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.

Adult Female Humans Immunologic Factors / adverse effects Leukoencephalopathy, Progressive Multifocal / epidemiology Middle Aged Multiple Sclerosis / drug therapy Multiple Sclerosis, Relapsing-Remitting / drug therapy Natalizumab / adverse effects Retrospective Studies
Discontinuation rate Multiple sclerosis Natalizumab Reasons for discontinuation

Journal

Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161

Informations de publication

Date de publication:
Feb 2022
Historique:
received: 01 03 2021
accepted: 16 06 2021
revised: 15 06 2021
pubmed: 29 6 2021
medline: 27 1 2022
entrez: 28 6 2021
Statut: ppublish

Résumé

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. 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". 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). 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.

Sections du résumé

BACKGROUND 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 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 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 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.

Identifiants

DOI: 10.1007/s00415-021-10676-6 PMID: 34181077
pubmed: 34181077
doi: 10.1007/s00415-021-10676-6
pii: 10.1007/s00415-021-10676-6
doi:

Substances chimiques

Immunologic Factors 0
Natalizumab 0

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

933-944

Investigateurs

Carlo Avolio (C)
Roberto Balgera (R)
Paola Banfi (P)
Paolo Bellantonio (P)
Placido Bramanti (P)
Lorenzo Capone (L)
Guido Cavalletti (G)
Luca Chiveri (L)
Raffaella Clerici (R)
Marinella Clerico (M)
Francesco Corea (F)
Vincenzo Dattola (V)
Francesca De Robertis (F)
Giancarlo Di Battista (G)
Simonetta Galgani (S)
Maurizia Gatto (M)
Maria Grazia Grasso (MG)
Lorenzo Lo Russo (LL)
Francesco Ottavio Logullo (FO)
Renato Mantegazza (R)
Alessandra Protti (A)
Monica Rezzonico (M)
Mariarosa Rottoli (M)
Marco Salvetti (M)
Elio Scarpini (E)
Leonardo Sinisi (L)
Maddalena Sparaco (M)
Daniele Spitaleri (D)
Tiziana Tassinari (T)
Simone Tonietti (S)
Paola Valentino (P)
Franco Valzania (F)
Simonetta Venturi (S)

Informations de copyright

© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.

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Auteurs

Clara G Chisari (CG)

Department "GF. Ingrassia", Section of Neurosciences, University of Catania, via S. Sofia 78, 95129, Catania, Italy.

Giancarlo Comi (G)

Institute of Experimental Neurology, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Massimo 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.

Damiano Paolicelli (D)

Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari Aldo Moro, Bari, Italy.

Pietro Iaffaldano (P)

Department of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari Aldo Moro, Bari, Italy.

Mauro Zaffaroni (M)

Multiple Sclerosis Center, ASST Della Valle Olona, Gallarate Hospital, Gallarate (VA), Italy.

Vincenzo 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.

Eleonora Cocco (E)

Multiple Sclerosis Centre Binaghi Hospital, ATS Sardegna-University of Cagliari, Cagliari, Italy.

Girolama Alessandra 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.

Luigi Maria Grimaldi (LM)

Foundation Institute "G. Giglio", MS Center, Cefalù-Palermo, Italy.

Matilde Inglese (M)

Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Genoa, Italy.
San Martino Hospital-IRCCS, Genoa, Italy.

Simona 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.

Alessandra Lugaresi (A)

IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.
Department of Biomedic and Neuromotor Sciences, University of Bologna, Bologna, Italy.

Giuseppe Salemi (G)

Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy.

Giovanna De Luca (G)

Multiple Sclerosis Center, Neurology Clinic, Policlinico SS Annunziata, University of Chieti-Pescara, Chieti, Italy.

Salvatore Cottone (S)

Department of Neurology, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.

Antonella Conte (A)

Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
IRCCS Neuromed Pozzili, Pozzili (IS), Italy.

Patrizia Sola (P)

Department of Neuroscience, UO of Neurology, AOU Policlinico OB, Modena, Italy.

Umberto Aguglia (U)

Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy.
Great Metropolitan Hospital, Reggio Calabria, Italy.

Giorgia Teresa Maniscalco (GT)

Neurological Clinic and Multiple Sclerosis Center, Cardarelli Hospital, Naples, Italy.

Claudio Gasperini (C)

Department of Neurology, Multiple Sclerosis Centre, San Camillo-Forlanini Hospital, Rome, Italy.

Maria Teresa Ferrò (MT)

Neuroimmunology Center for Multiple Sclerosis, Cerebrovascular Department, ASST Crema, Crema, Italy.

Ilaria Pesci (I)

Multiple Sclerosis Center, Fidenza-S. Secondo Hospital, Fidenza, Parma, Italy.

Maria Pia Amato (MP)

Division Neurological Rehabilitation, Department of NEUROFARBA, University of Florence, Florence, Italy.
Department of Neurorehabilitation, IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.

Marco Rovaris (M)

IRCCS Don C. Gnocchi Foundation ONLUS, Milan, Italy.

Claudio Solaro (C)

Rehabilitation Department, CRRF Mons L Novarese, Moncrivello VC, Italy.

Giacomo Lus (G)

Multiple Sclerosis Center, II Division of Neurology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples, Italy.

Davide Maimone (D)

Multiple Sclerosis Center, Neurology Unit, ARNAS Garibaldi, Catania, Italy.

Roberto Bergamaschi (R)

IRCCS Mondino Foundation, Pavia, Italy.

Franco Granella (F)

Neurosciences Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy.

Alessia Di Sapio (A)

Department of Neurology, Regina Montis Regalis Hospital, Mondovì, Italy.

Antonio Bertolotto (A)

Neurologia & CRESM (Centro Riferimento Regionale SM), AOU San Luigi Gonzaga, Orbassano, Italy.

Rocco Totaro (R)

Demyelinating Disease Center, Department of Neurology, San Salvatore Hospital, L'Aquila, Italy.

Marika Vianello (M)

Unit of Neurology, Cà Foncello Hospital, Treviso, Italy.

Paola Cavalla (P)

Multiple Sclerosis Center, Department of Neuroscience and Mental Health, City of Health and Science University Hospital of Turin, Torino, Italy.

Paolo Bellantonio (P)

Unit of Neurology and Neurorehabilitation, IRCCS Neuromed, Pozzilli, IS, Italy.

Vito Lepore (V)

Coreserach Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.
Istituto Di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.

Francesco Patti (F)

Department "GF. Ingrassia", Section of Neurosciences, University of Catania, via S. Sofia 78, 95129, Catania, Italy. patti@unict.it.
ORCID: 0000-0002-6923-0846

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › PML risk is the main factor driving the choice...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › PML risk is the main factor driving the choice...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Effets physiologiques des médicaments › Facteurs immunologiques › PML risk is the main factor driving the choice...
questionsmedicales.fr › Maladies du système nerveux › Encéphalite › Encéphalite infectieuse › Encéphalite virale › Leucoencéphalopathie multifocale progressive › PML risk is the main factor driving the choice...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › PML risk is the main factor driving the choice...
questionsmedicales.fr › Maladies du système immunitaire › Maladies auto-immunes › Maladies auto-immunes du système nerveux › Maladies démyélinisantes auto-immunes du SNC › Sclérose en plaques › PML risk is the main factor driving the choice...
questionsmedicales.fr › Maladies du système immunitaire › Maladies auto-immunes › Maladies auto-immunes du système nerveux › Maladies démyélinisantes auto-immunes du SNC › Sclérose en plaques › Sclérose en plaques récurrente-rémittente › PML risk is the main factor driving the choice...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps monoclonaux › Anticorps monoclonaux humanisés › Natalizumab › PML risk is the main factor driving the choice...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études rétrospectives › PML risk is the main factor driving the choice...