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Etanercept, an anti-tumour necrosis factor α drug, has been approved and licensed for the treatment of active, treatment resistance, polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 years or older. An etanercept registry was begun in January 2001 by paediatric rheumatologists in Germany and Austria, and data from the first 34 months of the registry have been reported (
Up to the end of October 2003 data had been collected on 322 patients from 36 centres. All had failed to respond to methotrexate before starting etanercept and they had been treated with etanercept for up to 48 months. Half of the patients had either systemic onset JIA (21%) or seronegative polyarticular JIA (29%). Twelve per cent had seropositive polyarticular JIA and 17% extended oligoarticular JIA. The remaining 21% had persistent oligoarticular JIA, enthesitis and arthritis JIA subtype, psoriasis and arthritis JIA subtype, or unclassified JIA. Patients with systemic onset JIA had more severe disease. A therapeutic effect of etanercept was documented at 1 month and increased throughout the first year. Overall, a 70% improvement was achieved in 30% at 1 month and 54% at 12 months. A 50% improvement was achieved in 54% at 1 month and 71% at 12 months. Among patients with systemic onset JIA the 70% improvement rates were 11% at 1 month and around 30% at 12 months, and the corresponding 50% improvement rates were 33% and 39%. Among 66 patients with systemic onset JIA 14 (21%) discontinued etanercept because of lack of effectiveness. Among 256 patients with non-systemic disease 11 (4%) stopped treatment because it was ineffective. Complete remission occurred in 26% of patients overall and in 13% of those with systemic onset disease. Treatment was stopped because of disease remission in 14 patients. Six of these had a relapse after 1–11 months. Re-treatment in five patients was successful. Sixty-nine adverse events were reported in 56 patients. Eleven patients stopped treatment because of an adverse event—uveitis in three patients. Twelve adverse events were judged to be severe. The most common adverse events were local skin reaction (7), raised liver enzymes (7), and itching and a rash (6). Twenty patients had a variety of infections, the most serious of which was pneumonia, requiring mechanical ventilation. One patient developed central nervous system demyelination. Demyelination has been reported in three patients with JIA, and 17 with other forms of arthritis, on treatment with either etanercept or infliximab. The authors of this paper suggest performing MRI scans of the central nervous system in selected patients.
Etanercept is effective treatment for patients with refractory JIA. Improvement occurs within the first month of treatment and the rate and degree of improvement increase throughout the first year. Patients with systemic onset disease respond less well. The treatment is well tolerated on the whole.
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