Sintilimab Pharmacovigilance in Real-World Practice: Analysis Utilizing the WHO VigiAccess Database

Sintilimab, a high-affinity PD-1 inhibitor, blocks the interaction between PD-1 and PD-L1 to restore T-cell function. Clinically used with chemotherapy for cancers like non-small cell lung carcinoma and hepatocellular carcinoma, its adverse event (AE) profile remains critical. Here we conducted the pharmacovigilance analysis of sintilimab-associated AEs using the WHO VigiAccess database. Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) were used to detect the risk signals, characterizing AE distribution at System Organ Class (SOC) and Preferred Term (PT) levels. Our analysis reveals hematologic toxicity as the predominant SOC-level AE. At the PT level, myelosuppression was the most frequently reported event. To our knowledge, these findings provide the first evidence from real-world global safety data on sintilimab’s AEs, and may enhance clinical monitoring and risk mitigation strategies for sintilimab therapy.