Influence of personalized extended interval dosing on the natalizumab wearing-off effect - a sub-study of the NEXT-MS trial.

Autor:	Toorop AA; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands., Wessels MHJ; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands., Gelissen LMY; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands., Hoitsma E; Department of Neurology, MS center Alrijne Hospital, Leiden, the Netherlands., Zeinstra EMPE; Department of Neurology, Isala, Meppel, the Netherlands., van Rooij LC; Department of Neurology, Maasstad Hospital, Rotterdam, the Netherlands., van Munster CEP; Department of Neurology, Amphia, Breda, the Netherlands., Vennegoor A; Department of Neurology, Flevoziekenhuis, Almere, the Netherlands., Mostert JP; Department of Neurology, Rijnstate Hospital, Arnhem, the Netherlands., Wokke BHA; Department of Neurology, ErasMS, Erasmus Medical Center, Rotterdam, the Netherlands., Kalkers NF; Department of Neurology, OLVG, Amsterdam, the Netherlands., Hoogervorst ELJ; Department of Neurology, St Antonius Ziekenhuis, Utrecht, the Netherlands., van Eijk JJJ; Department of Neurology, Jeroen Bosch Ziekenhuis / Hospital, 's Hertogenbosch, the Netherlands., Roosendaal CM; Department of Neurology, Slingeland Hospital, Doetinchem, the Netherlands., Kragt JJ; Department of Neurology, Reinier de Graaf Hospital, Delft, the Netherlands., Eurelings M; Department of Neurology, Spaarne Gasthuis, Haarlem, the Netherlands., van Genugten J; Department of Neurology, Ziekenhuisgroep Twente, Almelo, the Netherlands., Nielsen J; Department of Neurology, Ommelander Ziekenhuis, Scheemda, the Netherlands., Sinnige LGF; Department of Neurology, Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands., Kloosterziel ME; Department of Neurology, Wilhelmina Hospital, Assen, the Netherlands., Arnoldus EPJ; Department of Neurology, Elizabeth TweeSteden Hospital, Tilburg, the Netherlands., van Dijk GW; Department of Neurology, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands., Bouvy WH; Department of Neurology, Diakonessenhuis Hospital, Utrecht, the Netherlands., Strijbis EMM; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands., van Oosten BW; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands., de Jong BA; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands., Lissenberg-Witte BI; Department of Epidemiology and Data Science, Amsterdam. University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands., Rispens T; Sanquin Diagnostic Services, Amsterdam, the Netherlands; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands., Uitdehaag BMJ; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands., Killestein J; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands., van Kempen ZLE; MS Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam, the Netherlands. Electronic address: z.vankempen@amsterdamumc.nl.
Jazyk:	angličtina
Zdroj:	Journal of the neurological sciences [J Neurol Sci] 2024 Jul 15; Vol. 462, pp. 123102. Date of Electronic Publication: 2024 Jun 22.
DOI:	10.1016/j.jns.2024.123102
Abstrakt:	Background and Objectives: Wearing-off symptoms during natalizumab treatment in multiple sclerosis are characterized by an increase of MS-related symptoms prior to natalizumab administration. The influence of extended interval dosing (EID) on wearing-off symptoms are important to consider, as this might cause hesitancy in initiating or continuing EID. Methods: Participants of the NEXT-MS trial, in which treatment intervals are adjusted based on drug concentrations, were divided into two groups: an extended group containing participants with at least one week of additional interval extension, and a group with a fixed interval during the trial (range 4-7 weeks). Changes in the occurrence, frequency, onset, and severity of wearing-off symptoms were evaluated. Results: 255 participants were included (extended group n = 171, fixed group n = 84). The odds on occurrence of wearing-off symptoms in the extended group did not increase after extending the treatment interval. Additional analyses for frequency, onset, and severity of wearing-off symptoms showed no changes over time. Mean decrease in natalizumab drug concentration did not influence the frequency of wearing-off symptoms. Discussion: Wearing-off symptoms were not reinforced by further extending the natalizumab interval. Wearing-off symptoms might increase in a minority of patients after EID, although our data support the view that wearing-off symptoms appear to be unrelated to the decrease in natalizumab trough drug concentrations. Competing Interests: Declaration of competing interest A.A. Toorop: nothing to disclose. M.H.J. Wessels: nothing to disclose. L.M.Y. Gelissen: nothing to disclose. E. Hoitsma: has accepted (speaker and congress) fees from Merck Serono, Biogen Idec, Roche, and Sanofi Genzyme. E.M.P.E. Zeinstra: reports advisory boards/consultancy fees for Merck, Novartis, Genzyme and Roche. L.C. van Rooij: nothing to disclose. C.E.P. van Munster: nothing to disclose. A. Vennegoor: nothing to disclose. J.P. Mostert: nothing to disclose. B.H.A. Wokke: nothing to disclose. N.F. Kalkers: nothing to disclose. E.L.J. Hoogervorst: nothing to disclose. J.J.J. van Eijk: reports honoraria for advisory boards and/or speakers fee from Merck Serono, Biogen Idec, Sanofi Genzyme, Roche and Novartis. C.M. Roosendaal: nothing to disclose. J.J. Kragt: nothing to disclose. M. Eurelings: nothing to disclose. J. Nielsen: nothing to disclose. J. van Genugten: nothing to disclose. L.G.F. Sinnige: nothing to disclose. M.E. Kloosterziel: nothing to disclose. E.P.J. Arnoldus: nothing to disclose. G.W. van Dijk: nothing to disclose. W.H. Bouvy: nothing to disclose. E.M.M. Strijbis: nothing to disclose. B.W. van Oosten: nothing to disclose. B.A. de Jong: nothing to disclose. B.I. Lissenberg-Witte: nothing to disclose. T. Rispens received funding for research from Genmab and consultancy fees from Novartis. B.M.J. Uitdehaag: reports research support and/or consultancy fees from Genzyme, Biogen Idec, Novartis, Teva Pharmaceutical Industries, Merck Serono, Roche, and Immunic Therapeutics. J. Killestein: received research grants for multicentre investigator initiated trials DOT-MS trial, ClinicalTrials.gov Identifier: NCT04260711 (ZonMW) and BLOOMS trial (ZonMW and Treatmeds), ClinicalTrials.gov Identifier: NCT05296161); received consulting fees for F. Hoffmann-La Roche Ltd., Biogen, Teva, Merck, Novartis and Sanofi/Genzyme (all payments to institution); reports speaker relationships with F. Hoffmann-La Roche Ltd., Biogen, Immunic, Teva, Merck, Novartis and Sanofi/Genzyme (all payments to institution); adjudication committee of MS clinical trial of Immunic (payments to institution only). Z.L.E. van Kempen: nothing to disclose. (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze:	MEDLINE
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