LONG-TERM safety data from three Phase III studies indicate that upadacitinib maintains a consistent safety profile for patients with moderate-to-severe atopic dermatitis across approved age groups. The analysis included outcomes assessed over 6 years in global and U.S. populations.
Key Findings:
- Participants: 2,683 patients received treatment, with exposure-adjusted rates of adverse events monitored.
- Dosing: Patients were given upadacitinib 15 mg or 30 mg daily, either alone or with topical corticosteroids.
- Safety Profile: Adverse event rates were generally low across most age groups, but slightly higher in older adults (65+ years) on the 30 mg dose.
- Notable Observations: No major cardiovascular adverse events were reported in younger adults (12-49 years). A dose-dependent increase in herpes zoster was observed, emphasizing careful dose selection.
Clinical Implications: Upadacitinib remains a viable option for long-term management of atopic dermatitis, with the 15 mg dose preferred for older adults to optimize safety. Individualized treatment based on age and dose exposure is recommended.