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Clin Infect Dis. 2018 Nov 12. doi: 10.1093/cid/ciy958. [Epub ahead of print]

Disseminated gonococcal infections in patients receiving eculizumab: a case series.

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Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.



Gonorrhea is the second most commonly reported notifiable condition in the United States (U.S.). Infrequently, Neisseria gonorrhoeae can cause disseminated gonococcal infection (DGI). Eculizumab, a monoclonal antibody, inhibits terminal complement activation which impairs the ability of the immune system to respond effectively to Neisseria infections. This series describes cases of N. gonorrhoeae infection among patients receiving eculizumab.


Pre- and postmarketing safety reports of N.gonorrhoeae infection in patients receiving eculizumab worldwide were obtained from FDA safety databases and the medical literature, including reports from the start of pivotal clinical trials in 2004 through December 31, 2017. Included patients had at least one eculizumab dose within the three months prior to N. gonorrhoeae infection.


Nine cases of N. gonorrhoeae infection were identified; eight were classified as disseminated (89%). Of the disseminated cases, eight patients required hospitalization, seven had positive blood cultures, and two required vasopressor support. One patient required mechanical ventilation. N. gonorrhoeae may have contributed to complications prior to death in one patient; however, the fatality was attributed to underlying disease per the reporter.


Patients receiving eculizumab may be at higher risk for DGI than the general population. Prescribers are encouraged to educate patients receiving eculizumab on their risk for serious gonococcal infections and perform screening for sexually transmitted diseases (STDs) per Centers for Disease Control and Prevention STD treatment guidelines or in suspect cases. If antimicrobial prophylaxis is used during eculizumab therapy, prescribers should consider trends in gonococcal antimicrobial susceptibility due to emerging resistance concerns.


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