Analysis of adverse drug reactions in 507 cases of Tislelizumab: A real-world retrospective study based on data from Guangxi, China

Abstract

Objective To analyze the real-world characteristics and patterns of adverse drug reactions (ADRs) associated with tislelizumab, providing valuable insights for clinical practice. Methods We conducted a comprehensive analysis of tislelizumab-related ADR reports within the pharmacovigilance system of Guangxi, China, spanning from 01/04/2021–31/08/2024. Our analysis focused on population characteristics, temporal distribution of ADR occurrences, system organ classes (SOCs) of serious adverse drug reactions (SADRs), profiles of major SOCs, and factors influencing SADRs and blood and lymphatic system disorders (BLSDs). Results This study analyzed 507 tislelizumab ADR reports (698 events), including 282 SADRs (356 events), with no deaths reported. Pharmacists were the primary reporters (60.55% of reports). Most patients were aged 46–75 years (77.32%), male (72.58%), and of Han ethnicity (75.54%), and 1.78% (9/507) were of Zhuang ethnicity. A total of 86.19% of ADRs occurred within 30 days of medication. Among the SADRs, there were 83 PTs and 17 SOCs, with the most common SOCs being blood and lymphatic system disorders (15.47%, 108/698), investigations (14.90%, 104/698), hepatobiliary disorders (4.15%, 29/698), and skin and subcutaneous tissue disorders (3.15%, 22/698). Logistic regression analysis showed that chemotherapy was a significant risk factor for SADRs (OR = 4.634, 95%CI: 2.871–7.917, P < 0.001). The risk of BLSDs - related ADRs was 5.545 times higher in the chemotherapy-incorporating group than in the monotherapy group (95%CI: 3.423–8.701, P < 0.001). Conclusions Close monitoring, particularly in patients receiving chemotherapy-incorporating regimens, is crucial during the first 30 days post-tislelizumab treatment to manage SADR risks. Proactive measures should be implemented if SADR occur.