(C-206) Real-World Prospective Data Assessing the Long-Term Safety of Abrocitinib Treatment in Adults with Moderate to Severe Atopic Dermatitis (AD): Over Two years of Experience from the CorEvitas AD Registry

Background: Abrocitinib is an oral Janus kinase inhibitor (JAKi) approved in the United States (US) in 2022 for adults with moderate-to-severe atopic dermatitis (AD). A post-approval prospective observational study assessing long-term safety of abrocitinib in AD patients from the US and Canada using the CorEvitas AD Registry from 2022 to 2034 is ongoing.

Objectives: To estimate the incidence rates (IRs) of prespecified delayed (eg, malignancies) and acute-onset (eg, serious infections) safety events separately in AD patients exposed to abrocitinib and in a comparator cohort exposed to biologic and non-biologic (non-JAKi) chronic systemic AD treatments.

Methods: AD patients ≥18 years enrolled in the Registry during 14 Jan 2022 - 3 Jul 2024 who received abrocitinib or a comparator drug within 12 months prior to, at or after Registry enrollment were included in the study. Crude IRs for each safety event [number of first events per 100 patient-years (PY)] and 95% confidence intervals (CI) based on Poisson counts were calculated.

Results: Delayed-onset outcomes: Mean (±SD) age of patients was 47.0 (±18.6) and 51.5 (±18.6) years in the abrocitinib (n=100) and comparator cohort (n=1096), respectively. The abrocitinib cohort was comprised of 51.0% female and 65.0% White compared to 57.1% female and 72.5% White in the comparator coho rt. The total follow-up exposure time in the abrocitinib and comparator cohorts was 87.3 and 1168.0 PY, respectively. There were 0 and 17 total malignancies in the abrocitinib and comparator cohorts, with an IR per 100 PY of 0.0 (95% CI: 0.0-4.2) and 1.5 (95% CI: 0.9-2.4), respectively.
Acute-onset outcomes: Mean (±SD) age of patients was 46.6 (±18.3) and 51.4 (±18.4) years in the abrocitinib (n=88 exposures) and comparator cohort (n=996 exposures), respectively. Of the total abrocitinib exposures, 53.4% were female and 61.4% White compared to 58% female and 72. 9% White in the comparator exposures. The total follow-up exposure time in the abrocitinib and comparator cohorts was 58.7 and 833.8 PY, respectively. The number of events and IRs per 100 PY (95% CI) in the abrocitinib cohort were as follows: major adverse cardiac events (MACE), retinal detachment (RD), thrombosis and hepatotoxicity [n=0]; opportunistic infection (OI) [n=1, 1.7 (0.0-9.6)]; serious infections (SI) [n=2, 3.4 (0.4-12.4)]. The number of events and IRs per 100 PY (95% CI) in the comparator cohort were as follows: RD and hepatotoxicity [n=0]; MACE and thrombosis [n=2, 0.2 (0.0-0.9)], OI [n=6, 0.7 (0.3-1.6)]; SI [n=11, 1.3 (0.7-2.4)].

Conclusions: During 2 years, no new safety signals and a low incidence of prespecified safety events was observed in the abrocitinib cohort, aligning with the known safety profile of abrocitinib.