Evidence map›Paper›PMID 39361234›Full record

Trial reportInternational journal of hematology2024

Ruxolitinib for steroid-refractory chronic graft-versus-host disease: Japanese subgroup analysis of REACH3 study.

Souichi Shiratori, Kentaro Fukushima, Yasushi Onishi, Noriko Doki, Tatsunori Goto, Masaya Okada, Hirohisa Nakamae, Yoshinobu Maeda, Koji Kato, Takayuki Ishikawa and 9 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in International journal of hematology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

19 authors.

Souichi ShiratoriDepartment of Hematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Kentaro FukushimaDepartment of Hematology and Oncology, Osaka University Graduate School of Medicine, Osaka, Japan.
Yasushi OnishiDepartment of Hematology, Tohoku University Hospital, Miyagi, Japan.
Noriko DokiTokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Tatsunori GotoJapanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Aichi, Japan.
Masaya OkadaHyogo College of Medicine, Kansai Medical University Medical Center, Hyogo, Japan.
Hirohisa NakamaeDepartment of Hematology, Osaka Metropolitan University, Osaka, Japan.
Yoshinobu MaedaDepartment of Hematology, Oncology and Respiratory Medicine, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Koji KatoDepartment of Hematology, Oncology and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan.
Takayuki IshikawaDepartment of Hematology, Kobe City Medical Center General Hospital, Hyogo, Japan.
Tadakazu KondoDepartment of Hematology, Kobe City Medical Center General Hospital, Hyogo, Japan.
Masako ToyosakiDepartment of Hematology and Oncology, Tokai University School of Medicine, Kanagawa, Japan.
Takashi IkedaDivision of Hematology and Stem Cell Transplantation, Shizuoka Cancer Center, Shizuoka, Japan.
Naoyuki UchidaDepartment of Hematology, Toranomon Hospital, Tokyo, Japan.
Akio MakiNovartis Pharma K.K, Tokyo, Japan.
Fumika ShimadaNovartis Pharma K.K, Tokyo, Japan.
Takeshi TajimaNovartis Pharma K.K, Tokyo, Japan.
Tommaso StefanelliNovartis Pharma AG, Basel, Switzerland.
Takanori TeshimaDepartment of Hematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan. teshima@med.hokudai.ac.jp.ORCID http://orcid.org/0000-0002-0941-271X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ruxolitinib, a Janus kinase (JAK1-JAK2) inhibitor, has demonstrated safety and efficacy in patients with graft-versus-host disease (GvHD). This phase 3 randomized trial (REACH3) evaluated the efficacy and the safety of ruxolitinib 10 mg twice daily compared with investigator-selected best available therapy (BAT) in a subgroup of Japanese patients (n = 37) with steroid-refractory or dependent (SR/D) chronic GvHD. At data cut-off, treatment was ongoing in 17 patients and discontinued in 20. The overall response rate (complete or partial) at week 24 was greater with ruxolitinib than BAT (50% vs. 20%; odds ratio, 4.13 [95% CI, 0.90-18.9]). The best overall response rate (complete or partial response at any time point up to week 24) was higher with ruxolitinib than BAT (68.2% vs. 46.7%; odds ratio, 2.69 [95% CI, 0.66-10.9]). Ruxolitinib led to longer median failure-free survival than BAT (18.6 months vs. 3.7 months; hazard ratio, 0.34; [95% CI, 0.14-0.85]). The most common grade ≥ 3 adverse events up to week 24 were anemia (ruxolitinib: 22.7%; BAT: 6.7%) and pneumonia (22.7% and 20.0%, respectively). Ruxolitinib showed a higher response rate and improvement in failure-free survival in Japanese patients with SR/D chronic GvHD, with a safety profile consistent with the overall study population.

Indexed as

Graft vs Host DiseaseNitrilesPyrazolesPyrimidinesAdolescentAdultAgedChronic DiseaseEast Asian PeopleFemaleHumansJapanMaleMiddle AgedSteroidsTreatment OutcomeNitrilesPyrazolesPyrimidinesruxolitinibSteroidsChronic graft-versus-host diseaseJAK inhibitorJapaneseREACH3Ruxolitinib

Identifiers

PMID39361234
PMCPMC11588829

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Registered trials

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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.