Evidence map›Paper›PMID 34181077›Full record

ArticleJournal of neurology2022

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.

Clara G Chisari, Giancarlo Comi, Massimo Filippi, Damiano Paolicelli, Pietro Iaffaldano, Mauro Zaffaroni, Vincenzo Brescia Morra, Eleonora Cocco, Girolama Alessandra Marfia, Luigi Maria Grimaldi and 29 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Journal of neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Observational
  3. Real-world effectiveness and safety of ofatumumab in relapsing-remitting multiple sclerosis: Insights from naïve and switch patients.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Review
  9. Article
  10. Multiple Sclerosis: Switching from Natalizumab to Other High-Efficacy Treatments to Mitigate Progressive Multifocal Leukoencephalopathy Risk.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021
    Review
  11. Real-world treatment outcomes and safety of natalizumab in Finnish multiple sclerosis patients.Multiple sclerosis journal - experimental, translational and clinical
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 2 countries.

Clara G ChisariDepartment "GF. Ingrassia", Section of Neurosciences, University of Catania, via S. Sofia 78, 95129, Catania, Italy.
Giancarlo ComiInstitute of Experimental Neurology, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Massimo FilippiNeurology Unit and MS Center, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Damiano PaolicelliDepartment of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari Aldo Moro, Bari, Italy.
Pietro IaffaldanoDepartment of Basic Medical Sciences, Neurosciences and Sense Organs, School of Medicine, University of Bari Aldo Moro, Bari, Italy.
Mauro ZaffaroniMultiple Sclerosis Center, ASST Della Valle Olona, Gallarate Hospital, Gallarate (VA), Italy.
Vincenzo Brescia MorraMultiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Science and Odontostomatology, Multiple Sclerosis Centre, University Federico II, Naples, Italy.
Eleonora CoccoMultiple Sclerosis Centre Binaghi Hospital, ATS Sardegna-University of Cagliari, Cagliari, Italy.
Girolama Alessandra MarfiaMultiple Sclerosis Clinical and Research Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
Luigi Maria GrimaldiFoundation Institute "G. Giglio", MS Center, Cefalù-Palermo, Italy.
Matilde IngleseDepartment of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Genoa, Italy.
Simona BonavitaSecond Division of Neurology, Department of Advanced Medical and Surgical Sciences, MRI Research Center SUN-FISM, AOU-University of Campania "Luigi Vanvitelli", Naples, Italy.
Alessandra LugaresiIRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.
Giuseppe SalemiDepartment of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy.
Giovanna De LucaMultiple Sclerosis Center, Neurology Clinic, Policlinico SS Annunziata, University of Chieti-Pescara, Chieti, Italy.
Salvatore CottoneDepartment of Neurology, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
Antonella ConteDepartment of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
Patrizia SolaDepartment of Neuroscience, UO of Neurology, AOU Policlinico OB, Modena, Italy.
Umberto AgugliaDepartment of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy.
Giorgia Teresa ManiscalcoNeurological Clinic and Multiple Sclerosis Center, Cardarelli Hospital, Naples, Italy.
Claudio GasperiniDepartment of Neurology, Multiple Sclerosis Centre, San Camillo-Forlanini Hospital, Rome, Italy.
Maria Teresa FerròNeuroimmunology Center for Multiple Sclerosis, Cerebrovascular Department, ASST Crema, Crema, Italy.
Ilaria PesciMultiple Sclerosis Center, Fidenza-S. Secondo Hospital, Fidenza, Parma, Italy.
Maria Pia AmatoDivision Neurological Rehabilitation, Department of NEUROFARBA, University of Florence, Florence, Italy.
Marco RovarisIRCCS Don C. Gnocchi Foundation ONLUS, Milan, Italy.
Claudio SolaroRehabilitation Department, CRRF Mons L Novarese, Moncrivello VC, Italy.
Giacomo LusMultiple Sclerosis Center, II Division of Neurology, Department of Clinical and Experimental Medicine, Second University of Naples, Naples, Italy.
Davide MaimoneMultiple Sclerosis Center, Neurology Unit, ARNAS Garibaldi, Catania, Italy.
Roberto BergamaschiIRCCS Mondino Foundation, Pavia, Italy.
Franco GranellaNeurosciences Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy.
Alessia Di SapioDepartment of Neurology, Regina Montis Regalis Hospital, Mondovì, Italy.
Antonio BertolottoNeurologia & CRESM (Centro Riferimento Regionale SM), AOU San Luigi Gonzaga, Orbassano, Italy.
Rocco TotaroDemyelinating Disease Center, Department of Neurology, San Salvatore Hospital, L'Aquila, Italy.
Marika VianelloUnit of Neurology, Cà Foncello Hospital, Treviso, Italy.
Paola CavallaMultiple Sclerosis Center, Department of Neuroscience and Mental Health, City of Health and Science University Hospital of Turin, Torino, Italy.
Paolo BellantonioUnit of Neurology and Neurorehabilitation, IRCCS Neuromed, Pozzilli, IS, Italy.
Vito LeporeCoreserach Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.
Francesco PattiDepartment "GF. Ingrassia", Section of Neurosciences, University of Catania, via S. Sofia 78, 95129, Catania, Italy. patti@unict.it.ORCID http://orcid.org/0000-0002-6923-0846
Italian MS Register Study Group.
Istituto Neurologico Mediterraneo · ITVita-Salute San Raffaele University · ITDon Carlo Gnocchi Foundation · ITUniversity of Catania · ITUniversity of Bari Aldo Moro · ITUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Chieti-Pescara · ITUniversity of Parma · ITAzienda Ospedaliera Ospedale Maggiore · ITAzienda Ospedaliero-Universitaria di Modena · ITAzienda Socio Sanitaria Territoriale della Valle OlonaCa' Foncello Hospital · ITCarlo Forlanini Hospital · ITFondazione Istituto G. Giglio di Cefalù · ITIstituto delle Scienze Neurologiche di Bologna · ITMagna Graecia University · ITMario Negri Institute for Pharmacological Research · ITOspedale Garibaldi · ITOspedale Policlinico San Martino · ITOspedale San Luigi Gonzaga · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNatalizumab (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

methodsThe 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".

resultsOut 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).

conclusionsRoughly 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.

Indexed as

Leukoencephalopathy, Progressive MultifocalMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingAdultFemaleHumansImmunologic FactorsMiddle AgedNatalizumabRetrospective StudiesImmunologic FactorsNatalizumabDiscontinuation rateMultiple sclerosisNatalizumabReasons for discontinuation

Identifiers

PMID34181077
OpenAlexW3177468047

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.