POS0928 NETAKIMAB EFFICACY IN ANTI-TNF-NAIVE AND ANTI-TNF-EXPERIENCED PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS OF SUBANALYSIS OF PHASE 3 ASTERA TRIAL

Background: According to previous studies, the effectiveness of interleukin-17 (IL-17) inhibitors was higher in anti-TNF-naïve patients with ankylosing spondylitis (AS) [1,2]. Netakimab (NTK) is a humanized anti-IL-17A antibody approved for treatment AS, psoriatic arthritis, moderate-to-severe plaque psoriasis Russia and Belarus. Objectives: To compare efficacy NTK anti-TNF-experienced active AS at week 16 therapy. Methods: ASTERA ( NCT03447704 ) an ongoing phase 3 placebo (PBO)-controlled clinical study, aimed evaluating [3]. 228 adult (BASDAI ≥ 4) were randomly assigned (1:1) receive 120 mg or PBO subcutaneously 0,1,2 then q2w. This analysis includes 112 group. Efficacy endpoints included ASAS20/40, ASAS5/6 ASAS partial remission (PR) Results: 28 (25.0%) group had inadequate response/intolerance anti-TNF (anti-TNF-IR): 24 (21.4%) – one anti-TNF, 4 (3.6%) two anti-TNF. 84 (75.0%) TNF-naive. Achievement criteria response similar both groups (Table 1). Table 1. Parameter TNF-naïve (n = 84) anti-TNF-IR 28) p-value* ASAS20, n (%) 52 (61.9%) 17 (60.7%) 0.91 ASAS40, 35 (41.7%) 11 (39.3%) 0.82 ASAS5/6, 39 (46.4%) 0.51 ASAS(PR), 15 (17.9%) (14.3%) 0.78 *- Fisher’s exact test Conclusion: provided sustained improvements signs symptoms anti-TNF-naive weeks References: [1]Blair HA, Dhillon S. Secukinumab: A Review Ankylosing Spondylitis. Drugs. 2016;76(10):1023-30. [2]Dougados M, et al. safety ixekizumab through 3, randomised, controlled trials radiographic axial spondyloarthritis (COAST-V COAST-W). Ann Rheum Dis. 2020;79(2):176-185. [3]Mazurov VI, Netakimab, monoclonal antibody, spondylitis. Results III international, multicenter, randomized double-blind trial BCD-085-5/ASTERA. Nauchno-Practicheskaya Revmatologia=Rheumatology Science Practice. 2020;58 (4):376–386 (In Russ). Acknowledgements: study sponsored by JSC BIOCAD. Disclosure Interests: Shandor Erdes: None declared, V Mazurov: Tatiana Dubinina: Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, Alena Kundzer: Nikolaj Soroka: Anna Eremeeva Employee of: Biocad