Cargando…

Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab

Migraine is a highly disabling neurological condition, and preventative treatment still remains problematic, due to aspecificity of the majority of the currently available prophylactic drugs. Calcitonin-gene-related peptide (CGRP) plays a crucial role in migraine pathophysiology; agents aimed at blo...

Descripción completa

Detalles Bibliográficos
Autores principales: Giamberardino, Maria Adele, Affaitati, Giannapia, Costantini, Raffaele, Cipollone, Francesco, Martelletti, Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5727105/
https://www.ncbi.nlm.nih.gov/pubmed/29263689
http://dx.doi.org/10.2147/JPR.S128143
_version_ 1783285805740982272
author Giamberardino, Maria Adele
Affaitati, Giannapia
Costantini, Raffaele
Cipollone, Francesco
Martelletti, Paolo
author_facet Giamberardino, Maria Adele
Affaitati, Giannapia
Costantini, Raffaele
Cipollone, Francesco
Martelletti, Paolo
author_sort Giamberardino, Maria Adele
collection PubMed
description Migraine is a highly disabling neurological condition, and preventative treatment still remains problematic, due to aspecificity of the majority of the currently available prophylactic drugs. Calcitonin-gene-related peptide (CGRP) plays a crucial role in migraine pathophysiology; agents aimed at blocking its activity have, therefore, been developed in recent years, among which are monoclonal antibodies (mAbs) against CGRP, to prevent migraine. Erenumab is the only mAb that targets the CGRP receptor instead of the ligand, with high specificity and affinity of binding. This review will report on the most recent data on erenumab characteristics and on the results of clinical trials on its employment in the prevention of episodic migraine (4–14 monthly migraine days): one Phase II and two Phase III trials (completed) and one Phase III trial (ongoing). Monthly subcutaneous administration (70 mg or 140 mg) of erenumab vs placebo for 3–6 months showed significantly higher efficacy in reducing the mean monthly number of migraine days and the use of migraine-specific medication, and in decreasing physical impairment and impact of migraine on everyday activities (P<0.001). A favorable safety profile was demonstrated by the lack of significant differences in the occurrence of adverse events in erenumab-treated vs placebo-treated patients. Global results so far obtained point to erenumab as a new promising candidate for the preventative treatment of episodic migraine. Licence applications for erenumab were recently submitted to the Food and Drug Administration in the USA and European Medicines Agency in Europe (May/June 2017).
format Online
Article
Text
id pubmed-5727105
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher Dove Medical Press
record_format MEDLINE/PubMed
spelling pubmed-57271052017-12-20 Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab Giamberardino, Maria Adele Affaitati, Giannapia Costantini, Raffaele Cipollone, Francesco Martelletti, Paolo J Pain Res Review Migraine is a highly disabling neurological condition, and preventative treatment still remains problematic, due to aspecificity of the majority of the currently available prophylactic drugs. Calcitonin-gene-related peptide (CGRP) plays a crucial role in migraine pathophysiology; agents aimed at blocking its activity have, therefore, been developed in recent years, among which are monoclonal antibodies (mAbs) against CGRP, to prevent migraine. Erenumab is the only mAb that targets the CGRP receptor instead of the ligand, with high specificity and affinity of binding. This review will report on the most recent data on erenumab characteristics and on the results of clinical trials on its employment in the prevention of episodic migraine (4–14 monthly migraine days): one Phase II and two Phase III trials (completed) and one Phase III trial (ongoing). Monthly subcutaneous administration (70 mg or 140 mg) of erenumab vs placebo for 3–6 months showed significantly higher efficacy in reducing the mean monthly number of migraine days and the use of migraine-specific medication, and in decreasing physical impairment and impact of migraine on everyday activities (P<0.001). A favorable safety profile was demonstrated by the lack of significant differences in the occurrence of adverse events in erenumab-treated vs placebo-treated patients. Global results so far obtained point to erenumab as a new promising candidate for the preventative treatment of episodic migraine. Licence applications for erenumab were recently submitted to the Food and Drug Administration in the USA and European Medicines Agency in Europe (May/June 2017). Dove Medical Press 2017-12-08 /pmc/articles/PMC5727105/ /pubmed/29263689 http://dx.doi.org/10.2147/JPR.S128143 Text en © 2017 Giamberardino et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Review
Giamberardino, Maria Adele
Affaitati, Giannapia
Costantini, Raffaele
Cipollone, Francesco
Martelletti, Paolo
Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab
title Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab
title_full Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab
title_fullStr Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab
title_full_unstemmed Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab
title_short Calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab
title_sort calcitonin gene-related peptide receptor as a novel target for the management of people with episodic migraine: current evidence and safety profile of erenumab
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5727105/
https://www.ncbi.nlm.nih.gov/pubmed/29263689
http://dx.doi.org/10.2147/JPR.S128143
work_keys_str_mv AT giamberardinomariaadele calcitoningenerelatedpeptidereceptorasanoveltargetforthemanagementofpeoplewithepisodicmigrainecurrentevidenceandsafetyprofileoferenumab
AT affaitatigiannapia calcitoningenerelatedpeptidereceptorasanoveltargetforthemanagementofpeoplewithepisodicmigrainecurrentevidenceandsafetyprofileoferenumab
AT costantiniraffaele calcitoningenerelatedpeptidereceptorasanoveltargetforthemanagementofpeoplewithepisodicmigrainecurrentevidenceandsafetyprofileoferenumab
AT cipollonefrancesco calcitoningenerelatedpeptidereceptorasanoveltargetforthemanagementofpeoplewithepisodicmigrainecurrentevidenceandsafetyprofileoferenumab
AT martellettipaolo calcitoningenerelatedpeptidereceptorasanoveltargetforthemanagementofpeoplewithepisodicmigrainecurrentevidenceandsafetyprofileoferenumab