Evaluation of bleeding-related episodes in patients with immune thrombocytopenia (ITP) receiving romiplostim or medical standard of care.

International Journal of Hematology
Roberto StasiMark Danese

Abstract

Romiplostim increases platelet counts and reduces the risk of bleeding in patients with immune thrombocytopenia (ITP). This post hoc analysis compared the effect of romiplostim versus medical standard of care (SOC) on clinically relevant bleeding-related episodes (BREs) in a 52-week open-label study of patients with ITP. BREs were defined as actual bleeding events and/or use of rescue medication. Nonsplenectomized adult patients with ITP were randomized to receive weekly subcutaneous injections of romiplostim (n = 157) or SOC (n = 77). The rate of all BREs (per 100 patient-weeks) was lower in patients treated with romiplostim (3.1) than in those treated with SOC (9.4); the relative rate (romiplostim/SOC) was 0.33 (95 % CI 0.27-0.40). The rate of BREs associated with immunoglobulin (Ig) rescue medication was also lower for romiplostim (0.2) than SOC (4.8); the relative rate (romiplostim/SOC) was 0.05 (95 % CI 0.03-0.08). BRE rates were lower in patients with platelet counts ≥50 × 10(9)/L, and patients treated with romiplostim spent more time with platelet counts ≥50 × 10(9)/L than did patients treated with SOC. Bleeding-related hospitalizations were rare in both groups. Thus, romiplostim treatment provided greater reductions in ...Continue Reading

References

Apr 28, 2009·Blood·Douglas B CinesEline T Luning Prak
Nov 12, 2010·The New England Journal of Medicine·David J KuterDietmar P Berger
Feb 18, 2011·Blood·Cindy NeunertUNKNOWN American Society of Hematology

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Citations

Apr 1, 2015·British Journal of Haematology·Quentin A Hill, Adrian C Newland
Dec 4, 2016·Hematology·Rachael F Grace, Cindy Neunert
Mar 7, 2021·Journal of Clinical Medicine·Anurag SinghTamam Bakchoul

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