Vol.21 No.6

Original Article

Etanercept in the treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory polyarticular course juvenile idiopathic arthritis: experience from Japanese clinical trials


Masaaki Mori1,5 , Syuji Takei2 , Tomoyuki Imagawa1 , Hiroyuki Imanaka2 , Yasuhito Nerome2 , Rumiko Kurosawa1 , Yoshifumi Kawano2 , Shumpei Yokota1 , Noriko Sugiyama3 , Hirotoshi Yuasa3 , Tracey Fletcher4 , Joseph S. Wajdula4

  • Yokohama City University School of Medicine, Yokohama, Japan
  • Kagoshima University School of Medicine, Kagoshima, Japan
  • Pfizer Inc, Tokyo, Japan
  • Pfizer Inc, Collegeville, PA, USA
  • Department of Pediatrics, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan

14 January 2011


18 March 2011

Published online:

11 April 2011

Full Text

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Efficacy, safety, and pharmacokinetics results from 4 studies-3 open-label (OL) and 1 randomized double-blind (DB)-have provided data for approval of etanercept for treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory juvenile idiopathic arthritis (JIA) in Japan. Results from the 3 shorter-term (2 OL and 1 DB) studies are reported here. Subjects (4-17 years) enrolled in the OL studies had active JIA, i.e. ≥5 swollen joints and ≥3 joints with limitation of motion and pain or tenderness. Subjects enrolled in the primary OL study received etanercept 0.4 mg/kg subcutaneously twice weekly; in the lower-dose OL study subjects received etanercept 0.2 mg/kg. Subjects in the primary OL study who completed ≥48 weeks could continue into a 12-week DB dose-down extension study in which subjects received etanercept 0.4 or 0.2 mg/kg twice weekly. The primary endpoint in all 3 studies, i.e. 30% improvement in the American College of Rheumatology criteria for JIA (ACR Pedi 30) at 12 weeks, was achieved by ≥80% of subjects by week 2 and sustained to week 12. Common adverse events reported were injection site reactions, nasopharyngitis, and gastroenteritis. These results provide further evidence that etanercept is effective therapy for DMARDrefractory polyarticular JIA patients.

Key words

Children - Clinical trial - Etanercept - Polyarticular course - Juvenile idiopathic arthritis