Real-world evaluation of efficacy and safety of abrocitinib in moderate-to-severe atopic dermatitis across a multi-site hospital system

Summary: Abrocitinib, a selective JAK-1 inhibitor, is approved to treat moderate-severe atopic dermatitis (AD) in adults and adolescents. Although clinical trials have demonstrated the efficacy and safety of abrocitinib in AD, there remains a lack of comprehensive, long-term real-world studies to further evaluate its effectiveness and safety in diverse patient populations. The objective of the study was to characterize long-term treatment responses and adverse events in patients with moderate to severe AD in real-world practice. In this retrospective observational study, electronic medical records of adolescents and adult AD patients treated with abrocitinib across a multi-site hospital system were reviewed from January 1, 2021, and March 2024. 50 patients were included (mean age 40 ± 14 years), with 56% female. The racial distribution was 36% White, 24% Asian, 24% Black, and 16% other. 96% of patients had prior exposure to systemic therapy, which they had discontinued due to inadequate response or intolerance before initiating abrocitinib, including prior treatment with dupilumab (80%), prednisone (34%), and upadacitinib (10%). Mean ± SD treatment duration of abrocitinib was 57 ± 40 weeks. Mean ± SD improvements in BSA, EASI, and IGA were 60.3% ± 44.3%, 58.6% ± 30.4%, and 48.5% ± 35.1%, respectively (p < 0.0001). Of the patients (n = 29) treated with abrocitinib for over 1 year, 49% achieved 75% improvement in EASI and 57% achieved IGA 0/1. No significant changes in AST, ALT, cholesterol, triglycerides, or LDL were observed throughout treatment. 15 patients had adverse events (30%), of which acne (16%) and abdominal pain (6%) were the most common. Of 10 patients discontinuing abrocitinib, 5 due to inefficacy, 1 to infection, and 4 lost to follow-up. No serious adverse events occurred. Abrocitinib was well-tolerated and effective across various age, sex, race, or ethnicity and demonstrated strong therapeutic potential in refractory cases where other systemic therapies failed. Megan Lau¹, J Largen¹, J Levine¹, A Amangeldiyeva¹, Joel Correa da Rosa¹, Benjamin Ungar¹, Emma Guttman-Yassky¹ 1. Icahn School of Medicine at Mount Sinai, New York, NY, United States. Clinical Research: Epidemiology and Observational Research