Evidence map›Paper›PMID 32043777›Full record

ArticleThe oncologist2020

FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Donna Przepiorka, Lola Luo, Sriram Subramaniam, Junshan Qiu, Ramadevi Gudi, Lea C Cunningham, Lei Nie, Ruby Leong, Lian Ma, Christopher Sheth and 4 more

3 registry-linked trialsOpen access · bronzeAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 78 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 4 pooled it
11.5field-weighted citation impact, top 1% 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.

NCT02953678 phase2completednot on this map

A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)

TypeinterventionalSponsorIncyte CorporationRan2016 to 2019Enrolled71ConditionsGraft-versus-host Disease (GVHD)ArmsRuxolitinib, Prednisone or methylprednisolone
NCT05663827 phase3completednot on this map

Ruxolitinib Add-on in Steroid-refractory Graft-vs-host Disease After Allogeneic Stem Cell Transplantation: a Single Institutional Experience

TypeinterventionalSponsorYi-Lun WangRan2019 to 2022Enrolled6ConditionsSteroid Refractory GVHDArmsRuxolitinib
NCT07708987 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

A Phase II Clinical Trial of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease

TypeinterventionalSponsorTata Memorial CentreRan2023 to 2028Enrolled34ConditionsHematological Malignancy, GVHD - Graft-Versus-Host Disease, Steriod RefractoryArmsStandardized Withaferin A (SWA)
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 4 syntheses or guidelines pooled it, 130 citations in OpenAlex.

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  13. MAGIC Composite Score Predicts Outcomes of Second-Line Therapy for Acute GVHD.medRxiv : the preprint server for health sciences · 2026
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18 more citing papers are in PubMed but not listed here.

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

14 authors at 2 institutions in 1 country.

Donna PrzepiorkaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Lola LuoCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Sriram SubramaniamCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Junshan QiuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Ramadevi GudiCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Lea C CunninghamCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Lei NieCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Ruby LeongCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Lian MaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Christopher ShethCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Albert DeisserothCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Kirsten B GoldbergOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Gideon M BlumenthalOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Richard PazdurOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
United States Food and Drug Administration · USCenter for Drug Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

On May 24, 2019, the Food and Drug Administration approved ruxolitinib for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in adult and pediatric patients 12 years and older. Approval was based on Study INCB 18424-271 (REACH-1; NCT02953678), an open-label, single-arm, multicenter trial that included 49 patients with grades 2-4 SR-aGVHD occurring after allogeneic hematopoietic stem cell transplantation. Ruxolitinib was administered at 5 mg twice daily, with dose increases to 10 mg twice daily permitted after 3 days in the absence of toxicity. The Day-28 overall response rate was 57.1% (95% confidence interval [CI]: 42.2-71.2). The median duration of response was 0.5 months (95% CI: 0.3-2.7), and the median time from Day-28 response to either death or need for new therapy for acute GVHD was 5.7 months (95% CI: 2.2 to not estimable). Common adverse reactions included anemia, thrombocytopenia, neutropenia, infections, edema, bleeding, and elevated transaminases. Ruxolitinib is the first drug approved for treatment of SR-aGVHD. IMPLICATIONS FOR PRACTICE: Ruxolitinib is the first Food and Drug Administration-approved treatment for steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. Its approval provides a treatment option for the 60% of those patients who do not respond to steroid therapy.

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationAdultChildHumansNitrilesPyrazolesPyrimidinesSteroidsNitrilesPyrazolesPyrimidinesruxolitinibSteroidsGraft-versus-host diseaseHematopoietic stem cell transplantationRuxolitinib

Identifiers

PMID32043777
PMCPMC7011641
OpenAlexW2981813473

What OpenQuestion holds

Textmetadata
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.