Fingolimod Shows Potential to Reduce Retinal Neurodegeneration in Relapsing MS

Analysis from a prospective observational study of patients with relapsing-remitting multiple sclerosis (RMSS) revealed that fingolimod (Gilenya; Novartis) has a potential role in reducing retinal neurodegeneration. The findings for this study were presented virtually at the ACTRIMS Forum 2021, February 25-27, by Marwa Baalbaki, MD, resident doctor, The George Washington University Hospital.¹

Baalbaki and colleagues aimed to explore the rate of retinal layer changes in 128 stable patients with RRMS using optimal coherence tomography (OCT) who were either treated with fingolimod (n = 71) or interferon (Avonex; Biogen; n = 56). They noted that with the advent of OCT, the retina has been considered as a potential adjuvant biomarker of disease activity, progression, and therapeutic response, but the potential differential effects of disease-modifying therapies (DMTs) on retinal changes had not yet been assessed.

At the end of the study, patients treated with fingolimod showed no significant differences in the rate of thinning of all retinal layers when compared to healthy controls and had significantly less GCIPL thinning when compared to interferons. The study authors concluded, “longitudinal OCT measures appear to be sensitive to changes in cognitive function and may be useful for monitoring neuroprotective therapies.”

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Patients included in the study had Symbol-Digit Modality Test (SDMT) and retinal OCT scans obtained at baseline and every 6 to 12 months. Mixed effects regression was used to study annualized changes in retinal layers and cognitive function, including differences between treatment groups. Regardless of treatment group, SDMT scores improved similarly.

A subgroup of patients underwent expanded cognitive tests annually that included the Brief Visual-Spatial Memory (BVMT)-total recall, BVMT-delayed recall, and the Montreal Cognitive Assessment (MOCA). Despite the aforementioned similar SDMT scores, those treated with interferon had a significant decline in the MOCA and total recall scores. This observation was not found in the fingolimod-treated group.

The study authors also explore correlations between the annualized changes in retinal measurements and cognitive scores. They noted a correlation between annualized change in GCIPL thickness and annualized changes in MOCA scores, as well as a similar correlation with annualized change in total recall scores.

In 2018, the FDA approved an expanded indication for fingolimod to include the treatment of children and adolescents age 10 years and older with relapsing MS, making the immunomodulating drug the first agent specifically approved to treat MS in pediatric patients. The drug was first approved in 2010 but was only indicated for adult patients.²

There have been a number of studies conducted using fingolimod in recent years. Data presented at the 2019 Annual Meeting of the Consortium of Multiple Sclerosis Centers demonstrated the superiority of fingolimod over placebo and interferon beta-1a in patients with MS both with and without migraine or headache.³

REFERENCES

1. El Ayoubi NK, Bou Reslan SW, Baalbaki MM, Darwish H, Khoury SJ. Effect of fingolimod vs interferon treatment on OCT measurements and cognitive function in RRMS. Presented at ACTRIMS 2021 Forum; February 25–27, 2021. Abstract P018.

2. FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients. News release. FDA. May 11, 2018. Accessed February 25, 2021. https://www.fda.gov/news-events/press-announcements/fda-expands-approval-gilenya-treat-multiple-sclerosis-pediatric-patients

3. Willis MA, Conway D, Berkovich R, Men X, Kolodny S, Cheadle A. Post hoc Analyses of Clinical Outcomes in Patients With and Without Migraine/Headache in the Pooled FREEDOMS, FREEDOMS II and TRANSFORMS Populations. Presented at: 2019 CMSC Annual Meeting. May 28-June 1, 2019; Seattle, WA. Abstract DXT24.