A to Z of MS
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A to Z of MS Fingolimod (Gilenya)
Fingolimod has been approved for use on the NHS since 2012. Across the UK, fingolimod can be prescribed for people with highly active relapsing remitting MS, that is those people who continue to have relapses despite treatment with one of the beta interferon drugs for at least one year.
In England and Scotland, fingolimod approval has been extended to include additional groups.
In Scotland, fingolimod can also be prescribed for people with rapidly evolving severe relapsing remitting MS (two or more disabling relapses in one year and MRI evidence of new areas of MS activity).
Studies have shown that fingolimod reduces the number of relapses by around one half and slows down progression.
How is fingolimod taken?
Fingolimod is taken as a capsule, once daily. The first dose is taken under medical supervision to monitor heart rate and blood pressure (see Side effects).
Side effects and contraindications
Fingolimod causes a temporary bradycardia (decrease in the heart rate) and may be associated with atrioventricular block (a type of heart rhythm disorder). Following a formal safety review by the European Medicines Agency (EMA), guidelines are in place that mean people should take their first dose of fingolimod under medical supervision and have their heart rate and blood pressure monitored for at least six hours.
Other common side effects include increased risk of infections, headache, liver enzyme increases, influenza, diahorrea, back pain, and cough. Fingolimod may also cause macular oedema (a swelling in the eye affecting vision).
How fingolimod works
Fingolimod works by binding to the surface of white blood cells (lymphocytes) in the immune system. This causes a large proportion of the lymphocytes to be retained in the lymph nodes, reducing the number that can reach the central nervous system and attack nerve cells in the brain and spinal cord.
Relapsing remitting MS
Two main studies have provided the evidence to support licensing of fingolimod for relapsing remitting MS:
- FREEDOMS was a double-blind, placebo-controlled study involving 1,272 people with relapsing remitting MS in 22 countries. Participants received one of two doses of fingolimod or placebo over two years. The relapse rate for people in the placebo group was 0.40, compared to 0.18 for a 0.5mg fingolimod dose (a reduction of 54%) and 0.16 with a 1.25 mg dose (a reduction of 60%). The reduction of progression of disability was 30% and 32% respectively compared to placebo.
- TRANSFORMS was a one year phase III study. It compared two doses of fingolimod (0.5mg and 1.25mg) against interferon beta-1a (Avonex) in 1,292 people with relapsing remitting MS. Relapse rates at one year were 0.33 for interferon beta-1a, 0.16 on the lower dose of fingolimod (a reduction of 52% compared to interferon beta-1a) and 0.2 on the higher dose (a 38% reduction). 80-83% of the fingolimod groups remained relapse-free over the year compared with 69% of those on interferon beta-1a.
Primary progressive MS
Laboratory investigations provided evidence that, in addition to its effect on the immune system, fingolimod may have neuroprotective and remyelinating properties in the brain and spinal cord.
- INFORMS was a phase III double blind study testing whether fingolimod (0.5mg taken daily for three years) was effective in delaying disability progression compared to placebo in 951 people with primary progressive MS. The initial results, announced in December 2014, showed that fingolimod was no more effective than placebo.
National Institute for Health and Clinical Excellence (NICE).
Fingolimod for the treatment of highly active relapsing-remitting multiple sclerosis.
NICE technology appraisal guidance 254.
Available from NICE website
Clinical Commissioning policy for MS disease modifying therapies - May 2014.
Available from NHS England website
Kappos L, et al.
Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis.
New England Journal of Medicine 2010;362(5):387-401.
Cohen J, et al.
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
New England Journal of Medicine 2010;362:402-415.
Kappos L, et al.
Long-term effects of fingolimod in multiple sclerosis: The randomized FREEDOMS extension trial.
Neurology 2015 Mar 20. pii: 10.1212/WNL.0000000000001462. [Epub ahead of print].
Brinkmann V, et al.
FTY720: sphingosine 1-phosphate receptor-1 in the control of lymphocyte egress and endothelial barrier function.
American Journal of Transplantation 2004;4:1019-1025.
Miron VE, et al.
Fingolimod (FTY720) enhances remyelination following demyelination of organotypic cerebellar slices.
American Journal Pathology 2010;176:2682-2694.
Available from ClinicalTrials.gov website
Novartis INFORMS press release - December 2014
Available from Novartis website
Patient Information Leaflet
- Gilenya (EMC website)