PMID- 23053683
OWN - NLM
STAT- MEDLINE
DCOM- 20130507
LR  - 20211021
IS  - 1434-9949 (Electronic)
IS  - 0770-3198 (Print)
IS  - 0770-3198 (Linking)
VI  - 31
IP  - 12
DP  - 2012 Dec
TI  - Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with 
      juvenile idiopathic arthritis in Japan.
PG  - 1713-21
LID - 10.1007/s10067-012-2082-5 [doi]
AB  - The objective of this study was to evaluate the efficacy, pharmacokinetics, and 
      safety of adalimumab in patients with polyarticular juvenile idiopathic arthritis 
      (JIA) in Japan. Patients aged 4 to 17 years were enrolled in a single-arm, 
      open-label, multicentre study of adalimumab. Patients weighing <30 kg received 20 
      mg every other week (eow), and those >/=30 kg received 40 mg eow. Concomitant 
      methotrexate (MTX) was allowed (</=10 mg/m(2) per week). The primary efficacy 
      outcome was the percent of patients with American College of Rheumatology 
      Pediatric 30 response (ACR Pedi 30) at week 16. JIA core variables, serum 
      adalimumab concentrations, and anti-adalimumab antibodies (AAAs) were analysed. 
      Patients were monitored for adverse events (AEs). Twenty-five patients (20 with 
      concomitant MTX at baseline and 5 without) were enrolled: 24 patients completed 
      16 weeks of therapy and 22 patients completed 60 weeks. At week 16, 90 % of 
      patients with MTX and 100 % without MTX achieved ACR Pedi 30; response rates were 
      maintained through week 60 in 94 and 80 % of patients, respectively. Each JIA 
      core variable improved over time. Six patients became AAA positive (two each at 
      weeks 8, 16, and 60), some of which were transient. All six AAA-positive patients 
      achieved ACR Pedi 30 at week 16, and four maintained that response at week 60. 
      Six patients (all with MTX) experienced nine serious AEs (JIA, pyrexia, 
      arthralgia, pneumonia, hepatitis B infection, pharyngitis, dehydration, 
      pharyngeal pain, and pneumonia). In pediatric patients with polyarticular JIA in 
      Japan, adalimumab was safe and effective for reducing disease activity for up to 
      60 weeks.
FAU - Imagawa, Tomoyuki
AU  - Imagawa T
AD  - Yokohama City University, Japan. timagawa@ca2.so-net.ne.jp
FAU - Takei, Syuji
AU  - Takei S
FAU - Umebayashi, Hiroaki
AU  - Umebayashi H
FAU - Yamaguchi, Kenichi
AU  - Yamaguchi K
FAU - Itoh, Yasuhiko
AU  - Itoh Y
FAU - Kawai, Toshinao
AU  - Kawai T
FAU - Iwata, Naomi
AU  - Iwata N
FAU - Murata, Takuji
AU  - Murata T
FAU - Okafuji, Ikuo
AU  - Okafuji I
FAU - Miyoshi, Mari
AU  - Miyoshi M
FAU - Onoe, Yasuhiro
AU  - Onoe Y
FAU - Kawano, Yoshifumi
AU  - Kawano Y
FAU - Kinjo, Noriko
AU  - Kinjo N
FAU - Mori, Masaaki
AU  - Mori M
FAU - Mozaffarian, Neelufar
AU  - Mozaffarian N
FAU - Kupper, Hartmut
AU  - Kupper H
FAU - Santra, Sourav
AU  - Santra S
FAU - Patel, Gina
AU  - Patel G
FAU - Kawai, Shinichi
AU  - Kawai S
FAU - Yokota, Shumpei
AU  - Yokota S
LA  - eng
SI  - ClinicalTrials.gov/NCT00690573
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20121002
PL  - Germany
TA  - Clin Rheumatol
JT  - Clinical rheumatology
JID - 8211469
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - FYS6T7F842 (Adalimumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adalimumab
MH  - Adolescent
MH  - Antibodies, Monoclonal, Humanized/adverse effects/pharmacokinetics/*therapeutic 
      use
MH  - Antirheumatic Agents/adverse effects/pharmacokinetics/*therapeutic use
MH  - Arthritis, Juvenile/*drug therapy
MH  - Child
MH  - Child, Preschool
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor-alpha/antagonists & inhibitors
PMC - PMC3505492
EDAT- 2012/10/12 06:00
MHDA- 2013/05/08 06:00
PMCR- 2012/10/02
CRDT- 2012/10/12 06:00
PHST- 2012/04/12 00:00 [received]
PHST- 2012/08/28 00:00 [accepted]
PHST- 2012/08/01 00:00 [revised]
PHST- 2012/10/12 06:00 [entrez]
PHST- 2012/10/12 06:00 [pubmed]
PHST- 2013/05/08 06:00 [medline]
PHST- 2012/10/02 00:00 [pmc-release]
AID - 2082 [pii]
AID - 10.1007/s10067-012-2082-5 [doi]
PST - ppublish
SO  - Clin Rheumatol. 2012 Dec;31(12):1713-21. doi: 10.1007/s10067-012-2082-5. Epub 
      2012 Oct 2.