Evidence map›Paper›PMID 39777927›Full record

Observational studyAmerican journal of hematology2025

Budesonide, Added to PTCy-Based Regimen, for Prevention of Acute GI GVHD After Allogeneic Stem Cell Transplantation.

Piyanuch Kongtim, Piyatida Chumnumsiriwath, Pongthep Vittayawacharin, Deepa Jeyakumar, Benjamin J Lee, Jean Doh, Shawn P Griffin, Richard A Van Etten, Stefan Ciurea

Erratum issuedAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in American journal of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Piyanuch KongtimHematopoietic Stem Cell Transplant and Cellular Therapy Program, Division of Hematology/Oncology, Department of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, California, USA.
Piyatida ChumnumsiriwathHematopoietic Stem Cell Transplant and Cellular Therapy Program, Division of Hematology/Oncology, Department of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, California, USA.
Pongthep VittayawacharinHematopoietic Stem Cell Transplant and Cellular Therapy Program, Division of Hematology/Oncology, Department of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, California, USA.ORCID 0000-0002-1131-5564
Deepa JeyakumarHematopoietic Stem Cell Transplant and Cellular Therapy Program, Division of Hematology/Oncology, Department of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, California, USA.
Benjamin J LeeDepartment of Pharmacy, University of California Irvine, Orange, California, USA.ORCID 0000-0002-1678-1345
Jean DohDepartment of Pharmacy, University of California Irvine, Orange, California, USA.
Shawn P GriffinDepartment of Pharmacy, University of California Irvine, Orange, California, USA.
Richard A Van EttenHematopoietic Stem Cell Transplant and Cellular Therapy Program, Division of Hematology/Oncology, Department of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, California, USA.
Stefan CiureaHematopoietic Stem Cell Transplant and Cellular Therapy Program, Division of Hematology/Oncology, Department of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, California, USA.ORCID 0000-0001-8597-3271

Funding

Data Resource for Analyzing Blood &Marrow TransplantsU24CA076518 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI Amy M Moskop, Bronwen Shaw · 1998 to 2026
$105.2M
Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Melanie Funes · 1994 to 2026
$57.9M
NCI NIH HHS P30 CA062203NCI NIH HHS U24 CA076518
6 · The paper itself

Abstract

Oral budesonide exerts local effects with negligible systemic glucocorticoid activity, due to rapid first-pass metabolism, therefore, could potentially be efficacious in preventing gastrointestinal (GI) acute GVHD (aGVHD). We explored the use of budesonide, added to posttransplant cyclophosphamide (PTCy), tacrolimus, and mycophenolate mofetil, for prevention of GI aGVHD after allogeneic hematopoietic stem cell transplantation (AHSCT) in a prospective observational study and treated 80 patients with a median age of 53 years (range 19-74). Results were compared with a publicly available CIBMTR dataset of 646 patients who received PTCy-based GVHD prophylaxis (CIBMTR Study # GV17-02) (control). Cumulative incidence (CI) of 3-month grade 2-4 and grade 3-4 aGVHD in the budesonide and control groups were 3.8% vs. 34.4% (p < 0.001) and 1.3% vs. 9.8% (p = 0.029), respectively. One-year GRFS (70.5% vs. 31.5%, p < 0.001), PFS (73.4% vs. 52.8%, p = 0.003), and OS (80.1% vs. 64.2%, p = 0.038) were significantly higher in the budesonide group compared with control group. Propensity score-adjusted analyses showed that the addition of budesonide significantly decreased risk of aGVHD grade 2-4 (HR 0.29, p < 0.001), grade 3-4 (HR 0.12, p = 0.045), and cGVHD (HR 0.22, p < 0.001), which resulted in better GRFS (HR 0.38, p < 0.001), PFS (HR 0.58, p = 0.012), and OS (HR 0.72, p = 0.044). Similar results were found when using propensity score-matched analysis restricted to recipients of haploidentical transplantation. In conclusion, addition of budesonide to PTCy-based GVHD prophylaxis is safe and effective in preventing severe acute GI GVHD with significantly improved GRFS. These results could facilitate transition to peripheral blood grafts for all allogeneic transplant recipients.

Indexed as

BudesonideCyclophosphamideGastrointestinal DiseasesGraft vs Host DiseaseHematopoietic Stem Cell TransplantationAcute DiseaseAdultAgedDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsMaleMiddle AgedMycophenolic AcidProspective StudiesBudesonideCyclophosphamideImmunosuppressive AgentsMycophenolic AcidTacrolimusallogeneic stem cell transplantationgastrointestinal GVHDGVHD algorithmoral budesonideposttransplant cyclophosphamideReg3αST2

Identifiers

PMID39777927
PMCPMC12483468

What OpenQuestion holds

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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.