Immunogenicity to Botulinum Toxin Type A: A Systematic Review With Meta-Analysis Across Therapeutic Indications

Aesthet Surg J. 2022 Jan 1;42(1):106-120. doi: 10.1093/asj/sjab058.

Abstract

Background: Botulinum toxin A (BTX-A) is commonly employed as a neuromodulator in several neurological diseases and aesthetic indications. Formation of neutralizing antibodies (NAbs) after BTX-A injections may be responsible for treatment failure.

Objectives: The authors sought to quantify the prevalence of NAbs following treatment with Abobotulinumtoxin A, Incobotulinumtoxin A, and Onabotulinumtoxin A for therapeutic indications.

Methods: An electronic systematic search (2000-2020) of PubMed, Scopus, Web of Science, and Embase was conducted. Original studies reporting prevalence of NAbs were included. Data analysis was carried out through open meta-analysis softwares.

Results: Forty-three studies involving 8833 patients were included in this meta-analysis. The incidence of NAbs was 1.8% (summary estimate = 0.018, 95% CI [0.012, 0.023]); a meta-regression analysis revealed that BTX-A duration was significantly associated with increased incidence of NAbs (P = 0.007). Patients with dystonia had the highest incidence (7.4%) of NAbs against BTX-A (summary estimate = 0.074, 95% CI = [0.045, 0.103], I2 = 93.%, P < 0.00) followed by patients with spasticity (6.7%) and urological indications (6.2%). Abobotulinumtoxin A was associated with the highest incidence of NAbs (7.4%) (summary estimate = 0.074, 95% CI = [0.053, 0.096], I2 = 97.24%, P < 0.00) by the Incobotulinumtoxin A and Onabotulinumtoxin A 0.3% (summary estimate <0.003%, 95% CI = [-0.001, 0.007], P < 0.003).

Conclusions: Although the overall incidence of NAbs following BTX-A injections is relatively low, patients with secondary nonresponse to BTX-A with no apparent causes should be investigated for NAbs. A consensus needs to be developed for the optimal management of such patients.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Antibodies, Neutralizing
  • Botulinum Toxins, Type A* / adverse effects
  • Esthetics
  • Humans
  • Muscle Spasticity
  • Neuromuscular Agents* / adverse effects

Substances

  • Antibodies, Neutralizing
  • Neuromuscular Agents
  • Botulinum Toxins, Type A