A multinational, open-label, phase 2 study of ruxolitinib in Asian patients with myelofibrosis: Japanese subset analysis

Kenji Oritani, Shinichiro Okamoto, Tetsuzo Tauchi, Shigeki Saito, Kohshi Ohishi, Hiroshi Handa, Katsuto Takenaka, Prashanth Gopalakrishna, Taro Amagasaki, Kazuo Ito, Koichi Akashi

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13 Citations (Scopus)

Abstract

Ruxolitinib is a potent Janus kinase (JAK) 1/JAK2 inhibitor that has demonstrated rapid and durable improvements in splenomegaly and symptoms and a survival benefit in 2 phase 3 trials in patients with myelofibrosis. Ruxolitinib was well tolerated and effectively reduced splenomegaly and symptom burden in Asian patients with myelofibrosis in the Asian multinational, phase 2 Study A2202. We present a subset analysis of Japanese patients (n = 30) in Study A2202. At data cutoff, 22 patients were ongoing; 8 discontinued, mainly due to adverse events (n = 4). At week 24, 33 % of patients achieved ≥35 % reduction from baseline in spleen volume; 56.0 % achieved ≥50 % reduction from baseline in total symptom score, as measured by the 7-day Myelofibrosis Symptom Assessment Form v2.0. The most common adverse events were anemia (63 %), thrombocytopenia (40 %), nasopharyngitis (37 %), decreased platelet counts (30 %), and diarrhea (30 %). Dose reductions or interruptions due to hemoglobin decreases were more frequent in Japanese patients; no loss of efficacy and no discontinuations due to hematologic abnormalities were observed. Ruxolitinib was well tolerated in Japanese patients and provided substantial reductions in splenomegaly and myelofibrosis-related symptoms similar to those observed in the overall Asian population and phase 3 COMFORT studies.

Original languageEnglish
Pages (from-to)295-304
Number of pages10
JournalInternational journal of hematology
Volume101
Issue number3
DOIs
Publication statusPublished - 2015 Mar 6

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Keywords

  • JAK inhibitor
  • Japan
  • Myelofibrosis
  • Ruxolitinib

ASJC Scopus subject areas

  • Hematology

Cite this

Oritani, K., Okamoto, S., Tauchi, T., Saito, S., Ohishi, K., Handa, H., Takenaka, K., Gopalakrishna, P., Amagasaki, T., Ito, K., & Akashi, K. (2015). A multinational, open-label, phase 2 study of ruxolitinib in Asian patients with myelofibrosis: Japanese subset analysis. International journal of hematology, 101(3), 295-304. https://doi.org/10.1007/s12185-015-1746-8