Evidence map›Paper›PMID 28411254›Full record

ArticleHaematologica2017

Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia.

Douglas B Cines, Jeffrey Wasser, Francesco Rodeghiero, Beng H Chong, Michael Steurer, Drew Provan, Roger Lyons, Jaime Garcia-Chavez, Nancy Carpenter, Xuena Wang and 1 more

6 registry-linked trialsOpen access · goldAbstract readControlled Clinical Trial
In one paragraph

Article in Haematologica, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
4.5field-weighted citation impact, top 5% 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.

NCT00102323 phase3completednot on this map

A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy

TypeinterventionalSponsorAmgenRan2005 to 2007Enrolled63ConditionsThrombocytopenia, Idiopathic Thrombocytopenic PurpuraArmsPlacebo, AMG 531
NCT00102336 phase3completednot on this map

A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy

TypeinterventionalSponsorAmgenRan2005 to 2007Enrolled62ConditionsThrombocytopenia, Idiopathic Thrombocytopenic PurpuraArmsAMG 531, Placebo
NCT00111475 phase2completednot on this map

A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

TypeinterventionalSponsorAmgenRan2002 to 2004Enrolled45ConditionsIdiopathic Thrombocytopenic PurpuraArmsRomiplostim, Placebo
NCT00117143 phase1 / phase2completednot on this map

An Open-label, Unit Dose-finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

TypeinterventionalSponsorAmgenRan2002 to 2004Enrolled16ConditionsThrombocytopenic PurpuraArmsRomiplostim
NCT00907478 phase4completednot on this map

A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

TypeinterventionalSponsorAmgenRan2009 to 2014Enrolled169ConditionsThrombocytopenia, Idiopathic Thrombocytopenic PurpuraArmsromiplostim
NCT01143038 phase2completednot on this map

A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim

TypeinterventionalSponsorAmgenRan2010 to 2013Enrolled75ConditionsIdiopathic Thrombocytopenic PurpuraArmsRomiplostim
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 62 citations in OpenAlex.

  1. Platelet Disorders and Medication Strategies.Thrombosis and haemostasis · 2026
    Review
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  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of a Romiplostim Biosimilar in Chronic Refractory Immune Thrombocytopenic Purpura (ITP) Patients.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2022
    Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Review
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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

11 authors at 10 institutions in 6 countries.

Douglas B CinesPerelman University of Pennsylvania School of Medicine, Philadelphia, PA, USA dcines@mail.med.upenn.edu.
Jeffrey WasserUniversity of Connecticut Health Center, Farmington, CT, USA.
Francesco RodeghieroHematology Project Foundation, Vicenza, Italy.
Beng H ChongSt George Hospital/University of New South Wales, Sydney, Australia.
Michael SteurerMedical University of Innsbruck, Austria.
Drew ProvanBarts and the London School of Medicine and Dentistry, London, UK.
Roger LyonsTexas Oncology and US ONCOLOGY Research, San Antonio, TX.
Jaime Garcia-ChavezCentro Médico Nacional La Raza, Mexico City, Mexico.
Nancy CarpenterAmgen Limited, Uxbridge, UK.
Xuena WangAmgen Inc., Thousand Oaks, CA, USA.
Melissa EisenAmgen Inc., Thousand Oaks, CA, USA.
Amgen (United States) · USAmgen (United Kingdom) · GBCentro Médico Nacional La Raza · MXInnsbruck Medical University · ATOspedale San Bortolo · ITQueen Mary University of London · GBSt George Hospital · AUTexas Oncology · USUConn Health · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Primary immune thrombocytopenia is an autoimmune disorder characterized by increased platelet destruction and insufficient platelet production without another identified underlying disorder. Splenectomy may alter responsiveness to treatment and/or increase the risk of thrombosis, infection, and pulmonary hypertension. The analysis herein evaluated the safety and efficacy of the thrombopoietin receptor agonist romiplostim in splenectomized and nonsplenectomized adults with primary immune thrombocytopenia. Data were pooled across 13 completed clinical studies in adults with immune thrombocytopenia from 2002-2014. Adverse event rates were adjusted for time of exposure. Results were considered different when 95% confidence intervals were non-overlapping. Safety was analyzed for 1111 patients (395 splenectomized; 716 nonsplenectomized) who received romiplostim or control (placebo or standard of care). At baseline, splenectomized patients had a longer median duration of immune thrombocytopenia and a lower median platelet count, as well as a higher proportion with >3 prior immune thrombocytopenia treatments

Indexed as

SplenectomyFemaleHumansMaleMiddle AgedPlatelet CountPurpura, Thrombocytopenic, IdiopathicReceptors, FcRecombinant Fusion ProteinsThrombopoietinTreatment OutcomeReceptors, FcRecombinant Fusion ProteinsromiplostimThrombopoietin

Identifiers

PMID28411254
PMCPMC5541869
OpenAlexW2606192897

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.