Study and Use of Botulinum Toxin A or B
with botulinum toxin A or B administered to the head or neck area was
required to be discontinued at least 4 months prior to entering the
prospective baseline or baseline period in
galcanezumab phase 3 chronic or episodic migraine prevention
phase 2 proof-of-concept and migraine prevention trials.4,5
such, the use of Botox with galcanezumab has not been studied.
CGRP Monoclonal Antibodies Used With Botox
search of the literature found 1 small study (N=158) that included
some information on the concomitant use of a CGRP monoclonal antibody
in combination with Botox.6
This study evaluated the add-on of erenumab to Botox, oral migraine
preventives, or erenumab alone in patients with chronic migraine who
have failed >3 prior preventives. The authors of this study
concluded that in the population studied, erenumab as an add-on to a
preventive therapy was more efficacious than erenumab alone, and that
the add-on to Botox was more effective than add-on to oral
Mechanism of Action
is a humanized IgG4 mAb that
is indicated for the prophylaxis of migraine in adults who have at
least 4 migraine days per month.8
Mechanism of Action
blocks the release of neurotransmitters associated with the genesis
of pain. The presumed mechanism for headache prophylaxis is by
blocking peripheral signals to the central nervous system, which
inhibits central sensitisation, as suggested by pre-clinical and
clinical pharmacodynamic studies.9
is indicated for prophylaxis of headaches in adults with chronic
migraine (headaches on at least 15 days per month of which at least 8
days are with migraine).9
refer to the manufacturer's prescribing information for additional
information about Botox.
Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab
for the prevention of episodic migraine: the EVOLVE-1 randomized
clinical trial. JAMA Neurol. 2018;75(9):1080-1088.
Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of
galcanezumab for the prevention of episodic migraine: results of the
EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia.
Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic
migraine: the randomized, double-blind, placebo-controlled REGAIN
study. Neurology. 2018;91(24):e2211-e2221.
Skljarevski V, Oakes TM, Zhang Q, et al. Effect of different doses
of galcanezumab vs placebo for episodic migraine prevention: a
randomized clinical trial. JAMA Neurol. 2018;75(2):187-193.
Dodick DW, Goadsby PJ, Spierings EL, et al. Safety and efficacy of
LY2951742, a monoclonal antibody to calcitonin gene-related peptide,
for the prevention of migraine: a phase 2, randomised, double-blind,
placebo-controlled study. Lancet Neurol. 2014;13(9):885-892.
Boudreau GP, Demers C. Treatment of chronic migraine with erenumab
alone or as an add on therapy; a real world prospective observational
study. Talk presented at: Congress of the International Headache
Society; September 5-8, 2019; Dublin, Ireland.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Emgality [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Botox [summary of product characteristics]. Allergan Limited Marlow
International The Parkway, Marlow, UK - accessed on 20/08/2020
= calcitonin gene-related peptide
= monoclonal antibody
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.