Baseline retinal nerve fiber layer thickness as a predictor of multiple sclerosis progression: New insights from the FREEDOMS II study

Wang L 1 , Tan H 1 , Yu J 2 , ZhangBao J 1 , Huang W 1 , Chang X 1 Show all authors , Zhou L 1 , Lu C 1 , Xiao Y 3 , Lu J 1 , Zhao C 1 , Wang M 2 , Wu X 4 , Wu M 4 , Dong Q 1 , Ngew KY 5 , Quan C 1

Affiliations 

  • 1 Department of Neurology and Rare Disease Center, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China
  • 2 Department of Ophthalmology and Vision Science, Eye and ENT Hospital, Shanghai Medical College, Fudan University, Shanghai, China
  • 3 Department of Ophthalmology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China
  • 4 Novartis Pharmaceuticals, Shanghai, China
  • 5 Novartis Corporation (Malaysia) Sdn. Bhd., Petaling Jaya, Malaysia
Eur J Neurol, 2023 Feb;30(2):443-452.
PMID: 36286605 DOI: 10.1111/ene.15612

Abstract

BACKGROUND AND PURPOSE: The aim was to evaluate the potential of retinal nerve fiber layer thickness (RNFLT) measured with optical coherence tomography in predicting disease progression in relapsing-remitting multiple sclerosis (RRMS).

METHODS: Analyses were conducted post hoc of this 24-month, phase III, double-blind study, in which RRMS patients were randomized (1:1:1) to once daily oral fingolimod 0.5 mg, 1.25 mg or placebo. The key outcomes were the association between baseline RNFLT and baseline clinical characteristics and clinical/imaging outcomes up to 24 months. Change of RNFLT with fingolimod versus placebo within 24 months and time to retinal nerve fiber layer (RNFL) thinning were evaluated.

RESULTS: Altogether 885 patients were included. At baseline, lower RNFLT was correlated with higher Expanded Disability Status Scale score (r = -1.085, p = 0.018), lower brain volume (r = 0.025, p = 0.006) and deep gray matter volume (r = 0.731, p 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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