Evidence map›Paper›PMID 38796666›Full record

Trial reportInternational journal of hematology2024

Ruxolitinib in steroid-refractory acute graft-vs-host disease: Japanese subgroup analysis of the randomized REACH2 trial.

Takanori Teshima, Yasushi Onishi, Koji Kato, Shuichi Taniguchi, Koichi Miyamura, Kentaro Fukushima, Jun Kato, Takayuki Ishikawa, Noriko Doki, Hirohisa Nakamae and 9 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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.

Takanori TeshimaDepartment of Hematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan. teshima@med.hokudai.ac.jp.ORCID http://orcid.org/0000-0002-0941-271X
Yasushi OnishiDepartment of Hematology, Tohoku University Hospital, Sendai, Japan.
Koji KatoDepartment of Hematology, Oncology and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan.
Shuichi TaniguchiDepartment of Hematology, Toranomon Hospital, Tokyo, Japan.
Koichi MiyamuraDepartment of Hematology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya, Japan.
Kentaro FukushimaDepartment of Hematology and Oncology, Osaka University Graduate School of Medicine, Suita, Japan.
Jun KatoDivision of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.
Takayuki IshikawaDepartment of Hematology, Kobe City Medical Center General Hospital, Kobe, Japan.
Noriko DokiHematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Hirohisa NakamaeGraduate School of Medicine, Osaka City University, Osaka, Japan.
Yoshinobu MaedaDepartment of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
Yoshihiro InamotoDepartment of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
Masaya OkadaHyogo College of Medicine, Kansai Medical University Medical Center, Hyogo, Japan.
Akio MakiNovartis Pharma K.K., Tokyo, Japan.
Fumika ShimadaNovartis Pharma K.K., Tokyo, Japan.
Takeshi TajimaNovartis Pharma K.K., Tokyo, Japan.
Monika WroclawskaNovartis Pharma AG, Basel, Switzerland.
Robert ZeiserDepartment of Medicine I, Faculty of Medicine, Medical Center-Universi Medical Center - University of Freiburg, Freiburg, Germany.
Makoto OnizukaDepartment of Hematology/Oncology, Tokai University School of Medicine, Kanagawa, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Acute graft-versus-host disease (aGvHD) is a major complication after allogeneic hematopoietic stem cell transplantation in Japan and other countries. Nearly one-third of patients do not respond to standard systemic steroid therapy and no standard second-line treatment has been established in Japan. We report efficacy and safety findings of ruxolitinib versus best available therapy (BAT) from a subgroup analysis of the international, phase 3 REACH2 study in Japanese patients with steroid-refractory aGvHD. The primary endpoint was overall response rate (ORR) at day 28. Overall, 9 patients received ruxolitinib and 21 received BAT. The ORR at day 28 (88.9% vs 52.4%) and durable ORR at day 56 (66.7% vs 28.6%) were higher with ruxolitinib versus BAT. The estimated cumulative incidence of loss of response at 6 months was 12.5% with ruxolitinib and 18.2% with BAT. The median failure-free survival was longer with ruxolitinib versus BAT (2.73 vs 1.25 months). The most common adverse events up to day 28 in the ruxolitinib and BAT groups were anemia (55.6% vs 19.0%) and thrombocytopenia (44.4% vs 4.8%, respectively). Ruxolitinib showed better efficacy outcomes and a consistent safety profile compared with BAT in the Japanese subgroup, and the findings were consistent with overall study results.

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationNitrilesPyrazolesPyrimidinesAcute DiseaseAdolescentAdultAgedEast Asian PeopleFemaleHumansJapanMaleMiddle AgedSteroidsNitrilesPyrazolesPyrimidinesruxolitinibSteroidsAcute graft-versus-host diseaseJAK inhibitorJapaneseRuxolitinib

Identifiers

PMID38796666
PMCPMC11226530

What OpenQuestion holds

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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.