title: A multinational, open-label, phase 2 study of ruxolitinib in Asian patients with myelofibrosis: Japanese subset analysis.
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.
authors: Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan, oritani@bldon.med.osaka-u.ac.jp.
authors: Kenji
authors: K
authors: Oritani
authors: Shinichiro
authors: S
authors: Okamoto
authors: Tetsuzo
authors: T
authors: Tauchi
authors: Shigeki
authors: S
authors: Saito
authors: Kohshi
authors: K
authors: Ohishi
authors: Hiroshi
authors: H
authors: Handa
authors: Katsuto
authors: K
authors: Takenaka
authors: Prashanth
authors: P
authors: Gopalakrishna
authors: Taro
authors: T
authors: Amagasaki
authors: Kazuo
authors: K
authors: Ito
authors: Koichi
authors: K
authors: Akashi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D005260:Female; D006801:Humans; D053612:Janus Kinases / Q000037:antagonists & inhibitors*; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D055728:Primary Myelofibrosis / Q000188:drug therapy* / Q000473:pathology; D047428:Protein Kinase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D011720:Pyrazoles / Q000009:adverse effects* / Q000627:therapeutic use*; D011743:Pyrimidines; D013154:Spleen / Q000187:drug effects / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D009570:Nitriles; D047428:Protein Kinase Inhibitors; D011720:Pyrazoles; D011743:Pyrimidines; C540383:ruxolitinib; D053612:Janus Kinases
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