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

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

Drug summary box

Box 1. Drug summary

Declaration of interest

F Ahmed has been on the advisory board of Allergan, Teva, Lundbeck, Novartis, and Eli Lilly for which he has been paid honorarium donated to registered charities i.e. British Association for the Study of Headache, Migraine Trust and the Anglo-Dutch Migraine Association. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

AbbVie provided a scientific accuracy review at the request of the journal editor.

Reviewer disclosures

A reviewer on this manuscript has disclosed that they consult for Allergan. All other peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.