Evidence map›Paper›PMID 26201709›Full record

Trial reportInternational journal of hematology2015

Integrated analysis of long-term safety in patients with chronic immune thrombocytopaenia (ITP) treated with the thrombopoietin (TPO) receptor agonist romiplostim.

Douglas B Cines, Terry Gernsheimer, Jeffrey Wasser, Bertrand Godeau, Drew Provan, Roger Lyons, Ivy Altomare, Xuena Wang, Angela Lopez

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
7.6field-weighted citation impact, top 2% 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

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Chemically modifiedMolecular therapy. Nucleic acids · 2022
    Article
  14. Novel Therapies to Address Unmet Needs in ITP.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
  15. Article
  16. Review
  17. Article
  18. Evolving treatment modalities for immune thrombocytopenia in adults.Journal of community hospital internal medicine perspectives · 2021
    Review
  19. Review
  20. Review
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

9 authors at 8 institutions in 3 countries.

Douglas B CinesDepartments of Pathology and Laboratory Medicine, Perelman-University of Pennsylvania School of Medicine, 513 A Stellar Chance, 422 Curie Blvd, Philadelphia, PA, 19104, USA, dcines@mail.med.upenn.edu.
Terry Gernsheimer
Jeffrey Wasser
Bertrand Godeau
Drew Provan
Roger Lyons
Ivy Altomare
Xuena Wang
Angela Lopez
Amgen (United States) · USCancer Treatment Centers of America · USCentre Hospitalier Universitaire Henri-Mondor · FRDuke University · USRoyal London Hospital · GBUConn Health · USUniversity of Pennsylvania · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A safety analysis of pooled data from clinical studies of romiplostim, a thrombopoietin (TPO) receptor agonist, in which patients with immune thrombocytopaenia (ITP) received romiplostim, placebo, or medical standard of care (SOC) Rodeghiero et al. (Eur J Haematol 91:423-436, 2013), has been updated. Included are data from 14 trials spanning 2002-2011; placebo- and SOC-arm data are pooled. Most patients (n = 1059) were female (61 %) and Caucasian (85 %); 38 % had undergone splenectomy; 23 were children. Mean (SD) baseline platelet count was 20.6 (16.5) × 10(9)/L. Mean (SD) weekly dose of romiplostim was 4.2 (2.8) µg/kg; total exposure was 1520 patient-years. Overall, 921 patients received romiplostim only, 65 received placebo/SOC only, and 73 received placebo/SOC followed by romiplostim. Rates of haemorrhage (romiplostim, 205/100 patient-years; placebo/SOC, 263/100), thrombosis (both, 5.5/100 patient-years), haematological malignancy/myelodysplastic syndrome (romiplostim, 0.5/100 patient-years; placebo/SOC, 2.7/100), and non-haematological tumours (romiplostim, 2.2/100 patient-years; placebo/SOC, 3.6/100) were comparable among groups. Bone marrow reticulin was reported in 17 patients and collagen in one patient receiving romiplostim; one patient receiving placebo/SOC had reticulin reported. Three patients developed neutralizing antibodies to romiplostim, but not to endogenous TPO. This integrated analysis of the safety profile of romiplostim in patients with ITP is consistent with previously reported studies; no new safety concerns emerged.

Indexed as

AdolescentAdultAgedChildChild, PreschoolFemaleFollow-Up StudiesHumansMaleMiddle AgedPurpura, Thrombocytopenic, IdiopathicReceptors, FcReceptors, ThrombopoietinRecombinant Fusion ProteinsThrombopoietinMPL protein, humanReceptors, FcReceptors, ThrombopoietinRecombinant Fusion ProteinsromiplostimThrombopoietin

Identifiers

PMID26201709
OpenAlexW941376371

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.