J Dermatolog Treat. 2026 Dec;37(1):2670890. doi: 10.1080/09546634.2026.2670890. Epub 2026 Jul 6.
ABSTRACT
OBJECTIVES: This post-hoc analysis of CM310AD005 conductedaimed to analyze the efficacy and safety of stapokibart in adults with moderate-to-severe atopic dermatitis (AD) with and without prior systemic treatment.
METHODS: In CM310AD005, eligible patients were randomized 1:1 to receive stapokibart 600 (loading dose)-300 mg and placebo Q2W for 16 weeks; all patients subsequently received stapokibart 300 mg Q2W for 36 weeks.
RESULTS: At week 16, in systemic treatment-naïve patients, stapokibart led to significantly higher response rates than placebo for ≥75% improvement from baseline in the Eczema Area and Severity Index score (EASI-75, 70.3% vs. 29.1%), EASI-90 (38.1% vs. 13.3%), Investigator’s Global Assessment score of 0 or 1 (45.2% vs. 19.4%), and ≥4-point reduction in weekly average of daily Peak Pruritus Numerical Rating Scale score (34.8% vs. 13.9%) (all p < 0.0001). Among patients with prior systemic treatment, these response rates were also significantly higher in the stapokibart group, reaching 61.5% vs. 19.3%, 35.4% vs. 7.2%, 42.7% vs. 9.6%, and 37.5% vs. 7.2% (all p < 0.0001), respectively. All patients showed further improvements through week 52. The most common treatment-emergent adverse events were infections and infestations, occurring in 61.6% and 70.5% of patients with and without prior systemic treatment.
CONCLUSIONS: Stapokibart demonstrated significant clinical efficacy and manageable safety in AD patients irrespective of prior systemic treatment.
PMID:42403221 | DOI:10.1080/09546634.2026.2670890
