Botulinum Toxin Off Label Use in Chronic Migraine Patients: An American Headache Society Clinical Survey Study
Ashhar Ali1, Kendra Davis2, Paul Mathew3
1Henry Ford, 2Henry Ford Hospital, 3Harvard Medical School/BWH/HVMA
Objective:
To investigate the off-label clinical use of botulinum toxins (BTX) in patients with chronic migraine (CM) amongst the American Headache Society (AHS) Membership.
Background:
CM is defined as the presence of headache >=15 days per month with 8 days of headache meeting criteria for migraine with or without aura for 3 months. The FDA approved onabotulinumtoxin A for the treatment of CM in 2010, but in clinical practice other BTX are used off-label. The objective of this study was to better understand the frequency and nature of off-label BTX use, by surveying members of AHS.
Design/Methods:
The AHS Procedural Headache Medicine Special Interest Group created a 15 question survey. Questions included demographic inquiry (practice type, location, provider specialty, board certification status) and questions pertaining to the use of BTX. Dissemination of the survey was approved by AHS. It was sent electronically to 1,665 members via the AHS membership listserv in September 2021.
Results:
168 out of 1,665 (10%) members responded. Among the respondents, 127 (76%) were trained in Neurology, 69 respondents (41%) were headache board certified and/or headache fellowship trained, and 70.83% reported never using a toxin other than onabotulinumtoxinA for CM. In terms of off-lablel BTX use, 16.1% have used incobotulinumtoxinA, followed by abobotulinumtoxinA (13.1%) and rimabotulinumtoxinB (6.6%). The most common reason to use an alternative toxin was administration/payer imposed. In terms of efficacy, 67% of those who used a different toxin reported similar efficacy, 19% reported better efficacy, and 16.3% reported worse efficacy.
Conclusions:
Alternative toxins are not used by the majority of headache providers for the treatment of CM. When used, however, (1) incobotulinumtoxinA is the most commonly used alternative toxin, (2) it is due to administrator/payer request, and (3) most clinicians feel it is as effective as onabotulinumtoxinA. Limitations of this study include low survey responder rate.