Evidence map›Paper›PMID 24892263›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2014

Etanercept plus topical corticosteroids as initial therapy for grade one acute graft-versus-host disease after allogeneic hematopoietic cell transplantation.

Erin Gatza, Thomas Braun, John E Levine, James L M Ferrara, Shuang Zhao, Tianyi Wang, Lawrence Chang, Andrew Harris, Attaphol Pawarode, Carrie Kitko and 8 more

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

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00726375 (The Use of Etanercept), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.9field-weighted citation impact, top 14% 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.

NCT00726375 phase3completednot on this map

The Use of Etanercept (Enbrel) as Sole Treatment for Grade I Acute Graft Versus Host Disease

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2008 to 2014Enrolled34ConditionsAcute Graft Versus Host DiseaseArmsEtanercept (Enbrel)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 24 citations in OpenAlex.

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  7. Immunotherapy of multiple myeloma.The Journal of clinical investigation · 2020
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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

18 authors at 2 institutions in 1 country.

Erin GatzaBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Thomas BraunDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan.
John E LevineBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
James L M FerraraBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Shuang ZhaoBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Tianyi WangBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Lawrence ChangBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Andrew HarrisBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Attaphol PawarodeBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
Carrie KitkoBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
John M MagenauBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
Gregory A YanikBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Daniel R CourielBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
Steven GoldsteinBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
James ConnellyBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
Pavan ReddyBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
Sophie PaczesnyDepartment of Pediatrics, Indiana University, Indianapolis, Indiana.
Sung Won ChoiBlood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan; Department of Pediatrics, University of Michigan, Ann Arbor, Michigan. Electronic address: sungchoi@med.umich.edu.
University of Michigan · USIndiana University – Purdue University Indianapolis · US

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Alexey I Nesvizhskii · 1988 to 2026
$178.2M
TUMOR VACCINES AND BONE MARROW TRANSPLANTATIONP01CA039542 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI JAMES L. M. FERRARA · 1985 to 2026
$47.9M
High Throughput Screening (HTS) to Discover Graft-Versus-Host Disease InhibitorsR01CA174667 · NCI · INDIANA UNIVERSITY INDIANAPOLIS · PI PACZESNY, SOPHIE, YANG, CHAO-YIE · 2013 to 2015
$975k
Phase II Trial of Vorinostat plus Tacrolimus and Mycophenolate to Prevent GVHDK23AI091623 · NIAID · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CHOI, SUNG WON · 2011 to 2015
$658k
NCI NIH HHS P01 CA039542NCI NIH HHS P30 CA046592NCI NIH HHS R01 CA174667NCI NIH HHS R01CA174667NIAID NIH HHS 1K23AI091623NIAID NIH HHS K23 AI091623
6 · The paper itself

Abstract

Clinical diagnosis of grade 1 acute graft-versus-host disease (GVHD) marks the beginning of a potentially progressive and fatal course of GVHD after hematopoietic stem cell transplantation (HSCT). However, interventional studies to treat early GVHD are lacking. We conducted a single-arm prospective phase II trial to test the hypothesis that treatment of newly diagnosed grade 1 acute GVHD with etanercept and topical corticosteroids would reduce progression to grade 2 to 4 within 28 days. Study patients (n = 34) had a median age of 51 years (range, 10 to 67 years) and had undergone unrelated (n = 22) or related (n = 12) donor HSCT. Study patients were treated with etanercept (.4 mg/kg, maximum 25 mg/dose) twice weekly for 4 to 8 weeks. Ten of 34 patients (29%) progressed to grade 2 to 4 acute GVHD within 28 days. The cumulative incidence of grade 2 to 4 and grade 3 to 4 acute GVHD at 1 year was 41% and 3%, respectively. Nonrelapse mortality was 19% and overall survival was 63% at 2 years. Among a contemporaneous control cohort of patients who were diagnosed with grade 1 acute GVHD and treated with topical corticosteroids but not etanercept during the study period, 12 of 28 patients (43%) progressed to grade 2 to 4 GVHD within 28 days, with a 1-year incidence of grade 2 to 4 GVHD and grade 3 to 4 GVHD of 61% (41% versus 61%, P = .08) and 18% (3% versus 18%, P = .05), respectively. Patients treated with etanercept also experienced less increase in GVHD plasma biomarkers suppression of tumorigenicity 2 (P = .06) and regenerating islet-derived 3-alpha (P = .01) 28 days after grade 1 acute GVHD diagnosis compared with contemporaneous control patients. This study was terminated early because of poor accrual. Future prospective studies are needed to identify patients with grade 1 acute GVHD at risk of swift progression to more severe GVHD and to establish consensus for the treatment of grade 1 acute GVHD. This trial is registered with ClinicalTrials.gov, number NCT00726375.

Indexed as

Acute DiseaseCohort StudiesEtanerceptFemaleGlucocorticoidsGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansImmunoglobulin GMaleMiddle AgedProspective StudiesReceptors, Tumor Necrosis FactorTransplantation ConditioningTransplantation, HomologousEtanerceptGlucocorticoidsImmunoglobulin GReceptors, Tumor Necrosis FactorClinical trialEtanerceptGrade 1 acuteGraft-versus-host diseaseHematopoietic stem cell transplantation

Identifiers

PMID24892263
PMCPMC4145722
OpenAlexW1984186467

What OpenQuestion holds

Textmetadata
LicenceTDM
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.