Evidence map›Paper›PMID 38925580›Full record

Trial reportEuropean journal of neurology2024

Sex- and age-related shift of relapse phenotypes in a cohort of relapsing multiple sclerosis patients: Post hoc analysis from the OPERA phase 3 trials.

A Leon Betancourt, Robert Hoepner, Helly Hammer, Andrew Chan, Anke Salmen

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in European journal of neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

5 authors.

A Leon BetancourtDepartment of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Robert HoepnerDepartment of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.ORCID 0000-0002-0115-7021
Helly HammerDepartment of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Andrew ChanDepartment of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Anke SalmenDepartment of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.ORCID 0000-0002-4751-299X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeRelapse presentation in relapsing multiple sclerosis (RMS) differs between sexes, leading to differential outcomes. An influence of age seems likely but is less well investigated separately for women and men.

methodsUsing the large well-defined dataset of the pivotal trials of ocrelizumab in RMS, OPERA I and II, and their open-label extension, we performed a post hoc analysis to investigate relapse phenotypes for sex- and age-related differences in n = 929 relapses in 534 subjects (171 men, 363 women). Frequencies of affected functional systems were analyzed separated by sex and for three age strata (<35, 35-44, ≥45 years). Exact p-values are given for this exploratory analysis.

resultsFrequencies of mono- versus polysymptomatic relapse presentations were different neither between sexes nor in different age groups. Cerebellar symptoms were more frequent in relapses in men (female [f]: 23.1%, male [m]: 33.0%, p = 0.002), and women's relapses included more sensory (f: 53.8%, m: 32.3%, p < 0.001) and fatigue symptoms (f: 22.6%, m: 14.7%, p = 0.006). Whereas the sex difference for sensory involvement was present over all age groups (<35 years: f: 58.3%, m: 30.4%, p < 0.001; 35-44 years: f: 53.7%, m: 36.0%, p = 0.003; ≥45 years: f: 47.8%, m: 28.8%, p = 0.009), the difference for cerebellar involvement diminished with age (<35 years: f: 20.1%, m: 33.3%, p = 0.009; 35-44 years: f: 22.7%, m: 34.2%, p = 0.034; ≥45 years: f: 27.8%, m: 30.3%, p = 0.750). Relapse presentation seemed to shift with age in women only.

conclusionsWe describe sex-specific relapse presentations and an influence of age only for women. Underlying causal factors warrant further investigations.

Indexed as

Multiple Sclerosis, Relapsing-RemittingPhenotypeAdultAge FactorsAntibodies, Monoclonal, HumanizedCohort StudiesFemaleHumansMaleMiddle AgedRecurrenceSex CharacteristicsSex FactorsAntibodies, Monoclonal, HumanizedocrelizumabageMSrelapsesexsymptoms

Identifiers

PMID38925580
PMCPMC11414797

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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.