Long-Term Safety of Abrocitinib in Moderate-to-Severe Atopic Dermatitis: Integrated Analysis by Age

Abstract

Abrocitinib has a manageable long-term safety profile for patients with moderate-to-severe atopic dermatitis. Identifying populations at higher risk of adverse events (AEs) will help optimize dose selection. To evaluate abrocitinib long-term safety by age. Data (September 25, 2021 cutoff) from JADE clinical trials were pooled in a consistent-dose cohort (patients who received the same abrocitinib dose throughout exposure) or a variable-dose cohort (patients who received abrocitinib 200 mg [12 weeks], were randomly assigned later to receive abrocitinib 200 mg, 100 mg, or placebo [up to 40 weeks], and assigned to receive abrocitinib 200 mg or 100 mg in the long-term study). Data were stratified post hoc by age at baseline (12 to <18 years, 18 to <40 years, 40 to <65 years, and ≥65 years). Incidence rates (IRs) of treatment-emergent AEs (TEAEs) of special interest were assessed. Analysis included 3802 patients (exposure: 5214 patient-years). IRs for serious AEs, TEAEs leading to study discontinuation, serious infections, herpes zoster, thrombocytopenia, lymphopenia, nonmelanoma skin cancer (NMSC), malignancies (excluding NMSC), major cardiovascular events, and venous thromboembolism were numerically higher in patients aged ≥65 years than in younger patients. Overall, adolescents had the lowest rates for TEAEs of special interest. Abrocitinib has a manageable long-term safety profile. TEAEs of special interest were lower in adolescents and higher in the ≥65-year age group. Risk of specific TEAEs was numerically higher in patients aged ≥65 years treated with abrocitinib 200 mg and underscores the importance of dose selection in older patients. • What is already known about this topic? Abrocitinib has a manageable long-term safety profile that can be optimized using proper dose and patient selection. The long-term safety of abrocitinib in patients of different age groups remains to be elucidated. • What does this article add to our knowledge? Long-term abrocitinib is well-tolerated across all age groups. Incidence rates of most treatment-emergent adverse events of special interest were numerically higher in patients aged ≥65 years than younger age groups, particularly in those treated with 200 mg. • How does this study impact current management guidelines? Adverse events associated with the Janus kinase inhibitor class were infrequent with abrocitinib but more common in older patients. Safety risk may be minimized by starting older patients on the abrocitinib lower dose (100 mg).

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