Evaluation of the dose and efficacy of ruxolitinib in Japanese patients with myelofibrosis

Keita Kirito, Shinichiro Okamoto, Kohshi Ohishi, Tetsuzo Tauchi, Hiroshi Handa, Shigeki Saito, Katsuto Takenaka, Kazuya Shimoda, Kenji Oritani, Koichi Akashi, Hikaru Okada, Taro Amagasaki, Kazuyuki Suzuki, Toshio Yonezu, Norio Komatsu

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Abstract

Ruxolitinib, a potent JAK1/JAK2 inhibitor, improved splenomegaly and myelofibrosis-associated symptoms and prolonged survival compared with placebo and best available therapy in the phase 3 COMFORT studies. Although cytopenias were the most common adverse events associated with ruxolitinib treatment, a COMFORT-I analysis showed that they were managed effectively with dose modifications, without a negative impact on the efficacy of ruxolitinib. Subsequently, studies A2202 and AJP01 showed that ruxolitinib is an effective treatment for Japanese patients with myelofibrosis. We conducted a pooled analysis of these two studies (N = 81) to evaluate the association between ruxolitinib dose and changes in spleen volume or symptoms in Japanese patients. Most patients began treatment at 15 or 20 mg twice daily (BID); 70% received a final titrated dose ≥ 10 mg BID. Overall, 91% of patients exhibited spleen volume reductions; patients with final titrated doses ≥ 10 mg BID had larger spleen volume reductions. Similarly, 83% of patients showed improvements in symptom scores; those with a final titrated dose of 20 or 25 mg BID had the greatest reductions. Consistent with COMFORT-I, this pooled analysis indicates that, despite dose adjustments, ruxolitinib provides spleen and symptom control in Japanese patients, with higher doses associated with better responses.

Original languageEnglish
Pages (from-to)1-6
Number of pages6
JournalInternational Journal of Hematology
DOIs
Publication statusAccepted/In press - 2017 Oct 6

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Keywords

  • JAK inhibitor
  • Japanese patients
  • Myelofibrosis
  • Ruxolitinib

ASJC Scopus subject areas

  • Hematology

Cite this

Kirito, K., Okamoto, S., Ohishi, K., Tauchi, T., Handa, H., Saito, S., Takenaka, K., Shimoda, K., Oritani, K., Akashi, K., Okada, H., Amagasaki, T., Suzuki, K., Yonezu, T., & Komatsu, N. (Accepted/In press). Evaluation of the dose and efficacy of ruxolitinib in Japanese patients with myelofibrosis. International Journal of Hematology, 1-6. https://doi.org/10.1007/s12185-017-2332-z