Risk factors for humanized IgG1 monoclonal antibody in the treatment of Crohn's disease: pharmacovigilance of the FDA adverse event reporting system (FAERS)

Abstract Background Ustekinumab and risankizumab, humanized IgG1 monoclonal antibody that selectively inhibits interleukin(IL)-23/IL-12 and IL-23, respectively, is currently approved for treating Crohn’s disease(CD). This study identified and characterized adverse events (AEs) significantly related to IgG1 monoclonal antibodies in treating CD and compared the differences between the two drugs to provide clinical reference. Methods AEs reports were collected from the United States Food and Drug Administration Adverse Event Reporting System(FAERS). Ustekinumab’s AEs were collected from the third quarter of 2016 to the second quarter of 2024, while risankizumab’s AEs were collected from the second quarter of 2022 to the second quarter of 2024. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to assess the reporting of AEs induced by ustekinumab and risankizumab in treating CD. When the lower limit of the 95% confidence interval (CI) of ROR > 1.0 and PRR ≥ 2 with an associated χ2 value of 4 or more was considered the threshold for a signal. Results A total of 2,5223 AE reports were retrieved from FAERS, with 1,9753 for ustekinumab, and 5470 for risankizumab. Reports for females were approximately 20% more than males, and patients aged 18-64.9 years reported the highest number of AEs. Interestingly, 50/77 PTs in at least 10 cases were classified as unexpected AEs, such as clostridium difficile infection, cellulitis, abdominal abscess, therapeutic response decreased, etc. for ustekinumab, and fall, intestinal obstruction, injection site haemorrh, loss of consciousnesss, etc. for risankizumab. There are similarities and differences in the presentation of ustekinumab-related and risankizumab-related AEs in males and females. Conclusions Gender-specific patients should be concerned about the occurrence of appropriate AEs when taking medications for CD. Our study provided evidence for ustekinumab and risankizumab in the treatment of CD.