International Journal of Hematology

DOI: 10.1007/s12185-017-2332-z Pages: 92-97

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

1. University of Yamanashi, Department of Hematology and Oncology

2. Keio University Hospital, Division of Hematology, Department of Medicine

3. Mie University Hospital, Blood Transfusion Service

4. Tokyo Medical University, Department of Hematology

5. Gunma University Hospital, Department of Medicine

6. Nagoya University Hospital, Department of Hematology

7. Japanese Red Cross Nagoya Daini Hospital, Department of Hematology and Oncology

8. Kyushu University Hospital, Center for Cellular and Molecular Medicine

9. University of Miyazaki, Department of Gastroenterology and Hematology

10. Osaka University, Department of Hematology and Oncology

11. Kyushu University, Department of Medicine and Biosystemic Science

12. Novartis Pharma KK

13. Juntendo University School of Medicine, Department of Hematology

Correspondence to:
Keita Kirito
Tel: 81-55-273-9432



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.

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