From Headache Professional Organizations on Incorporating New
Migraine Preventive Agents
there are no systematically collected data to address how to switch
patients from other migraine preventive medications to galcanezumab,
the European Headache Federation1
and the American Headache Society2
have issued guidance for practitioners summarized in Table
1. Management of Other Preventives When Using CGRP mAbs in Patients
oral preventive medications prior to initiating therapy with
anti-CGRP mAb therapy to existing preventive treatment; make no
further changes until efficacy of anti-CGRP mAb has been
anti-CGRP mAb to existing oral preventive treatment and reassess
need to withdraw oral preventive treatment.a
patients treated with onabotulinumtoxinA who do not have an
adequate response, discontinue onabotulinumtoxinA before
initiating treatment with anti-CGRP mAb.
patients treated with an anti-CGRP mAb who may benefit from
additional prevention, add oral preventive to anti-CGRP mAb
AHS = American Headache Society; CGRP = calcitonin gene-related
peptide; EHF = European Headache Federation; mAb = monoclonal
Guidance applies to patients with chronic migraine as well as
patients with a history of chronic migraine.
From Another Migraine Preventive Medication
following information summarizes exclusion criteria specific to
migraine preventive treatments in
phase 3, randomized, double-blind, placebo-controlled, 6-month
episodic migraine prevention studies (EVOLVE-1 and EVOLVE-2), and3,4
phase 3, randomized, double-blind, placebo-controlled, 3-month
chronic migraine prevention study with an optional 9-month
open-label extension phase (REGAIN).5
preventive treatments were not allowed at any time in the episodic
migraine studies from the start of the prospective lead-in phase
through the end of the double-blind treatment period.3,4
in the chronic migraine prevention study, REGAIN, up to one-third of
enrolled patients were allowed to continue migraine prophylactic
treatment with either topiramate or propranolol if
patient had been on a stable dose for at least 2 months prior to
remained stable throughout the double-blind treatment period.5
percentage of patients who ultimately enrolled in REGAIN under this
condition was 15%.5
each study, patients discontinued botulinum toxin A or B in the head
or neck area at least 4 months prior to baseline.3-5
This information is described in Table
2. Phase 3 Protocol Criteria for Discontinuation of Prior Migraine
prior medications or treatments for the prevention of migraine
least 30 days
the prospective baseline or baseline period.
toxin A and B that has been administered in the head or neck area
least 4 months
In REGAIN, up to one-third of enrolled patients were allowed
to continue migraine prophylactic treatment with either topiramate or
propranolol if the patient had been on a stable dose for at least 2
months prior to baseline, and dosing remained stable throughout the
double-blind treatment period.
is indicated for the prophylaxis of migraine in adults who have at
least 4 migraine days per month.7
recommended dose is 120 mg galcanezumab injected subcutaneously once
monthly, with a 240 mg loading dose as the initial dose.7
Sacco S, Bendtsen L, Ashina M, et al. European headache federation
guideline on the use of monoclonal antibodies acting on the
calcitonin gene related peptide or its receptor for migraine
prevention [published correction appears in J Headache Pain
]. J Headache Pain. 2019;20(1):6.
American Headache Society. The American Headache Society position
statement on integrating new migraine treatments into clinical
practice [published correction appears in Headache.
]. Headache. 2019;59(1):1-18.
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.
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.
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.