Safety of upadacitinib in atopic dermatitis in randomized clinical trials across 6 years.
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BACKGROUND: Atopic dermatitis (AD) is a common inflammatory skin disease characterized by eczematous lesions, dry skin and intense pruritus. Upadacitinib, a selective JAK1 inhibitor approved for moderate-to-severe AD in adults and adolescents, is a once-daily oral treatment. OBJECTIVES: To evaluate the long-term safety profile of the treatment of moderate-to-severe AD with upadacitinib 15 mg (UPA15) or 30 mg (UPA30) across 6 years. METHODS: Safety data for adverse events (AEs), including treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs) from three global phase 3 studies (MeasureUp 1, MeasureUp 2 and ADUp), were analysed. Data were included for all adolescent and adult patients (12-75 years) receiving at least 1 dose of UPA15 or UPA30 across 6 years. RESULTS: Serious adverse event rates were similar for UPA15 (6.6 events [E] per 100 patient-years [PY]) and UPA30 (7.4 E/100 PY). Nasopharyngitis was the most frequently reported adverse event (UPA15, 9.8 E/100 PY; UPA30, 9.3 E/100 PY) excluding COVID-19. Event rates for serious infections were similar for both groups (UPA15, 2.2 E/100PY; UPA30, 2.6 E/100 PY). Rates of most AESIs were similar between UPA15 and UPA30, except for those known to be dose dependent: herpes zoster, hepatic disorder, neutropenia and CPK elevation. Adjudicated major adverse cardiovascular event incidence rates were 0.2 n/100PY and <0.1 n/100PY for UPA15 and UPA30, respectively. Adjudicated venous thromboembolic event incidence rates were 0.1 n/100PY for both UPA15 and UPA30. Rates of malignancy excluding non-melanoma skin cancer were 0.3 n/100PY for UPA15 and 0.5 n/100PY for UPA30. Rates of lymphoma were <0.1 n/100PY for both groups. Rates of TEAEs leading to death were low (<0.1 E/100PYs and 0.1 E/100 PYs for UPA15 and UPA30, respectively). CONCLUSIONS: This analysis provides information about the long-term safety of upadacitinib in AD, with no new important safety signals identified for up to 6 years.