After vaccine, meningococcal disease risk still high with Soliris use

The risk for meningococcal disease remains high in patients using the blood disorder drug Soliris, even after they have received a meningococcal vaccine, according to CDC researchers.

Patients should still receive meningococcal vaccines before they begin treatment with Soliris (eculizumab, Alexion Pharmaceuticals), and antimicrobial prophylaxis could be an option, the researchers wrote in MMWR.

“Health care providers should continue to follow recommendations from the Advisory Committee on Immunization Practices for eculizumab recipients to receive both MenACWY and MenB vaccines and could consider antimicrobial prophylaxis for the duration of eculizumab treatment to potentially reduce the risk for meningococcal disease,” Lucy A. McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, and colleagues wrote.

Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), both of which can lead to damage to vital organs. PNH is an acquired disease that attacks red blood cells, and aHUS is a genetic disease affecting children and adults.

Eculizumab comes with a warning of increased meningococcal disease risk. In 2014, the FDA announced that use of eculizumab is associated with a 1,000 to 2,000-fold increase in the risk for meningococcal disease.

In their own study, McNamara and colleagues found 16 cases of meningococcal disease in patients who received eculizumab in the United States from 2008 to 2016. Of those, 11 were caused by nongroupable Neisseria meningitidis. Fourteen patients had documented treatment with at least one dose of a meningococcal vaccine before disease onset, the researchers said.

Isolates taken from the 14 cases were mostly susceptible to six of seven antibiotics. However, 11 isolates were resistant to trimethoprim/sulfamethoxazole. One isolate was resistant to ciprofloxacin, and one to penicillin.

Ten cases involved meningococcemia — the presence of the associated bacterium in the blood — without meningitis, the researchers said. Meningococcemia can cause relatively mild, influenza-like symptoms.

“However, these symptoms can progress to severe illness and death within hours,” the researchers warned. “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.”

The CDC is asking all state health departments to fill out a report form for all meningococcal disease cases in patients receiving eculizumab. That form can be found at www.cdc.gov/meningococcal/surveillance/index.html.

The agency asks that forms be sent by secure email to meningnet@cdc.gov or secure fax at 404-471-8372. If available, isolates can also be submitted for whole genome sequencing. – by Joe Green

Disclosure: The researchers report no relevant financial disclosures.

 

The risk for meningococcal disease remains high in patients using the blood disorder drug Soliris, even after they have received a meningococcal vaccine, according to CDC researchers.

Patients should still receive meningococcal vaccines before they begin treatment with Soliris (eculizumab, Alexion Pharmaceuticals), and antimicrobial prophylaxis could be an option, the researchers wrote in MMWR.

“Health care providers should continue to follow recommendations from the Advisory Committee on Immunization Practices for eculizumab recipients to receive both MenACWY and MenB vaccines and could consider antimicrobial prophylaxis for the duration of eculizumab treatment to potentially reduce the risk for meningococcal disease,” Lucy A. McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, Division of Bacterial Diseases, and colleagues wrote.

Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), both of which can lead to damage to vital organs. PNH is an acquired disease that attacks red blood cells, and aHUS is a genetic disease affecting children and adults.

Eculizumab comes with a warning of increased meningococcal disease risk. In 2014, the FDA announced that use of eculizumab is associated with a 1,000 to 2,000-fold increase in the risk for meningococcal disease.

In their own study, McNamara and colleagues found 16 cases of meningococcal disease in patients who received eculizumab in the United States from 2008 to 2016. Of those, 11 were caused by nongroupable Neisseria meningitidis. Fourteen patients had documented treatment with at least one dose of a meningococcal vaccine before disease onset, the researchers said.

Isolates taken from the 14 cases were mostly susceptible to six of seven antibiotics. However, 11 isolates were resistant to trimethoprim/sulfamethoxazole. One isolate was resistant to ciprofloxacin, and one to penicillin.

Ten cases involved meningococcemia — the presence of the associated bacterium in the blood — without meningitis, the researchers said. Meningococcemia can cause relatively mild, influenza-like symptoms.

“However, these symptoms can progress to severe illness and death within hours,” the researchers warned. “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.”

The CDC is asking all state health departments to fill out a report form for all meningococcal disease cases in patients receiving eculizumab. That form can be found at www.cdc.gov/meningococcal/surveillance/index.html.

The agency asks that forms be sent by secure email to meningnet@cdc.gov or secure fax at 404-471-8372. If available, isolates can also be submitted for whole genome sequencing. – by Joe Green

Disclosure: The researchers report no relevant financial disclosures.