PMID- 28448193
OWN - NLM
STAT- MEDLINE
DCOM- 20180705
LR  - 20181202
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 28
IP  - 1
DP  - 2018 Jan
TI  - Safety and effectiveness of etanercept for treatment of juvenile idiopathic 
      arthritis: Results from a postmarketing surveillance.
PG  - 101-107
LID - 10.1080/14397595.2017.1310704 [doi]
AB  - OBJECTIVES: The objectives of this surveillance were to determine safety and 
      effectiveness of etanercept in patients with juvenile idiopathic arthritis (JIA). 
      METHODS: In this postmarketing surveillance, patients aged 5-16 years with active 
      polyarthritis JIA were treated with etanercept at the doses approved in the 
      Japanese package insert. The occurrence and seriousness of adverse events (AEs) 
      were assessed using the Japanese Medical Dictionary for Regulatory Activities 
      version 15.1. Effectiveness was determined as the improvement from baseline in 
      disease activity score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR), 
      remission, and physician's assessment of overall improvement. The number of 
      responders was expressed as a percentage. The last observation carried forward 
      method was used to impute missing data. RESULTS: Safety analysis included 102 
      patients; 22 patients experienced 36 treatment-related AEs, three of which were 
      unexpected. None of the AEs were deemed to need special safety warnings. 
      Effectiveness analysis included 87 patients. At 24 weeks, 29/46 (63.0%) patients 
      demonstrated either good or moderate response in DAS28-4/ESR and treatment was 
      assessed to be markedly effective or effective by physicians in 79/83 (95.2%) 
      patients. CONCLUSIONS: These data are consistent with earlier reports showing 
      that etanercept was effective and demonstrated no safety signals in patients with 
      JIA.
FAU - Mori, Masaaki
AU  - Mori M
AD  - a Department of Lifetime Clinical Immunology , Graduate School of Medical and 
      Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan.
FAU - Sugiyama, Naonobu
AU  - Sugiyama N
AD  - b Pfizer Japan Inc. , Tokyo , Japan.
FAU - Morishima, Yosuke
AU  - Morishima Y
AD  - b Pfizer Japan Inc. , Tokyo , Japan.
FAU - Sugiyama, Noriko
AU  - Sugiyama N
AD  - b Pfizer Japan Inc. , Tokyo , Japan.
FAU - Kokubo, Takeshi
AU  - Kokubo T
AD  - b Pfizer Japan Inc. , Tokyo , Japan.
FAU - Takei, Syuji
AU  - Takei S
AD  - c Department of Maternal and Child Health Nursing , School of Health Sciences, 
      Faculty of Medicine, Kagoshima University , Kagoshima , Japan.
FAU - Yokota, Shumpei
AU  - Yokota S
AD  - d Fuji Toranomon Orthopedics Hospital , Shizuoka , Japan.
LA  - eng
PT  - Journal Article
DEP - 20170427
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adolescent
MH  - Antirheumatic Agents/adverse effects/*therapeutic use
MH  - Arthritis, Juvenile/diagnosis/*drug therapy
MH  - Blood Sedimentation
MH  - Child
MH  - Child, Preschool
MH  - Etanercept/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Product Surveillance, Postmarketing
MH  - Receptors, Tumor Necrosis Factor/therapeutic use
MH  - Severity of Illness Index
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Etanercept
OT  - juvenile idiopathic arthritis
OT  - observational surveillance
EDAT- 2017/04/28 06:00
MHDA- 2018/07/06 06:00
CRDT- 2017/04/28 06:00
PHST- 2017/04/28 06:00 [pubmed]
PHST- 2018/07/06 06:00 [medline]
PHST- 2017/04/28 06:00 [entrez]
AID - 10.1080/14397595.2017.1310704 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2018 Jan;28(1):101-107. doi: 10.1080/14397595.2017.1310704. Epub 
      2017 Apr 27.