Safety and tolerability of onabotulinumtoxinA in the treatment of upper facial lines from global registration studies in 5298 participants: A meta-analysis

Mitchell F Brin; Koen De Boulle; Steven Liew; Alastair Carruthers; Jean Carruthers; Alexander Rivkin; Yan Wu; Makoto Kawashima; Irina Yushmanova; Terry I Boodhoo; Elisabeth Lee

doi:10.1016/j.jdin.2023.07.021

Safety and tolerability of onabotulinumtoxinA in the treatment of upper facial lines from global registration studies in 5298 participants: A meta-analysis

JAAD Int. 2023 Sep 9:14:4-18. doi: 10.1016/j.jdin.2023.07.021. eCollection 2024 Mar.

Authors

Affiliations

¹ Allergan Aesthetics, an AbbVie Company, Irvine, California.
² University of California, Irvine, California.
³ Aalst Dermatology Clinic, Aalst, Belgium.
⁴ Private Practice, Sydney, NSW, Australia.
⁵ University of British Columbia, Vancouver, British Columbia, Canada.
⁶ Private Practice, Los Angeles, California.
⁷ Peking University First Hospital, Beijing, China.
⁸ Tokyo Women's Medical University School of Medicine, Tokyo, Japan.

Abstract

Background: Since its discovery as a facial aesthetic treatment >30 years ago, onabotulinumtoxinA has received worldwide approval for dynamic upper facial line treatment.

Objective: Meta-analysis examining the safety of onabotulinumtoxinA for treatment of glabellar lines (GL), crow's feet lines (CFL), and forehead lines (FHL).

Methods: Participants (N = 5298) with moderate to severe GL, CFL, or FHL at maximum contraction received onabotulinumtoxinA or placebo in 1 of 18 registration studies (14 double-blind, placebo-controlled [DBPC]; 1 double-blind; 3 open-label). Adverse events (AEs) were analyzed by descriptive statistics and fixed-effects meta-analysis.

Results: In the overall double-blind placebo-controlled (DBPC) population, AEs were reported in 1443 (42.1%) and 486 (35.8%) participants in the onabotulinumtoxinA (n = 3431) and placebo (n = 1359) groups, respectively. Serious AEs were reported in 54 (1.6%) and 17 (1.3%) participants; 1 (spontaneous abortion) was considered possibly treatment related by the investigator. Using fixed-effects statistical meta-analysis, AEs of interest that were found to be statistically higher for onabotulinumtoxinA than placebo in the DBPC population were eyelid ptosis, eyelid sensory disorder, skin tightness, brow ptosis, eyelid edema, and facial pain (P ≤ .05).

Limitations: Retrospective, ad hoc analysis.

Conclusion: This meta-analysis confirms the onabotulinumtoxinA safety profile for GL, CFL, and FHL treatment, with no new onabotulinumtoxinA-associated AEs.

Keywords: Botox; aesthetic; botulinum toxin; cosmetic; crow’s feet lines; forehead lines; glabellar lines; lateral canthal lines; onabotulinumtoxinA; rhytids.