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OP0232 NETAKIMAB REDUCES THE DISEASE ACTIVITY OF RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS. RESULTS OF ASTERA STUDY
  1. Inna Gaydukova1,
  2. V Mazurov1,
  3. Shandor Erdes2,
  4. Tatiana Dubinina2,
  5. Olga Nesmeyanova3,
  6. Elena Ilivanova4,
  7. Alena Kundzer5,
  8. Nikolaj Soroka6,
  9. Aleksander Kastanayan7,
  10. Tatyana Povarova8,
  11. Elena Zhugrova9,
  12. Tatyana Plaksina10,
  13. Pavel Shesternya11,
  14. Tatyana Kropotina12,
  15. Olga Antipova13,
  16. Elena Smolyarchuk14,
  17. Oksana Tciupa15,
  18. Diana Abdulganieva16,
  19. Diana Kretchikova17,
  20. Ivan Gordeev18,
  21. Vadim Tyrenko19,
  22. Aleksandra Strelkova20,
  23. Anna Eremeeva21,
  24. Ekaterina Chernyaeva21,
  25. Roman Ivanov21
  1. 1Mechnikov North-Western State Medical University, St-Petersburg, Russian Federation
  2. 2Nasonova Research Institute of Rheumatology, Moscow, Russian Federation
  3. 3Regional Clinical Hospital, Chelyabinsk, Russian Federation
  4. 4Leningrad Region Clinical Hospital, St-Petersburg, Russian Federation
  5. 5Healthcare Institution Municipal Clinical Hospital No. 1, Minsk, Belarus
  6. 6Scientific and Practical Center of Surgery, Transplantology and Hematology, Minsk, Belarus
  7. 7Rostov State Medical University, Rostov-on-Don, Russian Federation
  8. 8Road Clinical Hospital, Saratov, Russian Federation
  9. 9Municipal Inpatient Facility No 38, St-Petersburg, Russian Federation
  10. 10Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, Russian Federation
  11. 11Krasnoyarsk State Medical University, Krasnoyarsk, Russian Federation
  12. 12Municipal Clinical Hospital, Omsk, Russian Federation
  13. 13Municipal Clinical Hospital No 1, Irkutsk, Russian Federation
  14. 14Sechenov First Moscow State Medical University, Moscow, Russian Federation
  15. 15Municipal Clinical Hospital No 4, Barnaul, Russian Federation
  16. 16Kazan State Medical University, Kazan, Russian Federation
  17. 17Regional Clinical Hospital, Smolensk, Russian Federation
  18. 18City Clinical Hospital No 15, Moscow, Russian Federation
  19. 19Kirov Military Medical Academy, St-Petersburg, Russian Federation
  20. 20Volosevich First Clinical Hospital, Smolensk, Russian Federation
  21. 21JSC BIOCAD, St-Petersburg, Russian Federation

Abstract

Background 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)1 and psoriasis2.

Objectives The abstract presents 16-week data from ongoing ASTERA study (NCT03447704) in pts with active r-axSpA.

Methods 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.

Results 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<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.

Conclusion 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.

References [1] Mazurov V, et al. Ann Rheum Dis 2018;77:A64. 2Samtsov A, et al. Vestn Dermatol Venerol 2017;0(5):52-63.

Table 1

Safety data

Disclosure of Interests 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

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