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Fingolimod vs dimethyl fumarate in multiple sclerosis: A real-world propensity score-matched study.
- Source :
-
Neurology [Neurology] 2018 Jul 10; Vol. 91 (2), pp. e153-e161. Date of Electronic Publication: 2018 Jun 06. - Publication Year :
- 2018
-
Abstract
- Objective: To directly compare fingolimod (FNG) and dimethyl fumarate (DMF) on no evident disease activity (NEDA) status in patients with relapsing-remitting multiple sclerosis (RRMS) from 7 multiple sclerosis outpatient clinics in Central Italy.<br />Methods: We analyzed data of patients with RRMS who started an oral agent, namely DMF or FNG, either as first treatment (naives) or after switching from self-injectable drugs (switchers). We performed a propensity score (PS)-based nearest-neighbor matching within a caliper of 0.05 to select patients with homogeneous baseline characteristics. Pairwise censoring was adopted to adjust for difference in length of follow-up between the 2 treatment groups. Comparisons were then conducted in matched samples with Cox models (stratified by center) with NEDA-3 as the main outcome. NEDA-3 was defined as no relapses, no disability worsening, and no MRI activity.<br />Results: Overall, 483 and 456 patients eligible for analysis started on FNG and DMF, respectively. The PS-matching procedure retained a total of 550 patients (275 per group). After a median on-study follow-up of 18 months, the proportions of patients with NEDA-3 were similar (FNG 73%, DMF 70%; hazard ratio [HR] 0.74, p = 0.078). Subgroup analyses showed a comparable effectiveness of the 2 drugs in naives (n = 170, HR 1.15, p = 0.689), whereas FNG was superior to DMF in the achievement of NEDA-3 status among switchers (n = 380, HR 0.57, p = 0.007).<br />Conclusion: We found no significant difference between FNG and DMF on NEDA-3 status, while subgroup analyses suggest the superiority of FNG over DMF in patients switching from self-injectable drugs.<br />Classification of Evidence: This study provides Class IV evidence that for patients with RRMS, DMF and FNG have comparable efficacy in treatment-naive patients and that FNG is superior to DMF in patients switching from self-injectable drugs.<br /> (© 2018 American Academy of Neurology.)
- Subjects :
- Adult
Female
Humans
Immunosuppressive Agents therapeutic use
Male
Product Surveillance, Postmarketing statistics & numerical data
Propensity Score
Retrospective Studies
Treatment Outcome
Young Adult
Dimethyl Fumarate therapeutic use
Fingolimod Hydrochloride therapeutic use
Multiple Sclerosis, Relapsing-Remitting drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1526-632X
- Volume :
- 91
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Neurology
- Publication Type :
- Academic Journal
- Accession number :
- 29875218
- Full Text :
- https://doi.org/10.1212/WNL.0000000000005772