Etanercept (Enbrel) in the treatment of DMARD-refractory polyarticular course JIA

[Guest guest]

Etanercept in the treatment of disease-modifying anti-rheumatic drug

(DMARD)-refractory polyarticular course juvenile idiopathic arthritis:

Experience from Japanese clinical trials

www.mdlinx.com/rheumatology/newsl-article.cfm/3563875/ZZ535270975115220484126/?n\

ews_id=751 & newsdt=052411 & subspec_id=359

Modern Rheumatology, 04/15/2011 Clinical Article

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.