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Blood, 5 March 2009, Vol. 113, No. 10, pp. 2161-2171.
Prepublished online as a Blood First Edition Paper on November 3, 2008; DOI 10.1182/blood-2008-04-150078.
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Submitted April 8, 2008
Accepted October 14, 2008
Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP
James B. Bussel*, David J. Kuter, Vinod Pullarkat, Roger M. Lyons, Matthew Guo, and Janet L. Nichol
Departments of Pediatrics and Medicine, Division of Hematology, New York Presbyterian Hospital, New York, NY, United States
Massachusettes General Hospital, Boston, MA, United States
Division of Hematology, City of Hope Medical Center, Duarte, CA, United States
Cancer Care Centers South Texas/US Oncology, San Antonio, TX, United States
Amgen, Inc., Thousand Oaks, CA, United States
* Corresponding author; email: jbussel{at}med.cornell.edu.
Chronic immune thrombocytopenic purpura (ITP) is characterized by low platelet counts and mucocutaneous bleeding. In previous studies of  24 weeks' duration, romiplostim (AMG531), a thrombopoiesis-stimulating protein, increased platelet counts in most patients with chronic ITP. This ongoing, open-label, single arm extension study investigated safety and efficacy of long-term treatment in patients who had completed a previous romiplostim study, and had platelet counts 50x109/L. 142 patients enrolled and were treated for up to 156 weeks (mean, 69 weeks). Platelet responses (platelet count  50x109/L and double baseline) were observed in 87% of all patients and occurred on average 67% of the time in responding patients. In 77% of patients the romiplostim dose remained within 2µg/kg of their most frequent dose 90% of the time. Ninety (63%) patients received treatment by self-administration. Treatment-related serious adverse events were reported in 13 (9%) patients. Bone marrow reticulin was observed in 8 patients; bone marrows were not routinely performed in this study so the true incidence of this event cannot be determined. Bleeding events decreased over time, with severe bleeding events reported in 12 (9%) patients. Thrombotic events occurred in 7 (5%) patients. In conclusion, romiplostim increased platelet counts in most patients for up to 156 weeks without tachyphylaxis and had an acceptable safety profile. This study is registered with ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT00116688)
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