Abstract
Fingolimod 0.5-mg once-daily is an approved therapy for patients with relapsing–remitting multiple sclerosis (MS). Several pivotal and real-world studies have demonstrated that fingolimod is associated with the development of macular edema (ME). Herein, we present a case of a diabetic MS patient who developed severe bilateral ME during fingolimod treatment. By means of this case study we provide a detailed review about fingolimod associated macular edema (FAME), its current incidence with or without diabetes mellitus, and previous therapy attempts and outcomes in MS patients. Intravitreal administration of antibodies raised against vascular endothelial growth factor A (VEGF-A) has not yet been used in the management of FAME, however, the excellent therapeutic response in our patient may justify the use of anti-VEGF-A agents in combination with cessation of fingolimod to achieve fast resolution of FAME and to prevent visual deficits, particularly in bilateral FAME.
Highlights
Fingolimod was approved in the European Union in March 2011 as 0.5-mg once-daily therapy for patients with highly active relapsing–remitting multiple sclerosis (RRMS) [1]
Besides several organ-specific adverse events, macular edema (ME) was observed in patients receiving fingolimod during four phase III MS trials (FREEDOMS, FREEDOMSII, TRANSFORMS, and INFORMS) [11,12,13]
The aim of this study was to report the successful use of ranibizumab, an antibody raised against human vascular endothelial growth factor A (VEGF-A), in fingolimod-associated macular edema (FAME) and to provide a detailed review about this adverse event with emphasis on diabetic MS patients
Summary
Fingolimod was approved in the European Union in March 2011 as 0.5-mg once-daily therapy for patients with highly active relapsing–remitting multiple sclerosis (RRMS) [1]. Fingolimod was evaluated as a treatment for renal transplant rejection, wherein patients received higher doses of fingolimod (2.5 and 5 mg), in combination with cyclosporine, tacrolimus, and/or steroids [3,4,5,6] In this context, macular edema (ME) has been identified as a specific adverse event of fingolimod in renal transplant patients [3,4,5,6]. The aim of this study was to report the successful use of ranibizumab, an antibody raised against human vascular endothelial growth factor A (VEGF-A), in fingolimod-associated macular edema (FAME) and to provide a detailed review about this adverse event with emphasis on diabetic MS patients
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