Article Text
Abstract
Background: Netakimab (NTK) is an anti-interleukin-17A monoclonal antibody approved for psoriasis, ankylosing spondylitis, psoriatic arthritis (PsA) in Russia and Belarus. PATERA is an ongoing phase 3 international double-blind, placebo-controlled clinical study of NTK in PsA (NCT03598751).
Objectives: A subanalysis was performed to assess the effect of NTK on domains of the 5-level EuroQol 5 Dimensions questionnaire (EQ-5D-5L) in patients with inflammatory back pain (IBP) (IBP(+)) and without (IBP(-)) at baseline according to self-reported ASAS IBP criteria, 2009.
Methods: 194 adult patients with PsA (CASPAR criteria, 2006) 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. The proportion of patients reported >1 problem in each domain was evaluated. Patients with missing values were considered as non-responders in the analysis.
Results: 97 PsA patients (N=54 IBP(+), N=43 IBP(-)) received NTK. The subpopulations didn’t differ significantly in gender, age, and PsA activity at baseline. Comparable percentage of patients reported any problems for each domain at baseline (p≥0.05) (data not shown). IBP(-) subpopulation had a greater improvement for all domains except of anxiety/depression. The absolute declines for IBP(+) vs IBP(-) patients were as followed: 24.1% vs 41.9% (mobility), 18.5 vs 41.9% (self-care), 24.0% vs 51.1% (usual activities), 24.1% vs 37.2% (pain/discomfort), 33.3% vs 9.3% (anxiety/depression). However, the only significant difference between IBP(+) and IBP(-) was observed in usual activity (Figure 1).
Conclusion: NTK resulted in the growing improvement of each EQ-5D-5L domain through 24 weeks irrespectively of the presence of IBP. IBP(-) subjects showed trend to greater benefit compared to IBP(+).
Acknowledgements: This study was sponsored by JSC BIOCAD.
Disclosure of Interests: Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, Tatiana Korotaeva Speakers bureau: Abbvie, Biocad, Eli Lilly, Johnson & Johnson, Janssen, Novartis, Pfizer, UCB, 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.