PATIENTS with moderate-to-severe atopic dermatitis showed generally low long-term upadacitinib safety event rates across ages.
Upadacitinib Safety in Atopic Dermatitis Across Age Groups
LONG-TERM safety data from three Phase III studies suggest that upadacitinib maintains a generally consistent safety profile for patients with moderate-to-severe atopic dermatitis across approved age groups. The analysis included data from the long-term blinded extension periods of Measure Up 1, Measure Up 2, and AD Up, with outcomes assessed for up to 6 years in both global and U.S. populations.
The studies enrolled adults and adolescents with moderate-to-severe atopic dermatitis who received once-daily oral upadacitinib 15 mg or 30 mg, either as monotherapy or with concomitant topical corticosteroids. Patients initially assigned to placebo were re-randomized at Week 16 to one of the two active dose groups. Investigators reported exposure-adjusted rates of adverse events and adverse events of special interest to better define long-term safety across age categories.
A total of 2,683 patients received at least one dose of treatment. Of these, 1,337 received upadacitinib 15 mg, representing 4,435.2 patient-years of exposure, and 1,346 received upadacitinib 30 mg, representing 4,752.5 patient-years. The dataset also included 650 patients from the U.S.
Age-Specific Safety Findings Over 6 Years
Rates of adverse events of special interest were generally low and broadly consistent across patients younger than 65 years. However, relatively higher rates for some adverse events of special interest were observed in older adults aged 65 years and above, particularly among those receiving the 30 mg dose.
Notably, no major cardiovascular adverse events were reported among younger adults aged 12 to 49 years. A dose-dependent increase in herpes zoster was seen with the 30 mg regimen across all ages, reinforcing the importance of dose selection during long-term management. In adolescents, herpes zoster rates remained relatively low in the global population, and no cases were reported in the U.S. adolescent cohort.
Clinical Relevance for Long-Term Atopic Dermatitis Care
These findings support the use of upadacitinib across approved age groups in moderate-to-severe atopic dermatitis, while also highlighting important age- and dose-related safety considerations. The data suggest that upadacitinib 15 mg remains the preferred dose in patients aged 65 years and older when safety optimization is a priority.
For clinicians managing chronic inflammatory skin disease over the long term, the results add to the evidence base supporting individualized treatment selection according to both patient age and dose exposure. The 6-year analysis offers reassurance that long-term therapy can be considered across a broad age range, with additional caution warranted in older adults and at higher doses.
Reference
Bunick CG et al. Long-Term 6-Year Safety of Upadacitinib in Moderate-to-Severe Atopic Dermatitis Across Ages: Results From Three Phase 3 Studies. Abstract 75678. AAD Annual Meeting, 27-31 March, 2026.
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