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

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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.

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Acknowledgments

We would like to thank Professor Mineo Kurokawa for his contributions as a study investigator (University of Tokyo Hospital, Tokyo, Japan). Editorial assistance was provided by Karen Chinchilla, PhD, and was supported by Novartis.

Conflict of interest

K. Oritani has received grants-in-aid for scientific research and collaborated with Fujifilm; S. Okamoto has received research funding from Novartis; T. Tauchi, S. Saito, K. Ohishi, H. Handa, K. Takenaka, and K. Akashi have nothing to disclose; P. Gopalakrishna is an employee of Novartis Pharma AG; T. Amagasaki and K. Ito are employees of Novartis Pharma KK.

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Authors and Affiliations

  1. Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan

    Kenji Oritani

  2. Keio University Hospital, Tokyo, Japan

    Shinichiro Okamoto

  3. Tokyo Medical University Hospital, Tokyo, Japan

    Tetsuzo Tauchi

  4. Nagoya University Hospital and Japanese Red Cross Nagoya Daini Hospital, Nagoya, Aichi, Japan

    Shigeki Saito

  5. Mie University Hospital, Tsu, Mie, Japan

    Kohshi Ohishi

  6. Gunma University Hospital, Maebashi, Gunma, Japan

    Hiroshi Handa

  7. Kyushu University Hospital, Fukuoka, Japan

    Katsuto Takenaka & Koichi Akashi

  8. Novartis Pharma AG, Basel, Switzerland

    Prashanth Gopalakrishna

  9. Novartis Pharma KK, Tokyo, Japan

    Taro Amagasaki & Kazuo Ito

Authors
  1. Kenji Oritani
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  2. Shinichiro Okamoto
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  3. Tetsuzo Tauchi
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  4. Shigeki Saito
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  5. Kohshi Ohishi
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  6. Hiroshi Handa
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  7. Katsuto Takenaka
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  8. Prashanth Gopalakrishna
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  9. Taro Amagasaki
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  10. Kazuo Ito
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  11. Koichi Akashi
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Correspondence to Kenji Oritani.

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Oritani, K., Okamoto, S., Tauchi, T. et al. A multinational, open-label, phase 2 study of ruxolitinib in Asian patients with myelofibrosis: Japanese subset analysis. Int J Hematol 101, 295–304 (2015). https://doi.org/10.1007/s12185-015-1746-8

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  • DOI: https://doi.org/10.1007/s12185-015-1746-8

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