Evidence map›Paper›PMID 35430707›Full record

Trial reportInternational journal of hematology2022

Efficacy and safety of ropeginterferon alfa-2b in Japanese patients with polycythemia vera: an open-label, single-arm, phase 2 study.

Yoko Edahiro, Kohshi Ohishi, Akihiko Gotoh, Katsuto Takenaka, Hirohiko Shibayama, Takayuki Shimizu, Kensuke Usuki, Kazuya Shimoda, Masafumi Ito, Scott A VanWart and 7 more

Erratum issuedAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2022. 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 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
5.2field-weighted citation impact, top 4% of its field
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

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 36 citations in OpenAlex.

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  11. The impact of JAK2British journal of haematology · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 12 institutions in 2 countries.

Yoko EdahiroDepartment of Hematology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. yedahiro@juntendo.ac.jp.
Kohshi OhishiDepartment of Transfusion Medicine and Cell Therapy, Mie University Hospital, 2-174 Edobashi, Tsu-shi, 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-shi, Ehime, 791-0295, Japan.
Hirohiko ShibayamaDepartment of Hematology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.
Takayuki ShimizuDivision of Hematology, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Kensuke UsukiDepartment of Hematology, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan.
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.
Masafumi ItoDepartment of Pathology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, 3-35 Michishita-cho, Nakamura-ku, Nagoya-shi, Aichi, 453-8511, Japan.
Scott A VanWartEnhanced Pharmacodynamics, LLC, 701 Ellicott Street, Buffalo, NY, 14203, USA.
Oleh ZagrijtschukPharmaEssentia USA Corporation, 35 Corporate Drive, Suite 325, Burlington, MA, 01803, USA.
Albert QinPharmaEssentia Corporation, 13F, No. 3, YuanQu Sreet, NanKang District, Taipei, 115, Taiwan.
Hiroaki KawasePharmaEssentia Japan K.K, Akasaka Center Building 12F, 1-3-13 Moto-akasaka, Minato-ku, Tokyo, 107‑0051, Japan.
Narihisa MiyachiPharmaEssentia Japan K.K, Akasaka Center Building 12F, 1-3-13 Moto-akasaka, Minato-ku, Tokyo, 107‑0051, Japan.
Toshiaki SatoPharmaEssentia Japan K.K, Akasaka Center Building 12F, 1-3-13 Moto-akasaka, Minato-ku, Tokyo, 107‑0051, Japan.
Norio KomatsuDepartment of Hematology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Keita KiritoDepartment of Hematology and Oncology, University of Yamanashi, 1110 Shimokato, Chuo-shi, Yamanashi, 409-3898, Japan.
EA Pharma (Japan) · JPAngioDynamics (United States) · USEhime University · JPJapanese Red Cross Nagoya Daiichi Hospital · JPJuntendo University · JPKeio University · JPMie University Hospital · JPNTT Medical Center · JPOsaka National Hospital · JPTokyo Medical University · JPUniversity of Miyazaki · JPUniversity of Yamanashi Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ropeginterferon alfa-2b is a novel, site-selective, monopegylated recombinant human interferon alfa-2b. Safety and efficacy of ropeginterferon alfa-2b for the treatment of polycythemia vera were demonstrated in clinical studies conducted in European countries, but clinical studies in Japanese patients are lacking. This phase 2, open-label, multicenter, single-arm study investigated the safety and efficacy of ropeginterferon alfa-2b in 29 Japanese patients with polycythemia vera including young patients and patients with low thrombosis risk who are difficult to receive guideline-based standard treatments. The primary outcome of durable complete hematologic response without phlebotomy at months 9 and 12 was achieved by 8/29 (27.6%) patients. The fastest complete hematologic response was observed at week 12. A corresponding reduction in the JAK2 V617F allele burden from baseline to 52 weeks was also observed (mean ± standard deviation =  - 19.2% ± 22.6%). No new safety concerns were identified in Japanese patients when compared with previous studies of ropeginterferon alfa-2b in European populations; the most common treatment-related adverse events were alopecia (55.2%), fatigue (27.6%) and influenza-like illness (27.6%). Most treatment-related adverse events were mild or moderate, with none of grade ≥ 3. Ropeginterferon alfa-2b is a safe and efficacious treatment option in Japanese patients with polycythemia vera.

Indexed as

Interferon alpha-2Polycythemia VeraAllelesHumansJapanRecombinant ProteinsTreatment OutcomeInterferon alpha-2Recombinant ProteinsHematologic responseJAK2 V617F allele burdenMolecular responsePolycythemia veraRopeginterferon alfa-2b

Identifiers

PMID35430707
OpenAlexW4223946504

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.