PML risk is the main factor driving the choice of discontinuing natalizumab in a large multiple sclerosis population: results from an Italian multicenter retrospective study.

Autor: Chisari CG; Department 'GF. Ingrassia', Section of Neurosciences, University of Catania, via S. Sofia 78, 95129, Catania, Italy., Comi G; Institute of Experimental Neurology, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy., Filippi M; Neurology Unit and MS Center, IRCCS San Raffaele Scientific Institute, Milan, Italy.; Neuroimaging Research Unit, Institute of Experimental Neurology, Division of Neuroscience, Neurophysiology Unit, IRCCS San Raffaele Institute, Milan, Italy.; Vita-Salute San Raffaele University, Milan, Italy., Paolicelli D; Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari Aldo Moro, Bari, Italy., Iaffaldano P; Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari Aldo Moro, Bari, Italy., Zaffaroni M; Multiple Sclerosis Center, ASST Della Valle Olona, Gallarate Hospital, Gallarate (VA), Italy., Brescia Morra V; Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Centre, University Federico II, Naples, Italy., Cocco E; Multiple Sclerosis Centre Binaghi Hospital, ATS Sardegna-University of Cagliari, Cagliari, Italy., Marfia GA; Multiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.; Unit of Neurology, IRCCS Istituto Neurologico Mediterraneo NEUROMED, Pozzilli, Italy., Grimaldi LM; Foundation Institute 'G. Giglio', MS Center, Cefalù-Palermo, Italy., Inglese M; Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Genoa, Italy.; San Martino Hospital-IRCCS, Genoa, Italy., Bonavita S; Second Division of Neurology, Department of Advanced Medical and Surgical Sciences, MRI Research Center SUN-FISM, AOU-University of Campania 'Luigi Vanvitelli', Naples, Italy., Lugaresi A; IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.; Department of Biomedic and Neuromotor Sciences, University of Bologna, Bologna, Italy., Salemi G; Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy., De Luca G; Multiple Sclerosis Center, Neurology Clinic, Policlinico SS Annunziata, University of Chieti-Pescara, Chieti, Italy., Cottone S; Department of Neurology, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy., Conte A; Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy.; IRCCS Neuromed Pozzili, Pozzili (IS), Italy., Sola P; Department of Neuroscience, UO of Neurology, AOU Policlinico OB, Modena, Italy., Aguglia U; Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy.; Great Metropolitan Hospital, Reggio Calabria, Italy., Maniscalco GT; Neurological Clinic and Multiple Sclerosis Center, Cardarelli Hospital, Naples, Italy., Gasperini C; Department of Neurology, Multiple Sclerosis Centre, San Camillo-Forlanini Hospital, Rome, Italy., Ferrò MT; Neuroimmunology Center for Multiple Sclerosis, Cerebrovascular Department, ASST Crema, Crema, Italy., Pesci I; Multiple Sclerosis Center, Fidenza-S. Secondo Hospital, Fidenza, Parma, Italy., Amato MP; Division Neurological Rehabilitation, Department of NEUROFARBA, University of Florence, Florence, Italy.; Department of Neurorehabilitation, IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy., Rovaris M; IRCCS Don C. Gnocchi Foundation ONLUS, Milan, Italy., Solaro C; Rehabilitation Department, CRRF Mons L Novarese, Moncrivello VC, Italy., Lus G; Multiple Sclerosis Center, II Division of Neurology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples, Italy., Maimone D; Multiple Sclerosis Center, Neurology Unit, ARNAS Garibaldi, Catania, Italy., Bergamaschi R; IRCCS Mondino Foundation, Pavia, Italy., Granella F; Neurosciences Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy., Di Sapio A; Department of Neurology, Regina Montis Regalis Hospital, Mondovì, Italy., Bertolotto A; Neurologia & CRESM (Centro Riferimento Regionale SM), AOU San Luigi Gonzaga, Orbassano, Italy., Totaro R; Demyelinating Disease Center, Department of Neurology, San Salvatore Hospital, L'Aquila, Italy., Vianello M; Unit of Neurology, Cà Foncello Hospital, Treviso, Italy., Cavalla P; Multiple Sclerosis Center, Department of Neuroscience and Mental Health, City of Health and Science University Hospital of Turin, Torino, Italy., Bellantonio P; Unit of Neurology and Neurorehabilitation, IRCCS Neuromed, Pozzilli, IS, Italy., Lepore V; Coreserach Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.; Istituto Di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy., Patti F; Department 'GF. Ingrassia', Section of Neurosciences, University of Catania, via S. Sofia 78, 95129, Catania, Italy. patti@unict.it.
Jazyk: angličtina
Zdroj: Journal of neurology [J Neurol] 2022 Feb; Vol. 269 (2), pp. 933-944. Date of Electronic Publication: 2021 Jun 28.
DOI: 10.1007/s00415-021-10676-6
Abstrakt: Background: Natalizumab (NTZ) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). However, patients and physicians may consider discontinuing NTZ therapy due to safety or efficacy issues. The aim of our study was to evaluate the NTZ discontinuation rate and reasons of discontinuation in a large Italian population of RRMS patients.
Materials and Methods: The data were extracted from the Italian MS registry in May 2018 and were collected from 51,845 patients in 69 Italian multiple sclerosis centers. MS patients with at least one NTZ infusion in the period between June 1st 2012 to May 15th 2018 were included. Discontinuation rates at each time point were calculated. Reasons for NTZ discontinuation were classified as "lack of efficacy", "progressive multifocal leukoencephalopathy (PML) risk" or "other".
Results: Out of 51,845, 5151 patients, 3019 (58.6%) females, with a mean age of 43.6 ± 10.1 years (median 40), were analyzed. Out of 2037 (39.5%) who discontinued NTZ, a significantly higher percentage suspended NTZ because of PML risk compared to lack of efficacy [1682 (32.7% of 5151) vs 221 (4.3%), p < 0.001]; other reasons were identified for 99 (1.9%) patients. Patients discontinuing treatment were older, had longer disease duration and worse EDSS at the time of NTZ initiation and at last follow-up on NTZ treatment. The JCV index and EDSS at baseline were predictors for stopping therapy (HR 2.94, 95% CI 1.22-4.75; p = 0.02; HR 1.36, 95% CI 1.18-5.41; p = 0.04).
Conclusions: Roughly 60% of MS patients stayed on NTZ treatment during the observation period. For those patients in whom NTZ discontinuation was required, it was mainly due to PML concerns.
(© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
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