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  • Title: Prospective trial of natalizumab personalised extended interval dosing by therapeutic drug monitoring in relapsing-remitting multiple sclerosis (NEXT-MS).
    Author: Toorop AA, van Lierop ZY, Gelissen LM, Hoitsma E, Zeinstra EM, van Rooij LC, van Munster CE, Vennegoor A, Mostert JP, Wokke BH, Kalkers NF, Hoogervorst EL, van Eijk JJ, Roosendaal CM, Kragt JJ, Eurelings M, van Genugten J, Nielsen J, Sinnige L, Kloosterziel ME, Arnoldus EP, van Dijk GW, Bouvy WH, Wessels MH, Boonkamp L, Strijbis EM, van Oosten BW, De Jong BA, Lissenberg-Witte BI, Barkhof F, Moraal B, Teunissen CE, Rispens T, Uitdehaag BM, Killestein J, van Kempen ZL.
    Journal: J Neurol Neurosurg Psychiatry; 2024 Apr 12; 95(5):392-400. PubMed ID: 37963723.
    Abstract:
    BACKGROUND: Extended interval dosing (EID) of natalizumab is a promising strategy to optimise treatment in multiple sclerosis (MS). Personalised EID by therapeutic drug monitoring can enable further extension of treatment intervals. METHODS: The NEXT-MS trial is an investigator-initiated prospective phase IV non-randomised study. Adults with a diagnosis of relapsing-remitting MS who received ≥6 natalizumab infusions were included in three groups: personalised EID with a target drug trough concentration of 10 µg/mL (EID10), an exploratory group of personalised EID with a target of 5 µg/mL (EID5) and standard interval dosing (SID) of 4 weeks. The primary outcome is radiological disease activity (new/newly enlarged T2 lesions) comparing the EID10 group to a historical cohort of SID (HSID). RESULTS: Results of the first phase of the NEXT-MS trial are reported here (n=376) as the study will continue with an amended protocol. In the EID10 group (n=251), incidence rate of radiological activity was 10.0 per 1000 person-years, which was non-inferior to the HSID cohort (24.7 per 1000 person-years (n=87), incidence rate difference 14.7, 90% CI -4.5 to 34.0). Incidence rate of radiological activity was 10.0 per 1000 person-years in the EID5 group (n=65), and 47.0 per 1000 person-years in the SID group (n=60). Serum neurofilament light levels did not increase over time within the EID groups. There were no cases of progressive multifocal leukoencephalopathy. CONCLUSIONS: MS disease activity is adequately controlled with personalised natalizumab EID. Interval extension to a drug trough concentration of 5 µg/mL is likely a safe target to extend natalizumab treatment intervals >6 weeks. TRIAL REGISTRATION NUMBER: NCT04225312.
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