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

Research output: Contribution to journalArticle

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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 × 10 9/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 studydefined 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 × 10 9/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.

Original languageEnglish
Pages (from-to)652-659
Number of pages8
JournalInternational Journal of Hematology
Volume95
Issue number6
DOIs
Publication statusPublished - 2012 Jun

Fingerprint

Idiopathic Thrombocytopenic Purpura
Safety
Platelet Count
romiplostim
Oral Hemorrhage
Nasopharyngitis
Blood Platelets
Thrombopoietin
Therapeutics
Headache

Keywords

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

ASJC Scopus subject areas

  • Hematology

Cite this

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). / Shirasugi, Yukari; Ando, Kiyoshi; Miyazaki, Koji; Tomiyama, Yoshiaki; Iwato, Koji; Okamoto, Shinichiro; Kurokawa, Mineo; Kirito, Keita; Hashino, Satoshi; Ninomiya, Haruhiko; Mori, Shinichiro; Yonemura, Yuji; Usuki, Kensuke; Wei, Helen; Lizambri, Richard.

In: International Journal of Hematology, Vol. 95, No. 6, 06.2012, p. 652-659.

Research output: Contribution to journalArticle

Shirasugi, Y, Ando, K, Miyazaki, K, Tomiyama, Y, Iwato, K, Okamoto, S, Kurokawa, M, Kirito, K, Hashino, S, Ninomiya, H, Mori, S, Yonemura, Y, Usuki, K, Wei, H & Lizambri, R 2012, '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, vol. 95, no. 6, pp. 652-659. https://doi.org/10.1007/s12185-012-1065-2
Shirasugi, Yukari ; Ando, Kiyoshi ; Miyazaki, Koji ; Tomiyama, Yoshiaki ; Iwato, Koji ; Okamoto, Shinichiro ; Kurokawa, Mineo ; Kirito, Keita ; Hashino, Satoshi ; Ninomiya, Haruhiko ; Mori, Shinichiro ; Yonemura, Yuji ; Usuki, Kensuke ; Wei, Helen ; Lizambri, Richard. / 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). In: International Journal of Hematology. 2012 ; Vol. 95, No. 6. pp. 652-659.
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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 × 10 9/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 studydefined 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 × 10 9/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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AU - Tomiyama, Yoshiaki

AU - Iwato, Koji

AU - Okamoto, Shinichiro

AU - Kurokawa, Mineo

AU - Kirito, Keita

AU - Hashino, Satoshi

AU - Ninomiya, Haruhiko

AU - Mori, Shinichiro

AU - Yonemura, Yuji

AU - Usuki, Kensuke

AU - Wei, Helen

AU - Lizambri, Richard

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