RESULTS OF THE IV PHASE OF THE OPEN CLINICAL TRIAL ON EFFICACY AND SAFETY OF ABATACEPT USAGE IN CHILDREN AND ADOLESCENTS WITH POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WITHOUT SYSTEMIC MANIFESTATIONS IN RUSSIA

Abstract

Aim: to assess efficacy and safety of abatacept usage in children and adolescents with polyarticular juvenile idiopathic arthritis without systemic manifestations. Patients and methods: 15 patients aged 13 (11; 14,5) years old were included into the study; the mean duration of disease course was 4 (3; 5) years. The disease was diagnosed based on the ILAR criteria. All the patients were performed routine clinical and laboratory examination. Efficacy of treatment was assessed according to the pediatric criteria for improvement of the American College of Rheumatology (ACRpedi). Target characteristics of treatment efficacy were: the number of patients with 30/50/70/90% improvement according to the ACRpedi criteria during first 4 months from the therapy administration, and then – every 2 months; percentage of non-active stage and remission achievement. Results: in 4 months after beginning of treatment improvement according to the ACRpedi 30/50 criteria was observed in 60/30% of patients; in 6 months according to the ACRpedi 30/50/70 criteria — in 80/40/40%, respectively; in 12 months according to the ACRpedi 70 criteria — in 80% of patients. Non-active stage of disease in 6 and 12 months was confirmed in 6/15 (30%) and 10/15 (60%) of patients, respectively. Remission was confirmed in 10/15 (60%) of children in 12 months of therapy. Side effects were observed in 6/15 (40%) of children and were mild. Three patients had relapses of Herpes labialis infection, 3 other had acute respiratory tract infections. Conclusions: abatacept is effective for treatment of polyarticular juvenile idiopathic arthritis, resistant to steroids, methotrexate and combined immunosuppressive treatment.

Keywords

• polyarticular juvenile idiopathic arthritis
• abatacept
• treatment