Evidence map›Paper›PMID 37801628›Full record

Trial reportJournal of Crohn's & colitis2024

Baseline TREM-1 Whole Blood Gene Expression Does Not Predict Response to Adalimumab Treatment in Patients with Ulcerative Colitis or Crohn's Disease in the SERENE Studies.

Bram Verstockt, Valerie Pivorunas, Naim Al Mahi, Nizar Smaoui, Heath Guay, Nicholas A Kennedy, James R Goodhand, Simeng Lin, Benjamin Y H Bai, Stephen B Hanauer and 3 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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.

NCT02065570 phase3completednot on this map

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

TypeinterventionalSponsorAbbVieRan2014 to 2020Enrolled514ConditionsCrohn's DiseaseArmsAdalimumab, Placebo
NCT02065622 phase3completednot on this map

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorAbbVieRan2014 to 2019Enrolled952ConditionsUlcerative Colitis (UC)ArmsAdalimumab, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. Observational
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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

13 authors at 6 institutions in 4 countries.

Bram VerstocktDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0003-3898-7093
Valerie PivorunasPrecision Medicine Immunology, AbbVie Bioresearch Centre, Worcester, MA, USA.
Naim Al MahiGenomic Research Center, AbbVie, North Chicago, IL, USA.
Nizar SmaouiGenomic Research Center, AbbVie, North Chicago, IL, USA.
Heath GuayPrecision Medicine Immunology, AbbVie Bioresearch Centre, Worcester, MA, USA.
Nicholas A KennedyDepartment of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.
James R GoodhandDepartment of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.ORCID 0000-0003-3112-376X
Simeng LinDepartment of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.ORCID 0000-0002-4201-4879
Benjamin Y H BaiGenomics of Inflammation and Immunity Group, Wellcome Sanger Institute, Hinxton, UK.ORCID 0000-0003-0765-6398
Stephen B HanauerDepartment of Medicine, Northwestern University Feinberg School of Medicine, Evanston, IL, USA.
Marc FerranteDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0003-1492-0716
Julian PanésHospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain.
Séverine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0001-9942-3019
AbbVie (United States) · USKU Leuven · BERoyal Devon & Exeter NHS Foundation Trust · GBHospital Clínic de Barcelona · ESNorthwestern University · USWellcome Sanger Institute · GB

Funding

AbbVie
6 · The paper itself

Abstract

BACKGROUND AND

aimsThis study assessed whether baseline triggering receptor expressed on myeloid cells [TREM-1] whole blood gene expression predicts response to anti-tumour necrosis factor [anti-TNF] therapy in patients with ulcerative colitis [UC] or Crohn's disease [CD].

methodsTREM-1 whole blood gene expression was analysed by RNA sequencing in patients with moderately to severely active UC or CD treated with adalimumab in the Phase 3 SERENE-UC and SERENE-CD clinical trials. The predictive value of baseline TREM-1 expression was evaluated and compared according to endoscopic and clinical response vs non-response, and remission vs non-remission, at Weeks 8 and 52 [SERENE-UC], and Weeks 12 and 56 [SERENE-CD].

resultsTREM-1 expression was analysed in 95 and 106 patients with UC and CD, respectively, receiving standard-dose adalimumab induction treatment. In SERENE-UC, baseline TREM-1 expression was not predictive of endoscopic response [p = 0.48], endoscopic remission [p = 0.53], clinical response [p = 0.58], or clinical remission [p = 0.79] at Week 8, or clinical response [p = 0.60] at Week 52. However, an association was observed with endoscopic response [p = 0.01], endoscopic remission [p = 0.048], and clinical remission [p = 0.04997] at Week 52. For SERENE-CD, baseline TREM-1 expression was not predictive of endoscopic response [p = 0.56], endoscopic remission [p = 0.33], clinical response [p = 0.07], or clinical remission [p = 0.65] at Week 12, or endoscopic response [p = 0.61], endoscopic remission [p = 0.51], clinical response [p = 0.62], or clinical remission [p = 0.97] at Week 56.

conclusionsBaseline TREM-1 gene expression did not uniformly predict adalimumab response in SERENE clinical trials. Further research is needed to identify potential blood-based biomarkers predictive of response to anti-TNF therapy in patients with inflammatory bowel disease. CLINICALTRIALS.GOV IDENTIFIERS: NCT02065622; NCT02065570.

Indexed as

AdalimumabColitis, UlcerativeCrohn DiseaseTriggering Receptor Expressed on Myeloid Cells-1AdultBiomarkersFemaleGene ExpressionHumansMaleMiddle AgedPredictive Value of TestsRemission InductionTreatment OutcomeAdalimumabBiomarkersTREM1 protein, humanTriggering Receptor Expressed on Myeloid Cells-1Biomarkersclinical trials

Identifiers

PMID37801628
PMCPMC11037103
OpenAlexW4387420287

What OpenQuestion holds

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LicenceCC BY
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.