Efficacy and safety of alemtuzumab versus fingolimod in RRMS after natalizumab cessation.
Adult
Alemtuzumab
/ adverse effects
Disease Progression
Female
Fingolimod Hydrochloride
/ adverse effects
Humans
Immunologic Factors
/ adverse effects
Immunomodulation
Male
Middle Aged
Multiple Sclerosis, Relapsing-Remitting
/ therapy
Natalizumab
/ adverse effects
Retrospective Studies
Treatment Outcome
Alemtuzumab
Fingolimod
Immunomodulatory therapy
Natalizumab
Progressive multifocal leukoencephalopathy
Remitting-relapsing multiple sclerosis
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Jan 2019
Jan 2019
Historique:
received:
17
07
2018
accepted:
08
11
2018
revised:
04
11
2018
pubmed:
18
11
2018
medline:
8
5
2019
entrez:
18
11
2018
Statut:
ppublish
Résumé
Natalizumab (NTZ) was the first approved monoclonal antibody for the treatment of relapsing-remitting multiple sclerosis (RRMS). Despite proven and sustained efficacy, its use is limited by the risk of progressive multifocal leukoencephalopathy (PML). Moreover, some patients show ongoing disease activity under NTZ, requiring a switch to another disease-modifying treatment (DMT). However, evidence regarding the optimal DMT for treatment of active RRMS after NTZ-cessation is still scarce. To evaluate efficacy and safety outcomes of ALEM vs FTY treatment after cessation of NTZ. We retrospectively identified patients at 12 German neurology centers and analyzed risks for disease activity, adverse events, disability progression, and treatment discontinuation. 195 patients were identified and 144 underwent final analysis (FTY: 101; ALEM: 42). The hazard ratio for clinical relapses was 2.24 favoring ALEM (95% CI 1.12-4.50; p = 0.015). The hazard ratio for adverse events was 7.78 (95% CI 1.04-57.95; p = 0.006) and 2.41 for MRI progression (95% CI 1.26-4.60; p = 0.004). The odds ratio for disability progression after 12 months was 4.84 (95% CI 1.74-13.47, p = 0.003). Differences remained after adjusting for possible confounders (e.g., age, sex, baseline disability, NTZ treatment duration, washout time). Our findings indicated particular advantages of ALEM compared to FTY in patients stopping NTZ.
Sections du résumé
BACKGROUND
BACKGROUND
Natalizumab (NTZ) was the first approved monoclonal antibody for the treatment of relapsing-remitting multiple sclerosis (RRMS). Despite proven and sustained efficacy, its use is limited by the risk of progressive multifocal leukoencephalopathy (PML). Moreover, some patients show ongoing disease activity under NTZ, requiring a switch to another disease-modifying treatment (DMT). However, evidence regarding the optimal DMT for treatment of active RRMS after NTZ-cessation is still scarce.
OBJECTIVE
OBJECTIVE
To evaluate efficacy and safety outcomes of ALEM vs FTY treatment after cessation of NTZ.
METHODS
METHODS
We retrospectively identified patients at 12 German neurology centers and analyzed risks for disease activity, adverse events, disability progression, and treatment discontinuation.
RESULTS
RESULTS
195 patients were identified and 144 underwent final analysis (FTY: 101; ALEM: 42). The hazard ratio for clinical relapses was 2.24 favoring ALEM (95% CI 1.12-4.50; p = 0.015). The hazard ratio for adverse events was 7.78 (95% CI 1.04-57.95; p = 0.006) and 2.41 for MRI progression (95% CI 1.26-4.60; p = 0.004). The odds ratio for disability progression after 12 months was 4.84 (95% CI 1.74-13.47, p = 0.003). Differences remained after adjusting for possible confounders (e.g., age, sex, baseline disability, NTZ treatment duration, washout time).
CONCLUSION
CONCLUSIONS
Our findings indicated particular advantages of ALEM compared to FTY in patients stopping NTZ.
Identifiants
pubmed: 30446966
doi: 10.1007/s00415-018-9117-z
pii: 10.1007/s00415-018-9117-z
doi:
Substances chimiques
Immunologic Factors
0
Natalizumab
0
Alemtuzumab
3A189DH42V
Fingolimod Hydrochloride
G926EC510T
Types de publication
Comparative Study
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
165-173Subventions
Organisme : Sanofi Genzyme
ID : ALAIN01
Organisme : Competence Network Multiple Sclerosis
ID : 01GI1603D
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