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 [1225]

Abstract

Introduction: Abrocitinib is an oral Janus kinase inhibitor (JAKi) approved in the US 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. This analysis estimated 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.

Procedure/Study: 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 cohort. 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)]. 

Conclusion: 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.

Funding/Disclosures: This study was funded by Pfizer.