1. Influence of personalized extended interval dosing on the natalizumab wearing-off effect - a sub-study of the NEXT-MS trial
- Author
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Toorop, A. A., Wessels, M. H.J., Gelissen, L. M.Y., Hoitsma, E., Zeinstra, E. M.P.E., van Rooij, L. C., van Munster, C. E.P., Vennegoor, A., Mostert, J. P., Wokke, B. H.A., Kalkers, N. F., Hoogervorst, E. L.J., van Eijk, J. J.J., Roosendaal, C. M., Kragt, J. J., Eurelings, M., van Genugten, J., Nielsen, J., Sinnige, L. G.F., Kloosterziel, M. E., Arnoldus, E. P.J., van Dijk, G. W., Bouvy, W. H., Strijbis, E. M.M., van Oosten, B. W., de Jong, B. A., Lissenberg-Witte, B. I., Rispens, T., Uitdehaag, B. M.J., Killestein, J., van Kempen, Z. L.E., Toorop, A. A., Wessels, M. H.J., Gelissen, L. M.Y., Hoitsma, E., Zeinstra, E. M.P.E., van Rooij, L. C., van Munster, C. E.P., Vennegoor, A., Mostert, J. P., Wokke, B. H.A., Kalkers, N. F., Hoogervorst, E. L.J., van Eijk, J. J.J., Roosendaal, C. M., Kragt, J. J., Eurelings, M., van Genugten, J., Nielsen, J., Sinnige, L. G.F., Kloosterziel, M. E., Arnoldus, E. P.J., van Dijk, G. W., Bouvy, W. H., Strijbis, E. M.M., van Oosten, B. W., de Jong, B. A., Lissenberg-Witte, B. I., Rispens, T., Uitdehaag, B. M.J., Killestein, J., and van Kempen, Z. L.E.
- Abstract
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.
- Published
- 2024