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
David J KuterMelissa Eisen

Abstract

The thrombopoietin receptor agonist romiplostim is approved for second-line use in chronic immune thrombocytopenia (ITP), but its effects in patients with ITP for ≤1 year are not well characterized. This analysis of pooled data from 9 studies included patients with ITP for ≤1 year (n = 311) or >1 year (n = 726) who failed first-line treatments and received romiplostim, placebo or standard of care. In subgroup analysis by ITP duration, patient incidences for platelet response at ≥75% of measurements were higher for romiplostim [ITP ≤1 year: 74% (204/277); ITP >1 year: 71% (450/634)] than for placebo/standard of care [ITP ≤1 year: 18% (6/34); ITP >1 year: 9% (8/92)]. Of patients with ≥9 months on study, 16% with ITP ≤1 year and 6% with ITP >1 year discontinued romiplostim and maintained platelet counts ≥50 × 109 /l for ≥6 months without ITP treatment (treatment-free remission). Independent of ITP duration, rates of serious adverse events and bleeding were lower with romiplostim than placebo/standard of care and thrombotic events occurred at similar rates. In this analysis, romiplostim and placebo/standard of care had similar safety profiles and romiplostim increased platelet counts in patients with either ITP ≤1 year or ITP >1 ye...Continue Reading

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Citations

Jun 12, 2020·Therapeutic Advances in Hematology·Hanny Al-SamkariDavid J Kuter
Dec 1, 2020·Expert Review of Hematology·Maria L LozanoDavid J Kuter
Jul 28, 2020·La Revue de médecine interne·M EbboB Godeau
Mar 7, 2021·Journal of Clinical Medicine·Anurag SinghTamam Bakchoul
Mar 20, 2021·Blood Reviews·Manpreet Kochhar, Cindy Neunert
Nov 21, 2020·Blood Reviews·Wobke E M van DijkRolf T Urbanus
Jun 4, 2021·Drug Design, Development and Therapy·James B BusselJohn W Semple
Jul 18, 2021·Journal for Immunotherapy of Cancer·Rebecca BaurDimitrios Mougiakakos
Jul 27, 2021·Annals of Hematology·John D GraingerNichola Cooper
Jul 28, 2021·Expert Opinion on Biological Therapy·Frederick ChenAdrian Newland
Dec 29, 2021·British Journal of Haematology·Alessandra Di PaolaFrancesca Rossi

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Methods Mentioned

BETA
biopsies
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