Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial.

Abstract

Moderate-to-severe atopic dermatitis (AD) imposes a significant burden on adolescents and their families, leading to a substantial reduction in quality of life. Treatment options remain limited. Stapokibart, a novel humanized monoclonal antibody that targets interleukin-4Rα, has been approved in China for the treatment of adults with moderate-to-severe AD. To evaluate the efficacy and safety of stapokibart in adolescents with moderate-to-severe AD. In this randomized double-blind placebo-controlled phase III trial (NCT06277765), eligible patients were randomized (2 : 1) to stapokibart 300 mg (loading dose 600 mg) or placebo for 18 weeks. Patients with a baseline weight ≥ 60 kg received subcutaneous stapokibart or placebo every 2 weeks (Q2W), while those weighing 30 to < 60 kg received treatment every 3 weeks (Q3W). All patients were given moisturizers during the entire study period. Co-primary endpoints were the proportions of patients achieving a ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI 75) and an Investigator's Global Assessment (IGA) score of clear or almost clear (IGA 0 or 1) with ≥ 2-point reduction from baseline (IGA response) at week 18. Safety was also assessed. Of the 180 enrolled patients, 120 received stapokibart (Q2W, n = 54; Q3W, n = 66) and 60 received placebo (Q2W, n = 26; Q3W, n = 34). In total, 178 (98.9%) patients completed the double-blind treatment. At week 18, higher proportions of patients treated with stapokibart than those treated with placebo achieved EASI 75 [73.9% (n = 88/119) vs. 43% (n = 26/60); difference: 30.5% (95% confidence interval 15.3-44.3; P < 0.001)] and an IGA response [57.1% (n = 68/119) vs. 25% (n = 15/60); difference: 31.8% (95% confidence interval 16.6-44.4; P < 0.001)]. The proportion of patients achieving ≥ 4-point reductions in weekly average of daily Peak Pruritus Numerical Rating Scale score was also significantly higher in the stapokibart group than in the placebo group [36.1% (n = 43/119) vs. 15% (n = 9/60); difference: 21.1% (95% confidence interval 7.4-32.4; P = 0.004)]. The incidence of adverse events was similar between the stapokibart (62.5%; n = 75/120) and placebo (62%; n = 37/60) groups. No conjunctivitis was seen. Stapokibart has a high efficacy and favourable safety in adolescents with moderate-to-severe AD. An author video to accompany this article is available online.