Immunogenicity
No treatment-emergent ADAs were observed in any of the patients receiving ravulizumab during 26 weeks of treatment. Eight (9.3%) patients were ADA-positive at baseline (pre-treatment) but were ADA-negative at all times following the first dose of ravulizumab. The ADA titers were low and transient, no apparent impact of immunogenicity on ravulizumab pharmacokinetics/pharmacodynamics was observed, and all assay results for anti-drug neutralizing antibodies in ADA-positive samples were negative.