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Eculizumab Associated Meningitis

Eculizumab (Soliris, Alexion Pharmaceuticals) is a recombinant humanized monoclonal antibody (IgG2/4 kappa) that was designed to block the activation of terminal complement components. It is licensed in the United States for treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Eculizumab binds to the terminal complement protein C5, inhibiting its cleavage into C5a and C5b, thereby preventing the release of the inflammatory mediator C5a and the formation of the cytolytic pore C5b–C9. Blockade of the complement cascade at C5 preserves the early components of complement that are essential for the opsonization of microorganisms and clearance of immune complexes. In spite of this molecular design, recent evidence indicates that patients treated with eculizumab have a 1000 to 2000-fold increased incidence of meningococcal disease, even if they have received meningococcal vaccination. Food and Drug Administration (FDA)–approved prescribing information includes a boxed warning regarding increased risk for meningococcal disease in eculizumab recipients.

The majority of cases are caused by nongroupable Neisseria meningitidis and occur in patients who received at least 1 dose of meningococcal vaccine before disease onset. Nongroupable N. meningitidis is often carried asymptomatically in the nasopharynx, but it rarely causes disease in healthy persons.

The Advisory Committee on Immunization Practices recommends both MenACWY and MenB vaccination for patients taking eculizumab. MenACWY vaccines target the serogroup-specific polysaccharide capsule and provide no protection against nongroupable N. meningitidis. MenB vaccines are licensed specifically for protection against serogroup B meningococcal disease. Available evidence suggests that eculizumab interferes with the ability of anti-meningococcal antibodies to protect against invasive disease. Many clinicians and public health agencies recommend antimicrobial prophylaxis with penicillin for the duration of eculizumab treatment. Long-term penicillin prophylaxis is generally considered to be safe.

Neither vaccination nor antimicrobial prophylaxis can be expected to prevent all cases of meningococcal disease in eculizumab recipients.  Health care providers should have a high index of suspicion for meningococcal disease in patients taking eculizumab who develop any symptoms consistent with either meningitis or meningococcemia, even if the patient’s symptoms initially appear mild, and even if the patient has been fully vaccinated or is receiving antimicrobial prophylaxis.

Lucy A. McNamara, PhD; Nadav Topaz, MSc; Xin Wang, PhD; Susan Hariri, PhD; LeAnne Fox, MD; Jessica R. MacNeil, MPH. High Risk for Invasive Meningococcal Disease Among Patients Receiving Eculizumab (Soliris) Despite Receipt of Meningococcal Vaccine. MMWR Weekly / July 14, 2017 / 66(27);734-737.

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