Современная ревматология (Dec 2022)
New etanercept biosimilar — expanding treatment options for immune-mediated inflammatory rheumatic diseases
Abstract
The tumor necrosis factor-а inhibitor etanercept (ETC) is one of the most popular members of the group of biologic disease-modifying antirheumatic drugs used for treatment of immune-mediated inflammatory rheumatic diseases (IRD). According to a series of double-blind randomized controlled trials (RCTs) and related meta-analyses, the use of ETC in combination with methotrexate and as monotherapy allows to achieve a significant reduction in the activity of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). ETC is fastacting and provides a significant reduction in the most debilitating manifestations of IRD, such as pain, dysfunction and fatigue. ETC has a relatively low risk of developing serious infections.In 2017, the European Medical Agency registered a new ETC biosimilar (Erelzy®) for the treatment of RA, PsA, plaque psoriasis, AS, axial spondyloarthritis and juvenile idiopathic arthritis. This drug has been extensively tested in two large RCTs, EGALITY (n=531) and EQUIRA (n=376), comparing its efficacy and safety with a reference ETC (rETC) in patients with active psoriasis and RA. These studies showed that biosimilar did not differ from rETC in terms of therapeutic potential, risk of complications and immunogenicity, and switching from rETC to biosimilar did not lead to a decrease in the effectiveness and tolerability of therapy. In both RCTs, the new ETC biosimilar, in which the citrate buffer forms the basis of its solution, demonstrated a statistically significantly lower number of local post-injection complications (pain, hyperemia) than rETC, which contains phosphate buffer: 4.9 and 6.5% versus 14.2 and 18 .4% respectively.
