OP0232 NETAKIMAB REDUCES THE DISEASE ACTIVITY OF RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS. RESULTS OF ASTERA STUDY
Authors: Inna Gaydukova, V Mazurov, Shandor Erdes, Tatiana Dubinina, Olga Nesmeyanova, Elena Ilivanova, Alena Kundzer, Nikolaj Soroka, Aleksander Kastanayan, Tatyana Povarova, Elena Zhugrova, Tatyana Plaksina, Pavel Shesternya, Tatyana Kropotina, Olga Antipova, Elena Smolyarchuk, Oksana Tciupa, Diana Abdulganieva, Diana Kretchikova, Ivan Gordeev, Vadim Tyrenko, Aleksandra Strelkova, Anna Eremeeva, Ekaterina Chernyaeva, Roman Ivanov
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Efficacy and safety of netakimab (NTK), a humanized anti-IL17A antibody, was established in phase 2 clinical trials in patients (pts) with radiographic axial spondyloarthritis (r-axSpA)<sup>1</sup> and psoriasis<sup>2</sup>. <h3>Objectives</h3> The abstract presents 16-week data from ongoing ASTERA study (NCT03447704) in pts with active r-axSpA. <h3>Methods</h3> ASTERA is a phase 3 international double-blind placebo (PBO)-controlled study. 228 adult pts with r-axSpA, active (BASDAI ≥ 4) despite the standard NSAIDs, were randomly assigned (1:1) to receive 120 mg NTK or PBO SC at Week (Wk) 0,1,2 and then q2w through Wk 16. After Wk 16 all pts will start to receive NTK up to Wk 52. Primary endpoint was ASAS40 rate at Wk 16. <h3>Results</h3> The mean age at baseline was 39.14±9.9 years, the mean symptoms duration was 4.3±4.5 years. 76.8% of pts were naïve to biological treatment. At Wk 16 ASAS40 rate was higher in NTK arm compared to PBO: 40.35% versus (vs.) 2.63% pts (95% CI for the difference in ASAS40 rate was [27.37%; 48.07%] (p&lt;0.0001, Figure 1). Efficacy of NTK was also proved by comparison of secondary endpoints (Figure 2); improvement in BASDAI, MASES, BASFI became significant from Wk 4 and remained during the study (no data presented). Most reported adverse events (AE) and treatment-related AEs (TRAE) were mild/moderate (Table 1). The most frequent AEs were anemia, neutropenia, ALT increase. One serious AE (SAE), not related to the treatment (bone fracture), was reported in NTK arm. <h3>Conclusion</h3> NTK at a dose 120 mg is well-tolerated drug with favorable safety profile that leads to decline in r-axSpA activity, function improvement and axial mobility in 16 Wks. <h3>References</h3> [1] Mazurov V, et al. Ann Rheum Dis 2018;77:A64. 2Samtsov A, et al. Vestn Dermatol Venerol 2017;0(5):52-63. <h3>Disclosure of Interests</h3> Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: paiment from Pfizer, Novartis, Abbvie, Biocad, Selgene, MSD, Sanofy does not exceed 10 000 euros, V Mazurov Grant/research support from: JSC BIOCAD, Shandor Erdes Grant/research support from: JSC BIOCAD, Speakers bureau: JSC BIOCAD, Tatiana Dubinina: None declared, Olga Nesmeyanova Grant/research support from: JSC BIOCAD, Elena Ilivanova Grant/research support from: JSC BIOCAD, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Aleksander Kastanayan Grant/research support from: JSC BIOCAD, Tatyana Povarova Grant/research support from: JSC BIOCAD, Elena Zhugrova Grant/research support from: JSC BIOCAD, Tatyana Plaksina Grant/research support from: JSC BIOCAD, Pavel Shesternya Grant/research support from: JSC BIOCAD, Tatyana Kropotina Grant/research support from: JSC BIOCAD, Olga Antipova Grant/research support from: JSC BIOCAD, Elena Smolyarchuk Grant/research support from: JSC BIOCAD, Oksana Tciupa Grant/research support from: JSC BIOCAD, Diana Abdulganieva: None declared, Diana Kretchikova Grant/research support from: JSC BIOCAD, Ivan Gordeev Grant/research support from: JSC BIOCAD, Vadim Tyrenko Grant/research support from: JSC BIOCAD, Aleksandra Strelkova Grant/research support from: JSC BIOCAD, Anna Eremeeva Grant/research support from: JSC BIOCAD, Ekaterina Chernyaeva Employee of: JSC BIOCAD, Roman Ivanov Employee of: JSC BIOCAD