Netakimabis original monoclonal antibody against IL-17. This article outlines the key results of a phase II open-label extension trial of netakimab 80 mg and 120 mg in patients with moderate-to-severe psoriasis.The main aim of the trial is to estimate efficacy, safety and immunogenicity of long-term treatment with netakimab 80 mg and 120 mg in patients with moderate-to-severe psoriasis.Materials and methods. The BCD-085-2-ext study is a comparative, open-label phase 2 clinical study of the effi - cacy and safety of netakimab in patients with moderate-to-severe plaque psoriasis who had finished BCD-085-2 (NCT02762994) trial. Main efficacy endpoints includePASI75, PASI90, PASI100, sPGA = 0–1 on week 38 of the trial, long-term PASI75/90/100 retention, efficacy keeping after switch from once every 2 week regimen to once every 4 week regimen. Safety endpoints include adverse events, serious adverse events number and their profile.Results. 103 patients were included. PASI75 at week 38 was reached by 98.06 %, PASI90 — by 92.23 %, PASI100 — by 59.22 % of patients. There were no cases of serious adverse event, early with drawal due to adverse events and cases of grade 4 toxicity according to CTCAE 4.03. There were no cases of binding antibodies to netakimab during the 38 weeks of the study.Conclusion. The first Russian original IL-17 inhibitor netakimabis promising modern medicine for moderate-to-severe plaque psoriasis treatment. Netakimabshowed high efficacy, favorable safety profile and low immunogenicity during one year of the treatment.
Bimekizumab response maintenance through two years of treatment in patients with moderate to severe plaque psoriasis who responded after 16 weeks: Interim results from the BE BRIGHT open-label extension trial
