Switching from Natalizumab

Pfeuffer S, Schmidt R, Straeten FA, Pul R, Kleinschnitz C, Wieshuber M, Lee DH, Linker RA, 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. Efficacy and safety of alemtuzumab versus fingolimod in RRMS after natalizumab cessation.J Neurol. 2018 Nov 16. doi: 10.1007/s00415-018-9117-z.

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.

COI: Multiple. I do not need to comment, You cant read.

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  • 20/11/18 FDA: Multiple Sclerosis Patients Face Disability Risks if Stopping Fingolimod

    The FDA’s warning issued on Tuesday stated that stopping treatment with fingolimod could result in a patient’s condition becoming “much worse than before the medicine was start or while it was being taken.”

    “This MS worsening is rare but can result in permanent disability,” the administration stated. They further advised that healthcare providers inform patients prior to their starting treatment about the potential risk once stopping fingolimod, and to carefully observe patients for evidence of MS exacerbation in instances when therapy is stopped.

    Finally. Now we need to find something to do with the new -mods.

    • The new mods will have the same problem, this is rebound due to migration block. As i have said before you need to think about the exit strategy before you start

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