Efficacy and safety of netakimab therapy in patients with moderate and severe psoriasis in real clinical practice

Abstract

Rationale. Data from randomized clinical trials (RCTs) may differ from the results of the efficacy and safety of medicines in the conditions of daily work. Purpose: to obtain data on the long-term efficacy and safety of the use of the genetically engineered biological drug netakimab in real clinical practice. Methods. In everyday clinical practice, a multicenter non-interventional observational study BCD-085-NIS-01 (ORION) was conducted, which involved 260 adult patients with moderate to severe psoriasis. It has been shown that therapy with GIBA netakimab using a standard dose of 120 mg and a regimen in patients with psoriasis is effective for 104 weeks. Results. It was established that the survival rate of genetically engineered biological therapy of netakimab, when analyzing data of 104 weeks of observation, remains high both in bionaive patients and in persons who have previously received treatment for this dermatosis using monoclonal antibodies. The long-term safety profile of netakimab in real clinical practice is comparable to data previously obtained in RCTs and remains favorable for follow-ups up to 2 years. Keywords. Psoriasis; treatment; genetically engineered biological preparations; efficiency; safety