fetching data ...

POS1043 (2021)
NETAKIMAB REDUCES PSORIATIC ARTHRITIS ACTIVITY IN PATIENTS WITH OR WITHOUT AXIAL DISEASE: SUBANALYSIS OF THE PATERA STUDY
T. Korotaeva1, I. Gaydukova2, V. Mazurov2, A. Samtsov3, V. Khayrutdinov3, A. Bakulev4, A. Kundzer5, N. Soroka6, A. Eremeeva7
1Nasonova Research Institute of Rheumatology, Laboratory of Spondyloarthritides and Psoriatic Arthritis, 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
3Kirov Military Medical Academy, Department of Skin and Veneral Diseases, St-Petersburg, Russian Federation
4Razumovsky Saratov State Medical University, Department of Dermatovenereology and Cosmetology, Saratov, 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: PATERA is an ongoing phase 3 international double-blind, placebo-controlled clinical study of netakimab (NTK) in psoriatic arthritis (PsA) (NCT03598751). Netakimab (NTK) is an anti-interleukin-17A monoclonal antibody approved for psoriasis, ankylosing spondylitis, PsA in Russia and Belarus.


Objectives: A subanalysis was performed to define the impact of NTK on PsA activity depending on the presence of axial disease: a subset of patients with inflammatory back pain (IBP) according to self-reported ASAS IBP criteria, 2009 (IBP(+) was compared to those without IBP (IBP(-)).


Methods: 194 eligible adult patients with PsA fulfilling the CASPAR criteria, with inadequate response to csDMARD or one TNFi, were randomly assigned to receive NTK 120mg or placebo at weeks 0,1,2,4,6,8,10,14,18,22. Patients with missing values for categorical variables were considered as non-responders in the analysis. For quantitative variables, missing values were replaced using the multiple imputation method.


Results: 97 PsA patients (N=54 IBP(+), N=43 IBP(-)) received NTK. Both subpopulations were comparable in gender, age and PsA activity at baseline. The treatment led to a pronounced decline in PsA activity in both subpopulations, significant differences between arms were observed only in DAPSA remission and very low disease activity (VLDA) at week 24 ( Figure 1A ). Changes from baseline in DAS28-CRP were consistent between IBP(+) and IBP(-) patients with a rapid decline during the first month with further improvement up to week 24 ( Figure 1B ). A similar trend was observed PsA-specific composite responder index (PSARC) (data not shown). A comparable percentage of IBP(+) and IBP(-) patients achieved PSARC at each timepoint of evaluation with 87% and 86% of responders respectively at week 24.


Conclusion: NTK significantly improved PsA activity regardless of the presence of IBP.

PsA activity after 24-week treatment with NTK. (A) Percentage of patients with DAPSA remission (0-4), very low disease activity (VLDA), minimal disease activity (MDA) at week 24; (B) change from baseline in DAS28-CRP


Acknowledgements: This study was sponsored by JSC BIOCAD.


Disclosure of Interests: Tatiana Korotaeva Speakers bureau: Abbvie, Biocad, Eli Lilly, Johnson & Johnson, Janssen, Novartis, Pfizer, UCB, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, V Mazurov: None declared, Aleksey Samtsov: None declared, Vladislav Khayrutdinov: None declared, Andrey Bakulev: None declared, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Anna Eremeeva Employee of: Biocad.

Citation: Ann Rheum Dis, volume 80, supplement 1, year 2021, page 796
Session: Psoriatic arthritis – treatment (POSTERS only)