Pharmacokinetic, pharmacodynamic, and immunogenicity endpoints
file).Immunogenicity
RARE DISEASE
Pre-specified pharmacokinetic endpoints were the change in serum ravulizumab concentration over time, including the maximum/peak observed serum concentration (The pharmacodynamic effects of ravulizumab were measured as absolute values and changes and percentage changes from baseline in serum free C5 concentration over time. In these analyses, complete terminal complement inhibition was defined as a serum free C5 concentration of < 0.5 μg/mL (Alexion, AstraZeneca Rare Disease, data on file).Immunogenicity was assessed as the incidence of treatment-emergent ADAs throughout the duration of the study. Patients with treatment-emergent ADA responses would be further assessed for the impact of immunogenicity on pharmacokinetics and pharmacodynamics.