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FRI0346 (2020)
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)
T. Korotaeva1, I. Gaydukova2, V. Mazurov2, A. Samtsov3, V. Khayrutdinov3, A. Bakulev4, M. Kokhan5, A. Kundzer6, N. Soroka7, E. Dokukina8, A. Eremeeva8
1Nasonova Research Institute of Rheumatology, Moscow, Russian Federation
2Mechnikov North-Western State Medical University, St-Petersburg, Russian Federation
3Kirov Military Medical Academy, St-Petersburg, Russian Federation
4Razumovsky Saratov State Medical University, Saratov, Russian Federation
5Ural Research Institute of Dermatovenerology and Immunopathology, Ekaterinburg, Russian Federation
6Healthcare Institution Municipal Clinical Hospital No. 1, Minsk, Belarus
7Scientific and Practical Center of Surgery, Transplantology and Hematology, Minsk, Belarus
8JSC BIOCAD, St-Petersburg, Russian Federation

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<0.0001).

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

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)

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 & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & 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&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

Citation: Ann Rheum Dis, volume 79, supplement 1, year 2020, page 763
Session: Psoriatic arthritis (Poster Presentations)