Frontiers in Neurology (Dec 2021)

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

  • Raffaele Ornello,
  • Carlo Baraldi,
  • Simona Guerzoni,
  • Giorgio Lambru,
  • Matteo Fuccaro,
  • Bianca Raffaelli,
  • Astrid Gendolla,
  • Piero Barbanti,
  • Piero Barbanti,
  • Cinzia Aurilia,
  • Sabina Cevoli,
  • Valentina Favoni,
  • Fabrizio Vernieri,
  • Claudia Altamura,
  • Antonio Russo,
  • Marcello Silvestro,
  • Elisabetta Dalla Valle,
  • Andrea Mancioli,
  • Angelo Ranieri,
  • Gennaro Alfieri,
  • Nina Latysheva,
  • Elena Filatova,
  • Jamie Talbot,
  • Shuli Cheng,
  • Dagny Holle,
  • Armin Scheffler,
  • Tomáš Nežádal,
  • Dana Čtrnáctá,
  • Jitka Šípková,
  • Zuzana Matoušová,
  • Lucia Sette,
  • Alfonsina Casalena,
  • Maurizio Maddestra,
  • Stefano Viola,
  • Giannapia Affaitati,
  • Maria Adele Giamberardino,
  • Francesca Pistoia,
  • Uwe Reuter,
  • Uwe Reuter,
  • Simona Sacco

DOI
https://doi.org/10.3389/fneur.2021.774341
Journal volume & issue
Vol. 12

Abstract

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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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