Real‐World Efficacy and Safety of Abrocitinib in Chinese Atopic Dermatitis Patients: A Single‐Center Prospective Study

ABSTRACT 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