Evidence map›Paper›PMID 38087126›Full record

Observational studyDigestive diseases and sciences2024

Real World Clinical Effectiveness and Safety of Ozanimod in the Treatment of Ulcerative Colitis: 1-Year Follow-Up from a Tertiary Center.

Nathaniel A Cohen, David Choi, Nicole Garcia, Natalie K Choi, Emma Picker, Noa Krugliak Cleveland, Russell D Cohen, Sushila R Dalal, Joel Pekow, David T Rubin

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Digestive diseases and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.0field-weighted citation impact, top 13% 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.

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

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. Modern Advanced Therapies for Inflammatory Bowel Diseases: Practical Considerations and Positioning.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
    Review
  8. Review
  9. [Small Molecule Therapy for Inflammatory Bowel Disease: JAK Inhibitors and S1PR Modulators].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024
    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

10 authors at 1 institution in 1 country.

Nathaniel A CohenInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
David ChoiInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
Nicole GarciaInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
Natalie K ChoiInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
Emma PickerInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
Noa Krugliak ClevelandInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
Russell D CohenInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
Sushila R DalalInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
Joel PekowInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA.
David T RubinInflammatory Bowel Disease Center, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA. drubin@bsd.uchicago.edu.ORCID http://orcid.org/0000-0001-5647-1723
University of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOzanimod is a first-in-class Sphingosine-1-phosphate (S1P) receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC). Real world data describing use of ozanimod are limited.

aimTo provide 1-year follow-up results of our UC patient cohort treated with ozanimod.

methodsThis prospective, observational cohort study includes consecutive patients who initiated ozanimod at the University of Chicago IBD Center between 5/2021 and 12/2022. We collected demographic, clinical, and laboratory data. Clinical disease activity was prospectively assessed using the Simple Clinical Colitis Activity Index.

resultsForty-five patients with UC initiated ozanimod therapy and were included in the effectiveness analysis. The median age was 35 years (interquartile range (IQR) 28-52), median disease duration of 6 years (IQR 3-13), 26 (58%) were male, 23 (51%) had extensive colitis, 34 (76%) had previous advanced therapy exposure. Thirty-four patients had clinically active UC at the time of ozanimod initiation; week 10 clinical response and remission rates were 58% and 53%, respectively. By week 52, the rates were 25% for both clinical response and remission. In the 12 (39%) patients with a > 75% reduction in absolute lymphocyte count, numerically greater induction clinical response and remission rates were observed (80% vs 54%, p = 0.4 and 75% vs 53%, p = 0.4, respectively). There were no episodes of symptomatic bradycardia and no other new safety signals.

conclusionOzanimod effectively induced clinical response and remission patients with largely treatment refractory UC, however, had modest long-term effectiveness. The safety profile was favorable with no new signals.

Indexed as

Colitis, UlcerativeIndansOxadiazolesAdultFemaleFollow-Up StudiesHumansImmunologic FactorsMaleProspective StudiesRemission InductionTreatment OutcomeImmunologic FactorsIndansOxadiazolesozanimodOzanimodReal world evidenceSmall molecule therapiesUlcerative colitis

Identifiers

PMID38087126
OpenAlexW4389613203

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.