64775 Integrated Safety Update of Abrocitinib in 1014 Young Adult Patients Aged 18 to <40 Years With Moderate-to-Severe Atopic Dermatitis: Data From More Than 2250 Patient-Years With up to 4.5 Years of Exposure

Document Type

Conference Proceeding

Publication Date

9-1-2025

Publication Title

J Am Acad Dermatol

Abstract

Abrocitinib demonstrated a manageable long-term safety profile in adults and a more favorable safety profile in adolescents with moderate-to-severe atopic dermatitis (AD), with exposure up to 4.5 years. This analysis of data from patients aged 18 to <40 years, included in a previously reported integrated safety analysis, investigates long-term safety in young adults (18 to <30 years). Safety was evaluated in patients with moderate-to-severe AD aged 18 to <30 years (young adults) and adults aged 30 to <40 years treated with abrocitinib (100 mg/200 mg) in eight phase 2 or 3 parent trials and in the ongoing extension trial, JADE EXTEND (NCT03422822; data cutoff date: September 5, 2022). The analysis included 1014 young adults (patient-years [PY]: 1607.0) and 581 adults (PY: 962.6). Incidence rates (IR)/100 PY in young adults and adults were 1.90 (95% CI, 1.29-2.70) and 2.67 (1.74-3.91) for serious infections, 3.40 (2.55-4.43) and 3.15 (2.12-4.49) for all herpes zoster (HZ) infections, 0.00 (0.00-0.22) and 0.20 (0.02-0.73) for major adverse cardiovascular events (MACE), 0.06 (0.00-0.34; 1 event reported) and 0.00 (0.00-0.37) for venous thromboembolism (VTE), and 0.06 (0.00-0.34; 1 event reported) and 0.00 (0.00-0.37) for pulmonary embolism. No events of nonmelanoma skin cancer occurred. IRs of serious infections and HZ were numerically higher in both age groups compared with those reported in adolescents aged 12 to <18 years with overlapping confidence intervals. Abrocitinib was well tolerated in young adults aged 18 to <30 years treated up to 4.5 years, with no new safety signals.

Volume

93

First Page

AB234

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