A Prospective Open Label Trial of Clinical Efficacy and Safety of Etanercept in Juvenile Idiopathic Arthritis: Study from Iraq

Abstract

Objective: To evaluate the efficacy and safety of etanercept (ETN) in Iraqi patients with juvenile idiopathic arthritis (JIA).Patients and Methods: This open labeled single group observational study included 42 Iraqi patients who fulfilled International League of Associations for Rheumatology (ILAR) criteria of JIA. All the patients were given ETN 0.8 mg/kg (max: 50 mg) subcutaneous injection once weekly. Baseline data were collected during the first visit and patients were followed during the study at regular intervals: one month, three months, and six months. Outcome measures included juvenile arthritis disease activity score3-27 joints (JADAS3-27), functional class, and drug adverse effects were measured and recorded at each follow up time.Results: The mean age of patients was (11.91±3.78 years). Female patients were 22 (52.4%). The mean JADAS3-27 at base line was 20.29 ± 10.4 and reduced significantly after six months to reach 8.79 ± 6.6 (P<0.001). The overall number of patients who had advanced functional class (III and IV classes) at baseline changed significantly to lower classes after six months of follow up (P=0.001). Adverse events were leukopenia in two patients (4.8%), elevated liver enzymes in one patient (2.4%) and mild transient local skin rash at site of injection in five patients (11.9%).Conclusion: Etanercept drug was effective and relatively safe in treatment of Iraqi patients with JIA patients.

Key words: Juvenile idiopathic arthritis, JADAS 3-27, Functional class, Etanercept