(P-566) Reporting of Pancreatitis with Tocilizumab Use: A Disproportionality Analysis Using the United States Food and Drug Administration Adverse Event Reporting System

Background: Tocilizumab (TCZ) is an anti-interleukin-6 receptor monoclonal antibody used in the treatment of systemic inflammatory disorders, and more recently, coronavirus disease 2019. There are reports of occurrence of pancreatitis following its use.

Objectives: To determine the reporting of pancreatitis in patients receiving TCZ, in comparison with other drugs, using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: We extracted adverse event reports submitted to FAERS during 2013–2019; reports of pancreatitis were identified using the Medical Dictionary for Regulatory Activities terminology preferred terms. A disproportionality analysis was performed; a reporting odds ratio (ROR) with the lower bound 95% confidence interval > 1 and a lower limit of a two-sided 95% interval of information component (IC025) more than zero was considered significant.

Results: Following deduplication, 3383910 adverse event reports were available; 144 (0.004%) reports were of pancreatic adverse events following TCZ administration, and 15907 (0.47%) were associated with use of other drugs. Of the 144 cases, 67 (46.53%) received concomitant medications with potential to cause pancreatitis. The likelihood of reporting of pancreatic events, compared with any other adverse event, with TCZ use was 1.32 times higher than that with other drugs. The lower bound of the 95% confidence interval of the ROR and IC remained above the criteria of significance from 2014–2019.

Conclusions: The reporting of pancreatitis, in comparison to other adverse events, in patients receiving TCZ is marginally higher as compared with other drugs. However, considering the limitations of FAERS database, the marginally high reporting seen in this study needs to be further confirmed by monitoring future trends.