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Emgality ® ▼ (galcanezumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Can immunocompromised patients with migraine use Emgality® (galcanezumab)?
Immunocompromised patients were not explicitly excluded from galcanezumab clinical trials for migraine prevention. Subgroup analyses have not been conducted.
- Immunocompromised patients in galcanezumab migraine prevention trials
- Do calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) have an immunomodulatory effect?
Immunocompromised patients in galcanezumab migraine prevention trials
What were the criteria for participation in phase 3 double-blind, placebo-controlled migraine prevention clinical trials?
Immunocompromised patients were not explicitly excluded from phase 3 galcanezumab clinical trials for migraine prevention.1
However, patients were excluded if they had a history or presence of any medical illness including, but not limited to a hematologic disorder, autoimmune disorder, or any clinically significant laboratory abnormality or medical condition, that in the judgment of the investigator indicated a medical problem that would preclude study participation.1
Patients could also be excluded if, in the opinion of the investigator, the patient had other issues which would interfere with their reliability to
- be compliant with the study requirements
- follow study procedures, or
- complete evaluations and visits required for the study.1
Are there post hoc analyses of immunocompromised patients in galcanezumab migraine prevention trials?
Analyses of patients who may have been immunocompromised in the phase 3 migraine prevention studies have not been conducted.
You can find further details about migraine prevention studies in the Appendix.
The decision to administer galcanezumab to a patient who is immunocompromised, or has a history of being immunocompromised, 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 treatment. The decision remains at the discretion of the prescribing physician.
Do calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) have an immunomodulatory effect?
CGRP mAbs have no direct specific immunomodulatory effect.2
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.2-4
Galcanezumab is a humanised immunoglobulin G (subclass) 4 (IgG4) monoclonal antibody that binds CGRP thus preventing its biological activity.5
Antibodies also referred to as immunoglobulins, are composed of 2 identical heavy and 2 identical light chains.4 These chains contain variable and constant sections, involved in antigen binding and biological activity, respectively.
Five isotypes exist in humans including
- immunoglobulin A (IgA)
- immunoglobulin D (IgD)
- immunoglobulin E (IgE)
- immunoglobulin G (IgG), and
- immunoglobulin M (IgM).
Therapeutic mAbs are composed of IgG isotypes which are divided into 4 subclasses in order of decreasing serum concentrations including IgG1-4. IgG comprises approximately 85% of all antibodies and each IgG subclass has a different ability to activate host immune function.
Therapeutic monoclonal antibodies are introduced into the host for a specific purpose.4
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Levin 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
3Raffaelli 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
4Silberstein 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
5Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
6Stauffer 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
7Skljarevski 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
8Detke 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
9Mulleners 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
10Camporeale 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
Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of
Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study for the prevention of episodic or chronic migraine (CGAJ).10
▼ This 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.
Date of Last Review: 15 January 2021