Evidence map›Paper›PMID 38951434›Full record

Trial reportInternational journal of hematology2024

Efficacy and safety outcomes in Japanese patients with low-risk polycythemia vera treated with ropeginterferon alfa-2b.

Kazuya Shimoda, Albert Qin, Norio Komatsu, Keita Kirito

Abstract readClinical Trial, Phase II
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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. 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

4 authors.

Kazuya ShimodaDivision of Hematology, Diabetes and Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake‑cho, Miyazaki‑city, Miyazaki, 889‑1692, Japan. kshimoda@med.miyazaki-u.ac.jp.ORCID http://orcid.org/0000-0002-2555-8188
Albert QinMedical Research & Clinical Operations, PharmaEssentia Corporation, 13F, No. 3, Park Street, Nangang District, Taipei, 115, Taiwan.
Norio KomatsuPharmaEssentia Japan KK, Akasaka Center Building 12F, 1‑3‑13 Moto‑akasaka, Minato‑ku, Tokyo, 107‑0051, Japan.
Keita KiritoDepartment of Hematology and Oncology, University of Yamanashi, 1110 Shimokato, Chuo‑shi, Yamanashi, 409‑3898, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Polycythemia vera (PV) is a Philadelphia chromosome-negative myeloproliferative neoplasm characterized by clonal erythrocytosis. A phase 2 study reported that ropeginterferon alfa-2b is a well-tolerated and effective treatment for PV in Japanese patients. This post hoc analysis of the phase 2 data further evaluated outcomes in patients at low risk of thrombosis (low-risk PV). Among 20 patients with low-risk PV, 60.0% (12/20) and 85.0% (17/20) achieved < 45% hematocrit by weeks 24 and 52, respectively. The proportion of responders with complete hematologic response (CHR) was 60.0% (12/20) at week 52, and the median time to response was 11.9 months. The mean JAK2 V617F allele burden decreased from 75.8% at baseline to 53.7% at week 52. No patient experienced thrombosis or bleeding episodes. All patients experienced treatment-emergent adverse events (TEAEs) related to ropeginterferon alfa-2b, but no grade ≥ 3 TEAEs or deaths related to ropeginterferon alfa-2b occurred, and no new safety concerns arose. This analysis indicated that ropeginterferon alfa-2b may be an effective treatment option for Japanese patients with low-risk PV.

Indexed as

Interferon-alphaInterferon alpha-2Polycythemia VeraPolyethylene GlycolsRecombinant ProteinsAdultAgedEast Asian PeopleFemaleHumansJanus Kinase 2JapanMaleMiddle AgedTreatment OutcomeInterferon-alphaInterferon alpha-2JAK2 protein, humanJanus Kinase 2peginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsHematologic responseJAK2 V617F allele burdenLow-riskPolycythemia veraRopeginterferon alfa-2b

Identifiers

PMID38951434
PMCPMC11284189

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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.