Background: To minimize the risk of Progressive Multifocal Leukoencephalopathy and rebound in JCV-positive multiple sclerosis (MS) patients after 24 natalizumab doses, it has been proposed to extend the administrations interval. The objective is to evaluate the EID efficacy on MRI activity compared with the standard interval dosing (SID).Methods: Observational, multicentre, retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Three hundred and sixteen patients were enrolled. The median dose interval (MDI) following the 24th infusion was 5 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Patients were grouped into 2 categories according to the mean number of weeks between doses: < 5 weeks, SID; >= 5 weeks, EID.Results: One hundred and eighty-seven patients were in the SID group (MDI = 4.5 weeks) and 129 in the EID group (MDI 6.1 weeks). The risk to develop active lesions on MRI is similar in SID and EID groups during the 6 and 12 months after the 24th natalizumab infusion, respectively 4.27% (95% CI:0.84-7.70) vs 4.71% (95% CI:0.16-9.25%) [p = 0.89] and 8.50% (95% CI:4.05-12.95) vs 6.55% (95% CI:2.11-11.00%) [p = 0.56]. The EID regimen does not appear to increase the occurrence of MRI activity during follow-up.Conclusion: There is no evidence of the reduced efficacy of natalizumab in an EID setting regarding the MRI activity. This observation supports the need for a bigger randomized study to assess the need to change the standard of the natalizumab dosing schedule, to better manage JCV-positive patients.

De Mercanti, S.f., Signori, A., Cordioli, C., Signoriello, E., Lus, G., Bonavita, S., et al. (2021). MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study. JOURNAL OF THE NEUROLOGICAL SCIENCES, 424, 117385 [10.1016/j.jns.2021.117385].

MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study

Mataluni, Giorgia;Landi, Doriana;
2021

Abstract

Background: To minimize the risk of Progressive Multifocal Leukoencephalopathy and rebound in JCV-positive multiple sclerosis (MS) patients after 24 natalizumab doses, it has been proposed to extend the administrations interval. The objective is to evaluate the EID efficacy on MRI activity compared with the standard interval dosing (SID).Methods: Observational, multicentre, retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Three hundred and sixteen patients were enrolled. The median dose interval (MDI) following the 24th infusion was 5 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Patients were grouped into 2 categories according to the mean number of weeks between doses: < 5 weeks, SID; >= 5 weeks, EID.Results: One hundred and eighty-seven patients were in the SID group (MDI = 4.5 weeks) and 129 in the EID group (MDI 6.1 weeks). The risk to develop active lesions on MRI is similar in SID and EID groups during the 6 and 12 months after the 24th natalizumab infusion, respectively 4.27% (95% CI:0.84-7.70) vs 4.71% (95% CI:0.16-9.25%) [p = 0.89] and 8.50% (95% CI:4.05-12.95) vs 6.55% (95% CI:2.11-11.00%) [p = 0.56]. The EID regimen does not appear to increase the occurrence of MRI activity during follow-up.Conclusion: There is no evidence of the reduced efficacy of natalizumab in an EID setting regarding the MRI activity. This observation supports the need for a bigger randomized study to assess the need to change the standard of the natalizumab dosing schedule, to better manage JCV-positive patients.
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/26
English
Con Impact Factor ISI
Efficacy
Extended dose
Magnetic resonance imaging
Multiple sclerosis
Natalizumab
Humans
Immunologic Factors
Italy
Magnetic Resonance Imaging
Natalizumab
Retrospective Studies
Leukoencephalopathy, Progressive Multifocal
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
De Mercanti, S.f., Signori, A., Cordioli, C., Signoriello, E., Lus, G., Bonavita, S., et al. (2021). MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study. JOURNAL OF THE NEUROLOGICAL SCIENCES, 424, 117385 [10.1016/j.jns.2021.117385].
De Mercanti, Sf; Signori, A; Cordioli, C; Signoriello, E; Lus, G; Bonavita, S; Abbadessa, G; Lavorgna, L; Maniscalco, Gt; Curti, E; Lorefice, L; Cocco, E; Nociti, V; Mirabella, M; Baroncini, D; Mataluni, G; Landi, D; Petruzzo, M; Lanzillo, R; Gandoglia, I; Laroni, A; Frangiamore, R; Sartori, A; Cavalla, P; Costantini, G; Capra, R; Sormani, Mp; Clerico, M
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/306383
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