Evidence map›Paper›PMID 37550942›Full record

ArticleAnnals of clinical and translational neurology2023

SARS-CoV-2 vaccination and infection in ozanimod-treated participants with relapsing multiple sclerosis.

Bruce A C Cree, Rachel Maddux, Amit Bar-Or, Hans-Peter Hartung, Amandeep Kaur, Elizabeth Brown, Yicong Li, Yanhua Hu, James K Sheffield, Diego Silva and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Annals of clinical and translational neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02576717 (A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 34% 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.

NCT02576717 phase3completednot on this map

A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients

TypeinterventionalSponsorCelgeneRan2015 to 2023Enrolled2,494ConditionsMultiple SclerosisArmsRPC1063
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

11 authors at 4 institutions in 5 countries.

Bruce A C CreeDepartment of Neurology, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, California, USA.ORCID 0000-0001-7689-2533
Rachel MadduxBristol Myers Squibb, Princeton, New Jersey, USA.
Amit Bar-OrDepartment of Neurology, Center for Neuroinflammation, and Experimental Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.ORCID 0000-0002-0614-6989
Amandeep KaurBristol Myers Squibb, Princeton, New Jersey, USA.
Elizabeth BrownBristol Myers Squibb, Princeton, New Jersey, USA.ORCID 0000-0002-0832-3758
Yicong LiBristol Myers Squibb, Princeton, New Jersey, USA.
Yanhua HuBristol Myers Squibb, Princeton, New Jersey, USA.
James K SheffieldBristol Myers Squibb, Princeton, New Jersey, USA.
Diego SilvaBristol Myers Squibb, Princeton, New Jersey, USA.
Sarah HarrisBristol Myers Squibb, Princeton, New Jersey, USA.
Bristol-Myers Squibb (United States) · USThe University of Sydney · AUTranslational Therapeutics (United States) · USUniversity of California, San Francisco · US

Funding

University of Pennsylvania Clinical Autoimmunity Center of ExcellenceUM1AI144288 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI BAR-OR, AMIT, PAYNE, AIMEE S · 2019 to 2023
$551k
NIAID NIH HHS UM1 AI144288
6 · The paper itself

Abstract

objectiveTo investigate the serologic response, predictors of response, and clinical outcomes associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination and infection in ozanimod-treated participants with relapsing multiple sclerosis (RMS) from DAYBREAK.

methodsDAYBREAK (ClinicalTrials.gov-NCT02576717), an open-label extension study of oral ozanimod 0.92 mg, enrolled participants aged 18-55 years with RMS who completed phase 1-3 ozanimod trials. Participants who were fully vaccinated against SARS-CoV-2 with mRNA or non-mRNA vaccines, were unvaccinated, and/or had COVID-19-related adverse events (AEs, with or without vaccination) and postvaccination serum samples were included (n = 288). Spike receptor binding domain (RBD) antibody levels (seroconversion: ≥0.8 U/mL) and serologic evidence of SARS-CoV-2 infection (nucleocapsid IgG: ≥1 U/mL) were assessed (Roche Elecsys/Cobas e411 platform).

resultsIn fully vaccinated participants (n = 148), spike RBD antibody seroconversion occurred in 90% (n = 98/109) of those without serologic evidence of prior SARS-CoV-2 exposure (100% [n = 80/80] seroconversion after mRNA vaccination) and in 100% (n = 39/39) of participants with serologic evidence of viral exposure. mRNA vaccination predicted higher spike RBD antibody levels, whereas absolute lymphocyte count (ALC), age, body mass index, and sex did not. COVID-19-related AEs were reported in 10% (n = 15/148) of fully vaccinated participants-all were nonserious and not severe; all participants recovered.

interpretationMost ozanimod-treated participants with RMS mounted a serologic response to SARS-CoV-2 vaccination and infection, regardless of participant characteristics or ALC levels. In this analysis, all COVID-19-related AEs post-full vaccination in participants taking ozanimod were nonserious and not severe.

Indexed as

COVID-19Multiple SclerosisCOVID-19 VaccinesHumansIndansOxadiazolesRNA, MessengerSARS-CoV-2VaccinationCOVID-19 VaccinesIndansOxadiazolesozanimodRNA, Messenger

Identifiers

PMID37550942
PMCPMC10578897
OpenAlexW4385662331

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.