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J Neurol. 2019 Jan;266(1):165-173. doi: 10.1007/s00415-018-9117-z. Epub 2018 Nov 16.

Efficacy and safety of alemtuzumab versus fingolimod in RRMS after natalizumab cessation.

Author information

1
Department of Neurology and Institute for Translational Neurology, University Hospital Muenster, University of Muenster, Albert-Schweitzer-Campus 1, 48149, Muenster, Germany.
2
Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany.
3
Department of Neurology, University Duisburg-Essen, Duisburg, Germany.
4
Department of Neurology, Friedrich-Alexander-University, Erlangen-Nuremberg, Germany.
5
Department of Neurology, University of Wuerzburg, Wuerzburg, Germany.
6
Department of Neurology, Johannes-Wesling-Hospital Minden, Minden, Germany.
7
Department of Neurology, Clinics Osnabrueck, Osnabrueck, Germany.
8
Department of Neurology, University Medical Center Magdeburg, Magdeburg, Germany.
9
Department of Neurology, Herz-Jesu-Hospital Muenster-Hiltrup, Muenster, Germany.
10
Center for Neurology, Ulm, Germany.
11
Department of Neurology, University of Giessen-Marburg, Marburg, Germany.
12
Department of Neurology, Cologne General Hospitals, University of Cologne, Cologne, Germany.
13
Department of Neurology, University Hospital of Heidelberg, Heidelberg, Germany.
14
Department of Neurology and Institute for Translational Neurology, University Hospital Muenster, University of Muenster, Albert-Schweitzer-Campus 1, 48149, Muenster, Germany. sven.meuth@ukmuenster.de.

Abstract

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:

To evaluate efficacy and safety outcomes of ALEM vs FTY treatment after cessation of NTZ.

METHODS:

We retrospectively identified patients at 12 German neurology centers and analyzed risks for disease activity, adverse events, disability progression, and treatment discontinuation.

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:

Our findings indicated particular advantages of ALEM compared to FTY in patients stopping NTZ.

KEYWORDS:

Alemtuzumab; Fingolimod; Immunomodulatory therapy; Natalizumab; Progressive multifocal leukoencephalopathy; Remitting-relapsing multiple sclerosis

PMID:
30446966
DOI:
10.1007/s00415-018-9117-z
[Indexed for MEDLINE]

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