Long-Term Stapokibart Treatment Induces Sustained Clinical Improvements in Patients With Moderate-to-Severe Atopic Dermatitis

Abstract: Background: Stapokibart has been approved for the treatment of adults with atopic dermatitis (AD) in China. Objective: To report long-term efficacy of stapokibart in patients with moderate-to-severe AD. Methods: This post hoc analysis included 237 adult patients from a phase 3 trial (NCT05265923) who received stapokibart 300 mg (loading dose, 600 mg) every 2 weeks during the 16-week double-blind period and continued with the same dose of stapokibart in the subsequent 36-week maintenance period. Results: At week 20, 100% and 92.2% of patients who achieved coprimary endpoints (≥75% improvement in Eczema Area and Severity Index [EASI-75] and Investigator’s Global Assessment [IGA] 0/1 response) at week 16 retained their EASI-75 and IGA 0/1 response, respectively. At week 52, these figures reached 99.0% and 87.0%, respectively. Among those who had not achieved EASI-75 or IGA 0/1 at week 16, 65.4% achieved EASI-75 and 18.1% achieved IGA 0/1 at week 20, and reached 86.8% and 50.0% at week 52, respectively. The patient-reported outcomes also improved sustainedly. Conclusions: Long-term stapokibart treatment induced sustained clinical improvements in adult patients with moderate-to-severe AD, regardless of their initial response to 16-week treatments.