Soliris Side Effects May Increase Meningococcal Risk 2,000-Fold Despite Vaccination: CDC

Federal health officials indicate that side effects of the immunosuppressant Soliris may increase the risk of meningococcal infections, best known for causing meningitis, even if patients have been vaccinated. 

Soliris (eculizumab) is an immunosuppressant used to treat atypical hemolytic uremic syndrome and paroxysmal noctornal hemoglobinuria. It already carries a black box warning about the risk of meningococcal infection, which is the strongest warning the FDA can review. However, that same black box warning advises health care professionals to “immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection.”

Now, the U.S. Centers for Disease Control and Prevention (CDC), warns that even vaccination may not be enough to prevent meningococcal infections due to Soliris side effects.

In data published last week in the CDC’s Morbidity and Mortality Weekly Report (MMWR), the agency indicates that cases of meningococcal disease have occurred in patients taking Soliris who had been vaccinated.

“Following review of existing meningococcal disease case investigation records, 16 cases of meningococcal disease were identified in eculizumab recipients in the United States for the period 2008–2016,” CDC researchers report. “The majority of cases were caused by nongroupable Neisseria meningitidis and occurred in patients who had documentation of receipt of at least 1 dose of meningococcal vaccine before disease onset.”

Soliris has been linked to a 1,000-fold to 2,000-fold increased risk of meningococcal disease. It can only be prescribed by following an FDA-required Risk Evaluation and Mitigation Strategy (REMS) which is designed to educate doctors and patients about the risk and to detect early signs of infection. That strategy also includes ensuring that patients receive the meningococcal vaccine before beginning Soliris treatment.

The CDC reports that many doctors and health agencies around the world are now recommending that patients be placed on antimicrobial prophylaxis for as long as they take Soliris. For many patients, that means taking antimicrobial treatments for the rest of their lives. The CDC is also now recommending this course of action.

“However, neither vaccination nor antimicrobial prophylaxis can be expected to prevent all cases of meningococcal disease in eculizumab recipients,” the CDC warns. “Heightened awareness, early care seeking, and rapid treatment of any symptoms consistent with meningococcal disease are essential in all patients receiving eculizumab treatment, regardless of meningococcal vaccination or antimicrobial prophylaxis status.”