Romiplostim for the treatment of chronic immune thrombocytopenia in adult Japanese patients: A double-blind, randomized Phase III clinical trial

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

研究成果: Article査読

68 被引用数 (Scopus)

抄録

The efficacy and safety of romiplostim, a thrombopoietin-mimetic peptibody, were evaluated in a double-blind, placebo-controlled, randomized trial of Japanese patients with chronic immune thrombocytopenia (ITP). Thirty-four ITP patients received romiplostim (n = 22) or placebo (n = 12) for 12 weeks, with a starting romiplostim dose of 3 μg/kg weekly. The primary end point was the number of weeks with platelet response, defined as a platelet count ≥50 × 10 9/L (not including the 4 weeks after rescue medication administration). Patients received a median of 4 (range 1-19) prior ITP therapies including splenectomy in 44%. On study, 68% also received concomitant ITP therapy. Weekly responses occurred for a median of 11 weeks with romiplostim as compared to 0 weeks with placebo (p < 0.0001). Most romiplostim-treated patients (95%) achieved platelet responses; two showed extended responses after the treatment period. The use of rescue medication was required in 9% of romiplostim-treated patients as compared with 17% of placebo-treated patients. Both treatment groups had similar incidences of adverse events (91% romiplostim, 92% placebo). Adverse events that occurred more frequently (>10%) in romiplostim-treated patients included nasopharyngitis, headache, peripheral edema, back pain, and extremity pain. In conclusion, romiplostim significantly increased and maintained platelet counts and was well tolerated in Japanese patients with ITP.

本文言語English
ページ(範囲)71-80
ページ数10
ジャーナルInternational journal of hematology
94
1
DOI
出版ステータスPublished - 2011 7

ASJC Scopus subject areas

  • 血液学

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