PMID- 22212889
OWN - NLM
STAT- MEDLINE
DCOM- 20130207
LR  - 20161020
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 22
IP  - 5
DP  - 2012 Sep
TI  - Safety and efficacy of long-term etanercept in the treatment of 
      methotrexate-refractory polyarticular-course juvenile idiopathic arthritis in 
      Japan.
PG  - 720-6
LID - 10.1007/s10165-011-0578-5 [doi]
AB  - OBJECTIVES: Previous short-term trials found etanercept (0.2 or 0.4 mg/kg) to be 
      effective and well tolerated in Japanese children with juvenile idiopathic 
      arthritis (JIA) who were intolerant/resistant to methotrexate. The aim of this 
      study was to evaluate the long-term safety and efficacy of etanercept in Japanese 
      children with JIA. METHODS: Patients (4-19 years) who received etanercept in one 
      of three short-term studies continued onto this long-term open-label study. 
      RESULTS: Of the 32 patients enrolled, 18 (56.3%) completed 192 weeks of the study 
      and 14 (43.8%) were discontinued; 7 (21.9%) for patient refusal, 2 (6.3%) for 
      adverse events (AEs), and 5 (15.6%) for lack of efficacy. All patients reported 
      AEs; 31 (96.9%) reported infections and 6 (18.8%) reported serious AEs. Main 
      efficacy assessments included change from baseline in the American College of 
      Rheumatology Pediatric core components, including mean improvements from baseline 
      in the physician global assessment (90.7%), patient/guardian global assessments 
      (54.1%), Childhood Health Assessment Questionnaire (84.6%), and median 
      improvements in C-reactive protein levels (92.7%). No unexpected safety results 
      were reported, and early efficacy responses were sustained in the long term. 
      CONCLUSIONS: This study provides further evidence that etanercept is an effective 
      therapeutic option for Japanese children with polyarticular-course JIA.
FAU - Mori, Masaaki
AU  - Mori M
AD  - Department of Pediatrics, Yokohama City University Medical Center, 4-57 
      Urafune-cho, Minami-ku, Yokohama 232-0024, Japan. mmori@med.yokohama-cu.ac.jp
FAU - Takei, Syuji
AU  - Takei S
FAU - Imagawa, Tomoyuki
AU  - Imagawa T
FAU - Imanaka, Hiroyuki
AU  - Imanaka H
FAU - Nerome, Yasuhito
AU  - Nerome Y
FAU - Higuchi, Rumiko
AU  - Higuchi R
FAU - Kawano, Yoshifumi
AU  - Kawano Y
FAU - Yokota, Shumpei
AU  - Yokota S
FAU - Sugiyama, Noriko
AU  - Sugiyama N
FAU - Yuasa, Hirotoshi
AU  - Yuasa H
FAU - Fletcher, Tracey
AU  - Fletcher T
FAU - Wajdula, Joseph S
AU  - Wajdula JS
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20120104
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - OP401G7OJC (Etanercept)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adolescent
MH  - Antirheumatic Agents/adverse effects/*therapeutic use
MH  - Arthritis, Juvenile/blood/*drug therapy/physiopathology
MH  - C-Reactive Protein/analysis
MH  - Child
MH  - Child, Preschool
MH  - Drug Resistance
MH  - Drug Substitution
MH  - Etanercept
MH  - Female
MH  - Health Status
MH  - Humans
MH  - Immunoglobulin G/adverse effects/*therapeutic use
MH  - Male
MH  - Methotrexate/*therapeutic use
MH  - Quality of Life
MH  - Receptors, Tumor Necrosis Factor/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2012/01/04 06:00
MHDA- 2013/02/08 06:00
CRDT- 2012/01/04 06:00
PHST- 2011/08/15 00:00 [received]
PHST- 2011/12/07 00:00 [accepted]
PHST- 2012/01/04 06:00 [entrez]
PHST- 2012/01/04 06:00 [pubmed]
PHST- 2013/02/08 06:00 [medline]
AID - 10.1007/s10165-011-0578-5 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2012 Sep;22(5):720-6. doi: 10.1007/s10165-011-0578-5. Epub 2012 
      Jan 4.