Evidence map›Paper›PMID 39361233›Full record

Trial reportInternational journal of hematology2024

Long-term safety and efficacy of ropeginterferon alfa-2b in Japanese patients with polycythemia vera.

Keita Kirito, Yuka Sugimoto, Akihiko Gotoh, Katsuto Takenaka, Michiko Ichii, Tadaaki Inano, Shuichi Shirane, Masafumi Ito, Oleh Zagrijtschuk, Albert Qin and 4 more

Erratum issuedAbstract readClinical Trial, Phase IIMulticenter 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. An erratum has been issued. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–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

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Keita KiritoDepartment of Hematology and Oncology, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan. kirito@yamanashi.ac.jp.ORCID http://orcid.org/0000-0001-5682-2132
Yuka SugimotoDepartment of Hematology and Oncology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Akihiko GotohDepartment of Hematology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan.
Katsuto TakenakaDepartment of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, 454 Shitsukawa, Toon, Ehime, 791-0295, Japan.
Michiko IchiiDepartment of Hematology and Oncology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Tadaaki InanoDepartment of Hematology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Shuichi ShiraneDepartment of Hematology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Masafumi ItoDepartment of Pathology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, 3-35 Michishita-cho, Nakamura-ku, Nagoya, Aichi, 453-8511, Japan.
Oleh ZagrijtschukPharmaEssentia Corporation USA, 35 Corporate Drive, Suite 325, Burlington, MA, 01803, USA.
Albert QinMedical Research and Clinical Operations, PharmaEssentia Corporation, 13F, No. 3, YuanQu Street, Nangang District, Taipei, 115, Taiwan.
Hiroaki KawasePharmaEssentia Japan KK, Akasaka Center Building 12F, 1-3-13 Moto-akasaka, Minato-ku, Tokyo, 107-0051, Japan.
Toshiaki SatoPharmaEssentia Japan KK, Akasaka Center Building 12F, 1-3-13 Moto-akasaka, Minato-ku, Tokyo, 107-0051, Japan.
Norio KomatsuDepartment of Hematology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Kazuya ShimodaDivision of Hematology, Diabetes and Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kiyotakecho Kihara, Miyazaki, Miyazaki, 889-1692, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ropeginterferon alfa-2b (ropegIFN), a new-generation interferon-based agent, has been approved in Japan for patients with polycythemia vera (PV) who are ineligible for or respond inadequately to conventional treatment. However, long-term outcomes with ropegIFN in Japanese patients have not been reported. This extension of a phase 2 study of ropegIFN in Japanese patients with PV aimed to determine its long-term safety/efficacy, and changes over time in JAK2 V617F allele burden. Here, we report data from the phase 2 study and subsequent extension over a period of 36 months. The primary endpoint was the complete hematologic response (CHR) maintenance rate without phlebotomy (hematocrit value < 45% without phlebotomy during the previous 12 weeks, platelet count ≤ 400 × 10

Indexed as

Interferon-alphaInterferon alpha-2Janus Kinase 2Polycythemia VeraPolyethylene GlycolsRecombinant ProteinsAdultAgedAged, 80 and overAllelesEast Asian PeopleFemaleHumansJapanMaleMiddle AgedInterferon-alphaInterferon alpha-2JAK2 protein, humanJanus Kinase 2peginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsHematologic responseJAK2 V617F allele burdenMolecular responsePolycythemia veraRopeginterferon alfa-2b

Identifiers

PMID39361233
PMCPMC11588802

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.