Journal article
Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: Safety and efficacy
British Journal of Haematology, Vol.161(3), pp.411-423
2013
Abstract
Romiplostim was effective, safe, and well-tolerated over 6 – 12 months of continuous treatment in Phase 3 trials in patients with immune thrombocytopenia (ITP). This report describes up to 5 years of weekly treatment with romiplostim in 292 adult ITP patients in a long-term, single-arm, open-label study. Outcome measures included adverse events (including bleeding, thrombosis, malignancy, and reticulin/fibrosis), platelet response (platelet count > 50 9 10 9 per litre), and the proportion of patients requiring rescue treatments. Treatment – related serious adverse events were infrequent and did not increase with longer treatment. No new classes of adverse events emerged. Thrombotic events occurred in 6 5% of patients and were not associated with platelet count. Median platelet counts of 50 – 200 9 10 9 per litre were maintained with stable doses of romiplostim (mean 5 – 8 l g/kg; generally self-administered at home) throughout the study. A platelet response was achieved at least once by 95% of patients, with a platelet response maintained by all patients on a median 92% of study visits. There was a low rate of bleeding and infrequent need for rescue treatments. In conclusion, this study demonstrated that romiplostim was safe and well-tolerated over 614 patient-years of exposure in ITP patients, and that efficacy was maintained with stable dosing for up to 5 years of continuous treatment.
Details
- Title
- Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: Safety and efficacy
- Authors/Creators
- D.J. Kuter (Author/Creator) - Massachusetts General HospitalJ.B. Bussel (Author/Creator) - Cornell UniversityA. Newland (Author/Creator) - Royal London HospitalR.I. Baker (Author/Creator) - Royal Perth HospitalR.M. Lyons (Author/Creator) - Cancer Care Centers South Texas/US Oncology San Antonio TX USAJ. Wasser (Author/Creator) - University of ConnecticutJ-F Viallard (Author/Creator) - Hôpital Cardiologique du Haut-LévêqueG. Macik (Author/Creator) - University of VirginiaM. Rummel (Author/Creator) - Justus-Liebig-Universität GießenK. Nie (Author/Creator) - Amgen (United States)S. Jun (Author/Creator) - Amgen (United States)
- Publication Details
- British Journal of Haematology, Vol.161(3), pp.411-423
- Publisher
- Blackwell Publishing Inc.
- Identifiers
- 991005543235907891
- Copyright
- © 2013 Blackwell Publishing Ltd
- Murdoch Affiliation
- Centre for Haemophilia and Thrombosis Research
- Language
- English
- Resource Type
- Journal article
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Source: InCites
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Citation topics
- 1 Clinical & Life Sciences
- 1.103 Blood Disorders
- 1.103.1225 Immune Thrombocytopenia
- Web Of Science research areas
- Hematology
- ESI research areas
- Clinical Medicine