2.5. Clinical Response and Immune-Related AEs in Subjects with Treatment-Induced Binding Antibodies to DaxibotulinumtoxinA or RTP004
Despite the observation that no subjects developed neutralizing antibodies to daxibotulinumtoxinA, the impact of the presence of binding antibodies to daxibotulinumtoxinA or RTP004 on clinical efficacy was nonetheless evaluated. All subjects (100%) with treatment-induced binding antibodies to daxibotulinumtoxinA or RTP004 showed clinical efficacy, achieving a rating of none or mild glabellar line severity on both the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales at Week 4 following each cycle of DAXI treatment. The temporal distribution of binding antibody results, DAXI treatments, and efficacy based on IGA-FWS of none (0) or mild (1) severity, and duration of clinical response for each subject with treatment-related binding antibodies to daxibotulinumtoxinA are shown in Duration of clinical benefit was determined for the treatment cycles in which anti-daxibotulinumtoxinA binding antibodies were detected and compared with the duration in treatment cycles in which no anti-daxibotulinumtoxinA binding antibodies were detected. In the 21 subjects with at least one positive test result, the mean duration of efficacy in those study cycles (No subjects observed to have binding antibodies to either daxibotulinumtoxinA or RTP004 reported the occurrence of immune-related AEs.