Identifying the Patterns of Adverse Drug Responses of Cetuximab
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Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widelyused for the past 10 years in oncology. Although drug information package insert contains some representative adverse events whichwere observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were lessinvestigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab usingnational-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in theKorea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and informationcomponents indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, andKorea to compare the current labeling information and newly detected signals of our study. Some of the signals includinghyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightnesswere not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.
Abstract
Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widelyused for the past 10 years in oncology. Although drug information package insert contains some representative adverse events whichwere observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were lessinvestigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab usingnational-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in theKorea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and informationcomponents indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, andKorea to compare the current labeling information and newly detected signals of our study. Some of the signals includinghyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightnesswere not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.
참고문헌 (41)
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