Decrease of natalizumab drug levels after switching from intravenous to subcutaneous administration in patients with multiple sclerosis
| Autor: | Alyssa A Toorop, Zoé L E van Kempen, Maurice Steenhuis, Jessica Nielsen, L G F Sinnige, Gert van Dijk, Christiaan M Roosendaal, Edo P J Arnoldus, Elske Hoitsma, Birgit I Lissenberg-Witte, Brigit A de Jong, Bob W van Oosten, Eva M M Strijbis, Bernard M J Uitdehaag, Theo Rispens, Joep Killestein |
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| Přispěvatelé: | Neurology, Amsterdam Neuroscience - Neuroinfection & -inflammation, Epidemiology and Data Science, APH - Methodology, APH - Quality of Care, AII - Inflammatory diseases, Landsteiner Laboratory |
| Jazyk: | angličtina |
| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Journal of Neurology, Neurosurgery and Psychiatry, 94(6), 482-486. BMJ Publishing Group Toorop, A A, van Kempen, Z L E, Steenhuis, M, Nielsen, J, Sinnige, L G F, van Dijk, G, Roosendaal, C M, Arnoldus, E P J, Hoitsma, E, Lissenberg-Witte, B I, de Jong, B A, Oosten, B W V, Strijbis, E M M, Uitdehaag, B M J, Rispens, T & Killestein, J 2023, ' Decrease of natalizumab drug levels after switching from intravenous to subcutaneous administration in patients with multiple sclerosis ', Journal of Neurology, Neurosurgery and Psychiatry, vol. 94, no. 6, pp. 482-486 . https://doi.org/10.1136/jnnp-2022-330467 |
| ISSN: | 0022-3050 |
| Popis: | BackgroundNatalizumab is effective in the treatment of multiple sclerosis (MS). In 2021, the European Medicines Agency approved the subcutaneous (SC) variant of natalizumab which can be used instead of intravenous administration. However, the course of drug levels varies between administration routes, and the Food and Drug Administration rejected the request for approval of natalizumab SC for reasons that were not disclosed. Our objective was to evaluate the course of natalizumab trough drug levels in patients who switched from natalizumab intravenous to SC on various treatment intervals.MethodsThe NEXT-MS trial (N=382) investigates personalised treatment of natalizumab, in which infusion intervals are prolonged based on individual natalizumab trough drug levels. In 2021, an amendment was approved allowing participants to switch from intravenous to SC administration with frequent measurements of natalizumab drug levels and antidrug antibodies (ADAs). Results were compared with linear mixed model analyses.ResultsUntil December 2022, 15 participants switched to SC natalizumab. Natalizumab drug levels with SC administration were on average 55% lower compared with intravenous administration (Exp (estimate) 0.45, 95% CI 0.39 to 0.53, pConclusionsNatalizumab trough drug levels can decrease after switching from natalizumab intravenous to SC administration. We advise to monitor trough drug levels in patients with low natalizumab drug levels during intravenous treatment, patients with higher body mass index or patients on extended treatment intervals who switch to SC administration of natalizumab. |
| Databáze: | OpenAIRE |
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