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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| Format: | Article |
| Language: | English |
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Nature Portfolio
2021-09-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-021-98325-w |
| _version_ | 1818858362815643648 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-19T08:55:05Z |
| format | Article |
| id | doaj.art-053af8766c484ffb8b891c53dcaf4758 |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-12-19T08:55:05Z |
| publishDate | 2021-09-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-053af8766c484ffb8b891c53dcaf47582022-12-21T20:28:37ZengNature PortfolioScientific Reports2045-23222021-09-011111910.1038/s41598-021-98325-wAssessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System databaseAshwin Kamath0Sahana D. Acharya1Rashmi R. Rao2Sheetal D. Ullal3Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher EducationDepartment of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher EducationDepartment of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher EducationDepartment of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher EducationAbstract 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.https://doi.org/10.1038/s41598-021-98325-w |
| spellingShingle | 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 Scientific Reports |
| title | 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_short | 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 |
| url | https://doi.org/10.1038/s41598-021-98325-w |
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