Evidence map›Paper›PMID 33152120›Full record

Trial reportBritish journal of haematology2021

Efficacy and safety of romiplostim in refractory aplastic anaemia: a Phase II/III, multicentre, open-label study.

Jun Ho Jang, Yoshiaki Tomiyama, Koji Miyazaki, Koji Nagafuji, Kensuke Usuki, Nobuhiko Uoshima, Tomoaki Fujisaki, Hiroshi Kosugi, Itaru Matsumura, Ko Sasaki and 12 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06009497 (Romiplostim in Combination With Ciclosporin Versus Ciclosporin in the Treatment of Newly Diagnosed Non-severe Aplastic Anemia), which is not on this map. Cited by 42 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 3 pooled it
2.7field-weighted citation impact, top 8% 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.

NCT06009497 phase4unknown statusnot on this mapstarted 2023, after this paper: background citation

Romiplostim in Combination With Ciclosporin Versus Ciclosporin in the Treatment of Newly Diagnosed Non-severe Aplastic Anemia

TypeinterventionalSponsorPeking Union Medical College HospitalRan2023 to 2025Enrolled44ConditionsNon Severe Aplastic AnemiaArmsRomiplostim, Ciclosporin
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 20 institutions in 2 countries.

Jun Ho JangDepartment of Hematology, Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea.
Yoshiaki TomiyamaDepartment of Blood Transfusion, Osaka University Hospital, Osaka, Japan.
Koji MiyazakiDepartment of Transfusion and Cell Transplantation, Kitasato University School of Medicine, Sagamihara, Japan.
Koji NagafujiDepartment of Hematology, Kurume University Hospital, Kurume, Japan.ORCID 0000-0003-4795-121X
Kensuke UsukiDepartment of Hematology, NTT Medical Center Tokyo, Tokyo, Japan.
Nobuhiko UoshimaDepartment of Hematology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
Tomoaki FujisakiDepartment of Internal Medicine, Matsuyama Red Cross Hospital, Matsuyama, Japan.
Hiroshi KosugiDepartment of Hematology, Ogaki Municipal Hospital, Ogaki, Japan.
Itaru MatsumuraDepartment of Hematology and Rheumatology, Kindai University Faculty of Medicine, Osaka, Japan.
Ko SasakiDepartment of Hematology and Oncology, Dokkyo Medical University, Tochigi, Japan.
Masahiro KizakiDepartment of Hematology, International Medical Center, Saitama Medical University, Saitama, Japan.
Masashi SawaDepartment of Hematology and Oncology, Anjo Kosei Hospital, Anjo, Japan.
Michihiro HidakaDepartment of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Naoki KobayashiDepartment of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
Satoshi IchikawaDepartment of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.ORCID 0000-0003-3163-7197
Yuji YonemuraDepartment of Transfusion Medicine and Cell Therapy, Kumamoto University Hospital, Kumamoto, Japan.
Kouki EnokitaniKyowa Kirin Co., Ltd., Tokyo, Japan.ORCID 0000-0002-8360-0102
Akira MatsudaDepartment of Hemato-Oncology, International Medical Center, Saitama Medical University, Saitama, Japan.
Keiya OzawaDivision of Hematology, Jichi Medical University, Tochigi, Japan.
Kinuko MitaniDepartment of Hematology and Oncology, Dokkyo Medical University, Tochigi, Japan.ORCID 0000-0001-9736-9469
Jong Wook LeeDivision of Hematology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Shinji NakaoDivision of Transfusion Medicine, Kanazawa University Hospital, Kanazawa, Japan.
Dokkyo Medical University · JPSaitama Medical University · JPAnjo Kosei Hospital · JPJapanese Red Cross Society Kyoto Daini Hospital · JPJichi Medical University · JPKanazawa University Hospital · JPKindai University · JPKitasato University · JPKumamoto Medical Center · JPKumamoto University Hospital · JPKurume University Hospital · JPKyowa Kirin (Japan) · JPMatsuyama Red Cross Hospital · JPNTT Medical Center · JPOgaki Municipal Hospital · JPOsaka University Hospital · JPSamsung Medical Center · KRSapporo Hokuyu Hospital · JPThe Catholic University of Korea Seoul St. Mary's Hospital · KRTohoku University Hospital · JP

Funding

Kyowa Kirin Co., Ltd.
6 · The paper itself

Abstract

A previous dose-finding study has suggested that romiplostim is effective in patients with refractory aplastic anaemia (AA) and 10 µg/kg once weekly was recommended as a starting dose. In this Phase II/III, multicentre, open-label study, romiplostim was administered subcutaneously at a fixed dose of 10 µg/kg once weekly for 4 weeks (weeks 1-4) followed by weekly doses (5, 10, 15 and 20 µg/kg) titrated by platelet response for up to 52 weeks (weeks 5-52). A total of 31 patients with AA who were refractory to immunosuppressive therapy (IST) and thrombocytopenia (platelet count of ≤30 × 10

Indexed as

AdultAgedAnemia, AplasticAnemia, RefractoryBlood Cell CountFemaleHeadacheHematopoiesisHumansMaleMiddle AgedReceptors, FcRecombinant Fusion ProteinsSpasmThrombopoietinTreatment OutcomeReceptors, FcRecombinant Fusion ProteinsromiplostimThrombopoietinaplastic anaemiabone marrow failurehaematopoiesisthrombopoietin

Identifiers

PMID33152120
PMCPMC7821109
OpenAlexW3095039768

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.