Demographic, clinical symptoms, and infusion reaction
data were recorded from the patients' charts.
2% of patients in the sipuleucel-T group developed an acute infusion reaction
These fatalities were associated with an infusion reaction
symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock.
Also, if they don't have such a robust response, it probably means they have antibodies to pegylated uricase, which also increases their risk of an infusion reaction
During an infusion reaction
, early intervention may prevent serious side effects and death.
Safe use is possible if rising concentrations of serum urate - a sign of antibody development and impending infusion reaction
- are caught in time.
Antibody concentrations at or above the cutoff increased the relative risk of an infusion reaction
by a factor of 2.
The most common Grade 3-5 side effects (occurring in at least 5 percent of patients) observed more frequently in the Gazyva arm were low white blood cell count, infusion reactions
, low white blood cell count with fever and low platelet count.
ZW25 continues to be well-tolerated at all doses and schedules, with the most common adverse events being Grade 1 or 2 diarrhea, infusion reactions