PB0199 - Disseminated Intravascular Coagulation Associated with Immune Checkpoint Inhibitors: Analysis of FAERS Database

Background: Drug induced Disseminated Intravascular Coagulation is a potentially serious and life-threatening complication. While Immune Checkpoint Inhibitors (ICIs) have been linked with a variety of adverse events, their association with Disseminated Intravascular Coagulation (DIC) remains poorly studied.

Aims: To study the association of Immune Checkpoint Inhibitors with drug associated DIC

Methods: We conducted a retrospective pharmacovigilance study using the FDA Adverse Event Reporting System database to analyze the association of DIC with the commonly used Immune Checkpoint Inhibitors from the years 2018 to 2023. We used disproportionality signal analysis and calculated the reporting odds ratio with a 95% confidence interval.

Results: A total of 4,006 events of drug associated DIC were found within the FAERS database between the years 2018 to 2023, of which 409 events were reported with the commonly used ICIs. Nivolumab accounted for most cases (205 cases, ROR 12.4, 95% CI 10.8-14.3), followed by Pembrolizumab (128 cases, ROR 9.1, 95% CI 7.6-10.8), Ipilimumab (97 cases, ROR 14.4, 95% CI 11.8-17.6), and Atezolizumab (70 cases, ROR 9.8, 95% CI 7.7-12.4). The distribution of cases was 56.9% in males and 37.1% in females. Out of all reported cases, 54.5% patients died. While Nivolumab was associated with highest incidence of DIC and mortality (46%), signal strength was highest for Ipilimumab.

Conclusion(s): The study helps to identify and compare risk of DIC with the commonly used Immune Checkpoint Inhibitors. The findings highlight the importance of evaluating the safety profile of these drugs and monitor the patients for DIC. Presence of cancer could be a potential confounder. Further studies are needed to establish causality.