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POS0928 (2021)
NETAKIMAB EFFICACY IN ANTI-TNF-NAIVE AND ANTI-TNF-EXPERIENCED PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS OF SUBANALYSIS OF PHASE 3 ASTERA TRIAL
S. Erdes1, V. Mazurov2, T. Dubinina3, I. Gaydukova2,4, A. Kundzer5, N. Soroka6, A. Eremeeva7
1Nasonova Research Institute of Rheumatology, Laboratory of Spondyloarthritides, Moscow, Russian Federation
2Mechnikov North-Western State Medical University, Department of Therapy and Rheumatology of Temporary Disability and Medical Care Quality Expertise, St-Petersburg, Russian Federation
3Nasonova Research Institute of Rheumatology, Laboratory of Medical and Social Problems of Rheumatology, Moscow, Russian Federation
4Clinical Rheumatology Hospital No 25, Consultative Outpatient Department, St-Petersburg, Russian Federation
5Belarusian Medical Academy of Postgraduate Education, Department of Cardiology and Rheumatology, Minsk, Belarus
6Belarusian State Medical University, Department of Internal Diseases №2, Minsk, Belarus
7JSC BIOCAD, Clinical Development Department, St-Petersburg, Russian Federation

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 the treatment of AS, psoriatic arthritis, moderate-to-severe plaque psoriasis in Russia and Belarus.


Objectives: To compare the efficacy of NTK in anti-TNF-naïve patients with anti-TNF-experienced patients with active AS at week 16 of therapy.


Methods: ASTERA (NCT03447704) is an ongoing phase 3 placebo (PBO)-controlled clinical study, aimed at evaluating NTK efficacy in AS [3]. 228 adult patients with active AS (BASDAI ≥ 4) were randomly assigned (1:1) to receive 120 mg NTK or PBO subcutaneously at week 0,1,2 and then q2w. This analysis includes 112 patients in NTK group. Efficacy endpoints included ASAS20/40, ASAS5/6 and ASAS partial remission (PR) at week 16 of therapy.


Results: 28 (25.0%) of 112 patients in NTK group had previous inadequate response/intolerance to anti-TNF (anti-TNF-IR): 24 (21.4%) – one anti-TNF, and 4 (3.6%) – two anti-TNF. 84 (75.0%) patients were TNF-naive. Achievement of ASAS criteria response at week 16 was similar in both groups ( Table 1 ).

Efficacy of NTK at week 16

Parameter TNF-naïve (n = 84) anti-TNF-IR (n = 28) p-value*
ASAS20, n (%) 52 (61.9%) 17 (60.7%) 0.91
ASAS40, n (%) 35 (41.7%) 11 (39.3%) 0.82
ASAS5/6, n (%) 39 (46.4%) 11 (39.3%) 0.51
ASAS(PR), n (%) 15 (17.9%) 4 (14.3%) 0.78

*- Fisher’s exact test


Conclusion: NTK 120 mg provided sustained improvements in signs and symptoms of AS in anti-TNF-naive and anti-TNF-IR patients at 16 weeks of therapy.


REFERENCES:

[1]Blair HA, Dhillon S. Secukinumab: A Review in Ankylosing Spondylitis. Drugs. 2016;76(10):1023-30.

[2]Dougados M, et al. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020;79(2):176-185.

[3]Mazurov VI, 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-Practicheskaya Revmatologia=Rheumatology Science and Practice. 2020;58 (4):376–386 (In Russ).


Acknowledgements: This study was sponsored by JSC BIOCAD.


Disclosure of Interests: Shandor Erdes: None declared, V Mazurov: None declared, Tatiana Dubinina: None declared, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Anna Eremeeva Employee of: Biocad

Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 726
Session: Spondyloarthritis – treatment (POSTERS only)