ArticleIndian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion2022
Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of a Romiplostim Biosimilar in Chronic Refractory Immune Thrombocytopenic Purpura (ITP) Patients.
Article in Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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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.
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Who cites it
3 citing papers in PubMed, 8 citations in OpenAlex.
- Article
- Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial.Journal of translational internal medicine · 2023Article
- Risk of thrombotic events in immune thrombocytopenia patients treated with thrombopoietic agents: a systematic review and meta-analysis.Thrombosis journal · 2023Review
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Authors and funding
6 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Romiplostim (Nplate®, Amgen Inc.) is an orphan drug approved for the treatment of chronic refractory immune thrombolytic purpura (ITP) in adult and pediatric patients. Limited availability of pharmacokinetic (PK) data and large inter- and intra-subject variability in PK and platelet response is a challenge in the clinical development of a romiplostim biosimilar. We compared pharmacokinetics (PK), pharmacodynamics (PD)/efficacy, and safety of a romiplostim biosimilar with Nplate in 24 patients with ITP following a single 3 μg/kg dose, and assessed efficacy of the romiplostim biosimilar at a titrated dose range of 1-5 μg/kg in 50 patients with ITP. The PK of the romiplostim biosimilar did not differ compared to the PK of Nplate, and PD/efficacy responses were similar between the products following the single dose. The romiplostim biosimilar showed historically comparable PD/efficacy with Nplate over 8 weeks when treated at the titrated dose range. It was well tolerated in both the studies. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12288-021-01431-y.
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