Study and Use of Botulinum Toxin A or B
use of Botox® with galcanezumab has not been systematically
studied because treatment 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
galcanezumab phase 3 chronic or episodic migraine prevention
phase 2 proof-of-concept and migraine prevention trials.4,5
the use of galcanezumab is not contraindicated in patients treated
further studies in humans to assess the efficacy and safety of this
combination are needed.
data on the concomitant use of galcanezumab and Botox in patients
with chronic migraine are available from retrospective chart reviews
and these are summarized below.7-11
for Concomitant Use From Retrospective Chart Reviews
use of a CGRP mAb as add-on therapy in patients with chronic migraine
who are currently being treated with Botox and still need additional
preventive therapy was evaluated in a retrospective chart review.7
This analysis included a review of 153 patient records, of which
there were 51 patients (33%) using galcanezumab as add-on therapy.
Other CGRP mAbs used as add-on therapy in this analysis included
erenumab (n=89, 58%) and fremanezumab (n=13, 9%).
the overall cohort, patients had
monthly headache days at baseline
monthly headache days remaining following Botox monotherapy, p<.0001
vs baseline, and
monthly headache days remaining after add-on therapy with a CGRP
mAb, p≤.0001 vs Botox monotherapy.7
the subgroup of patients receiving galcanezumab as add-on therapy,
monthly headache days at baseline
monthly headache days remaining following Botox monotherapy, and
monthly headache days remaining after galcanezumab add-on therapy.7
events to the CGRP mAb medication
reported in 13/153 patients (8.5%), and
constipation, injection site reaction, and fatigue.7
are additional chart reviews evaluating the addition of a CGRP mAb
(erenumab, fremanezumab, or galcanezumab) to concurrent Botox for
migraine prevention in patients with chronic migraine.8,9
The results were discussed collectively for the CGRP mAbs used at the
centers, but authors generally concluded that the addition of a CGRP
generally beneficial regardless if it was added to Botox or other
concurrent Botox therapy further reduced migraine headache days
compared to Botox monotherapy,10
be beneficial in patients on Botox who need additional headache day
experience wear off prior to the next Botox injection.8
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.12
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.13
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 ELH, 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.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Cohen F, Armand CE, Vollbracht SE. Efficacy and tolerability of CGRP
monoclonal antibody medications in patients with chronic migraine
undergoing treatment with onabotulinumtoxinA. Headache.
2020;60(S1):13. 62nd Annual Scientific Meeting American Headache
Society abstract. https://doi.org/10.1111/head.13854
Ozudogru SN, Bartell JW, Yuan H, et al. The effect of adding
calcitonin gene-related peptide monoclonal antibodies to onabotulinum
toxin A therapy on headache burden: a retrospective observational
case series. Headache. 2020;60(7):1442-1443.
Toni T, Tamanaha R, Newman B, et al. Effectiveness of dual migraine
therapy with CGRP antagonists and onabotulinumtoxinA injections:
experience from a single migraine center in Hawaii. Cephalalgia.
2020;40(1_suppl):104. Migraine Trust Virtual 2020 – Digital
presentations abstract MTV20-DP-094.
Blumenfeld AM, Frishberg BM, Schim JD, et al. Real-world evidence
for control of patients with chronic migraine who received CGRP
monoclonal antibody therapy added to onabotulinumtoxinA treatment.
Cephalalgia. 2020;40(1_suppl):96-97. Migraine Trust Virtual
2020 – Digital presentations abstract MTV20-DP-087.
Gottschalk C, Henn K, Robinson J, Schobel V. Anti-CGRP class reduces
migraine burden regardless of concomitant therapies in US clinical
practice. Poster presented at: American Academy of Neurology (AAN
Virtual); April 25-May 1, 2020.
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.