Evidence map›Paper›PMID 37074388›Full record

ArticleJournal of neurology2023

Real-world use of natalizumab in Austria: data from the Austrian Multiple Sclerosis Treatment Registry (AMSTR).

Tobias Monschein, Sarinah Dekany, Tobias Zrzavy, Markus Ponleitner, Patrick Altmann, Gabriel Bsteh, Barbara Kornek, Paulus Rommer, Christian Enzinger, Franziska Di Pauli and 5 more

Erratum issuedAbstract read
In one paragraph

Article in Journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Integrins as Drug Targets in Vascular and Related Diseases.International journal of drug discovery and pharmacology · 2024
    Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Tobias MonscheinDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Sarinah DekanyDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Tobias ZrzavyDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Markus PonleitnerDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Patrick AltmannDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Gabriel BstehDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Barbara KornekDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Paulus RommerDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Christian EnzingerDepartment of Neurology, Karl-Franzens University, Graz, Austria.
Franziska Di PauliDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Jörg KrausDepartment of Neurology, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Thomas BergerDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Fritz LeutmezerDepartment of Neurology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. fritz.leutmezer@meduniwien.ac.at.ORCID http://orcid.org/0000-0001-5665-8635
Michael GugerClinic for Neurology 2, Kepler University Clinic, Linz, Austria.
Austrian MS Treatment Registry (AMSTR)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWith the approval of natalizumab in Europe in 2006, the Austrian Multiple Sclerosis Therapy Registry (AMSTR) was established. Here, we present data from this registry about effectiveness and safety of natalizumab in patients treated up to 14 years. PATIENTS/

methodsData retrieved from the AMSTR contained baseline characteristics and biannual documentation of annualised relapse rate (ARR) and Expanded Disability Status Scale (EDSS) score as well as adverse events and reasons for discontinuation on follow-up visits.

resultsA total of 1596 natalizumab patients (71% women, n = 1133) were included in the analysis and the observed treatment duration ranged from 0 to 164 months (13.6 years). The mean ARR was 2.0 (SD = 1.13) at baseline, decreasing to 0.16 after 1 year and 0.01 after 10 years. A total of 325 patients (21.6%) converted to secondary progressive multiple sclerosis (SPMS) during the observational period. Of 1502 patients, 1297 (86.4%) reported no adverse events (AE) during follow-up visits. The most common reported AEs were infections and infusion-related reactions. John Cunningham virus (JCV) seropositivity was the most common specified reason for treatment discontinuation (53.7%, n = 607). There were five confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) with 1 death.

conclusionThe effectiveness of natalizumab in patients with active relapsing-remitting multiple sclerosis (RRMS) could be confirmed in our real-world cohort even after follow-up of up to 14 years, though after year 10, there were less than 100 remaining patients. A low number of AE were reported in this nationwide registry study, establishing Natalizumab's favourable safety profile during long-term use.

Indexed as

Leukoencephalopathy, Progressive MultifocalMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingAustriaFemaleHumansImmunologic FactorsMaleNatalizumabRegistriesImmunologic FactorsNatalizumabEffectivenessMultiple sclerosisNatalizumabPMLSafety

Identifiers

PMID37074388
PMCPMC10344989

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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.