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Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy

BACKGROUND: We aimed to assess the efficacy and safety of erenumab, a fully human monoclonal antibody inhibiting the calcitonin gene-related peptide receptor (CGRPr), for the prevention of migraine in a real-life setting. MAIN BODY: We included in our observational study all patients with episodic o...

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Autores principales: Ornello, Raffaele, Casalena, Alfonsina, Frattale, Ilaria, Gabriele, Amleto, Affaitati, Giannapia, Giamberardino, Maria Adele, Assetta, Maurizio, Maddestra, Maurizio, Marzoli, Fabio, Viola, Stefano, Cerone, Davide, Marini, Carmine, Pistoia, Francesca, Sacco, Simona
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Milan 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137484/
https://www.ncbi.nlm.nih.gov/pubmed/32264820
http://dx.doi.org/10.1186/s10194-020-01102-9
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author Ornello, Raffaele
Casalena, Alfonsina
Frattale, Ilaria
Gabriele, Amleto
Affaitati, Giannapia
Giamberardino, Maria Adele
Assetta, Maurizio
Maddestra, Maurizio
Marzoli, Fabio
Viola, Stefano
Cerone, Davide
Marini, Carmine
Pistoia, Francesca
Sacco, Simona
author_facet Ornello, Raffaele
Casalena, Alfonsina
Frattale, Ilaria
Gabriele, Amleto
Affaitati, Giannapia
Giamberardino, Maria Adele
Assetta, Maurizio
Maddestra, Maurizio
Marzoli, Fabio
Viola, Stefano
Cerone, Davide
Marini, Carmine
Pistoia, Francesca
Sacco, Simona
author_sort Ornello, Raffaele
collection PubMed
description BACKGROUND: We aimed to assess the efficacy and safety of erenumab, a fully human monoclonal antibody inhibiting the calcitonin gene-related peptide receptor (CGRPr), for the prevention of migraine in a real-life setting. MAIN BODY: We included in our observational study all patients with episodic or chronic migraine treated with erenumab during the year 2019 in the Abruzzo region, central Italy, and with a 6-month follow-up. We included 89 patients; 76 (85.4%) received 6 doses of erenumab, 11 (12.4%) autonomously withdrew the drug due to perceived inefficacy, and 2 (2.2%) due to adverse events. Seventy-eight patients (87.6%) were female, with a mean age of 46.8 ± 11.2 years; 84 (94.4%) had chronic migraine, and 64 (71.9%) medication overuse. All patients had ≥2 prior preventive treatment failures. Fifty-three patients (69.7%) had a 50% decrease in monthly migraine days (MMDs) within the first three doses; 46 (71.9%) of 64 patients withdrew medication overuse. In the 76 patients who completed a 6-dose treatment, erenumab decreased median MMDs from 19 (interquartile range [IQR] 12–27.5) to 4 (IQR 2–9.5; P < 0.001), median monthly days of analgesic use from 10 (IQR 4.5–20) to 2 IQR 0–5; P < 0.001), and median monthly days of triptan use from 5 (IQR 0–15.5) to 1 (IQR 0–4; P < 0.001). We recorded 27 adverse events in 20 (22.5%) patients, the most common being constipation (13.5%). One adverse event, i.e. allergic reaction, led to treatment discontinuation in one patient. CONCLUSIONS: Our real-life data confirm the efficacy and tolerability of erenumab for the prevention of migraine in a difficult-to-treat population of patients with a high prevalence of chronic migraine and medication overuse.
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spelling pubmed-71374842020-04-11 Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy Ornello, Raffaele Casalena, Alfonsina Frattale, Ilaria Gabriele, Amleto Affaitati, Giannapia Giamberardino, Maria Adele Assetta, Maurizio Maddestra, Maurizio Marzoli, Fabio Viola, Stefano Cerone, Davide Marini, Carmine Pistoia, Francesca Sacco, Simona J Headache Pain Research Article BACKGROUND: We aimed to assess the efficacy and safety of erenumab, a fully human monoclonal antibody inhibiting the calcitonin gene-related peptide receptor (CGRPr), for the prevention of migraine in a real-life setting. MAIN BODY: We included in our observational study all patients with episodic or chronic migraine treated with erenumab during the year 2019 in the Abruzzo region, central Italy, and with a 6-month follow-up. We included 89 patients; 76 (85.4%) received 6 doses of erenumab, 11 (12.4%) autonomously withdrew the drug due to perceived inefficacy, and 2 (2.2%) due to adverse events. Seventy-eight patients (87.6%) were female, with a mean age of 46.8 ± 11.2 years; 84 (94.4%) had chronic migraine, and 64 (71.9%) medication overuse. All patients had ≥2 prior preventive treatment failures. Fifty-three patients (69.7%) had a 50% decrease in monthly migraine days (MMDs) within the first three doses; 46 (71.9%) of 64 patients withdrew medication overuse. In the 76 patients who completed a 6-dose treatment, erenumab decreased median MMDs from 19 (interquartile range [IQR] 12–27.5) to 4 (IQR 2–9.5; P < 0.001), median monthly days of analgesic use from 10 (IQR 4.5–20) to 2 IQR 0–5; P < 0.001), and median monthly days of triptan use from 5 (IQR 0–15.5) to 1 (IQR 0–4; P < 0.001). We recorded 27 adverse events in 20 (22.5%) patients, the most common being constipation (13.5%). One adverse event, i.e. allergic reaction, led to treatment discontinuation in one patient. CONCLUSIONS: Our real-life data confirm the efficacy and tolerability of erenumab for the prevention of migraine in a difficult-to-treat population of patients with a high prevalence of chronic migraine and medication overuse. Springer Milan 2020-04-07 /pmc/articles/PMC7137484/ /pubmed/32264820 http://dx.doi.org/10.1186/s10194-020-01102-9 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Ornello, Raffaele
Casalena, Alfonsina
Frattale, Ilaria
Gabriele, Amleto
Affaitati, Giannapia
Giamberardino, Maria Adele
Assetta, Maurizio
Maddestra, Maurizio
Marzoli, Fabio
Viola, Stefano
Cerone, Davide
Marini, Carmine
Pistoia, Francesca
Sacco, Simona
Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy
title Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy
title_full Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy
title_fullStr Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy
title_full_unstemmed Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy
title_short Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy
title_sort real-life data on the efficacy and safety of erenumab in the abruzzo region, central italy
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137484/
https://www.ncbi.nlm.nih.gov/pubmed/32264820
http://dx.doi.org/10.1186/s10194-020-01102-9
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