Results from a long-term integrated analysis support the favorable safety profile of upadacitinib for moderate-to-severe atopic dermatitis (AD) in adolescents and adults.
The analysis, presented at the recent Revolutionizing Atopic Dermatitis (RAD) Conference, included over 9,000 patient-years of data on the safety of 15 mg and 30 mg daily doses of upadacitinib. According to the analysis, adverse events (AEs) were consistent with prior findings and the drug's established safety profile. Rates of treatment-emergent adverse events (TEAEs), serious AEs, and AEs leading to drug discontinuation were similar across both dosage groups. Incidence rates for malignancies (excluding nonmelanoma skin cancer), major adverse cardiovascular events (MACE), and venous thromboembolism (VTE) were low (≤ 0.5 events per 100 patient-years in each category).
Herpes zoster occurred at a higher rate in the 30 mg dose group compared to the 15 mg group, aligning with a known dose-dependent nature of the side effect. Serious and opportunistic infections, including eczema herpeticum, were also slightly more frequent with the 30 mg dose, but were rare overall.
"There is still a bit of JAK-phobia out there in the world of dermatology, but as time goes on and we gain knowledge and experience with this class of medicines we continue to feel reassured about the safety profile of these life-changing medications," study co-author Lisa Swanson, MD, a dermatologist with Ada West Dermatology and St. Luke's Children's Hospital in Boise, told Practical Dermatology. "In this poster from RAD, we looked at six-year safety data for patients on upadacitinib and saw a similar safety profile to prior analyses, further supporting the favorable benefit-risk profile of upadacitinib."