Real-World Safety of Upadacitinib in Adults and Adolescents With Atopic Dermatitis: 12-Month Analysis of the Multicountry Observational AD-VISE Study

Introduction: Upadacitinib (UPA) is an oral selective Janus kinase inhibitor approved for the treatment of atopic dermatitis (AD) in adolescents and adults. Multiple clinical trials have reported on the efficacy and safety of UPA for the treatment of AD. AD-VISE is a real-world drug utilization cohort study of UPA in adolescent and adult patients with AD. Previously reported effectiveness analyses from the AD-VISE study have shown similar trends to those reported in clinical trials. Here we present the first real-world safety data through 12 months of treatment with UPA from the AD-VISE study. Methods: AD-VISE is an ongoing observational, prospective, multi-country study primarily evaluating the effectiveness of UPA (15 and 30 mg) in adults and adolescents with AD over a period of 2 years. Herein, we report the 12-month safety analysis, patients were followed until the earliest of one-year of UPA exposure or the UPA discontinuation date plus 30 days (data cutoff: Oct 17, 2025). Adverse events (AEs) are reported as number and percentage of patients experiencing an AE (n, %), and exposure adjusted event rate (events [E] per 100 patient-years [PYs]) for patients receiving any dose of UPA. The possibility of an AE being related to UPA was assessed by the investigators. Results: This analysis included 861 patients and a total of 757.4 PYs of exposure to UPA. A total of 441 (51.2%; 171.0 E/100PYs) patients experienced at least one AE, with 284 (33.0%; 74.1 E/100PYs) patients experiencing at least one AE with reasonable possibility of being related to UPA. Serious and severe AEs were experienced by 33 (3.8%; 6.7 E/100 PYs) and 30 (3.5%; 5.8 E/100 PYs) patients, respectively. AEs leading to discontinuation of UPA were experienced by 38 (4.4%; 8.3 E/100 PYs) patients. Serious AEs with a reasonable possibility of being UPA related were experienced by 10 (1.2%; 2.5 E/100 PYs) patients. No deaths or cases of malignancy excluding non-melanoma skin cancer were reported (n = 0; E = 0). Nineteen patients experienced at least one herpes zoster event (2.2%; 2.8 E/100 PYs). Cases of lymphoma, major adverse cardiovascular events, and venous thromboembolism were each reported once (each n = 1, 0.1%; 0.1 E/100 PYs). The most commonly reported AEs (occurring in ≥ 2% of patients, by preferred term) were acne (n = 94, 10.9%), upper respiratory tract infection (n = 61, 7.1%), continued or worsening of atopic dermatitis (n = 60, 7.0.%), COVID-19 (n = 58, 6.7%), herpes simplex (n = 23, 2.7%), headache (n = 22, 2.6%), nasopharyngitis (n = 21, 2.4%), and folliculitis (n = 18, 2.1%). Conclusion: These results of the real-world safety of UPA in patients with AD are consistent with the previously established UPA long-term safety profile in patients with AD in clinical trials.