2025 Volume 19 Issue 3 Pages 160-173
Biologics are essential for managing immune-related inflammatory diseases during pregnancy to prevent disease progression and adverse pregnancy outcomes. However, data on the safety of biologics in a broader population are limited. This study aims to evaluate abortion-related adverse events (AEs) associated with adalimumab, etanercept, ustekinumab, and dupilumab, using data from the FDA Adverse Event Reporting System (FAERS) database. A disproportionality analysis was performed using the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) to identify signals of abortion-related AEs. The time-to-onset profiles were assessed by analyzing the description and Weibull shape parameters (WSPs) for these events. Sensitivity analyses were also conducted, including drug–drug interaction studies, logistic regression, and a similar retrospective analysis using data from the Japanese Adverse Drug Event Report (JADER) database. Disproportionality analysis revealed specific signals for abortion-related AEs associated with adalimumab, etanercept, and ustekinumab. The drug–drug interaction analysis indicated that these biologics, particularly without methotrexate or prednisolone, increase the risk of abortion-related AEs. Logistic regression identified several factors influencing outcomes. The time-to-onset analysis revealed that dupilumab had an earlier onset of 62.5 days, while etanercept had a later onset at 184 days. WSPs analysis revealed that signals for adalimumab, ustekinumab, and dupilumab exhibited early failure-type features, indicating a decreasing risk of abortion-related AEs over time. In conclusion, adalimumab, etanercept, and ustekinumab are associated with an increased risk of abortion-related adverse pregnancy outcomes, though the signals remain relatively weak. Further large-scale studies are needed to provide more definitive evidence.
