An open-label extension study evaluating the safety and efficacy of romiplostim for up to 3.5 years in thrombocytopenic Japanese patients with immune thrombocytopenic purpura (ITP)
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Long-term use of the thrombopoietin mimetic romiplostim was examined in Japanese patients with chronic immune thrombocytopenic purpura (ITP) in this open-label extension. The starting dose of romiplostim was the previous trial dose or 3 μg/kg/week, which was titrated up to 10 μg/kg/week to maintain platelet counts between 50 and 200 × 109/L. As of April 2010, 44 patients had enrolled; 71 % women, median age 55.5 years, with five patients discontinuing romiplostim due to patient request (2), administrative decision (2), or not achieving study-defined platelet response (1). Median treatment duration was 100 weeks; median average weekly dose was 3.8 μg/kg. Twenty-eight patients (64 %) self-injected romiplostim. The most frequent adverse events were nasopharyngitis and headache. Nine patients (20 %) had a total of 14 serious adverse events (0.31/100 patient-weeks); of these, only oral hemorrhage was considered treatment related. Fifty hemorrhagic adverse events were reported in 20 patients (46 %) (1.12/100 patient-weeks). Ninety-six percent of patients had a platelet response (doubling of baseline platelet count and platelet count ≥50 × 109/L). Of the 25 patients receiving concurrent ITP therapy at baseline, all reduced or discontinued the therapy. Eight patients (18 %) received rescue medications. Administration of up to 3.5 years of romiplostim increased platelet counts and was well tolerated in Japanese patients with chronic ITP.
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- An open-label extension study evaluating the safety and efficacy of romiplostim for up to 3.5 years in thrombocytopenic Japanese patients with immune thrombocytopenic purpura (ITP)
International Journal of Hematology
Volume 95, Issue 6 , pp 652-659
- Cover Date
- Print ISSN
- Online ISSN
- Springer Japan
- Additional Links
- Immune thrombocytopenic purpura (ITP)
- Thrombopoietin receptor agonists
- Thrombopoietin mimetic
- Industry Sectors
- Author Affiliations
- 1. Department of Hematology and Oncology, Tokai University Hospital, Kanagawa, Japan
- 2. Department of Hematology, Kitasato University Hospital, Kanagawa, Japan
- 3. Department of Blood Transfusion, Osaka University Hospital, Osaka, Japan
- 4. Department of Blood Transfusion, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima, Japan
- 5. Division of Hematology, Keio University Hospital, Tokyo, Japan
- 6. Department of Hematology and Oncology, University of Tokyo Hospital, Tokyo, Japan
- 7. Department of Hematology and Oncology, University of Yamanashi Hospital, Yamanashi, Japan
- 8. Department of Gastroenterology and Hematology, Hokkaido University Hospital, Hokkaido, Japan
- 9. Division of Hematology, Tsukuba University Hospital, Ibaraki, Japan
- 10. Department of Hematology and Oncology, Kansai Medical University Hirakata Hospital, Osaka, Japan
- 11. Department of Transfusion Medicine and Cell Therapy, Kumamoto University Hospital, Kumamoto, Japan
- 12. Division of Hematology, NTT Kanto Medical Center, Tokyo, Japan
- 13. Amgen Inc., Thousand Oaks, CA, USA