Evidence map›Paper›PMID 23292204›Full record

Trial reportJournal of neurology2013

Clinical effects of natalizumab on multiple sclerosis appear early in treatment course.

Ludwig Kappos, Paul W O'Connor, Christopher H Polman, Patrick Vermersch, Heinz Wiendl, Amy Pace, Annie Zhang, Christophe Hotermans

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 5% 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

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Natalizumab for multiple sclerosis.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Observational
  8. Observational
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Disease-Modifying Drugs for Multiple Sclerosis and Association With Survival.Neurology(R) neuroimmunology & neuroinflammation · 2022
    Article
  16. Article
  17. Observational
  18. Aggressive multiple sclerosis (2): Treatment.Multiple sclerosis (Houndmills, Basingstoke, England) · 2020
    Article
  19. Article
  20. 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

8 authors at 6 institutions in 6 countries.

Ludwig KapposDepartments of Neurology and Biomedicine, University Hospital Basel, Petersgraben 4, Basel, Switzerland. lkappos@uhbs.ch
Paul W O'Connor
Christopher H Polman
Patrick Vermersch
Heinz Wiendl
Amy Pace
Annie Zhang
Christophe Hotermans
Biogen (United States) · USAmsterdam UMC Location VUmc · NLSt. Michael's Hospital · CAUniversité Lille Nord de France · FRUniversity Hospital of Basel · CHUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In clinical practice natalizumab is typically used in patients who have experienced breakthrough disease during treatment with interferon beta (IFNβ) or glatiramer acetate. In these patients it is important to reduce disease activity as quickly as possible. In a phase II study, differences between natalizumab and placebo in MRI outcomes reflecting inflammatory activity were evident after the first infusion and maintained through a 6-month period, suggesting a rapid onset of natalizumab treatment effects. To explore how soon after natalizumab initiation clinical effects become apparent, annualized relapse rates per 3-month period and time to first relapse were analyzed in the phase III AFFIRM study (natalizumab vs. placebo) and in the multinational Tysabri(®) Observational Program (TOP). In AFFIRM, natalizumab reduced the annualized relapse rate within 3 months of treatment initiation compared with placebo in the overall population (0.30 vs. 0.71; p < 0.0001) and in patients with highly active disease (0.30 vs. 0.94; p = 0.0039). The low annualized relapse rate was maintained throughout the 2-year study period, and the risk of relapse in AFFIRM patients treated with natalizumab was reduced [hazard ratio against placebo 0.42 (95 % CI 0.34-0.52); p < 0.0001]. Rapid reductions in annualized relapse rate also occurred in TOP (baseline 1.99 vs. 0-3 months 0.26; p < 0.0001). Natalizumab resulted in rapid, sustained reductions in disease activity in both AFFIRM and in clinical practice. This decrease in disease activity occurred within the first 3 months of treatment even in patients with more active disease.

Indexed as

Antibodies, Monoclonal, HumanizedDisability EvaluationDouble-Blind MethodFemaleHumansImmunologic FactorsInterferon-betaInternational CooperationLongitudinal StudiesMagnetic Resonance ImagingMaleMultiple SclerosisNatalizumabSecondary PreventionTime FactorsTreatment OutcomeAntibodies, Monoclonal, HumanizedImmunologic FactorsInterferon-betaNatalizumab

Identifiers

PMID23292204
PMCPMC3642366
OpenAlexW1986333359

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.