PrabotulinumtoxinA for the treatment of glabellar lines in adults, 65 years of age and older: The fourth in a series of post hoc analyses of the phase III clinical study data

Abstract

AbstractBackgroundDespite the absence of Phase III clinical trial data to support their use, 3.4% of all neurotoxin treatments performed internationally for esthetic purposes in 2020 were performed in patients 65 years of age and older.ObjectivesTo investigate the efficacy and safety of prabotulinumtoxinA for the treatment of moderate to severe glabellar lines in the subset of Phase III clinical trial participants who were 65 years of age and older.MethodsPost hoc analyses were performed on all patients who had been treated with a single dose of 20 U prabotulinumtoxinA in the three 150‐day, placebo‐controlled Phase III glabellar line clinical studies. Patients were grouped by age: ≥65 years (n = 70) versus <65 years (n = 667). The endpoints of primary interest were the proportion of responders with a ≥1‐point improvement from baseline at maximum frown on the 4‐point Glabellar Line Scale and treatment‐related adverse events.ResultsFor the efficacy endpoint of primary interest, responder rates among patients 65 years of age and older were numerically less than those of patients less than 65 years by an absolute mean difference of just −2.7% across all visits; none of the differences at any visit were statistically significant. The most common treatment‐related adverse event was headache, occurring in 5.7% of those 65 years of age and older and in 9.7% of those less than 65 years.Conclusions20 U prabotulinumtoxinA administered for the treatment of glabellar lines was efficacious in patients 65 years of age and older; it was also well tolerated by this cohort.