Real-world retention rate, effectiveness, and safety of netakimab in the treatment of patients with ankylosing spondylitis: First year results of the LIBRA post-registration safety study

Abstract

Background. Netakimab has shown high efficacy in controlled clinical trials in the treatment of patients with ankylosing spondylitis (AS). This article presents results of an observational study of netakimab using in routine clinical practice.Methods. Patients were recruited for the study from August 2020 to December 2021 at 23 centers in the Russian Federation. The study included patients who were prescribed netakimab therapy before enrollment, so clinical and medical history data for the first visit were entered retrospectively, and following visits at weeks 12, 24 and 52 of therapy were collected within the study. Drug survival rate has been calculated according to Kaplan – Meier analysis.Results. The study included 137 patients (93 men and 14 women) with AS. The average age of patients was 42.3 (±11.9) years, 34.3% of patients had previously received therapy with genetically engineered biologic drugs, mainly tumor necrosis factor inhibitors. At the end of the analyzed period (52 weeks of therapy), 90.4% [95% CI: 85.4–95.7] of patients continued treatment with netakimab. The BASDAI and ASDAS-CRP showed statistically significant decreases in scores from baseline at all time points. Netakimab was well tolerated by patients; adverse effects (AEs), related to therapy according to the investigator’s opinion, were reported in 7 (5.1%) patients. 2 patients stopped taking netakimab due to AEs: terminal ileitis and chronic colitis.Conclusions. In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy.