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

Pfeuffer S, Schmidt R, Straeten FA, Pul R, Kleinschnitz C, Wieshuber M, Lee DH, Linker R, Doerck S, Straeten V, Windhagen S, Pawlitzki M, Aufenberg C, Lang M, Eienbroeker C, Tackenberg B, Limmroth V, Wildemann B, Haas J, Klotz L, Wiendl H, Ruck T, Meuth SG (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Journal of Neurology Springer Verlag (Germany)

Book Volume: 266

Pages Range: 165-173

Journal Issue: 1

DOI: 10.1007/s00415-018-9117-z

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.

Authors with CRIS profile

De-Hyung Lee Medizinische Fakultät Ralf Linker Department of Neurology

Involved external institutions

Westfälische Wilhelms-Universität (WWU) Münster DE Germany (DE) Universität zu Köln DE Germany (DE) Universitätsklinikum Heidelberg DE Germany (DE) Universitätsklinikum Gießen und Marburg (UKGM) DE Germany (DE) Herz-Jesu-Krankenhaus Hiltrup DE Germany (DE) Universität Duisburg-Essen (UDE) DE Germany (DE) Julius-Maximilians-Universität Würzburg DE Germany (DE) Universitätsklinikum Magdeburg A.ö.R. DE Germany (DE) Klinikum Osnabrück DE Germany (DE) Johannes Wesling Klinikum Minden DE Germany (DE)

How to cite

APA:

Pfeuffer, S., Schmidt, R., Straeten, F.A., Pul, R., Kleinschnitz, C., Wieshuber, M.,... Meuth, S.G. (2019). Efficacy and safety of alemtuzumab versus fingolimod in RRMS after natalizumab cessation. Journal of Neurology, 266(1), 165-173. https://dx.doi.org/10.1007/s00415-018-9117-z

MLA:

Pfeuffer, Steffen, et al. "Efficacy and safety of alemtuzumab versus fingolimod in RRMS after natalizumab cessation." Journal of Neurology 266.1 (2019): 165-173.

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