RT Journal Article
T1 Comparison of first-line and second-line use of fingolimod in relapsing MS: The open-label EARLIMS study
A1 Fernandez, Oscar
A1 Izquierdo, Guillermo
A1 Aguera, Eduardo
A1 Ramo, Cristina
A1 Hernandez, Miguel
A1 Silva, Diego
A1 Walker, Rob
A1 Butzkueven, Helmut
A1 Wang, Chenyu
A1 Barnett, Michael
K1 Beta-interferon
K1 Clinical trial
K1 Disease-modifying therapies
K1 Glatiramer acetate
K1 Outcome measurement
K1 Relapsing/remitting
K1 Remitting multiple-sclerosis
K1 Reported outcome indexes
AB Background: Treatment of MS often begins with low-efficacy injectable disease-modifying therapy (iDMT).Objectives: To compare the effect of fingolimod 0.5 mg/day on clinical, MRI, patient-reported, and safety outcomes, in treatment-naive and previously treated (>= 1 iDMT) patients with early MS.Methods: EARLIMS was a multicentre, open-label, non-randomized, parallel-group phase 3 b/4 study in Australia and Spain. Patients with relapsing-remitting MS, Expanded Disability Status Scale (EDSS) score = 1 iDMT) patients with early MS.Methods: EARLIMS was a multicentre, open-label, non-randomized, parallel-group phase 3 b/4 study in Australia and Spain. Patients with relapsing-remitting MS, Expanded Disability Status Scale (EDSS) score = 1-5 years since diagnosis, received daily fingolimod for 48 weeks. The primary endpoint was annualized relapse rate (ARR).Results: Of 347 patients enrolled at 51 sites (treatment-naive, 200 [57.6%]; previously treated, 147 [42.4%]), 320 completed the study (treatment-naive, 184 [92.0%]; previously treated, 136 [92.5%]), but the study remained underpowered (planned enrolment, n=432). Fingolimod reduced ARR to similar levels in both treatment-naive (mean ARR [95% confidence interval], 0.21 [0.14, 0.29]) and previously treated groups (0.30 [0.20, 0.41]; p=0.1668). There were no new safety signals.Conclusions: Fingolimod appeared equally effective as first- or second-line therapy in relapsing MS. There was a trend for better outcomes with fingolimod in treatment-naive patients than in those previously treated with >1 iDMT.
PB Sage Publications
YR 2020
FD 2020-08-18
LK http://hdl.handle.net/10668/19108
UL http://hdl.handle.net/10668/19108
LA en
NO Fernández O, Izquierdo G, Aguera E, Ramo C, Hernandez M, Silva D, et al.  Comparison of first-line and second-line use of fingolimod in relapsing MS: The open-label EARLIMS study. Mult Scler J Exp Transl Clin. 2020 Sep 13;6(3):2055217320957358
DS RISalud
RD Apr 6, 2025