Upadacitinib Demonstrates Consistent Long-Term Safety Across Age Groups in Atopic Dermatitis Over 6 Years
An integrated safety analysis from 3 phase 3 trials suggests that upadacitinib maintains a consistent long-term safety profile for patients with moderate-to-severe atopic dermatitis (AD), with follow-up extending up to 6 years across global and US populations.
The investigators noted, “6 years of long-term safety data show that upadacitinib maintained a stable and consistent safety profile across years in patients with moderate-to-severe AD.”
Safety data were pooled from Measure Up 1, Measure Up 2, and AD Up phase 3 studies, including 2683 patients receiving at least 1 dose of upadacitinib (15 mg or 30 mg), with over 9000 patient-years of exposure. Patients were stratified into 4 age groups (12–17, 18–49, 50–64, and ≥65 years), and exposure-adjusted rates of adverse events (AEs) and adverse events of special interest (AESIs) were evaluated.
Across the cohort, serious infections and opportunistic infections remained low, with most opportunistic infections being eczema herpeticum. Herpes zoster incidence showed a dose-dependent increase with the 30-mg dose across age groups, although rates were lower in adolescents. No major cardiovascular events were reported in younger adults (12–49 years), and rates of malignancy, non-melanoma skin cancer, and venous thromboembolism were low and generally similar between doses.
Age-specific differences emerged. Rates of AESIs were generally similar across treatment groups in patients younger than age 65 years, while higher rates—particularly with the 30 mg dose—were observed in patients aged ≥65 years. The US subgroup showed similar safety trends, with no active tuberculosis cases reported and consistent AE profiles across populations.
“Based on the integrated analysis of long-term safety data for up to 6 years, rates of AESIs were low for upadacitinib (UPA) 15 mg and UPA 30 mg in patients with moderate-to-severe AD,” the authors concluded. “These findings support the use of UPA across all approved ages in moderate-to-severe AD, with UPA 15 mg remaining the recommended dose in patients ≥ 65 years to optimize safety.”
These results reinforce the durability of upadacitinib’s safety profile while highlighting the importance of dose selection and monitoring in older patients.
Reference
Bunick CG, Irvine AD, Lio P, et al. Long-term 6-year safety of upadacitinib in moderate-to-severe atopic dermatitis across ages: results from three phase 3 studies. Presented at: American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, Colorado.
