TY - JOUR
T1 - A multinational, open-label, phase 2 study of ruxolitinib in Asian patients with myelofibrosis
T2 - Japanese subset analysis
AU - Oritani, Kenji
AU - Okamoto, Shinichiro
AU - Tauchi, Tetsuzo
AU - Saito, Shigeki
AU - Ohishi, Kohshi
AU - Handa, Hiroshi
AU - Takenaka, Katsuto
AU - Gopalakrishna, Prashanth
AU - Amagasaki, Taro
AU - Ito, Kazuo
AU - Akashi, Koichi
N1 - Funding Information:
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.
Publisher Copyright:
© 2015, The Japanese Society of Hematology.
PY - 2015/3/6
Y1 - 2015/3/6
N2 - 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.
AB - 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.
KW - JAK inhibitor
KW - Japan
KW - Myelofibrosis
KW - Ruxolitinib
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U2 - 10.1007/s12185-015-1746-8
DO - 10.1007/s12185-015-1746-8
M3 - Article
C2 - 25638222
AN - SCOPUS:84925538391
SN - 0925-5710
VL - 101
SP - 295
EP - 304
JO - International journal of hematology
JF - International journal of hematology
IS - 3
ER -
