Evidence map›Paper›PMID 21706145›Full record

Trial reportInternational journal of hematology2011

Romiplostim for the treatment of chronic immune thrombocytopenia in adult Japanese patients: a double-blind, randomized Phase III clinical trial.

Yukari Shirasugi, Kiyoshi Ando, Koji Miyazaki, Yoshiaki Tomiyama, Shinichiro Okamoto, Mineo Kurokawa, Keita Kirito, Yuji Yonemura, Shinichiro Mori, Kensuke Usuki and 4 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 9 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

51 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  9. Efficacy and Safety of Romiplostim Versus Placebo in Immune Thrombocytopenia: A Systematic Review and Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
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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

14 authors.

Yukari ShirasugiDepartment of Hematology and Oncology, Tokai University Hospital, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan. whiteced@is.icc.u-tokai.ac.jp.
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University Hospital, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.
Koji MiyazakiDepartment of Hematology, Kitasato University Hospital, Kanagawa, Japan.
Yoshiaki TomiyamaDepartment of Blood Transfusion, Osaka University Hospital, Osaka, Japan.
Shinichiro OkamotoDivision of Hematology, Keio University Hospital, Tokyo, Japan.
Mineo KurokawaDepartment of Hematology and Oncology, The University of Tokyo Hospital, Tokyo, Japan.
Keita KiritoDepartment of Hematology and Oncology, University of Yamanashi Hospital, Yamanashi, Japan.
Yuji YonemuraDepartment of Transfusion Medicine and Cell Therapy, Kumamoto University Hospital, Kumamoto, Japan.
Shinichiro MoriDepartment of Hematology and Oncology, Kansai Medical University Hirakata Hospital, Osaka, Japan.
Kensuke UsukiDivision of Hematology, NTT Kanto Medical Center, Tokyo, Japan.
Koji IwatoDepartment of Blood Transfusion, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan.
Satoshi HashinoDepartment of Gastroenterology and Hematology, Hokkaido University Hospital, Hokkaido, Japan.
Helen WeiBiostatistics, Amgen Inc., Thousand Oaks, CA, USA.
Richard LizambriClinical Development, Amgen Inc., Thousand Oaks, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The efficacy and safety of romiplostim, a thrombopoietin-mimetic peptibody, were evaluated in a double-blind, placebo-controlled, randomized trial of Japanese patients with chronic immune thrombocytopenia (ITP). Thirty-four ITP patients received romiplostim (n = 22) or placebo (n = 12) for 12 weeks, with a starting romiplostim dose of 3 μg/kg weekly. The primary end point was the number of weeks with platelet response, defined as a platelet count ≥50 × 10(9)/L (not including the 4 weeks after rescue medication administration). Patients received a median of 4 (range 1-19) prior ITP therapies including splenectomy in 44%. On study, 68% also received concomitant ITP therapy. Weekly responses occurred for a median of 11 weeks with romiplostim as compared to 0 weeks with placebo (p < 0.0001). Most romiplostim-treated patients (95%) achieved platelet responses; two showed extended responses after the treatment period. The use of rescue medication was required in 9% of romiplostim-treated patients as compared with 17% of placebo-treated patients. Both treatment groups had similar incidences of adverse events (91% romiplostim, 92% placebo). Adverse events that occurred more frequently (>10%) in romiplostim-treated patients included nasopharyngitis, headache, peripheral edema, back pain, and extremity pain. In conclusion, romiplostim significantly increased and maintained platelet counts and was well tolerated in Japanese patients with ITP.

Indexed as

AdultAgedAsian PeopleBlood PlateletsDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsEdemaFemaleHumansMaleMiddle AgedNasopharyngitisPainPlatelet CountPurpura, Thrombocytopenic, IdiopathicReceptors, FcReceptors, FcRecombinant Fusion ProteinsromiplostimThrombopoietin

Identifiers

PMID21706145

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.