Терапия генно-инженерными биологическими препаратами: эффективность и безопасность переключения

Abstract

Aim : to assess efficacy and safety of «changeover» to the second genetically engineered biological agent (GEBA) in patients with juvenile idiopathic arthritis (JIA) with resistance or intolerability to the first GEBA. Patients and methods : the results of retrospective observational research of efficacy and safety of «changeover» to the second GEBA in 136 patients with various variants of JIA aged from 1 to 17 years old with primary resistance, partial effect or loss of efficacy to other biological agents are shown in this article. Among those 41 patient have systemic and 95 — JIA without extra-articular involvement. In 32 patients with JIA without extra-articular involvement the efficacy and safety of etanercept were assessed; in 63 — of adalimumab; in 22 patients with JIA and active extra-articular involvement — of tocilizumab, in 5 — of rituximab; in 14 patients with JIA without extra-articular involvement and active arthritis — of tumor necrosis factor (TNF) α inhibitors — adalimumab and etanercept. JIA was diagnosed according to the ILAR criteria. Results : in 6 and 12 months of treatment with the second GEBA inactive stage of disease / remission was detected in 65 and 84% of patients, respectively. In 13/22 patients with JIA and insufficient efficacy of rituximab remission was achieved in 24 weeks of follow-up after switching to the treatment with interleukin (IL) 6 receptors inhibitor, in 2/5 patients with resistance to tocilizumab — after switching to rituximab. In a year of treatment with etanercept as the second GEBA non-active stage / remission was induced in 100% of children with JIA without extra-articular involvement, in 85% — after switching to adalimumab, and in 100% of patients with JIA without extra-articular involvement — after administration of anti-TNF α-therapy. Conclusions : changeover to the second GEBA in patients with primary and secondary resistance or intolerability to the first GEBA allowed achieving of remission of systemic manifestations in patients with JIA and contributed to almost complete restoration of function in the joints in patients with JIA without extra-articular involvement and articular forms of JIA. Along with its high clinical efficacy the second GEBA was characterized by good tolerability and comparable safety profile.