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Two-year macular volume assessment in multiple sclerosis patients treated with fingolimod
Alessandro d'Ambrosio1, Rocco Capuano1, Settimio Rossi2
1Multiple Sclerosis Center, Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Background:
Fingolimod (FNG) is associated with the development of symptomatic macular edema (ME) in a small subset of multiple sclerosis (MS) patients. By using spectral domain optical coherence tomography (SD-OCT), an increase in the total macular volume (TMV) was rarely detected during the first months of treatment.
Objectives:
The objective of this study is to assess whether FNG treatment leads to long-term macular changes in a real-life setting.
Methods:
Sixty RRMS patients starting FNG, according to therapeutic indication, were enrolled at three Italian MS centers and followed for 2 years.
Results:
The mean TMV did not change between baseline and the follow-up. No patients experienced visual acuity drop during the follow-up.
Conclusions:
Initiation of FNG in MS is associated with a modest, not significant, increase in macular volume followed by no further significant changes over 2 years, highlighting the good safety profile of such treatment in MS.
Insights
Fingolimod (FNG) treatment for multiple sclerosis (MS) showed no significant long-term changes in macular volume or visual acuity over two years. This indicates a favorable safety profile for FNG in MS patients.
Area of Science:
- Ophthalmology
- Neurology
- Pharmacology
Background:
- Fingolimod (FNG) is a treatment for multiple sclerosis (MS).
- A small subset of MS patients on FNG may develop symptomatic macular edema (ME).
- Spectral domain optical coherence tomography (SD-OCT) rarely detected increased total macular volume (TMV) in early FNG treatment.
Purpose of the Study:
- To evaluate long-term macular changes associated with FNG treatment in a real-world clinical setting.
- To assess the safety profile of FNG concerning ocular health in MS patients over a two-year period.
Main Methods:
- Sixty relapsing-remitting multiple sclerosis (RRMS) patients initiating FNG therapy were enrolled.
- Patients were recruited from three Italian MS centers and followed for two years.
- Total macular volume (TMV) was monitored using SD-OCT.
Main Results:
- The average TMV remained stable from baseline throughout the two-year follow-up period.
- No instances of decreased visual acuity were observed in any patients during the study.
- A modest, non-statistically significant increase in TMV was noted initially.
Conclusions:
- Fingolimod initiation in MS patients is linked to a minor, non-significant initial increase in macular volume.
- No significant macular volume changes were observed over the subsequent two years.
- FNG demonstrates a good safety profile regarding ocular changes in MS patients.
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