Disseminated Gonococcal Infections in Patients Receiving Eculizumab: A Case Series

Author:

Crew Page E1ORCID,Abara Winston E2,McCulley Lynda1,Waldron Peter E1,Kirkcaldy Robert D2,Weston Emily J2,Bernstein Kyle T2,Jones S Christopher1,Bersoff-Matcha Susan J1

Affiliation:

1. Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland

2. Division of Sexually Transmitted Disease (STD) Prevention, National Center for Human Immunodeficiency Virus (HIV)/AIDS, Viral Hepatitis, STD and Tuberculosis Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia

Abstract

Abstract Background Gonorrhea is the second most commonly reported notifiable condition in the United States. 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. Methods Pre- and postmarketing safety reports of N. gonorrhoeae infection in patients receiving eculizumab worldwide were obtained from US Food and Drug Administration safety databases and the medical literature, including reports from the start of pivotal clinical trials in 2004 through 31 December 2017. Included patients had at least 1 eculizumab dose within the 3 months prior to N. gonorrhoeae infection. Results Nine cases of N. gonorrhoeae infection were identified; 8 were classified as disseminated (89%). Of the disseminated cases, 8 patients required hospitalization, 7 had positive blood cultures, and 2 required vasopressor support. One patient required mechanical ventilation. Neisseria gonorrhoeae may have contributed to complications prior to death in 1 patient; however, the fatality was attributed to underlying disease per the reporter. Conclusions 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 the Centers for Disease Control and Prevention STD treatment guidelines or in suspected cases. If antimicrobial prophylaxis is used during eculizumab therapy, prescribers should consider trends in gonococcal antimicrobial susceptibility due to emerging resistance concerns.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Reference17 articles.

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2. Gonococcal infections in the adult;Hook,2008

3. Gonococcal arthritis (disseminated gonococcal infection);Rice;Infect Dis Clin North Am,2005

4. Disseminated gonococcal infection in women;Bleich;Obstet Gynecol,2012

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