Netakimab for the treatment of psoriatic arthritis: 3-year results of the phase III BCD-085-8/PATERA study

Abstract

This article presents the results of the 3-year use of netakimab (NTK), a monoclonal antibody against interleukin 17, in patients with psoriatic arthritis (PsA) as part of the phase III PATERA study. Objective: to evaluate the long-term efficacy and safety of NTK in patients with PsA over a period of 3 years. Material and methods. PATERA is a double-blind, multicenter, randomized, phase III clinical trial. 194 patients with active PsA were randomized 1:1 to NTX or placebo/NTX. NTX/placebo was administered at weeks 0, 1, 2, 4, 6, 8, 10 and 14. Placebo patients who did not achieve a 20% improvement according to ACR criteria (ACR20) at week 16 received NTX at weeks 18 and 22. Patients who achieved ACR20 received placebo at weeks 18 and 22. Subsequently, all patients received NTX. At week 54, patients who did not meet ACR20 criteria were withdrawn from the study and the remaining patients were treated in the extension phase. The total duration of NTX use in all groups was 3 years. Results and discussion. Therapeutic response achieved in the first year of treatment was maintained in the extended phase of the study. Against the background of NTX use, a significant long-term decrease in clinical manifestations of PsA was observed. Adverse events occurred mainly in the form of laboratory abnormalities and infectious diseases, which were mostly mild to moderate. Antibodies against NTK were detected in 9.3% of patients and in most cases they were formed at the end of the first and beginning of the second year of therapy. Conclusion. NTK showed a favorable safety profile with long-term use over 3 years. The clinical effect on all manifestations of PsA was maintained in most patients over a long period of time without significant loss of response.