Long-Term Data Support Safety of Upadacitinib in Women With AD Using OCPs

Upadacitinib maintains a favorable benefit–risk profile in women with moderate-to-severe atopic dermatitis (AD), regardless of oral contraceptive pill (OCP) or hormone replacement therapy (HRT) use, according to long-term safety data presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference.

The data were presented in a poster titled "Patients With Atopic Dermatitis Using Oral Contraceptive Pills or Hormone Replacement Therapy: Long-Term Safety of Upadacitinib for Major Adverse Cardiovascular Events, Venous Thromboembolism, or Malignancy (Excluding Nonmelanoma Skin Cancer)," by Linda F. Stein Gold, Mona Shahriari, Emma Guttman-Yassky, Raj Chovatiya, David G. Cotter, Matthew Zirwas, Ruth Ann Vleugels, Paula Carolina Luna, Chia-Yu Chu, Christopher G. Bunick, Ayman Grada, Deanne M. Dilley, Alena Pechonkina, Lani Wegrzyn, Gweneth F. Levy, and Jonathan I. Silverberg.

The pooled analysis included 1,178 female participants from three phase 3 randomized controlled trials—Measure Up 1, Measure Up 2, and AD Up—who received once-daily upadacitinib 15 mg or 30 mg, with treatment extending up to 6 years. Researchers compared incidence rates of major adverse cardiovascular events (MACE), venous thromboembolism (VTE), and malignancy excluding nonmelanoma skin cancer (NMSC) with rates from a US real-world reference population of more than 22,000 women with AD.

Long-term incidence rates of MACE and VTE were low (<0.1 events per 100 patient-years), and malignancy rates (excluding NMSC) did not exceed 0.4 events per 100 patient-years across treatment groups. No MACE or VTE events were observed among patients using OCPs or HRT, and no malignancies were reported in the small HRT cohort (n = 5).

For OCP users, safety outcomes in the clinical trial population mirrored those observed in the broader US AD reference cohort, reinforcing the consistency of findings. Rates of cardiovascular risk factors, lipid abnormalities, and metabolic comorbidities were generally similar between OCP users and nonusers, suggesting that contraceptive use did not independently elevate long-term safety risks when combined with upadacitinib therapy.

“In female patients with moderate-to-severe atopic dermatitis who received up to 6 years of upadacitinib treatment, long-term incidence rates of MACE, VTE, and malignancy (excluding NMSC) were low, regardless of OCP or HRT use,” investigators concluded.