Evaluation of bleeding-related episodes in patients with immune thrombocytopenia (ITP) receiving romiplostim or medical standard of care
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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 × 109/L, and patients treated with romiplostim spent more time with platelet counts ≥50 × 109/L than did patients treated with SOC. Bleeding-related hospitalizations were rare in both groups. Thus, romiplostim treatment provided greater reductions in all BREs, as well as BREs involving Ig rescue medications, than did SOC.
KeywordsThrombocytopenia Bleeding Platelets Thrombopoietin
In collaboration with the investigators, Amgen Inc. designed the study, conducted statistical analyses, and interpreted the data, which Amgen Inc. holds. Each author participated in either the design or execution of the study, contributed to the interpretation of the study results, provided critical input during the manuscript review process, approved the final version of the manuscript, and took responsibility for the content of the manuscript. The authors had unrestricted access to the primary data and were not limited by Amgen Inc. in the writing of this article. Professional writing assistance was provided by Amy Lindsay PhD, who was funded by Amgen Inc, and Michelle Zakson, an employee of Amgen Inc. The authors thank the study coordinators, nurses, and patients who participated in the study.
Conflict of interest
This research was funded by Amgen Inc., Thousand Oaks, CA. Dr. Stasi has served as a consultant for Amgen, GlaxoSmithKline, and Suppremol and has participated on advisory boards and/or as a speaker at medical education events supported by Amgen, GlaxoSmithKline, Nycomed, Novo, Bayer, and Baxter. Dr Viallard is a consultant for Amgen and GSK, and has participated on advisory board and/or as a speaker at medical education events supported by Amgen or GSK. Dr. Marc Michel served as a consultant for Amgen, GlaxoSmithKline, and Suppremol and has participated on advisory boards and/or as a speaker at medical education events supported by Amgen, GlaxoSmithKline and Roche Drs Deuson and Legg are employees of Amgen, Inc. Dr. Danese is a paid consultant for Amgen, Inc.
- 2.Tarantino M, Sunkara U, George JN, Aledort LM, Guo M, Berger D, et al. Evaluation of bleeding and thrombotic events during long-term use of romiplostim in patients with chronic immune thrombocytopenic purpura. Blood. 2008;112:3422. (ASH Annual Meeting Abstracts).Google Scholar
- 5.Kuter DJ, Bussel J, Newland A, Wasser JS, Lyons RM, George JN, et al. Long-term efficacy and safety of romiplostim treatment of adult patients with chronic immune thrombocytopenia (ITP): final report from an open-label extension study. Blood 2010;116 (ASH Annual Meeting Abstracts).Google Scholar