Evidence map›Paper›PMID 38130041›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2024

Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial.

Robert T Naismith, Jeffrey A Cohen, Amit Bar-Or, Giancarlo Comi, Krzysztof W Selmaj, Hans-Peter Hartung, James K Sheffield, Anthony Krakovich, Daniel Tatosian, Chun-Yen Cheng and 5 more

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

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2024. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 22% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. 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

15 authors at 8 institutions in 7 countries.

Robert T NaismithWashington University School of Medicine, St. Louis, MO, USA.ORCID 0000-0003-0520-4283
Jeffrey A CohenMellen Center for MS Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9245-9772
Amit Bar-OrCenter for Neuroinflammation and Experimental Therapeutics, and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Giancarlo ComiVita-Salute San Raffaele University and Casa di Cura Igea, Milan, Italy.ORCID 0000-0002-6989-1054
Krzysztof W SelmajCenter for Neurology, Łódź, Poland.
Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.
James K SheffieldBristol Myers Squibb, Princeton, NJ, USA.
Anthony KrakovichBristol Myers Squibb, Princeton, NJ, USA.
Daniel TatosianBristol Myers Squibb, Princeton, NJ, USA.
Chun-Yen ChengBristol Myers Squibb, Princeton, NJ, USA.
Jennifer ReardonBristol Myers Squibb, Princeton, NJ, USA.
Vadim KhaychukBristol Myers Squibb, Princeton, NJ, USA.
Jon V RioloBristol Myers Squibb, Princeton, NJ, USA.
Diego SilvaBristol Myers Squibb, Princeton, NJ, USA.
Bruce Ac CreeWeill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.ORCID 0000-0001-7689-2533
Bristol-Myers Squibb (United States) · USCleveland Clinic · USThe University of Sydney · AUUniversity of California, San Francisco · USUniversity of Pennsylvania · USUniversity of Warmia and Mazury in Olsztyn · PLVita-Salute San Raffaele University · ITWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMonoamine oxidase (MAO) inhibitors can interact with selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs). There is clinical interest surrounding use of ozanimod with SSRIs/SNRIs because the major metabolites of ozanimod are weak inhibitors of MAO-B in vitro.

objectiveTo evaluate the incidence of treatment-emergent adverse events (TEAEs) potentially related to serotonin accumulation (SA) during concomitant ozanimod and SSRI/SNRI use by performing analyses of data from an open-label, oral ozanimod 0.92 mg trial (DAYBREAK; NCT02576717).

methodsSA narrow (serotonin syndrome, neuroleptic malignant syndrome, and hyperthermia malignant) and broad (terms potentially associated with SA) MedDRA v24.0 searches were performed using TEAE data from participants with relapsing multiple sclerosis who entered DAYBREAK from phase 3 studies (cutoff February 1, 2022). Incidences of TEAEs matching terms from each search were stratified by SSRI/SNRI use.

resultsOf 2257 DAYBREAK participants, 274 (12.1%) used an SSRI/SNRI. No participants had TEAEs matching the SA narrow search terms. There was no significant difference in the percentage of participants with ⩾1 TEAE matching the SA broad search for those on versus off SSRIs/SNRIs (on: 12.4%,

conclusionMedDRA searches showed no increase in TEAEs potentially associated with SA with concomitant SSRI/SNRI and ozanimod use.

Indexed as

IndansMultiple SclerosisOxadiazolesSerotonin and Noradrenaline Reuptake InhibitorsAntidepressive AgentsHumansSelective Serotonin Reuptake InhibitorsSerotoninAntidepressive AgentsIndansOxadiazolesozanimodSelective Serotonin Reuptake InhibitorsSerotoninSerotonin and Noradrenaline Reuptake InhibitorsMultiple sclerosisselective serotonin reuptake inhibitorsserotonin–norepinephrine reuptake inhibitorssphingosine 1-phosphate receptor modulators

Identifiers

PMID38130041
PMCPMC10851643
OpenAlexW4390110191

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.