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

Mitchell F. Brin, MD; Koen De Boulle, MD; Steven Liew, MBBS; Alastair Carruthers, MD; Jean Carruthers, MD; Alexander Rivkin, MD; Yan Wu, MD, PhD; Makoto Kawashima, MD; Irina Yushmanova, MD; Terry I. Boodhoo, MS; Elisabeth Lee, MPH

JAAD International (Mar 2024)

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

Mitchell F. Brin, MD,
Koen De Boulle, MD,
Steven Liew, MBBS,
Alastair Carruthers, MD,
Jean Carruthers, MD,
Alexander Rivkin, MD,
Yan Wu, MD, PhD,
Makoto Kawashima, MD,
Irina Yushmanova, MD,
Terry I. Boodhoo, MS,
Elisabeth Lee, MPH

Affiliations

Mitchell F. Brin, MD: Allergan Aesthetics, an AbbVie Company, Irvine, California; University of California, Irvine, California; Correspondence to: Mitchell F. Brin, MD, Allergan Aesthetics, an AbbVie Company, 2525 Dupont Dr, T2-3, Irvine, CA 92623-9534.
Koen De Boulle, MD: Aalst Dermatology Clinic, Aalst, Belgium
Steven Liew, MBBS: Private Practice, Sydney, NSW, Australia
Alastair Carruthers, MD: University of British Columbia, Vancouver, British Columbia, Canada
Jean Carruthers, MD: University of British Columbia, Vancouver, British Columbia, Canada
Alexander Rivkin, MD: Private Practice, Los Angeles, California
Yan Wu, MD, PhD: Peking University First Hospital, Beijing, China
Makoto Kawashima, MD: Tokyo Women’s Medical University School of Medicine, Tokyo, Japan
Irina Yushmanova, MD: Allergan Aesthetics, an AbbVie Company, Irvine, California
Terry I. Boodhoo, MS: Allergan Aesthetics, an AbbVie Company, Irvine, California
Elisabeth Lee, MPH: Allergan Aesthetics, an AbbVie Company, Irvine, California

Journal volume & issue: Vol. 14
pp. 4 – 18

Abstract

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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.

Published in JAAD International

ISSN: 2666-3287 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Dermatology
Website: https://www.journals.elsevier.com/jaad-international

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