1. A multinational, open-label, phase 2 study of ruxolitinib in Asian patients with myelofibrosis: Japanese subset analysis
- Author
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Shinichiro Okamoto, Koichi Akashi, Taro Amagasaki, Shigeki Saito, Tetsuzo Tauchi, Kohshi Ohishi, Katsuto Takenaka, Kenji Oritani, Hiroshi Handa, Prashanth Gopalakrishna, and Kazuo Ito
- Subjects
Adult ,Male ,Subset Analysis ,medicine.medical_specialty ,Ruxolitinib ,Anemia ,Phases of clinical research ,Gastroenterology ,Asian People ,Internal medicine ,Nitriles ,medicine ,Humans ,Adverse effect ,Myelofibrosis ,Protein Kinase Inhibitors ,Aged ,Janus Kinases ,Aged, 80 and over ,Hematology ,business.industry ,Middle Aged ,medicine.disease ,Surgery ,Clinical trial ,Pyrimidines ,Treatment Outcome ,Primary Myelofibrosis ,Pyrazoles ,Female ,business ,Spleen ,medicine.drug - 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.
- Published
- 2015