High Patient Satisfaction for up to 6 Months With OnabotulinumtoxinA Treatment for Upper Facial Lines.

BACKGROUND

OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL).

OBJECTIVE

To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL.

MATERIALS AND

METHODS

A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction.

RESULTS

OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days.

CONCLUSION

A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction.