Real-world incidence of fingolimod-associated macular oedema.

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.