Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy
<p>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-...
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| Format: | Article |
| Language: | Russian |
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ABV-press
2015-01-01
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| Series: | Онкогематология |
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| Online Access: | http://oncohematology.abvpress.ru/index.php/ongm/article/view/123 |
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| author | D. J. Kuter J. B. Bussel A. Newland R. I. Baker R. M. Lyons J. Wasser J.-F. Viallard G. Macik M. Rummel K. Nie S. Jun |
| author_facet | D. J. Kuter J. B. Bussel A. Newland R. I. Baker R. M. Lyons J. Wasser J.-F. Viallard G. Macik M. Rummel K. Nie S. Jun |
| author_sort | D. J. Kuter |
| collection | DOAJ |
| description | <p>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 × 109 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 × 109 per litre were maintained<br />with stable doses of romiplostim (mean 5–8 μg / 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 welltolerated 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.</p> |
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| format | Article |
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| institution | Directory Open Access Journal |
| issn | 1818-8346 |
| language | Russian |
| last_indexed | 2024-03-12T06:19:43Z |
| publishDate | 2015-01-01 |
| publisher | ABV-press |
| record_format | Article |
| series | Онкогематология |
| spelling | doaj.art-661feac80d794582bcdbb8c8690857d32023-09-03T02:17:39ZrusABV-pressОнкогематология1818-83462015-01-01934762138Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacyD. J. Kuter0J. B. Bussel1A. Newland2R. I. Baker3R. M. Lyons4J. Wasser5J.-F. Viallard6G. Macik7M. Rummel8K. Nie9S. Jun10Massachusetts General Hospital, Boston, MADivision of Hematology, Departments of Pediatrics and Medicine, Weill Medical College of Cornell University, New York, NY, USADepartment of Haematology, The Royal London Hospital, Whitechapel, London, UKCentre for Thrombosis and Haemophilia, Royal Perth Hospital, Murdoch University, Perth, WA, AustraliaCancer Care Centers South Texas / US Oncology, San Antonio, TXDivision of Hematology-Oncology, Department of Medicine, University of Connecticut School of Medicine, Farmington, CT, USAUniversitй Victor Segalen Bordeaux 2, Hфpital Haut-Lйvкque, CHU de Bordeaux, Pessac, FranceUniversity of Virginia, Charlottesville, VA, USAKlinikum der Justus-Liebig-Universität, Giessen, GermanyAmgen Inc., Thousand Oaks, CA, USAAmgen Inc., Thousand Oaks, CA, USA<p>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 × 109 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 × 109 per litre were maintained<br />with stable doses of romiplostim (mean 5–8 μg / 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 welltolerated 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.</p>http://oncohematology.abvpress.ru/index.php/ongm/article/view/123thrombopoiesisthrombopoietic agentsTPO receptor agonistsplateletsautoimmunity |
| spellingShingle | D. J. Kuter J. B. Bussel A. Newland R. I. Baker R. M. Lyons J. Wasser J.-F. Viallard G. Macik M. Rummel K. Nie S. Jun Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy Онкогематология thrombopoiesis thrombopoietic agents TPO receptor agonists platelets autoimmunity |
| title | Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy |
| title_full | Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy |
| title_fullStr | Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy |
| title_full_unstemmed | Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy |
| title_short | Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy |
| title_sort | long term treatment with romiplostim in patients with chronic immune thrombocytopenia safety and efficacy |
| topic | thrombopoiesis thrombopoietic agents TPO receptor agonists platelets autoimmunity |
| url | http://oncohematology.abvpress.ru/index.php/ongm/article/view/123 |
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