Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database
Abstract Background Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases. The high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however, its safety profile remains unknown in the real world. The purpose of th...
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| Format: | Article |
| Language: | English |
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BMC
2019-10-01
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| Series: | Journal of Pharmaceutical Health Care and Sciences |
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| Online Access: | http://link.springer.com/article/10.1186/s40780-019-0149-z |
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| author | Iku Niinomi Keiko Hosohata Yasuhiro Mori Yuki Yamaguchi Tomohito Wakabayashi Mayako Uchida Kazunori Iwanaga |
| author_facet | Iku Niinomi Keiko Hosohata Yasuhiro Mori Yuki Yamaguchi Tomohito Wakabayashi Mayako Uchida Kazunori Iwanaga |
| author_sort | Iku Niinomi |
| collection | DOAJ |
| description | Abstract Background Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases. The high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however, its safety profile remains unknown in the real world. The purpose of this study was to clarify the adverse events associated with IFX originator and its biosimilar using the Japanese Adverse Drug Event Report (JADER) database. Methods Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency between the third quarter of 2014 and the fourth quarter of 2018. We calculated the reporting odds ratio and 95% confidence interval for each adverse event. Results We obtained 2771 reports of adverse events associated with IFX originator and 402 reports with IFX biosimilar. Signals were detected for pneumonia, interstitial lung disease, tuberculosis, and sepsis with both IFX originator and its biosimilar, whereas there was no signal for infection with the biosimilar. Conclusions The strength of the association between IFX originator and its biosimilar with adverse events is partly different, but reports were quite limited for the biosimilar compared with originator. It is recommended that research be continued in order to accumulate a wide variety of information, and that newly reported data be placed in the multifaceted viewpoints for improvement of care levels. |
| first_indexed | 2024-12-11T10:34:21Z |
| format | Article |
| id | doaj.art-1888db929ef94a9da5636907542e2c0d |
| institution | Directory Open Access Journal |
| issn | 2055-0294 |
| language | English |
| last_indexed | 2024-12-11T10:34:21Z |
| publishDate | 2019-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Pharmaceutical Health Care and Sciences |
| spelling | doaj.art-1888db929ef94a9da5636907542e2c0d2022-12-22T01:10:46ZengBMCJournal of Pharmaceutical Health Care and Sciences2055-02942019-10-01511410.1186/s40780-019-0149-zEvaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system databaseIku Niinomi0Keiko Hosohata1Yasuhiro Mori2Yuki Yamaguchi3Tomohito Wakabayashi4Mayako Uchida5Kazunori Iwanaga6Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical SciencesEducation and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical SciencesEducation and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical SciencesEducation and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical SciencesEducation and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical SciencesEducation and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical SciencesEducation and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical SciencesAbstract Background Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases. The high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however, its safety profile remains unknown in the real world. The purpose of this study was to clarify the adverse events associated with IFX originator and its biosimilar using the Japanese Adverse Drug Event Report (JADER) database. Methods Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency between the third quarter of 2014 and the fourth quarter of 2018. We calculated the reporting odds ratio and 95% confidence interval for each adverse event. Results We obtained 2771 reports of adverse events associated with IFX originator and 402 reports with IFX biosimilar. Signals were detected for pneumonia, interstitial lung disease, tuberculosis, and sepsis with both IFX originator and its biosimilar, whereas there was no signal for infection with the biosimilar. Conclusions The strength of the association between IFX originator and its biosimilar with adverse events is partly different, but reports were quite limited for the biosimilar compared with originator. It is recommended that research be continued in order to accumulate a wide variety of information, and that newly reported data be placed in the multifaceted viewpoints for improvement of care levels.http://link.springer.com/article/10.1186/s40780-019-0149-zBiosimilarInfliximabAdverse drug eventsSpontaneous reporting systemReporting odds ratio (ROR)Japanese Adverse Drug Event Report (JADER) database |
| spellingShingle | Iku Niinomi Keiko Hosohata Yasuhiro Mori Yuki Yamaguchi Tomohito Wakabayashi Mayako Uchida Kazunori Iwanaga Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database Journal of Pharmaceutical Health Care and Sciences Biosimilar Infliximab Adverse drug events Spontaneous reporting system Reporting odds ratio (ROR) Japanese Adverse Drug Event Report (JADER) database |
| title | Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database |
| title_full | Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database |
| title_fullStr | Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database |
| title_full_unstemmed | Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database |
| title_short | Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database |
| title_sort | evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database |
| topic | Biosimilar Infliximab Adverse drug events Spontaneous reporting system Reporting odds ratio (ROR) Japanese Adverse Drug Event Report (JADER) database |
| url | http://link.springer.com/article/10.1186/s40780-019-0149-z |
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