PMID- 27832516
OWN - NLM
STAT- MEDLINE
DCOM- 20170426
LR  - 20211204
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 105
IP  - 3
DP  - 2017 Mar
TI  - Assessing the safety and efficacy of ruxolitinib in a multicenter, open-label 
      study in Japanese patients with myelofibrosis.
PG  - 309-317
LID - 10.1007/s12185-016-2130-z [doi]
AB  - Ruxolitinib is a potent JAK1/JAK2 inhibitor that has demonstrated durable 
      improvements in splenomegaly, symptoms, and overall survival in controlled 
      clinical trials in patients with myelofibrosis. The single-arm study reported 
      here was initiated to collect further safety and efficacy data in Japanese 
      patients with myelofibrosis and is the largest study of ruxolitinib in this 
      population. The primary objective was to assess safety. Secondary endpoints 
      included changes in spleen size and patient-reported outcomes. The primary 
      analysis occurred when all patients (N = 51) completed 24 weeks or discontinued. 
      Overall, 86.3% of patients completed treatment; 9.8% discontinued due to adverse 
      events (AEs). Consistent with previous studies, the most common AEs were anemia 
      (62.7%) and thrombocytopenia (29.4%). Furthermore, levels of select immunologic 
      biomarkers remained stable, and no deaths occurred. At week 24, 30.0% of 
      evaluable patients experienced >/=50% reductions from baseline in palpable spleen 
      length; 26.0% had >/=35% reductions in spleen volume. Additionally, ruxolitinib led 
      to clinically significant improvements in symptoms and quality of life. Overall, 
      findings from this study indicate that ruxolitinib is safe and effective in 
      Japanese patients with myelofibrosis, with these benefits extending to patients 
      with intermediate-1-risk myelofibrosis and to those with low platelet counts.
FAU - Komatsu, Norio
AU  - Komatsu N
AD  - Department of Hematology, Juntendo University School of Medicine, Juntendo 
      University, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan. 
      komatsun@juntendo.ac.jp.
FAU - Kirito, Keita
AU  - Kirito K
AD  - Department of Hematology and Oncology, University of Yamanashi, Yamanashi, 
      409-3898, Japan.
FAU - Shimoda, Kazuya
AU  - Shimoda K
AD  - Department of Gastroenterology and Hematology, University of Miyazaki, Miyazaki, 
      889-1692, Japan.
FAU - Ishikawa, Takayuki
AU  - Ishikawa T
AD  - Department of Hematology, Kobe City Medical Center General Hospital, Kobe, 
      650-0047, Japan.
FAU - Ohishi, Kohshi
AU  - Ohishi K
AD  - Blood Transfusion Service, Mie University, Tsu, Mie, 514-8507, Japan.
FAU - Ohyashiki, Kazuma
AU  - Ohyashiki K
AD  - Department of Hematology, Tokyo Medical University, Tokyo, 160-8402, Japan.
FAU - Takahashi, Naoto
AU  - Takahashi N
AD  - Department of Hematology, Nephrology, and Rheumatology, Akita University Graduate 
      School of Medicine, Akita, 010-8502, Japan.
FAU - Okada, Hikaru
AU  - Okada H
AD  - Novartis Pharma KK, Tokyo, 105-6333, Japan.
FAU - Amagasaki, Taro
AU  - Amagasaki T
AD  - Novartis Pharma KK, Tokyo, 105-6333, Japan.
FAU - Yonezu, Toshio
AU  - Yonezu T
AD  - Novartis Pharma KK, Tokyo, 105-6333, Japan.
FAU - Akashi, Koichi
AU  - Akashi K
AD  - Department of Medicine and Biosystemic Science, Kyushu University, Fukuoka, 
      812-8582, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20161110
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Nitriles)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyrimidines)
RN  - 82S8X8XX8H (ruxolitinib)
SB  - IM
EIN - Int J Hematol. 2017 Mar;105(3):387. PMID: 28176224
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anemia/chemically induced
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nitriles
MH  - Primary Myelofibrosis/complications/*drug therapy
MH  - Pyrazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Pyrimidines
MH  - Quality of Life
MH  - Spleen/drug effects
MH  - Splenomegaly
MH  - Thrombocytopenia/chemically induced
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Japanese patients
OT  - Myelofibrosis
OT  - Ruxolitinib
EDAT- 2016/11/11 06:00
MHDA- 2017/04/27 06:00
CRDT- 2016/11/11 06:00
PHST- 2016/08/17 00:00 [received]
PHST- 2016/11/02 00:00 [accepted]
PHST- 2016/11/01 00:00 [revised]
PHST- 2016/11/11 06:00 [pubmed]
PHST- 2017/04/27 06:00 [medline]
PHST- 2016/11/11 06:00 [entrez]
AID - 10.1007/s12185-016-2130-z [pii]
AID - 10.1007/s12185-016-2130-z [doi]
PST - ppublish
SO  - Int J Hematol. 2017 Mar;105(3):309-317. doi: 10.1007/s12185-016-2130-z. Epub 2016 
      Nov 10.