OnabotulinumtoxinA for the prophylactic treatment of headaches in adult patients with chronic migraine: a safety evaluation

Expert Opin Drug Saf. 2021 Nov;20(11):1275-1289. doi: 10.1080/14740338.2021.1948531. Epub 2021 Jul 5.

Abstract

Introduction: Existing oral prophylaxis for chronic migraine (CM) are often ineffective or poorly tolerated. OnabotulinumtoxinA (onabotA) is approved for headache prophylaxis in CM and ameliorates headaches in patients refractory to multiple preventatives.Areas covered: We appraise evidence regarding action mechanisms, pharmacodynamics, and pharmacokinetics of onabotA in CM prophylaxis. We critically evaluate salient clinical and real-world studies demonstrating its efficacy in improving multiple aspects of CM. We discuss onabotA safety, tolerability, and adverse events (AEs) for CM prophylaxis from clinical trials, post-authorization studies and meta-analyses, including novel pregnancy safety data and comparisons with oral prophylactics. We explore areas of future interest, particularly onabotA safety and efficacy in the context of novel antibody-based prophylaxis.Expert opinion: Clinical and real-world evidence demonstrate onabotA safety, tolerability and efficacy for CM prophylaxis. Most AEs are mild/moderate and self-limiting, with few serious AEs and no treatment-related deaths. Common AEs include neck pain, ptosis, muscle weakness, and stiffness. Modifying existing responder-criteria enables more patients to benefit from onabotA. OnabotA shows superior safety and efficacy to oral preventatives, and appears safe in pregnancy. Future pregnancy-risk register will clarify pregnancy and lactation safety further. Future research comparing onabotA safety and efficacy with newly emergent antibody-based prophylaxis is keenly awaited.

Keywords: Onabotulinumtoxin a; chronic migraine; prophylaxis; safety; tolerability.

Publication types

  • Review

MeSH terms

  • Adult
  • Animals
  • Botulinum Toxins, Type A / administration & dosage*
  • Botulinum Toxins, Type A / adverse effects
  • Botulinum Toxins, Type A / pharmacology
  • Headache / prevention & control
  • Humans
  • Migraine Disorders / drug therapy*
  • Migraine Disorders / physiopathology
  • Neuromuscular Agents / administration & dosage*
  • Neuromuscular Agents / adverse effects
  • Neuromuscular Agents / pharmacology

Substances

  • Neuromuscular Agents
  • Botulinum Toxins, Type A
  • onabotulinum toxin A