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

Abstract Tocilizumab (TCZ) is used to treat rheumatoid arthritis and other systemic inflammatory 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 t...

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Autores principales:	Ashwin Kamath, Sahana D. Acharya, Rashmi R. Rao, Sheetal D. Ullal
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/053af8766c484ffb8b891c53dcaf4758
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spelling	oai:doaj.org-article:053af8766c484ffb8b891c53dcaf47582021-12-02T18:14:22ZAssessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database10.1038/s41598-021-98325-w2045-2322https://doaj.org/article/053af8766c484ffb8b891c53dcaf47582021-09-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-98325-whttps://doaj.org/toc/2045-2322Abstract Tocilizumab (TCZ) is used to treat rheumatoid arthritis and other systemic inflammatory 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% confidence interval (CI) > 1 and a lower limit of a two-sided 95% interval of information component (IC025) more than zero was considered significant. 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 significance throughout the study period, except 2013. The findings 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.Ashwin KamathSahana D. AcharyaRashmi R. RaoSheetal D. UllalNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Ashwin Kamath Sahana D. Acharya Rashmi R. Rao Sheetal D. Ullal Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database
description	Abstract Tocilizumab (TCZ) is used to treat rheumatoid arthritis and other systemic inflammatory 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% confidence interval (CI) > 1 and a lower limit of a two-sided 95% interval of information component (IC025) more than zero was considered significant. 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 significance throughout the study period, except 2013. The findings 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.
format	article
author	Ashwin Kamath Sahana D. Acharya Rashmi R. Rao Sheetal D. Ullal
author_facet	Ashwin Kamath Sahana D. Acharya Rashmi R. Rao Sheetal D. Ullal
author_sort	Ashwin Kamath
title	Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database
title_short	Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database
title_full	Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database
title_fullStr	Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database
title_full_unstemmed	Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database
title_sort	assessment of pancreatitis associated with tocilizumab use using the united states food and drug administration adverse event reporting system database
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/053af8766c484ffb8b891c53dcaf4758
work_keys_str_mv	AT ashwinkamath assessmentofpancreatitisassociatedwithtocilizumabuseusingtheunitedstatesfoodanddrugadministrationadverseeventreportingsystemdatabase AT sahanadacharya assessmentofpancreatitisassociatedwithtocilizumabuseusingtheunitedstatesfoodanddrugadministrationadverseeventreportingsystemdatabase AT rashmirrao assessmentofpancreatitisassociatedwithtocilizumabuseusingtheunitedstatesfoodanddrugadministrationadverseeventreportingsystemdatabase AT sheetaldullal assessmentofpancreatitisassociatedwithtocilizumabuseusingtheunitedstatesfoodanddrugadministrationadverseeventreportingsystemdatabase
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Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database

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