Supplementary Materials for Reviewers

The present dataset comprises supplementary materials for the study "Retrospective analysis of post-marketing safety data for bimekizumab: A real-world pharmacovigilance study". These materials include additional tables and figures that provide detailed data and methodological information in support of the analysis.

Supplementary Materials
Figures:
Supplementary Figure 1. Signal detection of AEs related to bimekizumab.
Supplementary Figure 2. Time-to-onset of bimekizumab-related adverse events and comparison of cumulative incidence between patients with serious and non-serious outcomes. (A) Time-to-onset of bimekizumab-related AEs based on 381 reports. (B) Time-to-onset of bimekizumab-related AEs in patients with serious outcomes (325 reports). (C) Time-to-onset of bimekizumab-related AEs in patients with non-serious outcomes (56 reports). (D) The cumulative incidence of adverse events differed significantly between patients with serious and non-serious outcomes following bimekizumab treatment (log-rank test, P = 0.031).
Supplementary Figure 3. All positive signals at the PT level based on serious/non-serious outcomes in patients.
Supplementary Figure 4. Volcano plots illustrate all positive PT signals associated with bimekizumab across different stratifications, including risk signals related to gender (A), age (B), body weight (C), and reporter type (D).
Supplementary Figure 5. Analyze the risk differences of positive signals across different populations: (A) gender differences; (B) age differences; (C) weight differences; (D) reporter differences.
Supplementary Figure 6. Cumulative incidence of adverse events across subgroups. No significant differences in the cumulative incidence of adverse events were observed across gender (A), age (B), weight (B), or reporter (D) in bimekizumab-treated patients (log-rank test, P > 0.05).
Supplementary Figure 7. A comprehensive summary of all positive signals at the PT level was provided when reporting secukinumab as a comparator for bimekizumab.

Tables:
Supplementary Table 1. Four major algorithms used for signal detection.
Supplementary Table 2. A rating scale assessing clinical priority of disproportionality signals.