Emgality® (Galcanezumab)

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Galcanezumab: Switching From Another Migraine Preventive Medication

There are no systematically collected data to address how to switch patients from other migraine preventive medications to galcanezumab.

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The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country.

Switching From Another Migraine Preventive Medication

The following information summarizes exclusion criteria specific to migraine preventive treatments in

  • 2 phase 3, randomized, double-blind, placebo-controlled, 6-month episodic migraine prevention studies (EVOLVE-1 and EVOLVE-2), and1,2
  • 1 phase 3, randomized, double-blind, placebo-controlled, 3-month chronic migraine prevention study with an optional 9-month open-label extension phase (REGAIN).3

Migraine 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.1,2

However, 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 

  • 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.3

The percentage of patients who ultimately enrolled in REGAIN under this condition was 15%.3

In each study, patients discontinued botulinum toxin A or B in the head or neck area at least 4 months prior to baseline.1-3 This information is described in Phase 3 Protocol Criteria for Discontinuation of Prior Migraine Preventive Treatments.

Phase 3 Protocol Criteria for Discontinuation of Prior Migraine Preventive Treatments1-4

Treatment with

Must be discontinued

Prior to

All prior medications or treatments for the prevention of migraine headachesa

at least 30 days

entering the prospective baseline or baseline period.

Botulinum toxin A and B that has been administered in the head or neck area

at least 4 months

aIn 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.

Guidance From Headache Professional Organizations on Incorporating New Migraine Preventive Agents

While there are no systematically collected data to address how to switch patients from other migraine preventive medications to galcanezumab, the European Headache Federation5 and the American Headache Society6 have issued guidance for practitioners summarized in Management of Other Preventives When Using CGRP mAbs in Patients With Migraine.

Management of Other Preventives When Using CGRP mAbs in Patients With Migraine

 

EHF Recommendations5

AHS Consensus Statement6

Episodic Migraine

Stop oral preventive medications prior to initiating therapy with anti-CGRP mAbs

Add anti-CGRP mAb therapy to existing preventive treatment; make no further changes until efficacy of anti-CGRP mAb has been determined. 

Chronic Migraine

Add anti-CGRP mAb to existing oral preventive treatment and reassess need to withdraw oral preventive treatment.a

 

In patients treated with onabotulinumtoxinA who do not have an adequate response, discontinue onabotulinumtoxinA before initiating treatment with anti-CGRP mAb.

 

In patients treated with an anti-CGRP mAb who may benefit from additional prevention, add oral preventive to anti-CGRP mAb therapy.

Abbreviations: AHS = American Headache Society; CGRP = calcitonin gene-related peptide; EHF = European Headache Federation; mAb = monoclonal antibody.

aGuidance applies to patients with chronic migraine as well as patients with a history of chronic migraine.

References

1Stauffer 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. http://dx.doi.org/10.1001/jamaneurol.2018.1212

2Skljarevski 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. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543

3Detke 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. http://dx.doi.org/10.1212/WNL.0000000000006640

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5Sacco 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. J Headache Pain. 2019;20(1):58. http://dx.doi.org/10.1186/s10194-019-0972-5

6American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(1):1-18. http://dx.doi.org/10.1111/head.13456

Fecha de la última revisión: 2019 M06 24


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