Highlights
- •Disease activity during treatment predicts poor outcome in Multiple Sclerosis patients.
- •One third of patients on fingolimod treatment was free from disease activity at 5 years.
- •Baseline disability and relapse rate before treatment predict freedom from disease activity.
Abstract
Background and Purpose
Ongoing disease activity during treatment has been associated to worse disability
outcomes in patients with Multiple Sclerosis (MS). The aim of this study was to assess
the 5-year response to fingolimod (FTY) treatment in patients with relapsing-remitting
(RRMS) in a real-life setting.
Methods
We included RRMS patients who received FTY for at least 6 months and had a follow-up
≥ 60 months. Treatment response was assessed through the No Evidence of Disease Activity (NEDA)-3 status.
Results
Eighty-eight patients were included, of which 51 (58.0%) were NTZ-naïve and 37 (42.0%)
NTZ-switchers. The mean age was 38.9 (9.5) years and 58 (65.9%) were females. The
proportion of patients on FTY treatment who maintained the NEDA-3 status at 5 years
was 55.9% among NTZ-naïve patients and 35.0% among NTZ-switchers (p=0.138). Predictors
of NEDA-3 status were lower Expanded Disability Status Scale score at baseline (adjOR=0.28, 95% CI 0.10-0.77; p=0.013) in NTZ-naïve patients and fewer relapses in the
12 months before starting FTY in NTZ-switchers (adjOR=0.05, 95% CI 0.003-0.79; p=0.034).
Conclusions
This study supports the potential of FTY as a disease-modifying treatment for the
long-term management of RRMS patients. Patients with milder disability and fewer clinical
relapses before treatment may achieve a better disease control.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Multiple Sclerosis and Related DisordersAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Natalizumab versus fingolimod in patients with relapsing-remitting multiple sclerosis non-responding to first-line injectable therapies.Mult. Scler. 2016; 22: 1315-1326
- Fingolimod versus intramuscular interferon in patient subgroups from transforms.J. Neurol. 2013; 260: 2023-2032
- Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised transforms study.J. Neurol. Neurosurg. Psychiatry. 2016; 87: 468-475
- Current disease-modifying treatment of multiple sclerosis.Mt. Sinai J. Med. 2011; 78: 161-175
- Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled freedoms study.Lancet Neurol. 2012; 11: 420-428
- Long-term evaluation of NEDA-3 status in relapsing-remitting multiple sclerosis patients after switching from natalizumab to fingolimod.Ther. Adv. Neurol. Disord. 2018; 111756286418791103
- Long-term safety and real-world effectiveness of fingolimod in relapsing multiple sclerosis.Patient Relat. Outcome Meas. 2017; 9: 1-10
- Reliability of classifying multiple sclerosis disease activity using magnetic resonance imaging in a multiple sclerosis clinic.JAMA Neurol. 2013; 70: 338-344
- Is it time to target no evident disease activity (NEDA) in multiple sclerosis?.Mult. Scler. Relat. Disord. 2015; 4: 329-333
- Baseline characteristics associated with NEDA-3 status in fingolimod-treated patients with relapsing-remitting multiple sclerosis.Mult. Scler. Demyelinat Disord. 2017; 2: 10
- Alemtuzumab CARE-MS I 5-year follow-up: durable efficacy in the absence of continuous MS therapy.Neurology. 2017; 89: 1107-1116
- Freedom from disease activity in multiple sclerosis.Neurology. 2010; 74: S3-S7
- Fingolimod treatment increases the proportion of patients who are free from disease activity in multiple sclerosis: results from a phase 3, placebo-controlled study (freedoms).Neurology. 2011; 76: A563
- European multiple sclerosis platform. New insights into the burden and costs of multiple sclerosis in Europe.Mult. Scler. 2017; 23: 1123-1136
- Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS).Neurology. 1983; 33: 1444-1452
- Solitary sclerosis: progressive myelopathy from solitary demyelinating lesion.Neurology. 2012; 79: 393
- Cerebral hemodynamics in patients with multiple sclerosis.Mult. Scler. Relat. Disord. 2020;
- Oral and intravenous steroids for multiple sclerosis relapse: a systematic review and meta-analysis.J. Neurol. 2017; 264: 1697-1704
- Prediction of disability progression in fingolimod-treated patients.J. Neurol. Sci. 2015; 358: 432-434
- Persistence to oral disease-modifying therapies in multiple sclerosis patients.J. Neurol. 2017; 264: 2325-2329
- Progressive multifocal myelopathy or multiple sclerosis?.Mult. Scler. Relat. Disord. 2020; 37101373
- Multiple sclerosis, solitary sclerosis or something else?.Mult. Scler. 2014; 20: 1819-1824
- Epidemiology of multiple sclerosis.Rev. Neurol. (Paris). 2016; 172: 3-13
- Defining the clinical course of multiple sclerosis: results of an international survey.Neurology. 1996; 46: 907-911
- Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria.Ann. Neurol. 2011; 69: 292-302
- Long-term assessment of no evidence of disease activity with natalizumab in relapsing multiple sclerosis.J. Neurol. Sci. 2016; 364: 145-147
- Real-world effectiveness of natalizumab and fingolimod compared with self-injectable drugs in non-responders and in treatment-naïve patients with multiple sclerosis.J. Neurol. 2017; 264: 284-294
- Defining the response to interferon-beta in relapsing-remitting multiple sclerosis patients.Ann. Neurol. 2006; 59: 344-352
- Evaluation of no evidence of disease activity in a 7-year longitudinal multiple sclerosis cohort.JAMA Neurol. 2015; 72: 152-158
- Fingolimod: a review of its use in relapsing-remitting multiple sclerosis.Drugs. 2014; 74: 1411-1433
- Towards the implementation of ‘no evidence of disease activity’ in multiple sclerosis treatment: the multiple sclerosis decision model.Ther. Adv. Neurol. Disord. 2015; 8: 3-13
- Fingolimod treatment in relapsing-remitting multiple sclerosis patients: a prospective observational multicenter postmarketing study.Mult. Scler. Int. 2015; 2015763418
- Assessing 'no evidence of disease activity' status in patients with relapsing-remitting multiple sclerosis receiving fingolimod in routine clinical practice: a retrospective analysis of the multiple sclerosis clinical and magnetic resonance imaging outcomes in the USA (MS-MRIUS) study.CNS Drugs. 2018; 32: 75-84
- The immunopathophysiology of multiple sclerosis.Neurol. Clin. 2011; 29: 257-278
- The importance of collecting structured clinical information on multiple sclerosis.BMC Med. 2016; 14: 81
- Real-world persistence and benefit-risk profile of fingolimod over 36 months in Germany.Neurol. Neuroimmunol. Neuroinflamm. 2019; 6: e548
Article info
Publication history
Published online: July 20, 2020
Accepted:
July 20,
2020
Received in revised form:
June 22,
2020
Received:
May 20,
2020
Identification
Copyright
© 2020 Elsevier B.V. All rights reserved.