| Title: |
Immune cell subset profiling in multiple sclerosis after fingolimod initiation and continued treatment: The FLUENT study |
| Authors: |
Mao-Draayer, Yang; Cohen, Jeffrey A; Bar-Or, Amit; Han, May H; Singer, Barry; Williams, Ian M; Meng, Xiangyi; Elam, Chelsea; Weiss, Jamie L; Cox, Gina Mavrikis; Ziehn, Marina; Cree, Bruce AC; investigators, on behalf of the FLUENT study |
| Source: |
Multiple Sclerosis Journal - Experimental Translational and Clinical, vol 8, iss 3 |
| Publisher Information: |
eScholarship, University of California |
| Publication Year: |
2022 |
| Collection: |
University of California: eScholarship |
| Subject Terms: |
32 Biomedical and Clinical Sciences (for-2020); 3204 Immunology (for-2020); Clinical Research (rcdc); Clinical Trials and Supportive Activities (rcdc); Infectious Diseases (rcdc); Autoimmune Disease (rcdc); 6.1 Pharmaceuticals (hrcs-rac); 5.1 Pharmaceuticals (hrcs-rac); Inflammatory and immune system (hrcs-hc); Multiple sclerosis; fingolimod; sphingosine 1-phosphate receptor modulators; lymphocyte subsets; biomarkers; immunology; clinical trial; FLUENT study investigators; 3209 Neurosciences (for-2020); 4202 Epidemiology (for-2020); 4203 Health services and systems (for-2020) |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
qt83j3c6bg; https://escholarship.org/uc/item/83j3c6bg; https://escholarship.org/content/qt83j3c6bg/qt83j3c6bg.pdf |
| DOI: |
10.1177/20552173221115023 |
| Availability: |
https://escholarship.org/uc/item/83j3c6bg; https://escholarship.org/content/qt83j3c6bg/qt83j3c6bg.pdf; https://doi.org/10.1177/20552173221115023 |
| Rights: |
CC-BY-NC |
| Accession Number: |
edsbas.2FD3439F |
| Database: |
BASE |