Evidence map›Paper›PMID 25682602›Full record

Trial reportHaematologica2015

Effectiveness and safety of lower dose prednisone for initial treatment of acute graft-versus-host disease: a randomized controlled trial.

Marco Mielcarek, Terrence Furlong, Barry E Storer, Margaret L Green, George B McDonald, Paul A Carpenter, Mary E D Flowers, Rainer Storb, Michael Boeckh, Paul J Martin

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 5% 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

59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.

  1. The Role of Biomarkers in the Diagnosis and Risk Stratification of Acute Graft-versus-Host Disease: A Systematic Review.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016
    Pooled it
  2. Steroids Versus Steroids Plus Additional Agent in Frontline Treatment of Acute Graft-versus-Host Disease: A Systematic Review and Meta-Analysis of Randomized Trials.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016
    Pooled it
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  9. Ex Vivo CD34Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
    Trial
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  12. Review
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  15. Modern-Era Challenges in the Clinical Management of Graft-Versus-Host Disease.Advances in experimental medicine and biology · 2025
    Review
  16. Article
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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

10 authors at 3 institutions in 2 countries.

Marco MielcarekClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA University of Washington, Seattle, WA, USA mmielcar@fhcrc.org.
Terrence FurlongClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Barry E StorerClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA University of Washington, Seattle, WA, USA.
Margaret L GreenUniversity of Washington, Seattle, WA, USA Vaccines and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
George B McDonaldClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA University of Washington, Seattle, WA, USA.
Paul A CarpenterClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA University of Washington, Seattle, WA, USA.
Mary E D FlowersClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA University of Washington, Seattle, WA, USA.
Rainer StorbClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA University of Washington, Seattle, WA, USA.
Michael BoeckhUniversity of Washington, Seattle, WA, USA Vaccines and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Paul J MartinClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA University of Washington, Seattle, WA, USA.
Fred Hutch Cancer Center · USUniversity of Washington · USCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZA

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Thomas James Lynch · 1985 to 2026
$296.4M
VIRUS-MEDIATED MYELOSUPPRESSIONP01CA018029 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Evan Newell · 1985 to 2026
$128.4M
Project 3: Stem Cell Allografts for Lymphoid MalignanciesP01CA078902 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI GOOLEY, TED A · 1999 to 2025
$46.1M
Statins for Prevention of GVHDR01HL108307 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MIELCAREK, MARCO B · 2011 to 2015
$2.2M
NCI NIH HHS CA015704NCI NIH HHS CA018029NCI NIH HHS CA078902NCI NIH HHS P01 CA018029NCI NIH HHS P01 CA078902NCI NIH HHS P30 CA015704NHLBI NIH HHS HL108307NHLBI NIH HHS R01 HL108307
6 · The paper itself

Abstract

We conducted a phase III study to test the hypothesis that initial therapy with "lower dose" prednisone is effective and safe for patients with newly diagnosed acute graft-versus-host disease. We hypothesized that a 50% decrease in the initial dose of prednisone for treatment of acute graft-versus-host disease would suffice to control graft-versus-host disease without increasing the incidence of secondary treatment. Patients with grade IIa manifestations (upper gastrointestinal symptoms, stool volumes <1.0 L/day, rash involving <50% of the body surface, no hepatic dysfunction; n=102) were randomized to start treatment with prednisone at 1 mg/kg/day or 0.5 mg/kg/day. Those with grade IIb or higher manifestations (rash involving ≥50% of the body surface, stool volumes ≥1.0 L/day or hepatic involvement; n=62) were randomized to start treatment with prednisone at 2 mg/kg/day or 1 mg/kg/day. The primary study end point (a ≥33% relative reduction of the mean cumulative prednisone dose by day 42 after initial treatment with lower dose prednisone) was not reached. With a median follow up of 36 months (range 7-53), initial treatment with lower dose prednisone appeared to be effective for patients presenting with grade IIa manifestations since it did not increase the likelihood of requiring secondary immunosuppressive therapy. Further exploratory analyses suggested that for patients presenting with skin-predominant grade IIb or higher manifestations, initial treatment with lower dose prednisone was associated with an increased risk of requiring secondary immunosuppressive therapy (41% vs. 7%; P=0.001). In summary, initial treatment of newly diagnosed acute graft-versus-host disease with lower dose prednisone is effective. Within the statistical limitations of the study, results showed no suggestion that initial use of lower dose prednisone adversely affected survival.

Indexed as

Acute DiseaseAdolescentAdultAgedChildChild, PreschoolExanthemaFemaleFollow-Up StudiesGraft vs Host DiseaseHumansInfantMaleMiddle AgedPrednisoneSurvival RatePrednisone

Identifiers

PMID25682602
PMCPMC4450631
OpenAlexW2126622088

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.