Highlights
- •Fingolimod associated macular oedema (FAME) is a rare but recognised complication.
- •The real-world FAME incidence is consistent with fingolimod registration studies.
- •Most cases present within the first four months but a delayed onset is possible.
- •Newer optical coherence tomography devices may better detect subtle FAME.
Abstract
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.
Keywords
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Article info
Publication history
Published online: April 27, 2020
Accepted:
April 10,
2020
Received in revised form:
April 7,
2020
Received:
March 17,
2020
Identification
Copyright
Crown Copyright © 2020 Published by Elsevier B.V. All rights reserved.
