Serious Bacterial Infections Associated with Eculizumab: A Pharmacovigilance Study.
Intern Med
; 63(8): 1061-1066, 2024 Apr 15.
Article
en En
| MEDLINE
| ID: mdl-37690847
ABSTRACT
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. 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. Patients We evaluated a 74-year-old Japanese woman with refractory MG who developed severe bacteremia after receiving eculizumab. 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. Conclusion Careful monitoring of serious bacterial infections associated with eculizumab treatment is warranted.
Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Choque Séptico
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Infecciones Estreptocócicas
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Anticuerpos Monoclonales Humanizados
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Meningitis Meningocócica
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Miastenia Gravis
Tipo de estudio:
Risk_factors_studies
Límite:
Aged
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Female
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Humans
Idioma:
En
Revista:
Intern Med
Asunto de la revista:
MEDICINA INTERNA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Japón