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=Volume 12 - 2021

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=Objective: We reported gender-specific data on the efficacy and safety of erenumab, a monoclonal antibody antagonizing the calcitonin gene-related peptide (CGRP) receptor.
Method: 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 of 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 1410 patients from 16 centers; 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%) a 50-74% response, 35 (13.7%) a 30-49% response, and 86 (33.6%) 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%), 401 (34.7%), and 79 (6.8%). No gender difference was found in any of the outcomes. The ANCOVA showed that gender did not influence the efficacy outcomes.
Conclusion: We found that erenumab is equally safe and effective in men compared with women after a 12-week period.