Related Experiment Video
Updated: Jun 20, 2026
Determining Immune System Suppression versus CNS Protection for Pharmacological Interventions in Autoimmune Demyelination
Published on: September 12, 2016
Immune cell subset profiling in multiple sclerosis after fingolimod initiation and continued treatment: The FLUENT
Yang Mao-Draayer1, Jeffrey A Cohen2, Amit Bar-Or3
1Autoimmunity Center of Excellence, Multiple Sclerosis Center, University of Michigan, Ann Arbor, MI, USA.
Background:
Fingolimod is a sphingosine 1-phosphate receptor modulator approved for relapsing MS. Long-term effects on the immunological profile are not fully understood.
Objective:
Investigate fingolimod's temporal effects on immune cell subsets, and safety outcomes.
Methods:
In FLUENT, a 12-month, prospective, non-randomized, open-label, phase IV study, adult participants received fingolimod 0.5 mg/day. Changes in immune cell subsets, anti-John Cunningham virus (JCV) antibody index, and serum neurofilament levels were assessed.
Results:
165 fingolimod-naive and 217 participants treated for 2-12 years in routine clinical practice were enrolled. Levels of all monitored peripheral lymphocyte subsets were reduced from month 3 in fingolimod-naive participants. Greatest reductions occurred in naive and central memory CD4+ and CD8+ T cells, and in naive and memory B cells. Most lymphocyte subset levels remained stable in the continuous fingolimod group. Components of the innate immune system remained within reference ranges. No increase in JCV seropositivity was observed. No single cellular subset correlated with anti-JCV antibody index at any time point. Neurofilament levels remained within healthy adult reference limits throughout. No opportunistic infections were reported; no new or unexpected safety signals were observed.
Conclusion:
FLUENT provides insights into the utility of immunological profiling to evaluate therapy response and potential infection risk.
