Evidence map›Paper›PMID 34603507›Full record

ArticleTherapeutic advances in neurological disorders2021

No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP).

Helmut Butzkueven, Ludwig Kappos, Tim Spelman, Maria Trojano, Heinz Wiendl, Ray Su, Shirley Liao, Robert Hyde, Stephanie Licata, Pei-Ran Ho and 1 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic advances in neurological disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00493298 (TOP), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT00493298 completednot on this map

TOP: TYSABRI Observational Program

TypeobservationalSponsorBiogenRan2007 to 2023Enrolled6,620ConditionsRelapsing-Remitting Multiple SclerosisArmsTysabri
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Observational
  4. Observational
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
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

11 authors at 7 institutions in 5 countries.

Helmut ButzkuevenDepartment of Neuroscience, Central Clinical School, Monash University, Alfred Centre, Melbourne, VIC 3004, Australia. Department of Neurology, Box Hill Hospital, Monash University, Box Hill, VIC, Australia.ORCID https://orcid.org/0000-0003-3940-8727
Ludwig KapposResearch Center for Clinical Neuroimmunology and Neuroscience Basel, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland.ORCID https://orcid.org/0000-0003-4175-5509
Tim SpelmanDepartment of Medicine and Melbourne Brain Centre, Royal Melbourne Hospital, The University of Melbourne, Melbourne, VIC, Australia.
Maria TrojanoDepartment of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy.
Heinz WiendlDepartment of Neurology, University of Münster, Münster, Germany.ORCID https://orcid.org/0000-0003-4310-3432
Ray SuBiogen, Cambridge, MA, USA, at the time of this analysis.
Shirley LiaoBiogen, Cambridge, MA, USA, at the time of this analysis.
Robert HydeBiogen, Baar, Switzerland.
Stephanie LicataBiogen, Cambridge, MA, USA, at the time of this analysis.
Pei-Ran HoBiogen, Cambridge, MA, USA, at the time of this analysis.
Nolan CampbellBiogen, Cambridge, MA, USA.
Biogen (United States) · USBiogen (Switzerland) · CHBox Hill Hospital · AUThe Royal Melbourne Hospital · AUUniversity of Bari Aldo Moro · ITUniversity of Basel · CHUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExtended interval dosing of natalizumab is associated with significantly lower progressive multifocal leukoencephalopathy risk compared with every-4-week (Q4W) dosing in patients with relapsing-remitting multiple sclerosis. Previous studies have suggested that natalizumab effectiveness is maintained in patients who switch from Q4W to extended interval dosing but have been limited by a lack of well-matched patient cohorts.

methodsTysabri Observational Program (TOP) data as of November 2019 were used to identify patients with relapsing-remitting multiple sclerosis treated with natalizumab Q4W and those with a single physician-indicated dosing change from Q4W to every-6-week (Q6W) dosing after ⩾1 year of Q4W treatment. Patients were propensity score matched at the time of the switch from Q4W to Q6W dosing. Clinical outcomes (annualized relapse rate and probability of remaining relapse free or free of 24-week confirmed disability worsening) and safety outcomes were assessed for the two cohorts.

resultsThis study included 219 pairs of propensity score-matched Q6W and Q4W patients. Annualized relapse rates were similar for Q6W (0.150) and Q4W (0.157) patients. The probability of remaining relapse free [hazard ratio = 1.243 (95% confidence interval = 0.819-1.888);

conclusionThese real-world findings in well-matched patient cohorts from TOP demonstrate that natalizumab effectiveness is maintained in patients who switch to Q6W dosing after ⩾1 year of Q4W dosing. CLINICALTRIALSGOV IDENTIFIER: NCT00493298.

Indexed as

clinical outcomesextended interval dosingmultiple sclerosisnatalizumabreal-world evidence

Identifiers

PMID34603507
PMCPMC8481711
OpenAlexW3204242621

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.