Evidence map›Paper›PMID 39110143›Full record

Trial reportInternational journal of hematology2024

Momelotinib versus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis: an efficacy/safety analysis in the Japanese subgroup of the phase 3 randomized SIMPLIFY-1 trial.

Kazuya Shimoda, Norio Komatsu, Itaru Matsumura, Kazuhiko Ikeda, Masayuki Hino, Michihiro Hidaka, Yoshinobu Maeda, Takeshi Kondo, Tomoaki Fujisaki, Keita Shoshi and 4 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. Review
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.

Kazuya ShimodaHematology, Diabetes, and Endocrinology, University of Miyazaki, 5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan. kshimoda@med.miyazaki-u.ac.jp.ORCID http://orcid.org/0000-0002-2555-8188
Norio KomatsuDepartment of Hematology, Juntendo University School of Medicine, Tokyo, Japan.
Itaru MatsumuraDepartment of Hematology and Rheumatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
Kazuhiko IkedaDepartment of Blood Transfusion and Transplantation Immunology, Fukushima Medical University School of Medicine, Fukushima, Japan.
Masayuki HinoDepartment of Hematology, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan.
Michihiro HidakaDepartment of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Yoshinobu MaedaDepartment of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
Takeshi KondoDepartment of Hematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Tomoaki FujisakiDepartment of Hematology, Matsuyama Red Cross Hospital, Matsuyama, Japan.
Keita ShoshiClinical Development (Oncology), Japan Medical and Development, GlaxoSmithKline K.K., Tokyo, Japan.
Kyoichi AzumaClinical Development (Oncology), Japan Medical and Development, GlaxoSmithKline K.K., Tokyo, Japan.
Ryuichi FukushimaBiostatistics, Japan Medical and Development, GlaxoSmithKline K.K., Tokyo, Japan.
Jun KawashimaSierra Oncology, Inc., San Mateo, USA.
Hiroshi KosugiDepartment of Hematology, Ogaki Municipal Hospital, Ogaki, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Momelotinib, an oral Janus kinase (JAK) 1/2 and activin A receptor type 1 inhibitor, improved symptoms, splenomegaly, and anemia in patients with myelofibrosis (MF). This sub-analysis of SIMPLIFY-1 evaluated the efficacy and safety of momelotinib versus ruxolitinib in Japanese patients with JAK inhibitor (JAKi)-naïve MF. Patients were randomized 1:1 to receive momelotinib 200 mg once daily or ruxolitinib 20 mg twice daily (or modified based on label) for 24 weeks, after which patients could receive open-label momelotinib. The primary endpoint was splenic response rate (SRR; ≥ 35% reduction in spleen volume) at 24 weeks; main secondary endpoints were total symptom score (TSS) response (≥ 50% reduction) and transfusion independence (TI) rates. Fifteen Japanese patients (momelotinib, n = 6; ruxolitinib, n = 9) were enrolled; all completed treatment. At Week 24, SRR was 50.0% with momelotinib and 44.4% with ruxolitinib. TSS response rates were 33.3% and 0%, and TI rates were 83.3% and 44.4%. Any-grade treatment-related adverse event (TRAE) rates were 83.3% with momelotinib and 88.9% with ruxolitinib. Grade 3/4 TRAE rates were 0% and 55.6%, with specific events being anemia (55.6%) and vertigo (11.1%) with ruxolitinib. Momelotinib was well tolerated, improved spleen and symptom responses, and reduced transfusion requirements in Japanese patients with JAKi-naïve MF.

Indexed as

BenzamidesNitrilesPrimary MyelofibrosisPyrazolesPyrimidinesAdultAgedAged, 80 and overEast Asian PeopleFemaleHumansJanus Kinase InhibitorsJapanMaleMiddle AgedTreatment OutcomeBenzamidesJanus Kinase InhibitorsN-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamideNitrilesPyrazolesPyrimidinesruxolitinibJapanMomelotinibMyelofibrosisPhase 3Ruxolitinib

Identifiers

PMID39110143
PMCPMC11362197

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.