Efficacy and Safety of Netakimab in Children and Adolescents with Moderate-to-Severe Plaque Psoriasis: Results of the Core Treatment Period (12 Weeks) of the Randomized Placebo-Controlled Phase III Clinical Trial BCD-085-16/PLANETA-KIDS

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Abstract
Netakimab is a humanized anti-interleukin-17A monoclonal antibody, it has marketing approval for treatment of adult patients with moderate-tosevere plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. This paper provides the results of the first 12-week period of phase III BCD-085-16/PLANETA-KIDS clinical study. Objective. The aim of the BCD-085-16/PLANETA-KIDS is to evaluate netakimab efficacy and safety in pediatric patients 6+ years old with moderate-to-severe plaque psoriasis. Methods. BCD-085-16/PLANETA-KIDS (NCT06640517) is a randomized, double-blind, placebo-controlled phase III clinical study with open-label active-comparator arm (adalimumab). A total of 155 male and female patients aged from 6 to 18 years with confirmed moderate-to-severe plaque psoriasis were randomized to receive netakimab (n = 83), placebo (n = 35), or adalimumab (n = 37). Netakimab dosage was weight adjusted: for patients weighing 50 kg or more netakimab dose was 120 mg (two injections of 60 mg/ml each), for patients weighing less than 50 kg netakimab dose was 60 mg (one injection of 60 mg/ml). Patients in the Netakimab group received netakimab subcutaneously once per week for the first three weeks (induction) and once every 4 weeks thereafter (maintenance). Patients in the Placebo group received placebo in blinded manner like netakimab. Adalimumab was administered in open-label way in doses recommended by the product’s SmPC. In this study co-primary efficacy endpoints were the proportion of patients achieving PASI75 and sPGA0/1 at week 12. Results. Netakimab has shown superiority over placebo for both co-primary endpoints. The proportion of patients achieving PASI75 at week 12 was 89.2% in the Netakimab group and 14.3% in the Placebo group, odds ratio (OR) 59.0, 95% CI [16.5; 211.5] (p < 0.0001). The proportion of patients achieving sPGA0/1 at week 12 was 83.1% in the Netakimab group and 8.6% in the Placebo group, OR 54.9, 95% CI [14.6; 206.5] (p < 0.0001). The subgroup analysis has shown consistent netakimab superiority over placebo for both co-primary endpoints, regardless of age, body weight and psoriasis severity. Throughout the 12-week period netakimab has shown favorable safety profile comparable to that in the Placebo group. Conclusion. The results of the 12-week period in the BCD-085-16/PLANETA-KIDS study have shown high efficacy of netakimab compared with placebo with favorable safety profile in children aged 6 years and older and adolescents with moderate-to-severe plaque psoriasis.

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