Trial reportAnnals of hematology2016
Changes in bone marrow morphology in adults receiving romiplostim for the treatment of thrombocytopenia associated with primary immune thrombocytopenia.
Trial report in Annals of hematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00907478 (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), which is not on this map. Cited by 21 papers.
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.
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.
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)
Who cites it
21 citing papers in PubMed, 50 citations in OpenAlex.
- A single-arm, long-term efficacy and safety study of subcutaneous romiplostim in children with immune thrombocytopenia.Blood advances · 2023Trial
- Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials.American journal of hematology · 2020Trial
- Romiplostim in adult patients with newly diagnosed or persistent immune thrombocytopenia (ITP) for up to 1 year and in those with chronic ITP for more than 1 year: a subgroup analysis of integrated data from completed romiplostim studies.British journal of haematology · 2019Trial
- Guideline on the emergency management of critical bleeding in patients with immune thrombocytopenia.Blood advances · 2026Article
- [The application of thrombopoietin receptor agonists in the treatment of non-muscle myosin heavy chain 9-related disease].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Review
- Practical diagnostic approach to assess myeloid and precursor cell neoplasms on trephine bone marrow biopsies: reflection of middle European reality.Journal of hematopathology · 2025Review
- Article
- Romiplostim use in immune thrombocytopenia: Experience in Cuenca, EcuadorBiomedica : revista del Instituto Nacional de Salud · 2024Article
- [Chinese expert consensus on the clinical application of recombinant human thrombopoiein and thrombopoiein receptor agonist (2023)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2023Article
- The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Novel Therapies to Address Unmet Needs in ITP.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Primary Immune Thrombocytopenia: Novel Insights into Pathophysiology and Disease Management.Journal of clinical medicine · 2021Review
- Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib.Therapeutic advances in hematology · 2021Article
- Tapering thrombopoietin receptor agonists in primary immune thrombocytopenia: Expert consensus based on the RAND/UCLA modified Delphi panel method.Research and practice in thrombosis and haemostasis · 2021Article
- Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry.British journal of haematology · 2020Article
- Updated international consensus report on the investigation and management of primary immune thrombocytopenia.Blood advances · 2019Article
- Romiplostim for the management of pediatric immune thrombocytopenia: drug development and current practice.Blood advances · 2019Review
- Thrombopoietin receptor agonists: ten years later.Haematologica · 2019Review
- Optimal use of thrombopoietin receptor agonists in immune thrombocytopenia.Therapeutic advances in hematology · 2019Review
- Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia.Haematologica · 2017Article
Corrections and comments
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Authors and funding
10 authors at 7 institutions in 6 countries.
Funding
Abstract
The effects of romiplostim on bone marrow morphology were evaluated in adults with immune thrombocytopenia (ITP). Patients with platelet counts <50 × 10(9)/L, ≥1 prior ITP therapies, and no collagen at baseline received weekly subcutaneous romiplostim starting at 1 μg/kg, adjusted to maintain platelet counts between 50 and 200 × 10(9)/L. Biopsies were scheduled after 1, 2, or 3 years of romiplostim (cohorts 1, 2, and 3, respectively). Irrespective of scheduled time, biopsies were performed earlier if patients discontinued or failed to achieve/maintain a response to romiplostim. Reticulin (silver stain) and collagen (trichrome stain) were graded by two hematopathologists using the modified Bauermeister scale (0-4). Of 169 patients, 131 had evaluable biopsies; 9/131 (6.9 %) had increases of ≥2 grades on the modified Bauermeister scale (cohort 1: 0/34; cohort 2: 2/39; cohort 3: 7/58), including two with collagen. Three of the nine patients had follow-up biopsies, including one patient with collagen; changes were reversible after romiplostim discontinuation. Of the nine patients, one had neutropenia detected by laboratory test and two had adverse events of anemia, both non-serious and not treatment-related. By actual exposure (as some biopsies did not occur as scheduled), the number of patients with grade increases ≥2 were year 1: 3/41, year 2: 1/38, year 3: 5/52. Twenty-four patients sustained platelet counts ≥50 × 10(9)/L for ≥6 months with no ITP medications after discontinuing romiplostim, i.e., they entered clinical remission of their ITP. In conclusion, in patients with ITP receiving romiplostim, bone marrow changes were observed in a small proportion of patients.ClinicalTrials.gov identifier: NCT#00907478.
Indexed as
Identifiers
What OpenQuestion holds
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.