Abstract

Atopic dermatitis (AD) is becoming acknowledged as a systemic inflammatory disorder potentially linked to elevated cardiovascular risk. Abrocitinib, a selective inhibitor of Janus kinase 1 (JAK1) authorized for moderate-to-severe AD, demonstrates significant therapeutic efficacy. Concerns over the cardiovascular safety of JAK inhibitors have necessitated the assessment of major adverse cardiovascular events (MACE) and venous thromboembolism (VTE) in patients treated with abrocitinib. A comprehensive review and meta-analysis were performed of randomized controlled trials (RCTs) assessing abrocitinib versus placebo in individuals with moderate-to-severe AD. A thorough search of PubMed, MEDLINE, Scopus, Ovid, and CENTRAL databases
was conducted. The principal result was the occurrence of MACE; the secondary outcome was VTE. Six RCTs with 2,338 patients (1,703 receiving abrocitinib; 635 receiving placebo) were included. MACE was observed in one patient from each group, resulting in a pooled risk difference (RD) of 0.00 [95% confidence intervals (CI): -0.00 to 0.00; p-value = 0.96]. Two VTE occurrences transpired in the abrocitinib cohort, whereas none
were observed in the placebo cohort, yielding a pooled RD of 0.00 (95% CI: -0.00 to 0.01; p-value = 0.64). No heterogeneity was detected among the trials (I² = 0%). This meta-analysis revealed no elevated risk of MACE or VTE linked to abrocitinib in patients with moderate-to-severe AD during short- to mid-term follow-up. Although the findings are encouraging, more pharmacovigilance and longitudinal investigations are necessary to validate cardiovascular safety in larger groups.

Key words: Atopic dermatitis, abrocitinib, JAK1 inhibitor, cardiovascular safety, major adverse cardiovascular events, venous thromboembolism, meta-analysis.