OP0226 NETAKIMAB DECREASES DISEASE ACTIVITY IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM A RANDOMIZED DOUBLE-BLIND PHASE 3 CLINICAL TRIAL (PATERA)

Abstract

Background:Netakimab (NTK) is a humanized anti-interleukin 17A antibody approved for the treatment of moderate-to-severe plaque psoriasis.Objectives:To determine the efficacy and safety of NTK in patients (pts) with active psoriatic arthritis (PsA), based on 24-week (Wk) data from an ongoing phase 3 study (NCT03598751, PATERA).Methods:194 eligible adult pts with PsA (CASPAR, 2006) with inadequate response to csDMARD or one TNFi, were randomized (1:1) to receive NTK 120 mg or placebo (PBO) subcutaneously at Wk 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. 84 pts from PBO arm who did not meet ACR20 (20% improvement of the American College of Rheumatology criteria) by Wk 16 were switched to NTK 120 mg. The primary endpoint was AСR20 at Wk 24. DAPSA (Disease Activity Index for Psoriatic Arthritis), the proportion of pts achieved ACR50/70, minimal disease activity (MDA) (≥5/7 MDA criteria) and Psoriatic arthritis response criteria (PsARC) were also analyzed.Results:Baseline demographics and disease characteristics were similar across treatment arms (Table 1). 80 (82.47%) pts in NTK arm and 9 (9.28%) in the PBO arm achieved ACR20 at Wk 24 (р<0.0001). A significantly greater percentage of NTK-treated pts had ACR50/70, PsARC response, MDA at Wk 24 (Figure 1). By Wk 24 DAPSA significantly improved for NTK vs PBO. DAPSA remission was achieved by 36.08% and 13.40% in NTK and PBO arms, respectively (p=0.003). NTK was well tolerated. The most frequent AEs (≥3%) were lymphopenia, neutropenia, hypercholesterolemia, ALT increased, upper respiratory tract infection, systolic blood pressure increased, hyperglycemia, hyperbilirubinemia. Most AEs were mild to moderate. Severe treatment-related AEs were observed in 1.03% vs 2.06% for NTK and PBO, respectively. No treatment-related SAEs were reported. No anti-drug antibodies were detected.Table 1.Baseline demographics and disease severity characteristicsArmNTK (N=97)PBO (N=97)Age (years) *44.0 (11.66)43.1 (11.88)Male, n (%)52 (53.61)50 (51.55)PsA duration, mo*63.1 (73.12)68.2 (77.49)DAS28-CRP*4.62 (0.97)4.41 (1.11)DAPSA*32.19 (12.23)33.54 (15.98)TJC (66/68) *12.9 (9.97)12.0 (9.88)SJC (66/68) *7.0 (4.93)7.2 (7.18)MTX at baseline83 (85.6)83 (85.6)Previous PsA therapySulfasalazine, n (%)9 (9.28)11 (11.34)Leflunomide, n (%)4 (4.12)8 (8.25)Anti-TNFα, n (%)22 (22.68)17 (17.53)* mean (standard deviation); Mo=months, PsA=psoriatic arthritis, SJC=swollen joint count, TJC=tender joint count, DAS28=Disease Activity Score, MTX=methotrexate, CRP=C-reactive protein, DAPSA=Disease activity index for psoriatic arthritis, TNF=tumor necrosis factorFigure 1.Treatment response at Wk 24Conclusion:NTK is a well-tolerated monoclonal antibody, that provided sustained improvements in signs and symptoms of active PsA through 24 Wks of therapy.Table 2.Safety dataArmNTK (N=97)PBO (N=97)p-valueTreatment-related AEs12 (12.37)7 (7.22)0.2271Treatment-related SAEs0 (0)0 (0)1.002Treatment-related AEs (grade 3-4)1 (1.03)2 (2.06)1.002Local reactions0 (0)0 (0)-Grade 3-4 treatment-related AEsblood pressure increased1 (1.03)0(0)1.002lymphopenia0 (0)2 (2.06)0.4972n (%) are presented,1Pearson’s χ2test,2Fisher’s exact test; N=number of patients, AE=adverse event, SAE=serious adverse event, ALT=Alanine transaminaseAcknowledgments:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Consultant of: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Speakers bureau: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, 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&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&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Muza Kokhan Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&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