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Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men

Objective: We reported gender-specific data on the efficacy and safety of erenumab, a monoclonal antibody antagonizing the calcitonin gene-related peptide (CGRP) receptor. Methods: Our pooled patient-level analysis of real-world data included patients treated with erenumab and followed up for 12 wee...

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Autores principales: Ornello, Raffaele, Baraldi, Carlo, Guerzoni, Simona, Lambru, Giorgio, Fuccaro, Matteo, Raffaelli, Bianca, Gendolla, Astrid, Barbanti, Piero, Aurilia, Cinzia, Cevoli, Sabina, Favoni, Valentina, Vernieri, Fabrizio, Altamura, Claudia, Russo, Antonio, Silvestro, Marcello, Dalla Valle, Elisabetta, Mancioli, Andrea, Ranieri, Angelo, Alfieri, Gennaro, Latysheva, Nina, Filatova, Elena, Talbot, Jamie, Cheng, Shuli, Holle, Dagny, Scheffler, Armin, Nežádal, Tomáš, Čtrnáctá, Dana, Šípková, Jitka, Matoušová, Zuzana, Sette, Lucia, Casalena, Alfonsina, Maddestra, Maurizio, Viola, Stefano, Affaitati, Giannapia, Giamberardino, Maria Adele, Pistoia, Francesca, Reuter, Uwe, Sacco, Simona
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8717149/
https://www.ncbi.nlm.nih.gov/pubmed/34975732
http://dx.doi.org/10.3389/fneur.2021.774341
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author Ornello, Raffaele
Baraldi, Carlo
Guerzoni, Simona
Lambru, Giorgio
Fuccaro, Matteo
Raffaelli, Bianca
Gendolla, Astrid
Barbanti, Piero
Aurilia, Cinzia
Cevoli, Sabina
Favoni, Valentina
Vernieri, Fabrizio
Altamura, Claudia
Russo, Antonio
Silvestro, Marcello
Dalla Valle, Elisabetta
Mancioli, Andrea
Ranieri, Angelo
Alfieri, Gennaro
Latysheva, Nina
Filatova, Elena
Talbot, Jamie
Cheng, Shuli
Holle, Dagny
Scheffler, Armin
Nežádal, Tomáš
Čtrnáctá, Dana
Šípková, Jitka
Matoušová, Zuzana
Sette, Lucia
Casalena, Alfonsina
Maddestra, Maurizio
Viola, Stefano
Affaitati, Giannapia
Giamberardino, Maria Adele
Pistoia, Francesca
Reuter, Uwe
Sacco, Simona
author_facet Ornello, Raffaele
Baraldi, Carlo
Guerzoni, Simona
Lambru, Giorgio
Fuccaro, Matteo
Raffaelli, Bianca
Gendolla, Astrid
Barbanti, Piero
Aurilia, Cinzia
Cevoli, Sabina
Favoni, Valentina
Vernieri, Fabrizio
Altamura, Claudia
Russo, Antonio
Silvestro, Marcello
Dalla Valle, Elisabetta
Mancioli, Andrea
Ranieri, Angelo
Alfieri, Gennaro
Latysheva, Nina
Filatova, Elena
Talbot, Jamie
Cheng, Shuli
Holle, Dagny
Scheffler, Armin
Nežádal, Tomáš
Čtrnáctá, Dana
Šípková, Jitka
Matoušová, Zuzana
Sette, Lucia
Casalena, Alfonsina
Maddestra, Maurizio
Viola, Stefano
Affaitati, Giannapia
Giamberardino, Maria Adele
Pistoia, Francesca
Reuter, Uwe
Sacco, Simona
author_sort Ornello, Raffaele
collection PubMed
description Objective: We reported gender-specific data on the efficacy and safety of erenumab, a monoclonal antibody antagonizing the calcitonin gene-related peptide (CGRP) receptor. Methods: Our pooled patient-level analysis of real-world data included patients treated with erenumab and followed up for 12 weeks. We considered the following outcomes at weeks 9–12 of treatment compared with baseline: 0–29%, 30–49%, 50–75%, and ≥75% responder rates, according to the decrease in monthly headache days (MHDs), rate of treatment stopping, change in MHDs, monthly migraine days (MMDs), monthly days of acute medication and triptan use, and Headache Impact Test-6 (HIT-6) score from baseline to weeks 9–12. Outcomes were compared between men and women by the chi-squared test or t-test, as appropriate. An analysis of covariance (ANCOVA) was performed to identify factors influencing the efficacy outcomes. Results: We included 1,410 patients from 16 centers, of which 256 (18.2%) were men. Men were older than women and had a lower number of MHDs at baseline. At weeks 9–12, compared with baseline, 46 (18.0%) men had a ≥75% response, 75 (29.3%) had a 50–74% response, 35 (13.7%) had a 30–49% response, and 86 (33.6%) had a 0–29% response, while 14 (5.5%) stopped the treatment. The corresponding numbers for women were 220 (19.1%), 314 (27.2%), 139 (12.0%), 402 (34.8%), and 79 (6.8%). No gender difference was found in any of the outcomes. The ANCOVA showed that gender did not influence the efficacy of outcomes. Conclusion: We found that erenumab is equally safe and effective in men compared with women after 12 weeks.
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spelling pubmed-87171492021-12-31 Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men Ornello, Raffaele Baraldi, Carlo Guerzoni, Simona Lambru, Giorgio Fuccaro, Matteo Raffaelli, Bianca Gendolla, Astrid Barbanti, Piero Aurilia, Cinzia Cevoli, Sabina Favoni, Valentina Vernieri, Fabrizio Altamura, Claudia Russo, Antonio Silvestro, Marcello Dalla Valle, Elisabetta Mancioli, Andrea Ranieri, Angelo Alfieri, Gennaro Latysheva, Nina Filatova, Elena Talbot, Jamie Cheng, Shuli Holle, Dagny Scheffler, Armin Nežádal, Tomáš Čtrnáctá, Dana Šípková, Jitka Matoušová, Zuzana Sette, Lucia Casalena, Alfonsina Maddestra, Maurizio Viola, Stefano Affaitati, Giannapia Giamberardino, Maria Adele Pistoia, Francesca Reuter, Uwe Sacco, Simona Front Neurol Neurology Objective: We reported gender-specific data on the efficacy and safety of erenumab, a monoclonal antibody antagonizing the calcitonin gene-related peptide (CGRP) receptor. Methods: Our pooled patient-level analysis of real-world data included patients treated with erenumab and followed up for 12 weeks. We considered the following outcomes at weeks 9–12 of treatment compared with baseline: 0–29%, 30–49%, 50–75%, and ≥75% responder rates, according to the decrease in monthly headache days (MHDs), rate of treatment stopping, change in MHDs, monthly migraine days (MMDs), monthly days of acute medication and triptan use, and Headache Impact Test-6 (HIT-6) score from baseline to weeks 9–12. Outcomes were compared between men and women by the chi-squared test or t-test, as appropriate. An analysis of covariance (ANCOVA) was performed to identify factors influencing the efficacy outcomes. Results: We included 1,410 patients from 16 centers, of which 256 (18.2%) were men. Men were older than women and had a lower number of MHDs at baseline. At weeks 9–12, compared with baseline, 46 (18.0%) men had a ≥75% response, 75 (29.3%) had a 50–74% response, 35 (13.7%) had a 30–49% response, and 86 (33.6%) had a 0–29% response, while 14 (5.5%) stopped the treatment. The corresponding numbers for women were 220 (19.1%), 314 (27.2%), 139 (12.0%), 402 (34.8%), and 79 (6.8%). No gender difference was found in any of the outcomes. The ANCOVA showed that gender did not influence the efficacy of outcomes. Conclusion: We found that erenumab is equally safe and effective in men compared with women after 12 weeks. Frontiers Media S.A. 2021-12-16 /pmc/articles/PMC8717149/ /pubmed/34975732 http://dx.doi.org/10.3389/fneur.2021.774341 Text en Copyright © 2021 Ornello, Baraldi, Guerzoni, Lambru, Fuccaro, Raffaelli, Gendolla, Barbanti, Aurilia, Cevoli, Favoni, Vernieri, Altamura, Russo, Silvestro, Dalla Valle, Mancioli, Ranieri, Alfieri, Latysheva, Filatova, Talbot, Cheng, Holle, Scheffler, Nežádal, Čtrnáctá, Šípková, Matoušová, Sette, Casalena, Maddestra, Viola, Affaitati, Giamberardino, Pistoia, Reuter and Sacco. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Ornello, Raffaele
Baraldi, Carlo
Guerzoni, Simona
Lambru, Giorgio
Fuccaro, Matteo
Raffaelli, Bianca
Gendolla, Astrid
Barbanti, Piero
Aurilia, Cinzia
Cevoli, Sabina
Favoni, Valentina
Vernieri, Fabrizio
Altamura, Claudia
Russo, Antonio
Silvestro, Marcello
Dalla Valle, Elisabetta
Mancioli, Andrea
Ranieri, Angelo
Alfieri, Gennaro
Latysheva, Nina
Filatova, Elena
Talbot, Jamie
Cheng, Shuli
Holle, Dagny
Scheffler, Armin
Nežádal, Tomáš
Čtrnáctá, Dana
Šípková, Jitka
Matoušová, Zuzana
Sette, Lucia
Casalena, Alfonsina
Maddestra, Maurizio
Viola, Stefano
Affaitati, Giannapia
Giamberardino, Maria Adele
Pistoia, Francesca
Reuter, Uwe
Sacco, Simona
Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men
title Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men
title_full Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men
title_fullStr Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men
title_full_unstemmed Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men
title_short Gender Differences in 3-Month Outcomes of Erenumab Treatment—Study on Efficacy and Safety of Treatment With Erenumab in Men
title_sort gender differences in 3-month outcomes of erenumab treatment—study on efficacy and safety of treatment with erenumab in men
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8717149/
https://www.ncbi.nlm.nih.gov/pubmed/34975732
http://dx.doi.org/10.3389/fneur.2021.774341
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