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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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CLINICAL TRIALS AND OBSERVATIONS
Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP
James B. Bussel1,
David J. Kuter2,
Vinod Pullarkat3,
Roger M. Lyons4,
Matthew Guo5, and
Janet L. Nichol5
1 Departments of Pediatrics and Medicine, Division of Hematology, New York Presbyterian Hospital, NY;
2 Massachusetts General Hospital, Boston;
3 Division of Hematology, City of Hope, Duarte, CA;
4 Cancer Care Centers South Texas/US Oncology, San Antonio; and
5 Amgen, Thousand Oaks, CA
Chronic immune thrombocytopenic purpura (ITP) is characterized by low platelet counts and mucocutaneous bleeding. In previous studies romiplostim (AMG531), a thrombopoiesis-stimulating protein, increased platelet counts in most patients with chronic ITP. This ongoing, long-term open-label, single-arm study investigated safety and efficacy in patients who completed a previous romiplostim study and had platelet counts less than 5 x 109/L. One hundred forty-two patients were treated for up to 156 weeks (mean, 69 weeks). Platelet responses (platelet count  50 x 109/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 2 µg/kg of their most frequent dose at least 90% of the time. Ninety patients (63%) received treatment by self-administration. Treatment-related serious adverse events were reported in 13 patients (9%). Bone marrow reticulin was observed in 8 patients; marrows were not routinely performed in this study, so the true incidence of this event cannot be determined. Severe bleeding events were reported in 12 patients (9%). Thrombotic events occurred in 7 patients (5%). In conclusion, romiplostim increased platelet counts in most patients for up to 156 weeks without tachyphylaxis and had an acceptable safety profile. (ClinicalTrials.gov Identifier NCT00116688
[ClinicalTrials.gov]
).
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