. 2020 Mar;80(3):350-371.

doi: 10.1016/j.jinf.2019.11.015. Epub 2019 Nov 26.

Antibiotic prophylaxis in vaccinated eculizumab recipients who developed meningococcal disease

Page E Crew¹, Lucy McNamara², Peter E Waldron³, Lynda McCulley³, S Christopher Jones³, Susan J Bersoff-Matcha⁴

Affiliations

¹ Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Page.Crew@fda.hhs.gov.
² Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
³ Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
⁴ Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

PMID: 31783062
PMCID: PMC7197327
DOI: 10.1016/j.jinf.2019.11.015

Antibiotic prophylaxis in vaccinated eculizumab recipients who developed meningococcal disease

Page E Crew et al. J Infect. 2020 Mar.

. 2020 Mar;80(3):350-371.

doi: 10.1016/j.jinf.2019.11.015. Epub 2019 Nov 26.

Authors

Page E Crew¹, Lucy McNamara², Peter E Waldron³, Lynda McCulley³, S Christopher Jones³, Susan J Bersoff-Matcha⁴

Affiliations

¹ Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Page.Crew@fda.hhs.gov.
² Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
³ Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
⁴ Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA; Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

PMID: 31783062
PMCID: PMC7197327
DOI: 10.1016/j.jinf.2019.11.015

No abstract available

Keywords: Antibiotic prophylaxis; Eculizumab; Neisseria meningitidis.

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Conflict of interest statement

Transparency Declaration: The authors have no potential conflicts of interest to disclose.

Figures

**Figure 1.**
Age (years) of patients at time of starting eculizumab therapy versus TTO of first meningococcal disease episode The relationship between age when patients started treatment and TTO of first meningococcal disease episode, for prophylaxis recipients and non-prophylaxis recipients. Key: Orange square = patients taking antibiotic prophylaxis with reported TTO (n=11) Blue circle = patients not taking antibiotic prophylaxis with reported TTO (n=26) Orange … dotted line = median TTO (835 days) for patients taking antibiotic prophylaxis with reported TTO (n=11) Blue --- dashed line = median TTO (333 days) for patients not taking antibiotic prophylaxis with reported TTO (n=26) Note, one patient in the “prophylaxis group” was 18 years of age with a TTO=53 days, and one patient in the “no prophylaxis group” was also 18 years of age with a TTO=53. These data points overlap on the figure.

See this image and copyright information in PMC

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References

1. Crew PE, McNamara L, Waldron PE, McCulley L, Jones SC, Bersoff-Matcha SJ. Unusual Neisseria species as a cause of infection in patients taking eculizumab. J Infect 2019; 78 (2): 113–18. - PMC - PubMed
1. Soliris (eculizumab) [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc; 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf. Updated June 27, 2019 Accessed on September 6, 2019.
1. Crew PE, Abara WE, McCulley L, et al. Disseminated gonococcal infections in patients receiving eculizumab: a case series. Clin Infect Dis 2018. - PMC - PubMed
1. McNamara LA, Topaz N, Wang X, Hariri S, Fox L, MacNeil JR. High Risk for Invasive Meningococcal Disease Among Patients Receiving Eculizumab (Soliris) Despite Receipt of Meningococcal Vaccine. MMWR Morb Mortal Wkly Rep 2017; 66 (27): 734–37. - PMC - PubMed
1. Parikh SR, Lucidarme J, Bingham C, et al. Meningococcal B Vaccine Failure With a Penicillin-Resistant Strain in a Young Adult on Long-Term Eculizumab. Pediatrics 2017; 140 (3). - PubMed

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Antibiotic prophylaxis in vaccinated eculizumab recipients who developed meningococcal disease

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Antibiotic prophylaxis in vaccinated eculizumab recipients who developed meningococcal disease

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