Managing the Risk of Meningococcal Disease among Patients Who Receive Eculizumab Therapy

Recent data suggest that meningococcal vaccines likely provide incomplete protection against invasive meningococcal disease in eculizumab (Soliris®) recipients. In addition to vaccination, healthcare providers could consider antimicrobial prophylaxis for the duration of eculizumab therapy to potentially reduce the risk of meningococcal disease.

 

Taking Eculizumab Increases the Risk of Meningococcal Disease

Eculizumab is most commonly prescribed for treatment of two rare blood disorders: atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH).

Eculizumab recipients are at 1,000 to 2,000 times greater risk for getting meningococcal disease compared to otherwise healthy individuals in the United States. The Food and Drug Administration-approved prescribing information for eculizumab includes a black box warning for increased risk of meningococcal disease. The warning includes a recommendation to administer meningococcal vaccines to patients receiving eculizumab.

Heightened awareness, early care seeking, and rapid treatment of any symptoms consistent with meningococcal disease are essential in all patients receiving eculizumab, regardless of meningococcal vaccination or antimicrobial prophylaxis status.

Healthcare providers should have a high index of suspicion for meningococcal disease in patients taking eculizumab who present with any symptoms consistent with either meningitis or meningococcemia. You need to have this high index of suspicion even if your patient’s symptoms initially appear mild and even if your patient has been fully vaccinated or is receiving antimicrobial prophylaxis.

 

Patients Taking Eculizumab at High Risk for Meningococcal Disease Even if Vaccinated

Recent data show that some patients receiving eculizumab who were up to date with meningococcal vaccination still developed meningococcal disease. Nongroupable Neisseria meningitidis caused most of these infections. Nongroupable N. meningitidis typically does not cause invasive meningococcal disease.

Meningococcal conjugate (MenACWY) vaccine targets serogroups A, C, W, and Y, and provides no protection against nongroupable N. meningitidis. Serogroup B meningococcal (MenB) vaccines are licensed specifically for protection against serogroup B meningococcal disease. Researchers have not assessed the extent of any potential cross protection for nongroupable N. meningitidis strains.

Despite disease occurring among vaccinated individuals, healthcare providers should continue immunizing patients who receive eculizumab. According to the product label, you should administer meningococcal vaccines at least 2 weeks prior to administering the first dose of eculizumab, unless the risks of delaying eculizumab therapy outweigh the risks of developing meningococcal disease. CDC recommends both MenACWY vaccine and the full series of MenB vaccine (2 or 3 doses depending on brand) for eculizumab recipients. Administer a booster dose of MenACWY vaccine every 5 years, for the duration of eculizumab therapy. CDC does not currently have recommendations about if or when to administer booster doses of MenB vaccine.

 

References

• Food and Drug Administration. Soliris® (eculizumab) product label [33 pages]. Accessed 6/2017.

• McNamara LA, Topaz N, Wang X, Hariri S, Fox L, MacNeil J. High risk for invasive meningococcal disease among patients receiving eculizumab (Soliris) despite receipt of meningococcal vaccine. MMWR Morb Mortal Wkly Rep. 2017;66(27):734–7.