Table 7 Safety events from first dose of eculizumab in parent study
Outcome | Sex | Age Category | Description |
|---|---|---|---|
Experienced meningococcal infection while on eculizumab treatment | Female | 20–29 | • CFH mutation • Vaccinated with Mencevax® (ACYW135), not on prophylactic antibiotics • Meningococcal infection serogroup B identified • Received antibiotics for treatment of infection, which resolved after 9 days, and continued on eculizumab |
Female | 20–29 | • CFH mutation, renal transplant • Vaccinated with Mencevax® (ACYW135), not on prophylactic antibiotics • Meningococcal infection serogroup W135 identified • Received antibiotics for treatment of infection, which resolved after 17 days, and continued on eculizumab | |
Male | 20–29 | • No identified complement abnormality at diagnosis; renal transplant • Vaccinated with Menveo® (ACYW135), prophylactic antibiotics • Meningococcal infection serogroup B identified • Received antibiotics for treatment of infection, which resolved after 10 days, and continued on eculizumab | |
Male | 13–19 | • C3 mutation, renal transplant • Vaccinated with Menactra®, prophylactic antibiotics • Clinical presentation was consistent with possible meningococcal infection (sore throat, knee pain and swelling, skin lesions), but all blood cultures were negative • Received antibiotics for treatment of infection, which resolved after 6 days, and continued on eculizumab | |
Deatha | Male | 30–39 | • C3 mutation, renal transplant, hemorrhagic gastric ulcer s/p gastrotomy • Had discontinued eculizumab approximately 6 months prior to death • Cause of death: Severe intensive care complications and multiorgan dysfunction secondary to gastrointestinal hemorrhage, lithiasic cholecystitis, and sepsis |
Male | < 5 | • No complement abnormality identified at diagnosis; renal failure, respiratory distress, hepatitis, and seizure disorder • Patientb experienced abdominal pain, series of infections and bacterial infection after 10 months on eculizumab at a reduced dose; had seizures attributed to metabolic encephalopathy • Cause of death: Hypoxia due to diffuse alveolar hemorrhage | |
Female | < 5 | • No complement abnormality identified at diagnosis; renal and cardiac failure, pulmonary hypertension, cardiomyopathy • Was on dialysis at diagnosis and was treated with eculizumab for 2 months but discontinued due to “lack of efficacy” • Patient experienced a TMA manifestation with multiorgan failure • Cause of death: Respiratory failure led to cardiac arrest and anoxic brain injury after being off treatment for 7 months |