Evidence map›Paper›PMID 41190505›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2025

Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Final analysis of the DAYBREAK open-label extension trial.

Krzysztof W Selmaj, Lawrence Steinman, Giancarlo Comi, Amit Bar-Or, Douglas L Arnold, Hans-Peter Hartung, Xavier Montalbán, Eva K Havrdová, James K Sheffield, Anthony Krakovich and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2025. 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
–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.

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.

  1. Observational
  2. The Role of Lipid Alteration in Multiple Sclerosis.International journal of molecular sciences · 2026
    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

18 authors.

Krzysztof W SelmajCenter for Neurology, Łódź, Poland.
Lawrence SteinmanBeckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA, USA.
Giancarlo ComiVita-Salute San Raffaele University and Casa di Cura Igea, Milan, Italy.
Amit Bar-OrCenter for Neuroinflammation and Experimental Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.ORCID 0000-0001-7179-0335
Douglas L ArnoldNeuroRx Research and Montréal Neurological Institute, McGill University, Montreal, QC, Canada.ORCID 0000-0003-4266-0106
Hans-Peter HartungDepartment of Neurology, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Xavier MontalbánDepartment of Neurology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Eva K HavrdováDepartment of Neurology and Center for Clinical Neuroscience, First Medical Faculty and General University Hospital, Prague, Czech Republic.
James K SheffieldBristol Myers Squibb, Princeton, NJ, USA.
Anthony KrakovichBristol Myers Squibb, Princeton, NJ, USA.
Chun-Yen ChengBristol Myers Squibb, Princeton, NJ, USA.
Jon V RioloBristol Myers Squibb, Princeton, NJ, USA.
Chahin PachaiBristol Myers Squibb, Princeton, NJ, USA.
Andrew ThorpeBristol Myers Squibb, Princeton, NJ, USA.
Erik DeBoerBristol Myers Squibb, Princeton, NJ, USA.
Ludwig KapposResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Head Organs, Spine and Neuromedicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland.ORCID 0000-0003-4175-5509
Jeffrey A CohenMellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9245-9772
Bruce Ac CreeWeill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.ORCID 0000-0001-7689-2533

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOzanimod, a selective, oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for adults with relapsing forms of multiple sclerosis (RMS).

objectiveTo characterize the long-term safety and efficacy of ozanimod.

methodsParticipants were eligible for an open-label extension study of ozanimod 0.92 mg/d (DAYBREAK) if they completed a phase 1-3 RMS ozanimod 'parent' trial. DAYBREAK began 16 October 2015, and ended 5 January 2023.

resultsDAYBREAK included 2494 participants with a mean of 60.9 (range 0.03‒81.5) months of ozanimod exposure. During DAYBREAK, 2219 participants (89.0%) had treatment-emergent adverse events (TEAEs), 381 (15.3%) had a serious TEAE and 98 (3.9%) discontinued treatment due to TEAEs. Serious infections (4.3%), herpes zoster infections (2.0%), confirmed macular oedema cases (0.2%), and cardiac TEAEs (4.1 %) were infrequent. Adjusted annualized relapse rate was 0.098 (95% confidence interval, 0.082‒0.117). In total, 69.1% of participants remained relapse-free and 84.8% were free from 6-month confirmed disability progression at DAYBREAK completion. Adjusted mean numbers of new/enlarging T2 lesions/scan and gadolinium-enhancing lesions were low and remained relatively stable.

conclusionsLong-term ozanimod treatment had a favourable safety and tolerability profile and provided sustained control of clinical and MRI disease activity in participants with RMS.Registries:ClinicalTrials.gov ID: NCT02576717; EudraCT: 2015-002500-91.

Indexed as

IndansMultiple Sclerosis, Relapsing-RemittingOxadiazolesSphingosine 1 Phosphate Receptor ModulatorsAdultFemaleHumansMaleMiddle AgedIndansOxadiazolesozanimodSphingosine 1 Phosphate Receptor Modulatorsadverse eventsclinical efficacyextension studyMultiple sclerosisozanimodsphingosine 1-phosphate receptor modulators

Identifiers

PMID41190505
PMCPMC12589670

What OpenQuestion holds

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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 OpenQuestion graph.