Background The appearance of biologics in the last decade of the 20th century has significantly changed life perspectives for patients with rheumatic diseases. Etanercept, a soluble anti-tumor necrosis factor alpha (TNF-α) receptor - is one of the first in biologic group agent, which is widely used in rheumatic pediatric practice.
Objectives To assess efficacy and safety of etanercept in patients with different forms and variants of active juvenile idiopathic arthritis (JIA) in a real clinical practice.
Methods An open-label, non-randomised, observational study ofetanercept safety and efficacy in 24 children with juvenile idiopathic arthritis (JIA). 11 of all children (46%) had systemic JIA and 13 of all - (54%) had polyarticulare. All children had high degree (III) of disease activity. Average duration of the disease was 7,5±3,5yr. Prior to etanercept treatment all children received massive disease modifying anti-rheumatic (DMARDs) therapy with 2 and more DMARDs. Six children with heavy course of systemic JIA have had prior experience of infliximab treatment within 1-1,5 years. The study was subjected to information about forms and variants of JIA, sex, age, diagnosis, and therapy. Treatment efficacy was assessed according to the American College of Rheumatology (ACR) criteria for pediatric patients: ACR Pediatric 30 (Pedi 30), Pedi 50, Pedi 70. Criteria of ACR Pedi have been estimated in the endpoints of 6 and 12 month from the beginning of etanercept therapy. Etanercept was administered in the dose of 0.4 mg/kg twice weekly or 0.8 mg/kg once weekly.
Results In systemic JIA group at 6 mo endpoint 7 (64%) patients have demonstrated response in ACR Pedi 30, 6 (54,5%) – in ACR Pedi 50, and 4 (36,5%) – in ACR Pedi 70. 7 patients have reached 12 mo endpoint (others are still in treatment). The ACR Pedi 50 response was reached by 6 (85,7%) children, ACR pedi-70 – by 4 (57,1%). 1 patient have had low efficacy of etanercept therapy. In poliarticular JIA group at 6 mo endpoint all patients (100%) have demonstrated response in ACR Pedi 30, 8 (61,5%) – in ACR Pedi 50 and 6 (46,2%) – in ACR Pedi 70. 4 patients have reached 12 mo endpoint (others are still in treatment). The ACR Pedi 50 response was reached by 4 (100%) children, ACR pedi-70 – by 3 (75,0%). There were no serious adverse events (undesirable reactions) during etanercept therapy.
Conclusions Etanercept therapy is proven to be effective for the majority of patients with long standing history of the disease, high disease activity, and no/low efficacy of disease modifying anti-rheumatic drugs. The most positive results have been seen in patients with poliarticular JIA. An interruption of a treatment course in systemic JIA patients is associated with high possibility of disease exacerbation including non-articular sights, but does not increase the risk of adverse events in recommencement therapy causes.
Disclosure of Interest None Declared
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