Evidence map›Paper›PMID 41311363›Full record

Observational studyFuture oncology (London, England)2025

Long-term safety and effectiveness of ruxolitinib in Japanese patients with polycythemia vera: a post-marketing study.

Tomoko Hayashi, Wataru Hongo, Weizhe Lu

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Future oncology (London, England), 2025. 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

3 authors.

Tomoko HayashiDevelopment Division, Novartis Pharma K.K., Tokyo, Japan.
Wataru HongoDevelopment Division, Novartis Pharma K.K., Tokyo, Japan.
Weizhe LuDevelopment Division, Novartis Pharma K.K., Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThis study evaluated the long-term safety and effectiveness of ruxolitinib in Japanese patients with polycythemia vera in clinical practice. PATIENTS AND

methodsThis multicenter, single-arm, non-interventional, prospective, observational study assessed patients receiving ruxolitinib after approval.

resultsOf 550 patients (median age: 71 years, mean disease duration: 5.43 years, median treatment duration: 1091 days), 51.27% reported adverse drug reactions (ADRs) and 12.18% had serious ADRs, with anemia being the most common ADR. The highest incidence of ADRs (40%) was observed from treatment initiation to Day 182, with no tendency for increased incidence thereafter. ADRs of special interest included myelosuppression (27.64%), hepatic impairment (13.45%), infections (9.27%), hemorrhagic events (5.64%), cardiac failure (1.27%), malignancy (1.09%), interstitial lung disease (0.36%), and tuberculosis (0.18%). Baseline hepatic impairment did not increase the incidence of ADRs, but numerical incidence was higher in patients with baseline renal impairment, with similar events being observed in patients with or without renal impairment. At 36 months, spleen response and symptom improvement were observed in 31.43% and 61.14% of patients, respectively. Reductions in hematocrit, white blood cell count, and platelet count were observed throughout the treatment duration.

conclusionRuxolitinib demonstrated sustained effectiveness with no new safety concerns in the real-world setting.

Indexed as

Polycythemia VeraPyrazolesAdultAgedAged, 80 and overEast Asian PeopleFemaleHumansJapanMaleMiddle AgedNitrilesProduct Surveillance, PostmarketingProspective StudiesPyrimidinesTreatment OutcomeNitrilesPyrazolesPyrimidinesruxolitinibJAK inhibitionJapanese populationpolycythemia verapost-marketing surveillancereal-worldRuxolitinib

Identifiers

PMID41311363
PMCPMC12758285

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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.