Emgality® (Galcanezumab)

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Galcanezumab: Immunization During Preventive Treatment

Galcanezumab is not expected to interact with the host immune system. The decision to administer a vaccine to a patient treated with galcanezumab must be based on the clinical judgment of the prescribing healthcare practitioner.

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Clinical Trial Information

In the phase 3 migraine prevention clinical studies,

  • patients received vaccines for various indications during double-blind, placebo-controlled and open-label galcanezumab treatment, however
  • subgroup analyses were not completed in this population.1

Eli Lilly and Company has not evaluated the safety and efficacy of galcanezumab in combination with vaccines.

Based on the mechanism of action and mechanism of elimination of galcanezumab, there is no reason to expect an interaction with the host immune system.1

The decision to administer a vaccination to a patient prior to, during, or after galcanezumab treatment must be based on the clinical judgment of the prescribing healthcare practitioner after careful consideration of the patient's risk factors as well as the risks and benefits of vaccination.

Please follow local guidance regarding vaccine schedules and recommendations.

Vaccines Administered During Phase 3 Migraine Prevention Clinical Trials

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2)2,3
  • chronic migraine (REGAIN),4 and
  • episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).5

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study for the prevention of episodic or chronic migraine (CGAJ).6

Vaccine usage was low overall in the phase 3 migraine prevention studies.1 The influenza vaccine was the most commonly administered vaccine during galcanezumab treatment, with reported usage in 1.26% to 2.82% of patients receiving galcanezumab.

Other vaccines administered to at least 1 galcanezumab-treated patient included

  • anthrax
  • hepatitis
  • human papilloma
  • meningococcal
  • pneumococcal
  • tetanus
  • tick-borne encephalitis, and
  • varicella zoster.1

Subgroup analyses were not completed in this population.

CGRP mAbs Have No Direct Specific Immunomodulatory Effect

The CGRP mAbs have been engineered to bind to either the CGRP peptide or receptor with high specificity and minimized interaction with the immune system.7-9 As CGRP is not an immune system target, CGRP mAbs have no direct immunomodulatory effect.

Galcanezumab is a humanized IgG4 mAb that

  • binds CGRP, and
  • prevents its biological activity without blocking the CGRP receptor.1 

As such, it is not expected to

  • inhibit metabolic or induce enzymatic pathways
  • be metabolized by the cytochrome P450 families of drug-metabolizing enzymes, and
  • produce any active metabolites.1,10

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Stauffer 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

3Skljarevski 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

4Detke 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

5Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

6Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2

7Raffaelli B, Reuter U. The biology of monoclonal antibodies: focus on calcitonin gene-related peptide for prophylactic migraine therapy. Neurotherapeutics. 2018;15(2):324-335. http://dx.doi.org/10.1007/s13311-018-0622-7

8Silberstein S, Lenz R, Xu C. Therapeutic monoclonal antibodies: what headache specialists need to know. Headache. 2015;55(8):1171-1182. http://dx.doi.org/10.1111/head.12642

9Levin M, Silberstein SD, Gilbert R, et al. Basic considerations for the use of monoclonal antibodies in migraine. Headache. 2018;58(10):1689-1696. http://dx.doi.org/10.1111/head.13439

10Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93(11):2645-2668. https://doi.org/10.1002/jps.20178

Glossary

CGRP = calcitonin gene-related peptide

IgG4 = immunoglobulin G (subclass) 4

mAb = monoclonal antibody

Fecha de la última revisión: 2021 M01 21


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