Real-World Retention Rate, Effectiveness, and Safety of Netakimab in the Treatment of Patients with Ankylosing Spondylitis: Two-Year Results of the Real Word Evidence LIBRA Study.

-The aim of the study was to obtain data on the safety of netakimab (NTK) in a population of patients with ankylosing spondylitis (AS), including various somatic diseases, as well as to assess treatment retention during 2 years of observation in real world clinical practice. MATERIALS AND 

methods-Patients were recruited for the study from August 2020 to December 2021 at 23 centers in the Russian Federation. The study included 137 patients who were prescribed netakimab therapy before enrollment. Clinical and medical history data for the first visit were entered retrospectively, and following visits at 12, 24, 52, 76, and 104 weeks of therapy were collected within the study. The average age of the patients 42.3 years, 34.3% of them with previous biologics therapy.

results-Median observation period was 104 weeks (range 1-137 weeks). At the end of the analyzed period (104 weeks of therapy), 85.5% (95% confidence interval (95% CI): 79.7-91.8) of patients continued treatment with netakimab. Retention on NTK therapy was slightly better in "bio-naïve" vs patients who received biologics earlier: 88.7% (95% CI: 82.3-95.5) and 78.9% (95% CI: 67.5-92.2), respectively, without significant differences between groups (p = 0.16). As many as 21 (15.3%) patients withdrew from study before visit 6. The main end-of-study reasons were lost to follow-up (7 (5.1%) patients) and treatment inefficacy (6 (4.4%) patients). The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein) showed statistically significant decreases from baseline: by 3 times during the first 3 months of therapy and 2 times decrease during the first year of treatment. This trend continued in the second year of treatment, although with a lower rate of reduction. By week 104 of therapy, 52.9% (95% CI: 47.3-58.4) reached low disease activity (1.3 ≤ ASDAS < 2.1), 21.3% (95% CI: 12.8-29.8) had inactive disease (ASDAS < 1.3). Netakimab was well tolerated by patients: AEs, related to therapy according to the investigator's opinion, were reported in 8 (6.0%) patients.

conclusions-In real-world clinical practice, 85.5% of patients continued treatment with Netakimab at the end of 104 weeks. By 104 weeks 74% patients had low disease activity or inactive disease. Netakimab was well tolerated by most of patients.