Evidence map›Paper›PMID 35363318›Full record

Trial reportThe oncologist2022

FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy.

Robert Q Le, Xin Wang, Hongfei Zhang, Hongshan Li, Donna Przepiorka, Jonathon Vallejo, Ruby Leong, Lian Ma, Kirsten B Goldberg, Richard Pazdur and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03112603 (A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation), which is not on this map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 pooled it
4.2field-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.

NCT03112603 phase3completednot on this map

A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)

TypeinterventionalSponsorIncyte CorporationRan2017 to 2022Enrolled330ConditionsGraft-versus-host Disease (GVHD)ArmsRuxolitinib, Extracorporeal photopheresis (ECP), Low-dose methotrexate (MTX), Mycophenolate mofetil (MMF), mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 4 syntheses or guidelines pooled it, 27 citations in OpenAlex.

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  13. The JAK-STAT pathway: from structural biology to cytokine engineering.Signal transduction and targeted therapy · 2024
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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

12 authors at 2 institutions in 1 country.

Robert Q LeCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Xin WangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Hongfei ZhangCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Hongshan LiCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Donna PrzepiorkaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jonathon VallejoCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Ruby LeongCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Lian MaCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Kirsten B GoldbergOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Richard PazdurCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Marc R TheoretCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Angelo De ClaroCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 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 September 22, 2021, the Food and Drug Administration approved ruxolitinib for the treatment of chronic graft-versus-host disease (cGVHD) after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Approval was based on Study INCB 18424-365 (REACH-3; CINC424D2301; NCT03112603), a randomized, open-label, multicenter trial of ruxolitinib in comparison to best available therapy (BAT) for the treatment of corticosteroid-refractory cGVHD occurring after the allogeneic hematopoietic stem cell transplantation. A total of 329 patients were randomized 1:1 to receive either ruxolitinib 10 mg twice daily (n = 165) or BAT (n = 164). BAT was selected by the investigator prior to randomization. The overall response rate through Cycle 7 Day 1 was 70% (95% CI, 63-77) in the ruxolitinib arm, and 57% (95% CI, 49-65) in the BAT arm. The median duration of response, calculated from first response to progression, death, or initiation of new systemic therapies for cGVHD, was 4.2 months (95% CI, 3.2-6.7) for the ruxolitinib arm and 2.1 months (95% CI, 1.6-3.2) for the BAT arm; and the median time from first response to death or initiation of new systemic therapies for cGVHD was 25 months (95% CI, 16.8-not estimable) for the ruxolitinib arm and 5.6 months (95% CI, 4.1-7.8) for the BAT arm. Common adverse reactions included anemia, thrombocytopenia, and infections. Given the observed response rate with durability, the clinical benefit of ruxolitinib appears to outweigh the risks of treatment for cGVHD after the failure of one or two lines of systemic therapy.

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationAdultChildHumansNitrilesPyrazolesPyrimidinesNitrilesPyrazolesPyrimidinesruxolitinibgraft-versus-host diseasehematopoietic stem cell transplantationruxolitinib

Identifiers

PMID35363318
PMCPMC9177119
OpenAlexW4210879138

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.