Post-marketing safety signals of anifrolumab in systemic lupus erythematosus: a pharmacovigilance study based on FAERS.

Objective: Anifrolumab, a monoclonal antibody targeting the type I interferon-α receptor, has been approved for the treatment of moderate-to-severe systemic lupus erythematosus (SLE). This study aimed to assess its safety profile in real-world settings.

Methods: This study analyzed all adverse events reports involving anifrolumab as the primary suspected drug from the quarter of 2021 to the third quarter of 2024 in the FDA Adverse Event Reporting System database. Disproportionality analyses were conducted using reporting odds ratio, proportional reporting ratio, multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network. The temporal risk of AEs was modeled using the Weibull distribution.

Results: The most frequently reported AEs included upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, cough, hypersensitivity, and nasopharyngitis. Potential adverse reactions not listed in the product label were identified, such as dyspnea, pyrexia, vomiting, pruritus, dizziness, abnormal feeling, chest pain, urticaria, alopecia, increased blood pressure, swelling, and migraine. AEs primarily occurred within the initial month of treatment.

Conclusion: This study provides valuable safety data on the real-world application of anifrolumab, confirming known AEs and revealing additional potential risks. The findings offer critical safety information for clinicians prescribing anifrolumab for the treatment of SLE, aiding in the optimization of patient management and treatment decision-making.