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 

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

JOURNAL=Frontiers in Neurology

VOLUME=12

YEAR=2021

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.774341

DOI=10.3389/fneur.2021.774341

ISSN=1664-2295

ABSTRACT=<p><bold>Objective:</bold> We reported gender-specific data on the efficacy and safety of erenumab, a monoclonal antibody antagonizing the calcitonin gene-related peptide (CGRP) receptor.</p><p><bold>Methods:</bold> 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 <italic>t</italic>-test, as appropriate. An analysis of covariance (ANCOVA) was performed to identify factors influencing the efficacy outcomes.</p><p><bold>Results:</bold> 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.</p><p><bold>Conclusion:</bold> We found that erenumab is equally safe and effective in men compared with women after 12 weeks.</p>