PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data

Abstract

Background Despite evidence of a growing interest among men in minimally invasive cosmetic procedures such as botulinum toxin injections, comparator clinical trial data in this population are limited. Objectives To compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines. Methods Post-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20U prabotulinumtoxinA (n=25) or 20U onabotulinumtoxinA (n=31) in the EVB-003 single-dose Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with a ≥1 point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale (GLS). Adverse events were also summarized. Results Compared with onabotulinumtoxinA-treated males, the percentages of responders who had a ≥1 point improvement on the GLS at maximum frown were higher at all post-baseline time points for prabotulinumtoxinA-treated males (p>0.05 at all visits), by an absolute overall mean difference of 10.1% across all visit. Similar trends were observed for efficacy endpoints based on global aesthetic improvement and subject satisfaction. PrabotulinumtoxinA-treated males had a higher incidence of treatment-related headache and eyelid ptosis. Conclusions The percentages of patients who met the definition of a responder were higher at almost all time points examined for prabotulinumtoxinA-treated males. Despite the high level of consistency across measures, differences between the two treatment groups did not reach statistical significance. Further study is warranted to establish whether observations based on these post-hoc analyses are reproducible in a larger male patient population.

Efficacy, Safety, and Subject Satisfaction of PrabotulinumtoxinA for Moderate-to-Severe Crow’s Feet: A Phase IV, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

“…It is worth noting, however, that prabotulinumtoxin has been subjected to Phase 3 clinical trials that included diverse ethnic groups like Caucasians, African Americans, and Asians [15]. Moreover, in studies focused exclusively on men, prabotulinumtoxin has demonstrated comparable efficacy and side effect profiles to onabotulinumtoxin [16]. These considerations somewhat mitigate the limitations concerning gender and racial biases.…”

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

“…Similar in methodology to previously reported subgroup analyses of prabotulinumtoxinA-treated patients, [14][15][16] data extracted from these single-dose glabellar line studies were pooled and summarized-in this case, for patients less than 65 years of age and those 65 years of age and older. Safety data are reported for all 737 prabotulinumtoxinA-treated participants.…”

“…Kaplan-Meier methodology was used to calculate the durability of response (number of days at which 50% of patients had stopped responding) for the two age groups. As in each of the previous subgroup analyses, [14][15][16] the key efficacy endpoint was the percentage of responders with a ≥1-point improvement from baseline based on the GLS at maximum frown by investigator assessment. The other efficacy endpoint based on the GLS was the percentage of responders with a post-baseline score of 0 or 1 (none or mild) at maximum frown.…”

“…Of note, the approach taken and the endpoints examined in this latest subgroup analysis were intentionally similar to those taken and examined in the three previous post hoc analyses, which have included investigations of outcomes in prabotulinumtoxinA‐treated patients with skin of color, millennials, and males 14–16 . Because of the age‐based nature of both analyses, our paper most closely parallels that of the millennial analysis.…”