Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patientyears of exposure

Introduction: Abrocitinib is efficacious and well tolerated in patients with moderate-to-severe atopic dermatitis (AD). Here, we describe the updated long-term integrated safety profile of abrocitinib in the JADE clinical program. Methods: Analysis included 3802 patients (exposure: 5213.9 patient-years [PY]) from 7 parent phase 2/3 trials and one long-term extension trial (data cutoff September 25, 2021). Incidence rates (IRs; number of unique patients with events/ 100 PY) of serious adverse events (SAEs) and treatment-emergent AEs of special interest were assessed. Results: Of the total 3802 patients in the pooled safety population, 3004 received the same abrocitinib dose throughout exposure; duration of exposure was >= 96 weeks in 26.3% of patients who received abrocitinib 200 mg (n = 1981) and 41.3% of patients who received abrocitinib 100 mg (n = 1023). Median age was 30.0 years. Incidence was higher in older (>= 65 years, n = 146) versus younger (18 to <65 years, n = 2368) patients for SAEs (17.6 [95% CI, 11.7-25.5] versus 6.7 [5.8-7.8]), herpes zoster (HZ, 8.1 [4.3-13.8] versus 3.8 [3.1-4.6]), malignancy (excluding nonmelanoma skin cancer, 2.4 [0.6-6.0] versus 0.1 [0.0-0.4]), major adverse cardiac events (1.2 [0.1-4.2] versus 0.3 [0.1-0.6]), thrombocytopenia (confirmed platelet count <75 x 10(3)/mm(3), 1.8 [0.4-5.1] versus 0.3 [0.1-0.6]), and lymphopenia (3.5 [1.3-7.6] versus 0.1 [0.0-0.3]). The most frequent serious infections with abrocitinib 200 mg and 100 mg were HZ (0.5% and 0.2% ), herpes simplex (0.1% with either dose), and pneumonia (0.2% with either dose). Conclusion: Abrocitinib has an acceptable long-term safety profile with > 5000 PY of exposure in appropriate patients with moderate-to-severe AD.