Pfeuffer, Steffen, Schmidt, Rene, Straeten, Frederike Anne, Pul, Refik, Kleinschnitz, Christoph ORCID: 0000-0002-1650-8875, Wieshuber, Marinus, Lee, De-Hyung, Linker, Ralf A., Doerck, Sebastian, Straeten, Vera, Windhagen, Susanne, Pawlitzki, Marc, Aufenberg, Christoph, Lang, Michael, Eienbroeker, Christian, Tackenberg, Bjoern, Limmroth, Volker, Wildemann, Brigitte, Haas, Juergen ORCID: 0000-0002-2314-7465, Klotz, Luisa, Wiendl, Heinz, Ruck, Tobias and Meuth, Sven G. (2019). Efficacy and safety of alemtuzumab versus fingolimod in RRMS after natalizumab cessation. J. Neurol., 266 (1). S. 165 - 174. HEIDELBERG: SPRINGER HEIDELBERG. ISSN 1432-1459

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Abstract

BackgroundNatalizumab (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.ObjectiveTo evaluate efficacy and safety outcomes of ALEM vs FTY treatment after cessation of NTZ.MethodsWe retrospectively identified patients at 12 German neurology centers and analyzed risks for disease activity, adverse events, disability progression, and treatment discontinuation.Results195 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 12months 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).ConclusionOur findings indicated particular advantages of ALEM compared to FTY in patients stopping NTZ.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Pfeuffer, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, ReneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Straeten, Frederike AnneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pul, RefikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kleinschnitz, ChristophUNSPECIFIEDorcid.org/0000-0002-1650-8875UNSPECIFIED
Wieshuber, MarinusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lee, De-HyungUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Linker, Ralf A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doerck, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Straeten, VeraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Windhagen, SusanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pawlitzki, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aufenberg, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lang, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eienbroeker, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tackenberg, BjoernUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Limmroth, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wildemann, BrigitteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haas, JuergenUNSPECIFIEDorcid.org/0000-0002-2314-7465UNSPECIFIED
Klotz, LuisaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wiendl, HeinzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruck, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meuth, Sven G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-140082
DOI: 10.1007/s00415-018-9117-z
Journal or Publication Title: J. Neurol.
Volume: 266
Number: 1
Page Range: S. 165 - 174
Date: 2019
Publisher: SPRINGER HEIDELBERG
Place of Publication: HEIDELBERG
ISSN: 1432-1459
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
REMITTING MULTIPLE-SCLEROSIS; INTERFERON-BETA; MECHANISM; THERAPYMultiple languages
Clinical NeurologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/14008

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