RESUMEN
BACKGROUND: Immune checkpoint inhibitors (ICIs) show promise in cancer treatment, but recent cases highlight myositis as a serious complication. RESEARCH DESIGN AND METHODS: We did a retrospective study on drug safety using FAERS data up to Q3 2022, focusing on immune checkpoint inhibitors (ICIs) and myositis. We used IC and ROR to assess the association. Logistic regression in R 3.2.5 helped identify factors linked to fatal outcomes. RESULTS: We identified 558 cases of ICIs-associated myositis. Our study found a significant link between ICIs and myositis (ROR 15.54 [14.23-16.96], IC 3.79 [3.66-3.92], see Figure 1). Notably, myositis was more common in patients on ICI combination therapy compared to monotherapy (ROR 1.72 [1.39-2.11], IC 0.63 [0.30-0.93]). Age increased the risk of ICI-associated myositis and was also a factor in fatality (p = 0.011). Common accompanying adverse events included myocarditis (21.33%), severe myasthenia gravis (16.49%), and malignant neoplasm progression (8.06%). Fatal cases were more common when myositis was accompanied by myocarditis, severe myasthenia gravis, or malignant neoplasm progression. CONCLUSIONS: Clinicians must note the risk of ICI-associated myositis, especially dangerous in older patients or when combined with other issues like myocarditis or severe myasthenia gravis.
RESUMEN
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 χ2 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.