Evidence map›Paper›PMID 33890167›Full record

Observational studyJournal of neurology2021

Long-term outcome and predictors of long-term disease activity in natalizumab-treated patients with multiple sclerosis: real life data from the Austrian MS Treatment Registry.

Michael Guger, Christian Enzinger, Fritz Leutmezer, Franziska Di Pauli, Jörg Kraus, Stefan Kalcher, Erich Kvas, Thomas Berger, Austrian MS Treatment Registry (AMSTR)

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Journal of neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Effects of natalizumab on oligoclonal bands in the cerebrospinal fluid of patients with multiple sclerosis: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Article
  7. Monoclonal Antibodies in the Treatment of Relapsing Multiple Sclerosis: an Overview with Emphasis on Pregnancy, Vaccination, and Risk Management.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  8. Comparative effectiveness of natalizumabTherapeutic advances in neurological disorders · 2022
    Article
  9. Article
  10. 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

9 authors at 5 institutions in 2 countries.

Michael GugerClinic for Neurology 2, Med Campus III, Kepler University Hospital GmbH, Krankenhausstr. 9, 4021, Linz, Austria. Michael.Guger@kepleruniklinikum.at.ORCID http://orcid.org/0000-0001-8219-781X
Christian EnzingerDepartment of Neurology, Medical University of Graz, Graz, Austria.
Fritz LeutmezerDepartment of Neurology, Medical University of Vienna, Vienna, Austria.
Franziska Di PauliClinical Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Jörg KrausDepartment of Laboratory Medicine, Paracelsus Medical University and Salzburger Landeskliniken, Salzburg, Austria.
Stefan KalcherHermesoft, Data management, Graz, Austria.
Erich KvasHermesoft, Statistics, Graz, Austria.
Thomas BergerDepartment of Neurology, Medical University of Vienna, Vienna, Austria.
Austrian MS Treatment Registry (AMSTR)
Medical University of Vienna · ATInnsbruck Medical University · ATJohannes Kepler University of Linz · ATMedical University of Graz · ATParacelsus Medical University · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate long-term effectiveness of natalizumab (NTZ) and to determine demographic, clinical, and radiological predictors regarding long-term disease activity (≥ 7 years) in a nationwide observational cohort, using data collected prospectively in a real-life setting. MATERIALS AND

methodsWe analysed data from 230 patients from the Austrian Multiple Sclerosis Treatment Registry (AMSTR), who had started treatment with NTZ at any time since 2006 and stayed on NTZ for at least 7 years without treatment gap of more than three months.

resultsEstimated mean annualised relapse rates (ARR) over a mean treatment period of 9.3 years were 0.07 for NTZ. Sustained EDSS progression for 12 weeks was observed in 36 (19%) patients and for 24 weeks in 31 (16.3%) cases. Sustained EDSS regression for 12 and 24 weeks was seen in 45 (23.7%) and 42 (22.1%) cases. The baseline parameters ≥ 1 Gadolinium-enhancing MRI lesion(s) [incidence rate ratio (IRR) of 0.409 (95% CI 0.283-0.593), p = 0.001], ARR ≤ 1 in the prior 12 month before treatment initiation with NTZ [IRR of 0.353 (95% CI 0.200-0.623), p = 0.001] and EDSS ≤ 1 [incidence rate ratio (IRR) of 0.081 (95% CI 0.011-0.581), p = 0.012] were significantly associated with a reduced relapse risk, whereas a disease duration ≤ 5 years increased significantly the ARR [IRR of 1.851 (95% CI 1.249-2.743), p = 0.002]. The only predictive baseline parameter for experiencing EDSS progression (sustained for 12 and 24 weeks) was age > 35 years [HR of 2.482 (95% CI 1.110-5.549), p = 0.027, and HR of 2.492 (95% CI 1.039-5.978), p = 0.041, respectively].

conclusionsThese real-life data show a stable disease course regarding relapse activity and disease progression under NTZ treatment for more than 7 years. The main predictors for disease activity were higher relapse rate before treatment initiation, higher disability, shorter disease duration and absence of Gadolinium-enhancing MRI lesions at baseline. Older age at NTZ start was the only significant risk factor for disease progression over long-term.

Indexed as

Multiple SclerosisAdultAustriaHumansMagnetic Resonance ImagingNatalizumabRegistriesNatalizumabDisability progressionLong-termMultiple sclerosisNatalizumabPredictor

Identifiers

PMID33890167
PMCPMC8505366
OpenAlexW3155100174

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.