Original Article

International Journal of Hematology

, Volume 98, Issue 3, pp 323-330

First online:

Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia: an open-label, extension study

  • Shinya KatsutaniAffiliated withHiroshima University Email author 
  • , Yoshiaki TomiyamaAffiliated withOsaka University Hospital
  • , Akiro KimuraAffiliated withKure-kyosai Hospital
  • , Yoshitaka MiyakawaAffiliated withKeio University
  • , Shinichiro OkamotoAffiliated withKeio University
  • , Yasushi OkoshiAffiliated withUniversity of Tsukuba
  • , Haruhiko NinomiyaAffiliated withUniversity of Tsukuba
  • , Hiroshi KosugiAffiliated withOgaki Municipal Hospital
  • , Kazuyoshi IshiiAffiliated withKishiwada City Hospital
    • , Yasuo IkedaAffiliated withWaseda University Faculty of Science and Engineering
    • , Toshihiro HattoriAffiliated withGlaxoSmithKline
    • , Koichi KatsuraAffiliated withGlaxoSmithKline
    • , Yuzuru KanakuraAffiliated withOsaka University Graduate School of Medicine

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Eltrombopag is an oral, nonpeptide, thrombopoietin receptor agonist approved for treatment of chronic immune thrombocytopenia (ITP). The safety, tolerability, and efficacy of eltrombopag for up to 3 years were evaluated in 19 Japanese patients with chronic ITP who had completed a prior 6-month study. Patients received eltrombopag once daily at the last dosage received in the prior study (12.5, 25, or 50 mg). Dose adjustments and treatment interruptions were permitted to maintain platelet counts of 50,000–200,000/μL. Primary evaluations were safety and tolerability of long-term eltrombopag treatment. The median duration of exposure was 27.5 months (range, 9.9–32.3). Adverse events were similar to those reported with short-term use of eltrombopag, and none led to treatment discontinuation. Nine serious adverse events were reported. Median platelet counts began to increase after 1 week of treatment and remained above 50,000/μL for most assessments. Bleeding episodes decreased from 63 % at baseline to 21 % after 2 weeks of treatment and remained below baseline for all assessments. Of 15 patients receiving concomitant baseline ITP medications, 10 permanently discontinued or achieved a sustained reduction of at least one treatment without requiring rescue treatment. Long-term treatment with eltrombopag was safe, well tolerated, and effective in Japanese patients with chronic ITP.


Bleeding Platelets Thrombopoietin receptor agonist