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BACKGROUND: Fingolimod (Gilenya, Novartis, Basel Switzerland) 0.5 mg orally once-daily is widely used for relapsing-remitting multiple sclerosis. Patients are usually screened four months after starting fingolimod for fingolimod-associated macular oedema (FAME). Large registration trials with stringent eligibility criteria have reported a FAME incidence of 0 - 2.08%.

OBJECTIVES: To determine the real-world incidence of FAME in a London population, and to describe the clinical characteristics and management of confirmed cases.

METHODS: All patients started on fingolimod from September 2012 to September 2018 were referred for ophthalmology clinical examination and macular spectral-domain optical coherence tomography (SD-OCT) at four months after starting treatment. Exclusion criteria were failure to attend or non-gradable OCT images.

RESULTS: Of 228 patients, two had FAME at initial screening, giving an incidence of 0.88% (95% confidence interval 0.10-3.10). Another case emerged subsequently, at 637 days, resulting in a final incidence of 1.32% (95% confidence interval 0.30-3.80). Fingolimod was discontinued in two cases. FAME resolved in all cases within two to 10 months, with no persistent visual loss or symptoms.

CONCLUSIONS: The real-world FAME incidence is consistent with fingolimod registration studies. FAME may have a delayed onset and may be better detected with newer OCT devices.

Original languageEnglish
Article number102125
Pages (from-to)102125
JournalMultiple Sclerosis and Related Disorders
Early online date28 Apr 2020
Publication statusPublished - Jul 2020


  • Fingolimod
  • Macular oedema
  • Multiple sclerosis
  • Optical coherence tomography


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