Real-world Efficacy and Safety of Stapokibart in Children and Adolescents with Moderate-to-severe Atopic Dermatitis: A Retrospective Study

Abstract

Translate Article

Paediatric real-world evidence for stapokibart in moderate-to-severe atopic dermatitis (AD) is scarce. We retrospectively analysed 55 patients aged 6–17 years treated at a single centre for 16 weeks using weight-tiered dosing (<30 kg: 600 mg loading, then 300 mg every 4 weeks; ≥30 kg: 600 mg loading, then 300 mg every 2 weeks). Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), body surface area (BSA), Investigator’s Global Assessment (IGA), Children’s Dermatology Life Quality Index (CDLQI) and Pruritus Numerical Rating Scale (P-NRS) were assessed at baseline and weeks 4, 8, 12 and 16. At week 16, median EASI fell from 10.0 to 1.95 and SCORAD from 46.2 to 13.3; P-NRS from 8.0 to 1.0 and CDLQI from 14.0 to 4.0. Week 16 response rates were 92.7% (EASI-50), 70.9% (EASI-75), 38.2% (EASI-90), 52.7% (IGA 0/1) and 67.3% (P-NRS≤2). Mild adverse events occurred in 9.1%. Stapokibart was associated with rapid improvements in disease severity, itch and quality of life and was well tolerated in routine paediatric care.