Evidence map›Paper›PMID 35689489›Full record

Trial reportBritish journal of haematology2022

A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease.

Michael Pratta, Sophie Paczesny, Gerard Socie, Natalie Barkey, Hao Liu, Sherry Owens, Michael C Arbushites, Mark A Schroeder, Michael D Howell

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2022. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 23% 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.

NCT02614612 phase1completednot on this map

A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease

TypeinterventionalSponsorIncyte CorporationRan2015 to 2018Enrolled31ConditionsGraft-versus-host Disease (GVHD)ArmsItacitinib (200 mg), Itacitinib (300 mg), prednisone or methylprednisolone (corticosteroids)
NCT03139604 phase3completednot on this map

GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

TypeinterventionalSponsorIncyte CorporationRan2017 to 2020Enrolled439ConditionsGraft-versus-host Disease (GVHD)ArmsItacitinib, Placebo, Prednisone, Methylprednisolone
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. 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

9 authors at 4 institutions in 2 countries.

Michael PrattaIncyte Research Institute, Wilmington, Delaware, USA.ORCID 0000-0001-5093-2904
Sophie PaczesnyHollings Cancer Center, Charleston, South Carolina, USA.ORCID 0000-0001-5571-2775
Gerard SocieHematology-Transplantation AP-HP Hospital Saint Louis, INSERM UMR 976, University of Paris, Paris, France.ORCID 0000-0002-2114-7533
Natalie BarkeyIncyte Research Institute, Wilmington, Delaware, USA.
Hao LiuIncyte Research Institute, Wilmington, Delaware, USA.
Sherry OwensIncyte Research Institute, Wilmington, Delaware, USA.
Michael C ArbushitesIncyte Research Institute, Wilmington, Delaware, USA.
Mark A SchroederWashington University School of Medicine, St. Louis, Missouri, USA.
Michael D HowellIncyte Research Institute, Wilmington, Delaware, USA.
Incyte (United States) · USInserm · FRMUSC Hollings Cancer Center · USWashington University in St. Louis · US

Funding

Translating Novel Drug-Targetable Biomarkers to Treat Graft versus Host DiseaseR01CA168814 · NCI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI PACZESNY, SOPHIE · 2013 to 2024
$3.0M
NCI NIH HHS R01 CA168814
6 · The paper itself

Abstract

A broad proteomic analysis was conducted to identify and evaluate candidate biomarkers potentially predictive of response to treatment with an oral selective Janus kinase 1 (JAK1) inhibitor, itacitinib, in acute graft-versus-host disease (GVHD). Plasma samples from 25 participants (identification cohort; NCT02614612) were used to identify novel biomarkers that were tested in a validation cohort from a placebo-controlled, randomised trial (n = 210; NCT03139604). The identification cohort received corticosteroids plus 200 or 300 mg itacitinib once daily. The validation cohort received corticosteroids plus 200 mg itacitinib once daily or placebo. A broad proteomic analysis was conducted using a proximity extension assay. Baseline and longitudinal comparisons were performed with unpaired t-test and one-way analysis of variance used to evaluate biomarker level changes. Seven candidate biomarkers were identified. Monocyte-chemotactic protein (MCP)3, pro-calcitonin/calcitonin (ProCALCA/CALCA), together with a previously identified prognostic acute GVHD biomarker, regenerating islet-derived protein (REG)3A, stratified complete responders from non-responders (participants with progressive disease) to itacitinib, but not placebo, potentially representing predictive biomarkers of itacitinib in acute GVHD. ProCALCA/CALCA, suppressor of tumorigenicity (ST)2, and tumour necrosis factor receptor (TNFR)1 were significantly reduced over time by itacitinib in responders, potentially representing response-to-treatment biomarkers. Novel biomarkers have the potential to identify patients with acute GVHD that may respond to itacitinib plus corticosteroid treatment (NCT02614612; NCT03139604).

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationAcetonitrilesAcute DiseaseAdrenal Cortex HormonesBiomarkersHumansProteomicsPyrazolesPyrimidinesPyrrolesAcetonitrilesAdrenal Cortex HormonesBiomarkersitacitinibPyrazolesPyrimidinesPyrrolesacute graft-versus-host diseasebiomarkersitacitinibJAK inhibitors

Identifiers

PMID35689489
PMCPMC9540806
OpenAlexW4282937567

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.