FRI0346 EFFICACY OF NETAKIMAB IN THE TREATMENT OF AXIAL DISEASE IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS OF SUBANALYSIS FROM A DOUBLE-BLIND RANDOMIZED PHASE 3 TRIAL (PATERA)
Authors: T. Korotaeva, I. Gaydukova, V. Mazurov, A. Samtsov, V. Khayrutdinov, A. Bakulev, M. Kokhan, A. Kundzer, N. Soroka, E. Dokukina, A. Eremeeva
Journal: Annals of the Rheumatic Diseases (2020)

Background: The presence of axial involvement significantly impacts on psoriatic arthritis (PsA) activity, outcomes and patients (pts) quality of life. IL-17A inhibitors were previously shown to improve axial disease in PsA. Netakimab (NTK) is a humanized anti-interleukin 17A antibody approved for the treatment of moderate-to-severe plaque psoriasis. Objectives: To evaluate the effects of NTK on axial symptoms in patients with PsA, based on data of 24-week (wk) observation from an ongoing phase 3 PATERA study ( NCT03598751 ). Methods: PATERA is a phase 3 international double-blind, placebo-controlled clinical study. After completion of screening 194 eligible adult patients with PsA fulfilling the CASPAR criteria, with inadequate response to csDMARD or one TNFi, were randomly assigned (1:1) to receive NTK 120 mg or placebo (PBO) at Wks 0, 1, 2, 4, 6, 8, 10, 14, 18 and 22. 84 patients from PBO arm, failed to achieve ACR20 (20% improvement the American College of Rheumatology criteria) by Wk 16, were switched to NTK. A subset of pts with axial involvement (defined by presence of inflammatory back pain (IBP) according to ASAS IBP criteria, 2009) was evaluated with spondylitis-specific assessments: spinal pain (10-item numerical rating scale), nocturnal back pain (10-item numerical rating scale), BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein. Results: 104 PsA patients (NTK N=54, PBO N=50) with IBP at baseline (BL) were included in the analysis. Demographic and BL disease characteristics were comparable across the groups (Table 1). During the analyzed period, BASDAI and ASDAS-CRP scores significantly decreased in NTK-treated patients (Figure 1). Maximum decrease in axial disease activity developed by Wk 4-8 depending on index of assessment. The achieved values maintained throughout the entire analyzed period (Table 2). At Wk 24, mean changes in ASDAS-CRP and BASDAI were -1.57 and -2.83 in NTK arm vs -0.11 and -0.19 in PBO arm respectively (p&lt;0.0001). Table 1. Baseline demographics and mean composite endpoint scores Arm NTK (N=54) PBO (N=50) Age (years) * 43.5 (12.16) 42.7 (10.76) Male, n (%) 27 (50) 26 (52) PsA duration, mo * 70.0 (78.78) 79.0 (81.62) BASDAI score * 5.58 (1.80) 5.79 (1.94) ASDAS-CRP score * 3.38 (1.16) 3.38 (1.28) nocturnal pain * 4.2 (2.42) 5.1 (2.29) spinal pain * 4.4 (2.41) 5.3 (2.40) * mean (standard deviation) BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, ASDAS-CRP=Ankylosing Spondylitis Disease Activity Score with C-reactive protein Table 2. Changes in BASDAI and ASDAS-CRP vs baseline BASDAI ASDAS-CRP NTK (N=54) PBO (N=50) NTK (N=54) PBO (N=50) Wk 4 -2.45 (1.94) -0.51 (1.26) -1.44 (1.06) -0.19 (0.60) Wk 8 -2.77 (2.22) -0.38 (1.55) -1.53 (1.07) -0.21 (0.74) Wk 16 -2.77 (1.83) -0.17 (1.67) -1.52 (0.98) -0.10 (0.97) Wk 24 -2.83 (2.15) -0.19 (1.70) -1.57 (1.06) -0.11 (0.95) mean (standard deviation) Figure 1. Mean change in BASDAI, ASDAS-CRP, spinal pain, and nocturnal pain at Wk 24 Conclusion: About 50% of subjects, randomized to PATERA study, had IBP at baseline. NTK leads to rapid and sustained improvement in axial disease in patients with active PsA. Acknowledgments: This study was sponsored by JSC BIOCAD. Disclosure of Interests: Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp &amp; Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp &amp; Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi, V Mazurov: None declared, Aleksey Samtsov Grant/research support from: JSC BIOCAD, Novartis, Eli Lilly, Johnson&amp;Johnson, Celgene, Glenmark, Galderma, Sanofi, Vladislav Khayrutdinov Grant/research support from: Akrikhin, Alkoy, Belupo, JSC BIOCAD, Bosnaliejk, Verteks, Glenmark, Elfa, Leo Pharma, MSD, Novartis, Pfizer, Sun Pharma, Sanofi, Celgene, Pharmtec, AbbVie, Eli Lilly, Jadran, Janssen, Andrey Bakulev Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&amp;Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&amp;Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&amp;Johnson, Muza Kokhan Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&amp;Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&amp;Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&amp;Johnson, Alena Kundzer: None declared, Nikolaj Soroka Grant/research support from: JSC BIOCAD, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Employee of: JSC BIOCAD