Serious Bacterial Infections Associated with Eculizumab: A Pharmacovigilance Study
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- Okusa Shohei
- Department of Neurology, Keio University School of Medicine, Japan
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- Takizawa Tsubasa
- Department of Neurology, Keio University School of Medicine, Japan
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- Imai Shungo
- Division of Drug Informatics, Keio University Faculty of Pharmacy, Japan
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- Oyama Munenori
- Department of Neurology, Keio University School of Medicine, Japan
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- Ishizuchi Kei
- Department of Neurology, Keio University School of Medicine, Japan
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- Nakahara Jin
- Department of Neurology, Keio University School of Medicine, Japan
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- Hori Satoko
- Division of Drug Informatics, Keio University Faculty of Pharmacy, Japan
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- Suzuki Shigeaki
- Department of Neurology, Keio University School of Medicine, Japan
抄録
<p>Objective Molecular-targeted agents, including eculizumab and rituximab, are considered treatment options for refractory myasthenia gravis (MG), but bacterial infections can occur as serious adverse events when using these agents. The present study elucidated the relative risks of bacterial infections associated with eculizumab and rituximab using a pharmacovigilance database. </p><p>Methods We analyzed eculizumab- and rituximab-associated adverse events reported between 2007 and 2021 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) and herein report a refractory MG patient who developed streptococcal toxic shock syndrome during eculizumab treatment. </p><p>Patients We evaluated a 74-year-old Japanese woman with refractory MG who developed severe bacteremia after receiving eculizumab. </p><p>Results A total of 44,215 and 108,485 adverse events were reported with eculizumab and rituximab, respectively, from among 13,742,321 individual case safety reports in the FAERS database after data cleaning. We found a strong association between eculizumab and Neisseria infections. In contrast, we found only one case of meningococcal meningitis treated with rituximab. Both eculizumab and rituximab were weakly associated with streptococcal infections. Two cases of streptococcal toxic shock syndrome were associated with rituximab. </p><p>Conclusion Careful monitoring of serious bacterial infections associated with eculizumab treatment is warranted. </p>
収録刊行物
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- Internal Medicine
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Internal Medicine 63 (8), 1061-1066, 2024-04-15
一般社団法人 日本内科学会