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

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.

1. Erdes SF, Rebrov AP, Dubinina TV, Badokin VV, Bochkova AG, Bugrova OV, et al. Spondyloarthritis: Modern terminology and definitions. Terapevticheskii arkhiv. 2019;91(5):84-88 (In Russ.). doi: 10.26442/00403660.2019.05.000208

2. Merino M, Braçe O, González-Domínguez A, Hidalgo-Vega А, Garrido-Cumbrera M, Gratacós J. Social economic costs of ankylosing spondylitis in Spain. Clin Exp Rheumatol. 2021;39(2):357-364. doi: 10.55563/clinexprheumatol/lycdc8

3. Podryadnova MV, Balabanova RM, Urumova MM, Erdes SF. Correlation between clinical characteristics of ankylosing spondylitis and work capacity and productivity. Nauchno-Prakticheskaya Revmatologia = Rheumatology Science and Practice. 2014;52(5):513-519 (In Russ.). doi: 10.14412/1995-4484-2014-513-519

4. Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023;82(1):19-34. doi: 10.1136/ard-2022-223296

5. Gaidukova IZ, Rebrov AP, Lapshina SA, Otteva EN, Dubinina TV, Badokin VV, et al. Use of nonsteroidal anti-inflammatory drugs and biological agents for the treatment of axial spondyloarthritides. Recommendations of the Spondyloarthritis Study Group of experts, All-Russian public organization «The Association of Rheumatology of Russia». Nauchno-Prakticheskaya Revmatologia = Rheumatology Science and Practice. 2017;55(5):474-484 (In Russ.). doi: 10.14412/1995-4484-2017-474-484

6. Erdes S, Mazurov VI, Dubinina TV, Gaydukova IZ, Lapshina SA, Zonova EV, et al. Efficacy and safety of a new original interleukin 17A inhibitor in the treatment of patients with active ankylosing spondylitis: Results of a basic (BCD-085-3/AILAS) and extended (BCD-085-3ext/AILAS-II) phase II clinical trial. Nauchno-Prakticheskaya Revmatologia = Rheumatology Science and Practice. 2019;57(6):668-677 (In Russ.). doi: 10.14412/1995-4484-2019-668-677

7. Mazurov VI, Gaydukova IZ, Erdes S, Dubinina TV, Pristrom AM, Kunder EV, et al. Efficacy and safety of netakimab, anti-IL-17A monoclonal antibody, in patients with ankylosing spondylitis. Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA. Nauchno-Prakticheskaya Revmatologia = Rheumatology Science and Practice. 2020;58(4):376-386 (In Russ.). doi: 10.47360/1995-4484-2020-376-386

8. Mazurov VI, Erdes SF, Gaydukova IZ, Dubinina TV, Pristrom AM, Kunder EV, et al. Long-term efficacy and safety of netakimab in the treatment of ankylosing spondylitis: Results of phase III international, multicenter, randomized double-blind clinical trial BCD-085-5/ASTERA. Modern Rheumatology Journal. 2020;14(4):39-49 (In Russ.). doi: 10.14412/1996-7012-2020-4-39-49

9. Erdes S, Mazurov V, Dubinina T, Gaydukova I, Kundzer A, Soroka N, et al. POS0928 Netakimab efficacy in anti-tnf-naive and anti-tnf-experienced patients with active ankylosing spondylitis: Results of subanalysis of phase 3 ASTERA trial. Ann Rheum Dis. 2021;80:726-727. doi: 10.1136/annrheumdis-2021-eular.2209

10. Gaydukova I, Mazurov V, Erdes S, Dubinina T, Kundzer A, Soroka N, et al. OP0142 Netakimab reduces ankylosing spondylitis activity in patients with or without sacroiliits on MRI: Results of subanalysis of phase 3 ASTERA trial. Ann Rheum Dis. 2021;80:84. doi: 10.1136/annrheumdis-2021-eular.2187

11. Mazurov VI, Dubinina TV, Erdes S, Lapshina SA, Soroka NF, Kunder EV, et al. Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: A post-hoc analysis of the ASTERA study. Clin Exp Rheumatol. 2023;41(3):718-726. doi: 10.55563/clinexprheumatol/ljpqqe

12. Akulova AI, Gaydukova IZ, Rebrov AP. Validation of the EQ-5D-5L version in Russia. Nauchno-Prakticheskaya Revmatologia = Rheumatology Science and Practice. 2018;56(3):351-355 (In Russ.). doi: 10.14412/1995-4484-2018-351-355

13. Schulz KF, Grimes DA. Multiplicity in randomised trials II: Subgroup and interim analyses. Lancet. 2005;365(9471):1657-1661. doi: 10.1016/s0140-6736(05)66516-6

14. Tian C, Shu J, Shao W, Zhou Z, Guo H, Wang J. Efficacy and safety of IL inhibitors, TNF-α inhibitors, and JAK inhibitors in patients with ankylosing spondylitis: A systematic review and Bayesian network meta-analysis. Ann Transl Med. 2023;11(4): 178. doi: 10.21037/atm-23-195

15. Lindström U, Olofsson T, Wedrén S, Qirjazo I, Askling J. Biological treatment of ankylosing spondylitis: A nationwide study of treatment trajectories on a patient level in clinical practice. Arthritis Res Ther. 2019;21:128. doi: 10.1186/s13075-019-1908-9

16. Gomez Vargas M, Muñoz L. MAB0772 Safety and survival analysis of secukinumab treatment in a cohort of rheumatic patients naïve to biological therapy. Ann Rheum Dis. 2022;81:1512.

17. Michelsen B, Lindström U, Codreanu C, Ciurea A, Zavada J, Loft AG, et al. Drug retention, inactive disease and response rates in 1860 patients with axial spondyloarthritis initiating secukinumab treatment: Routine care data from 13 registries in the EuroSpA collaboration. RMD Open. 2020;6(3):e001280. doi: 10.1136/rmdo-pen-2020-001280

18. Arbabi-Ghahroudi M. Camelid single-domain antibodies: Historical perspective and future outlook. Front Immunol. 2017;8:1589. doi: 10.3389/fimmu.2017.01589

19. Caron B, Jouzeau JY, Miossec P, Petitpain N, Gillet P, Netter P, et al. Gastroenterological safety of IL-17 inhibitors: A systematic literature review. Expert Opin Drug Saf. 2022;21(2):223-239. doi: 10.1080/14740338.2021.1960981