International Journal of Hematology

, Volume 95, Issue 6, pp 652–659

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)

  • Yukari Shirasugi
  • Kiyoshi Ando
  • Koji Miyazaki
  • Yoshiaki Tomiyama
  • Koji Iwato
  • Shinichiro Okamoto
  • Mineo Kurokawa
  • Keita Kirito
  • Satoshi Hashino
  • Haruhiko Ninomiya
  • Shinichiro Mori
  • Yuji Yonemura
  • Kensuke Usuki
  • Helen Wei
  • Richard Lizambri
Original Article

DOI: 10.1007/s12185-012-1065-2

Cite this article as:
Shirasugi, Y., Ando, K., Miyazaki, K. et al. Int J Hematol (2012) 95: 652. doi:10.1007/s12185-012-1065-2

Abstract

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.

Keywords

Immune thrombocytopenic purpura (ITP) Romiplostim Thrombopoietin receptor agonists Thrombopoietin mimetic 

Copyright information

© The Japanese Society of Hematology 2012

Authors and Affiliations

  • Yukari Shirasugi
    • 1
  • Kiyoshi Ando
    • 1
  • Koji Miyazaki
    • 2
  • Yoshiaki Tomiyama
    • 3
  • Koji Iwato
    • 4
  • Shinichiro Okamoto
    • 5
  • Mineo Kurokawa
    • 6
  • Keita Kirito
    • 7
  • Satoshi Hashino
    • 8
  • Haruhiko Ninomiya
    • 9
  • Shinichiro Mori
    • 10
  • Yuji Yonemura
    • 11
  • Kensuke Usuki
    • 12
  • Helen Wei
    • 13
  • Richard Lizambri
    • 13
  1. 1.Department of Hematology and OncologyTokai University HospitalKanagawaJapan
  2. 2.Department of HematologyKitasato University HospitalKanagawaJapan
  3. 3.Department of Blood TransfusionOsaka University HospitalOsakaJapan
  4. 4.Department of Blood TransfusionHiroshima Red Cross Hospital and Atomic-bomb Survivors HospitalHiroshimaJapan
  5. 5.Division of HematologyKeio University HospitalTokyoJapan
  6. 6.Department of Hematology and OncologyUniversity of Tokyo HospitalTokyoJapan
  7. 7.Department of Hematology and OncologyUniversity of Yamanashi HospitalYamanashiJapan
  8. 8.Department of Gastroenterology and HematologyHokkaido University HospitalHokkaidoJapan
  9. 9.Division of HematologyTsukuba University HospitalIbarakiJapan
  10. 10.Department of Hematology and OncologyKansai Medical University Hirakata HospitalOsakaJapan
  11. 11.Department of Transfusion Medicine and Cell TherapyKumamoto University HospitalKumamotoJapan
  12. 12.Division of HematologyNTT Kanto Medical CenterTokyoJapan
  13. 13.Amgen Inc.Thousand OaksUSA

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