Evidence map›Paper›PMID 38568396›Full record

Trial reportDigestive diseases and sciences2024

Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn's Disease.

Sarah Harris, Brian G Feagan, Stephen Hanauer, Severine Vermeire, Subrata Ghosh, Jim Yan, Chun Wu, Yanhua Hu, Rachel Maddux, Douglas C Wolf and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02531113 (A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
4.4field-weighted citation impact, top 6% 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.

NCT02531113 phase2completednot on this map

A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy

TypeinterventionalSponsorCelgeneRan2015 to 2019Enrolled69ConditionsCrohn's DiseaseArmsRPC1063
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. 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 7 institutions in 6 countries.

Sarah HarrisBristol Myers Squibb, Princeton, NJ, USA. sarah.harris@bms.com.ORCID http://orcid.org/0000-0001-9433-7496
Brian G FeaganRobarts Clinical Trials, Robarts Research Institute, Western University, London, ON, Canada.
Stephen HanauerNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Severine VermeireUniversity Hospitals Leuven, Leuven, Belgium.
Subrata GhoshCollege of Medicine and Health, APC Microbiome Ireland, University College Cork, Cork, Ireland.
Jim YanLaboratory Corporation of America, Durham, NC, USA.
Chun WuBristol Myers Squibb, Princeton, NJ, USA.
Yanhua HuBristol Myers Squibb, Princeton, NJ, USA.
Rachel MadduxBristol Myers Squibb, Princeton, NJ, USA.
Douglas C WolfCenter for Crohn's Disease & Ulcerative Colitis, Atlanta Gastroenterology Associates, Atlanta, GA, USA.
Geert D'HaensInflammatory Bowel Disease Center, Amsterdam University Medical Center, Amsterdam, Netherlands.
Bristol-Myers Squibb (United States) · USAmsterdam University Medical Centers · NLAtlanta Gastroenterology Associates · USBristol-Myers Squibb (Germany) · DENorthwestern University · USUniversity College Cork · IEWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOzanimod showed efficacy and safety in the phase 2 STEPSTONE study conducted in patients with moderately to severely active Crohn's disease.

aimsThis analysis assessed the effects of ozanimod on circulating lymphocytes in Crohn's disease.

methodsPatients received ozanimod 0.92 mg for 12 weeks. Lymphocyte subtypes were evaluated using multicolor flow analysis on blood samples collected before treatment and on Week 12. Absolute lymphocyte count changes were analyzed by Wilcoxon signed rank tests. Disease activity changes and efficacy outcomes were evaluated at Week 12, and associations with lymphocyte subtype levels were assessed using Spearman's correlation and logistic regression.

resultsReductions in median total T, Th, and cytotoxic T cells occurred at Week 12 (45.4%-76.8%), with reductions in most subtypes of 47.5% to 91.3% (P < 0.001). CD8

conclusionsOzanimod reduced circulating levels of all B-cell and most T-cell subsets but not monocytes or natural killer cells. Key subsets relevant to immune surveillance were not reduced, supporting the low risk of infection and malignancy with ozanimod in chronic inflammatory diseases. Levels of nonswitched memory B cells were associated with efficacy, providing a potential marker for ozanimod response.

trial registrationClinicalTrials.gov: NCT02531113, EudraCT: 2015-002025-19.

Indexed as

Crohn DiseaseAdultAgedFemaleHumansIndansLymphocyte CountLymphocyte SubsetsMaleMiddle AgedOxadiazolesSeverity of Illness IndexSphingosine 1 Phosphate Receptor ModulatorsTreatment OutcomeYoung AdultIndansOxadiazolesozanimodSphingosine 1 Phosphate Receptor ModulatorsB lymphocytesCrohn diseaseLymphocytesT lymphocytes

Identifiers

PMID38568396
PMCPMC11162376
OpenAlexW4393872229

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.