Efficacy and Safety of Adalimumab Long-Term Administration with Immunosuppressants at Juvenile Idiopathic Arthritis without Systemic Manifestations

Abstract

Background: Treatment of patients with juvenile idiopathic arthritis (JIA) is one of the most complex and urgent problems of rheumatology.Objective: Our aim was to evaluate the efficacy and safety of adalimumab therapy combined with immunosuppressants in patients with JIA without systemic manifestations.Methods: A monocentre observational comparative study was held. We studied the results of treatment of patients with JIA being treated with adalimumab combined with immunosuppressants (n = 215) and methotrexate (n = 200). The efficacy of the therapy was evaluated using the paediatric criteria of the American College of Rheumatology (ACRpedi) and remission criteria by C. Wallace during 5 years.Results: After 6 and 12 months the remission of articular syndrome was registered in 72 and 81% of patients treated with adalimumab combined with immunosuppressants, and in 53 and 65% treated with methotrexate. Laboratory indicators of the disease activity corresponded to the reference values after 6 months in 73 and 48%, after 12 months — in 94 and 68% of patients in the comparison groups, respectively. After 6 and 12 months of supervision the activity according to the CHAQ questionnaire was fully recovered in 63 and 79%; 47 and 62% of children. After 1 month the improvement according to the ACRpedi30/50/70 criteria was registered in 87/54/25% of the observed treated with adalimumab. After 6 months the ACRpedi30/50/70 index was 93/89/76% and 63/57/47% for adalimumab therapy with immunosuppressants and methotrexate, respectively. Adalimumab combined with immunosuppressants more quickly than methotrexate induced the stage of inactive disease/remission — after 5 (3; 8) and 12 (6; 18) months, respectively (p < 0.001). After 6 and 12 months of supervision the stage of inactive disease/remission was reported in 43 and 47% of patients treated with adalimumab combined with immunosuppressants, and in 9 and 38% of patients receiving the methotrexate therapy. Adalimumab and methotrexate were well tolerated by 58 and 73% of patients with JIA without systemic manifestations. The adverse events were reported in 42 and 27% of patients, but became the reason for drug dechallenge only in 6 and 10% of patients.Conclusion: Adalimumab combination therapy combined with immunosuppressants has faster and more evident anti-inflammatory effect than the treatment with classical immunosuppressant methotrexate.

Keywords

• children
• juvenile idiopathic arthritis
• adalimumab
• methotrexate
• efficacy
• safety