title: Etanercept in the treatment of disease-modifying anti-rheumatic drug (DMARD)-refractory polyarticular course juvenile idiopathic arthritis: experience from Japanese clinical trials.
abstract: 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 DMARD-refractory polyarticular JIA patients.
authors.affiliation: Yokohama City University School of Medicine, Yokohama, Japan. mmori@med.yokohama-cu.ac.jp
authors.forename: Masaaki
authors.initials: M
authors.lastname: Mori
authors.forename: Syuji
authors.initials: S
authors.lastname: Takei
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Imagawa
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Imanaka
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Nerome
authors.forename: Rumiko
authors.initials: R
authors.lastname: Kurosawa
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Kawano
authors.forename: Shumpei
authors.initials: S
authors.lastname: Yokota
authors.forename: Noriko
authors.initials: N
authors.lastname: Sugiyama
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Yuasa
authors.forename: Tracey
authors.initials: T
authors.lastname: Fletcher
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Wajdula
mesh_terms: D000293:Adolescent; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept