Emgality® (Galcanezumab)

Para consultar la información para prescribir completa de Emgality® (Galcanezumab) de clic en el siguiente enlace: Información para prescribir

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Galcanezumab: Immunosuppressive Potential

Calcitonin gene-related peptide monoclonal antibodies, such as galcanezumab, have been engineered to bind to either CGRP or its receptor with high specificity and minimized interaction with the immune system.

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CGRP mAbs Have no Direct Specific Immunomodulatory Effect

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

Antibodies, also referred to as immunoglobulins, are composed of 2 identical heavy and 2 identical light chains.1 These chains contain variable and constant sections, involved in antigen binding and biological activity, respectively. Five isotypes exist in humans including IgA, IgD, IgE, IgG, and IgM. Therapeutic mAbs are composed of IgG isotypes which are divided into 4 subclasses in order of decreasing serum concentrations including IgG1 to IgG4.2 Immunoglobulin G comprises the majority of all antibodies and each IgG subclass has a different ability to activate host immune function.1,2

Therapeutic mAbs are introduced into the host for a specific purpose.1 

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.1-3 As CGRP is not an immune system target, CGRP mAbs have no direct immunomodulatory effect.

The use of galcanezumab is not associated with increased risk of infections or immunosuppression, nor are such events identified as important risks in the galcanezumab risk management plan.4

Galcanezumab is a humanized IgG4 mAb that

  • binds CGRP, and
  • prevents its biological activity without blocking the CGRP receptor.4 

References

1Silberstein 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

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

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

Glossary

CGRP = calcitonin gene-related peptide

Ig = immunoglobulin

IgA = immunoglobulin A

IgD = immunoglobulin D

IgE = immunoglobulin E

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

IgM = immunoglobulin M

mAb = monoclonal antibody

Fecha de la última revisión: 2020 M03 19


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