Venous Thromboembolism Risk in Patients with Atopic Dermatitis Treated with Abrocitinib: A Review of Female Patients on Oral Contraception and Nicotine Exposure From the JADE Clinical Trial Program.

OBJECTIVE: Oral Janus kinase inhibitors (JAKi) are effective in managing moderate-to-severe atopic dermatitis (AD), but concerns regarding venous thromboembolism (VTE) risk persist, particularly in female patients with overlapping risk factors such as oral contraceptive pill (OCP) use and nicotine exposure (primarily smoking). We evaluated VTE events in this population using data from the abrocitinib clinical trial program. METHODS: We reviewed the Phase II and Phase III clinical trial data (JADE program) for abrocitinib in AD, focusing on VTE incidence in female patients with documented OCP use and nicotine exposure to contextualize thromboembolic risk. RESULTS: VTE events were rare. Nonfatal VTE incidence was low, with dose-specific incidence rates less than 1.0 per 100 patient-years (PY). Among female patients taking OCPs and current or former smokers, no VTEs occurred (0 of 78). In the overall active study group, most VTEs arose in patients with multiple baseline risk factors (eg, obesity, immobilization, prior thrombosis). Discontinuation due to VTE-related adverse events was infrequent (n=7, 0.13/100 PY) in the overall study group. No VTE-related deaths were reported. Comparative rates were consistent with or lower than background risk in AD populations with similar demographics. LIMITATIONS: This review is limited by the lack of publicly available patient-level data, possible underreporting of lifestyle risk factors, inability to quantify total nicotine exposure, small sample size, and unmeasured confounding variables. CONCLUSION: VTE events in female patients with AD treated with abrocitinib, including those taking OCPs and with nicotine exposure, were rare and generally associated with multiple concurrent risk factors for VTE. No VTE events were noted in female patients treated with abrocitinib who were taking OCPs and with history of smoking/nicotine exposure. These findings may help contextualize VTE risk in real-world treatment decisions.