Open label multicenter study of once weekly Etanercept 0.8 mg/kg in active polyarticular Juvenile idiopathic arthritis (JIA)
© Horneff et al; licensee BioMed Central Ltd. 2008
Published: 15 September 2008
In Europe Etanercept is licensed for the treatment of resistant polyarticular JIA at a dosage of 0.4 mg/kg bw. twice weekly in children older than 4 years.
To evaluate the safety and efficacy of Etanercept once weekly 0.8 mg/kg up to 50 mg in a formal trial.
At each study site an independent ethics committee approved the protocol, and each patient's parent gave written informed consent (EudraCT No. 2007-000255-34). 20 patients 4 to 17 years old were included and received 0.8 mg/kg bw. of etanercept subcutaneously once weekly for 12 weeks "Active" polyarticular disease was defined by the presence of five or more active joints. PedACR30/50/70 criteria were calculated.
Safety assessments were based on adverse events (AE) reported.
15 of 20 JIA patients, 16 girls and 4 boys, mean age 12.9 years, disease duration 4.1 years, already have completed the 12 week study period. The mean dosage was 0.80 +/- 0.04 mg/kg Etanercept. Concomitant treatments were kept stable 3 months before and throughout the study and consisted of NSAID (n = 20), prednisone (n = 4), methotrexate (n = 12), leflunomide (n = 2), sulfsalazine (n = 1). A PedACR 30/50/70 response was reached by 73%/26%/10% of patients after 4 weeks, 86%/73%/40% after 8 weeks and 92%/92%/79% after 12 weeks of treatment. There were 33 AEs but no SAE: 9 minor infections 12 injection site reactions and 12 other AEs. There was no drop out.
These data indicate that once weekly application of Etanercept at double dosage of 0.8 mg/kg bodyweight up to 50 mg per injection is safe and efficacious in polyarticular JIA patients.
This article is published under license to BioMed Central Ltd.