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

Autor: De Mercanti SF; Clinical and Biological Sciences Department, Neurology Unit, University of Torino, San Luigi Gonzaga Hospital, Orbassano, Torino, Italy. Electronic address: sdemercanti@yahoo.it., Signori A; Department of Health Sciences, Section of Biostatistics, University of Genova, Italy., Cordioli C; Multiple Sclerosis Center, Spedali Civili of Brescia, Presidio di Montichiari, Brescia, Italy., Signoriello E; Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Second University of Naples, Italy., Lus G; Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Second University of Naples, Italy., Bonavita S; Clinic of Neurology, AOU - University of Campania 'Luigi Vanvitelli', Napoli, Italy., Abbadessa G; Clinic of Neurology, AOU - University of Campania 'Luigi Vanvitelli', Napoli, Italy., Lavorgna L; Clinic of Neurology, AOU - University of Campania 'Luigi Vanvitelli', Napoli, Italy., Maniscalco GT; Neurological Clinic and Multiple Sclerosis Centre of 'AORN A.Cardarelli', Naples, Italy., Curti E; Neurology Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy., Lorefice L; Multiple Sclerosis Center, Binaghi Hospital, Department of Medical Sciences and Public Health, University of Cagliari, Italy., Cocco E; Multiple Sclerosis Center, Binaghi Hospital, Department of Medical Sciences and Public Health, University of Cagliari, Italy., Nociti V; Multiple Sclerosis Center, Neuroscience Area, Neuroscience, Aging, Head and Neck and Orthopaedics Sciences Department, Fondazione Policlinico Universitario Gemelli, Roma, Italy., Mirabella M; Multiple Sclerosis Center, Neuroscience Area, Neuroscience, Aging, Head and Neck and Orthopaedics Sciences Department, Fondazione Policlinico Universitario Gemelli, Roma, Italy., Baroncini D; Centro Sclerosi Multipla - Presidio ospedaliero di Gallarate - ASST Valle Olona, Italy., Mataluni G; UOSD Centro di Riferimento Regionale Sclerosi Multipla - Dipartimento di Neuroscienze Policlinico Tor Vergata, Roma, Italy., Landi D; UOSD Centro di Riferimento Regionale Sclerosi Multipla - Dipartimento di Neuroscienze Policlinico Tor Vergata, Roma, Italy., Petruzzo M; Department of Neurosciences, Reproductive Sciences and Odontostomatology, Multiple Sclerosis Centre, Federico II University, Naples, Italy., Lanzillo R; Department of Neurosciences, Reproductive Sciences and Odontostomatology, Multiple Sclerosis Centre, Federico II University, Naples, Italy., Gandoglia I; Dept of Neuroscience, Rehabilititation, Ophthalmology, Genetics, Maternal and Child Health, Center of Excellence for Biomedical Research, University of Genova, Italy., Laroni A; IRCCS Ospedale Policlinico San Martino, Genova, Italy., Frangiamore R; Department of Neuroimmunology and Neuromuscular Diseases, Neurological Institute C. Besta, IRCCS Foundation, Milan, Italy., Sartori A; Neurology Unit, Azienda Sanitaria Univeristaria Integrata Clinica Neurologica, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste, Italy., Cavalla P; Department of Neuroscience, Città della Salute e della Scienza di Torino University Hospital, Torino, Italy., Costantini G; Department of Neuroscience, Città della Salute e della Scienza di Torino University Hospital, Torino, Italy., Capra R; Multiple Sclerosis Center, Spedali Civili of Brescia, Presidio di Montichiari, Brescia, Italy., Sormani MP; Clinical and Biological Sciences Department, Neurology Unit, University of Torino, San Luigi Gonzaga Hospital, Orbassano, Torino, Italy., Clerico M; Clinical and Biological Sciences Department, Neurology Unit, University of Torino, San Luigi Gonzaga Hospital, Orbassano, Torino, Italy.
Jazyk: angličtina
Zdroj: Journal of the neurological sciences [J Neurol Sci] 2021 May 15; Vol. 424, pp. 117385. Date of Electronic Publication: 2021 Mar 06.
DOI: 10.1016/j.jns.2021.117385
Abstrakt: 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.
(Copyright © 2021 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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