groups when compared to people on placebo. More people in the treatment group stayed relapse-free.

An 18 month extension of the original study, in which those previously taking a placebo started treatment, confirmed these results, with up to 70% remaining relapse-free after four years. These results were reported at the 2009 meeting of the Academy of American Neurologists (AAN).

A larger phase III trial was also reported at the AAN meeting. TRANSFORMS was a one year study involving 1,292 participants comparing two doses of fingolimod with interferon beta-1a (Avonex). 80 to 83% of the fingolimod groups remained relapse-free compared with 69% of those on interferon beta-1a.

How fingolimod works

Fingolimod works by binding to the surface of immune cells, trapping them in the lymph nodes and preventing them from attacking cells in the central nervous system.

How is fingolimod given?

Fingolimod is taken orally as capsules.

Side effects and contraindications

Although the trials so far have shown fingolimod to be well tolerated, common side effects include headache, liver enzyme increases, influenza, diahorrea, back pain, and cough. Fingolimod can cause temporary changes in heart rate, blood pressure, shortness of breath and macular oedema (a swelling in the eye affecting vision). The first dose of fingolimod should be taken in hospital so that these factors can be monitored.

Reference

Kappos L, et al.
Oral fingolimod (FTY720) for relapsing multiple sclerosis.
New England Journal of Medicine 2006;355(11):1124-1140.
abstract

Montalban X, et al.
Oral fingolimod (FTY720) shows sustained low rates of clinical and MRI disease activity in patients with relapsing multiple sclerosis: 4-year results from a phase II extension.
Poster presentation at the American Academy of Neurology Annual Meeting 2009. [P06.128].

Cohen J, et al.
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
New England Journal of Medicine 2010;362(5):402-415.
abstract

Kappos L, et al.
Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis.
New England Journal of Medicine 2010;362(5):387-401.
abstract

National Institute for Health and Clinical Excellence.
Multiple sclerosis (relapsing-remitting) - fingolimod: appraisal consultation document.
NICE; August 2011.
read online

Patient Information Leaflet

Gilenya (EMC website)

Webcast on drug therapy

Neurologist Prof David Bates addresses some of the questions people ask about disease modifying drugs

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