BACKGROUND: Phase 3 trials have demonstrated the efficacy and safety of abrocitinib for atopic dermatitis (AD), but real-world evidence remains limited. METHODS: This study prospectively enrolled 117 moderate-to-severe AD patients at Huashan Hospital, Shanghai, China. Physician- and patient-reported outcomes were evaluated at multiple time points. Blood eosinophil counts, serum IgE, and 24 cytokines/chemokines were measured. RESULTS: Abrocitinib treatment led to rapid and potent improvements in disease severity. At week 12, 74.3% and 50.5% of AD patients achieved at least 75% and 90% improvement in the eczema area and severity index (EASI), respectively. Compared to dupilumab, abrocitinib showed greater improvement in Itch-NRS at week 2 and a higher proportion of EASI-75 at week 4. Adverse events occurred in 42.7% of AD patients, with gastrointestinal symptoms being the most common (17.1%). No tuberculosis (TB) reactivation was observed in patients who screened positive for TB and received isoniazid prophylaxis during the study period. Lower body mass index (BMI <
24
adjusted OR: 4.01, 95% CI: 1.36-11.73) and no prior dupilumab use (adjusted OR: 5.81, 95% CI: 1.8-18.7) were identified as predictors of a good response. By week 4, blood eosinophil counts and serum IgE significantly decreased. Reductions in Th2-, Th1-, and Treg-related cytokines/chemokines after 4 weeks of abrocitinib treatment, including IL-5, CCL17, CCL18, TNF-α, IL-6, IL-10, and CD25/IL-2Rα, were more pronounced in good responders. CONCLUSION: Abrocitinib demonstrated robust efficacy and a well-tolerated safety profile in Chinese patients with moderate-to-severe AD in routine clinical practice, accompanied by normalization of elevated blood biomarkers. TRIAL REGISTRATION: ChiCRT Identifier: ChiCTR2200063195.