Abrocitinib, an oral, once-daily JAK1-selective inhibitor, was shown in pivotal phase III studies to be an effective monotherapy and in conjunction with topical therapy for moderate-to-severe atopic dermatitis (AD). The goal of this study was to assess the long-term safety of abrocitinib 200 mg and 100 mg in an integrated analysis of four phases III trials and one long-term extension study. There were two cohorts studied: a placebo-controlled cohort from 12- to 16-week trials and an all-abrocitinib cohort that included patients who received one or more abrocitinib doses. Adverse events (AEs) of interest are recorded, as well as laboratory data. The dose-related AEs in the placebo-controlled cohort were nausea, headache, and acne. Platelet count was transiently decreased in a dose-dependent manner; at week 4, 2/2718 individuals had verified platelet counts of 50 103/mm3. In the 200-mg and 100-mg groups, the IRs for severe infection were 2.33/100PY and 2.65/100 PY, 4.34/100PY and 2.04/100PY for herpes zoster, and 11.83/100PY and 8.73/100PY for herpes simplex, respectively. Both dosages had IRs of 0.5/100PY for nonmelanoma skin cancer, other malignancies, and severe adverse cardiovascular events. There were five cases of venous thromboembolism in the 200-mg group. Gastric cancer, abrupt death, and COVID-19 were the causes of three deaths.
Abrocitinib has tolerable tolerability and a long-term safety profile that is acceptable for long-term usage in patients with moderate-to-severe Alzheimer’s disease when used correctly in the right patient and dose.
Reference: https://link.springer.com/article/10.1007/s40257-021-00618-3
