Page E Crew1, Winston E Abara2, Lynda McCulley1, Peter E Waldron1, Robert D Kirkcaldy2, Emily J Weston2, Kyle T Bernstein2, S Christopher Jones1, Susan J Bersoff-Matcha1. 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
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. Published by Oxford University Press for the Infectious Diseases Society of America 2018.
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. Published by Oxford University Press for the Infectious Diseases Society of America 2018.
Authors: Robert D Kirkcaldy; Alesia Harvey; John R Papp; Carlos Del Rio; Olusegun O Soge; King K Holmes; Edward W Hook; Grace Kubin; Stefan Riedel; Jonathan Zenilman; Kevin Pettus; Tremeka Sanders; Samera Sharpe; Elizabeth Torrone Journal: MMWR Surveill Summ Date: 2016-07-15
Authors: John R Papp; A Jeanine Abrams; Evelyn Nash; Alan R Katz; Robert D Kirkcaldy; Norman P O'Connor; Pamela S O'Brien; Derek H Harauchi; Eloisa V Maningas; Olusegun O Soge; Ellen N Kersh; Alan Komeya; Juval E Tomas; Glenn M Wasserman; Gail Y Kunimoto; David L Trees; A Christian Whelen Journal: Emerg Infect Dis Date: 2017-05 Impact factor: 6.883
Authors: Page E Crew; Lucy McNamara; Peter E Waldron; Lynda McCulley; S Christopher Jones; Susan J Bersoff-Matcha Journal: J Infect Date: 2019-11-26 Impact factor: 6.072
Authors: Sami L Gottlieb; Francis Ndowa; Edward W Hook; Carolyn Deal; Laura Bachmann; Laith Abu-Raddad; Xiang-Sheng Chen; Ann Jerse; Nicola Low; Calman A MacLennan; Helen Petousis-Harris; Kate L Seib; Magnus Unemo; Leah Vincent; Birgitte K Giersing Journal: Vaccine Date: 2020-04-28 Impact factor: 3.641
Authors: Sunita Gulati; Michael W Pennington; Andrzej Czerwinski; Darrick Carter; Bo Zheng; Nancy A Nowak; Rosane B DeOliveira; Jutamas Shaughnessy; George W Reed; Sanjay Ram; Peter A Rice Journal: mBio Date: 2019-11-05 Impact factor: 7.867
Authors: Jutamas Shaughnessy; Y Tran; Bo Zheng; Rosane B DeOliveira; Sunita Gulati; Wen-Chao Song; James M Maclean; Keith L Wycoff; Sanjay Ram Journal: Front Immunol Date: 2020-10-26 Impact factor: 7.561