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. 2020 Nov 12;15(11):e0241989.
doi: 10.1371/journal.pone.0241989. eCollection 2020.

Characteristics of and meningococcal disease prevention strategies for commercially insured persons receiving eculizumab in the United States

Catherine H Bozio  1 , Cheryl Isenhour  2 , Lucy A McNamara  1
Affiliations

Characteristics of and meningococcal disease prevention strategies for commercially insured persons receiving eculizumab in the United States

Catherine H Bozio et al. PLoS One. .

Abstract

Introduction: Eculizumab is a licensed treatment for several rare, complement-mediated diseases. Eculizumab use is associated with an approximately 2,000-fold increased meningococcal disease risk. In the United States, meningococcal vaccines are recommended for eculizumab recipients but there are no recommendations on use of long-term antibiotic prophylaxis. We describe characteristics of and meningococcal vaccine and antibiotic receipt in U.S. eculizumab recipients to inform meningococcal disease prevention strategies.

Methods: Persons in the IBM® MarketScan® Research Databases with ≥1 claim for eculizumab injection during 2007-2017 were included. Indication for eculizumab use, meningococcal vaccine receipt, and antibiotic receipt were assessed using International Classification of Diseases-9/10 diagnosis codes, vaccine administration procedure codes, and antibiotic codes from pharmacy claims, respectively.

Results: Overall 696 persons met the inclusion criteria. Paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) were the most common indications for eculizumab use (41% and 37%, respectively); 20% had an undetermined indication. From June 2015 through December 2017, 28% (41/148) of continuously-enrolled patients received ≥1 serogroup B vaccine dose. For serogroup ACWY conjugate vaccine, 45% (91/201) of patients received ≥1 dose within five years of their most recent eculizumab dose, as recommended. Of eculizumab recipients with outpatient prescription data, 7% (41/579) received antibiotics for ≥50% of the period of increased risk for meningococcal disease.

Conclusion: Many eculizumab recipients had an undetermined indication for eculizumab use; few were up-to-date for recommended meningococcal vaccines or were prescribed antibiotics long-term. These findings can inform further investigation of how to best protect this population from meningococcal disease.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Inclusion criteria for full analytic cohort and sub-cohorts in the IBM Marketscan Commercial Database, 2007–2017.
Fig 2
Fig 2. Percentage of eculizumab recipients receiving antibiotics for ≥50% of the risk period by year of starting eculizumab treatment, IBM Marketscan Commercial Database, 2007–2017.
See this image and copyright information in PMC

References

    1. Food and Drug Administration. Soliris product insert. Silver Spring, Maryland: US Department of Health and Human Services, Food and Drug Administration; 2019.
    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):113–8. Epub 2018/11/09. 10.1016/j.jinf.2018.10.015 . - DOI - PMC - PubMed
    1. Crew PE, Abara WE, McCulley L, Waldron PE, Kirkcaldy RD, Weston EJ, et al. Disseminated gonococcal infections in patients receiving eculizumab: A case series. Clinical Infectious Diseases. 2019;69(4):596–600. 10.1093/cid/ciy958 - DOI - PMC - PubMed
    1. Bilukha OO, Rosenstein N, National Center for Infectious Diseases CfDC, Prevention. Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2005;54(RR-7):1–21. Epub 2005/05/27. . - PubMed
    1. Patton ME, Stephens D, Moore K, MacNeil JR. Updated Recommendations for Use of MenB-FHbp Serogroup B Meningococcal Vaccine—Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2017;66(19):509–13. Epub 2017/05/19. 10.15585/mmwr.mm6619a6 - DOI - PMC - PubMed

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