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

Pfeuffer S, Schmidt R, Ruck T, Kleinschnitz C, Lee DH, Linker R, Doerck S, Straeten V, Windhagen S, Pawlitzki M, Aufenberg C, Lang M, Eienbroeker C, Tackenberg B, Limmroth V, Wiendl H, Meuth SG

Forschungsartikel (Zeitschrift) | Peer reviewed

Zusammenfassung

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.

Details zur Publikation

FachzeitschriftJournal of Neurology (J Neurol)
Jahrgang / Bandnr. / Volume266
Ausgabe / Heftnr. / Issue1
Seitenbereich165-173
StatusVeröffentlicht
Veröffentlichungsjahr2019
Sprache, in der die Publikation verfasst istEnglisch
DOI10.1007/s00415-018-9117-z
StichwörterAlemtuzumab, Fingolimod, Immunomodulatory therapy, Natalizumab, Progressive multifocal leukoencephalopathy, Remitting-relapsing multiple sclerosis

Autor*innen der Universität Münster

Pfeuffer, Steffen
Klinik für Neurologie mit Institut für Translationale Neurologie
Schmidt, Rene
Institut für Biometrie und Klinische Forschung (IBKF)