Urinary tract infection following the use of BTK inhibitors: a real-world analysis of post-marketing surveillance data

Background: Emerging case reports have raised awareness of urinary tract infection (UTI) which maybe a potentially serious complication. The present study aimed to summarize the clinical characteristics of patients with BTK inhibitor-related UTI, and the association between BTK inhibitors and UTI events was also assessed by disproportionality analysis.Research design and methods: We conducted an observational, retrospective, and pharmacovigilance study using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Data were retrieved from Quarter 1, 2004 to Quarter 2, 2022. The clinical characteristics of cases were summarized using descriptive statistics. We used the ?2 or Fisher exact methods for the analysis of categorical variables and the Mann-Whitney test or Student's t-text for the comparisons of continuous variables between fatal and non-fatal cases. A p-value less than 0.05 is considered to be statistically significant. Information component (IC) and reporting odds ratio (ROR) were used to evaluate the association.Results: BTK inhibitors were identified as the suspected drug causing UTI in 539 cases. The age of those cases concentrated on 60-89 years (87.83%, data available in 263/539). UTI signals were detected during BTK inhibitors treatment (IC 0.95[0.83-1.08], ROR 1.96[1.80-2.13]). The association between BTK inhibitors and UTI events was shown among all groups but not in the group of age<60 years old. There were no significant differences in age and gender between fatal and non-fatal cases. However, a significant difference in reporting regions was found (p = 0.016), with the highest percentage of reported deaths occurring in Europe (26.15%, p = 0.000).Conclusions: Our study suggested a safety signal for UTI and BTK inhibitors compared to all other drugs in the database, especially in the elder (age = 60). Further studies are needed to clarify these results.