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

BACKGROUND

Abrocitinib has a manageable long-term safety profile for patients with moderate-to-severe atopic dermatitis. Identifying populations at higher risk of adverse events will help optimize dose selection.

OBJECTIVE

To evaluate abrocitinib long-term safety by age.

METHODS

Data (cutoff: September 25, 2021) 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 wk], were randomly assigned later to receive abrocitinib 200 mg, 100 mg, or placebo [up to 40 wk], 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 y; 18 to < 40 y, 40 to < 65 y, and ≥65 y). Incidence rates of treatment-emergent adverse events (TEAEs) of special interest were assessed.

RESULTS

Analysis included 3,802 patients (exposure: 5,214 patient-years). The incidence rates for serious adverse events, TEAEs leading to study discontinuation, serious infections, herpes zoster, thrombocytopenia, lymphopenia, nonmelanoma skin cancer, malignancies (excluding nonmelanoma skin cancer), major cardiovascular events, and venous thromboembolism were numerically higher in patients aged 65 years or older than in younger patients. Overall, adolescents had the lowest rates for TEAEs of special interest.

CONCLUSIONS

Abrocitinib has a manageable long-term safety profile. TEAEs of special interest were lower in adolescents and higher in the 65-years-old or older age group. Risk of specific TEAEs was numerically higher in patients aged 65 years or older treated with abrocitinib 200 mg and underscores the importance of dose selection in older patients.