Long-term efficacy and safety of netakimab in patients with moderate-to-severe psoriasis. Results of phase II open-label extension clinical study BCD-085-2-ext

Abstract

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.

Efficacy and Safety of Netakimab, A Novel Anti-IL-17 Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis. Results of A 54-Week Randomized Double-Blind Placebo-Controlled PLANETA Clinical Trial

“…Netakimab (NTK) is a novel recombinant humanized IgG1 anti-IL-17 monoclonal antibody (mAb) with modified Fc-fragment (Fc-fragment crystallisable region) and CDR (complementarity-determining regions). The superiority of NTK at the dose of 120 mg over placebo was shown in phase 2 trials in moderate-to-severe psoriasis (NCT02762994) and in ankylosing spondylitis (NCT02763111) [ 2 , 3 ].…”