Long‐term efficacy and safety of etanercept in children with polyarticular‐course juvenile rheumatoid arthritis: Interim results from an ongoing multicenter, open‐label, extended‐treatment trial

Objective To evaluate the long‐term efficacy and safety of etanercept in children with juvenile rheumatoid arthritis (JRA) participating in an ongoing multicenter, open‐label, extended‐treatment trial. All patients had been participants in an initial randomized efficacy and safety trial of etanercept. Methods Etanercept was administered at a dosage of 0.4 mg/kg (maximum 25 mg) subcutaneously twice each week. Safety and efficacy evaluations were performed every 3–4 months. The JRA 30% definition of improvement (DOI) was defined as improvement of ≥30% in at least 3 of 6 response variables used to assess disease activity, with no more than 1 variable worsening by more than 30%. Results At the time of analysis, 48 of the 58 patients (83%) were still enrolled in the study; 43 of them (74%) had completed 2 years of treatment. Of these 43 patients, 81% met the JRA 30% DOI, 79% met the JRA 50% DOI, and 67% met the JRA 70% DOI. Ten children started low‐dose methotrexate after year 1. Of the 32 children taking prednisone, the dosage was decreased to 2 years of continuous etanercept treatment. Etanercept was generally well‐tolerated. There were no increases in the rates of adverse events over time. However, children taking etanercept should be monitored closely for infections.