Real-world incidence of fingolimod-associated macular oedema

TY - JOUR

T1 - Real-world incidence of fingolimod-associated macular oedema

AU - Goh, Li Yen

AU - Kirthi, Varo

AU - Silber, Eli

AU - Harvey, Joshua P

AU - Jackson, Timothy L

N1 - Crown Copyright © 2020. Published by Elsevier B.V. All rights reserved.

PY - 2020/7

Y1 - 2020/7

N2 - 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.

AB - 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.

KW - Fingolimod

KW - Macular oedema

KW - Multiple sclerosis

KW - Optical coherence tomography

UR - http://www.scopus.com/inward/record.url?scp=85085152799&partnerID=8YFLogxK

U2 - 10.1016/j.msard.2020.102125

DO - 10.1016/j.msard.2020.102125

M3 - Article

C2 - 32403070

SN - 2211-0348

VL - 42

SP - 102125

JO - Multiple Sclerosis and Related Disorders

JF - Multiple Sclerosis and Related Disorders

M1 - 102125

ER -