Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database

Kamath, Ashwin K Anandaraya and Acharya, Sahana Devadasa and Rao, Rashmi R and *, Sheetal Dinkar Ullal (2021) Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database. Scientific Reports, 11. ISSN 20452322

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Abstract

Tocilizumab (TCZ) is used to treat rheumatoid arthritis and other systemic infammatory disorders. There is some evidence suggesting the occurrence of pancreatitis following TCZ use. We aimed to determine the reporting of pancreatitis following TCZ use in comparison with other drugs using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. We extracted adverse event reports submitted to FAERS during 2013–2019. A reporting odds ratio (ROR) with the lower bound 95% confdence interval (CI) > 1 and a lower limit of a two-sided 95% interval of information component (IC025) more than zero was considered signifcant. Following deduplication, 3,383,910 adverse event reports were available; 144 (0.004%) reports were of pancreatic adverse events associated with TCZ use, and 15,907 (0.47%) associated with other drugs. Of the 144 cases, 74 (51.39%) received concomitant medications with pancreatotoxic potential. 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% CI of the ROR and IC remained above the criteria of signifcance throughout the study period, except 2013. The fndings suggest disproportionately high reporting of pancreatitis in patients receiving TCZ as compared with other drugs. This marginally high reporting is not likely to be of immediate clinical concern and needs to be interpreted cautiously

Item Type: Article
Uncontrolled Keywords: Tocilizumab, Pancreatitis, Rheumatoid arthritis, Coronavirus disease, Adverse event
Subjects: Medicine > KMC Mangalore > Pharmacology
Depositing User: KMCMLR User
Date Deposited: 17 Dec 2021 11:02
Last Modified: 17 Dec 2021 11:02
URI: http://eprints.manipal.edu/id/eprint/157832

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