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

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. 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.

Keywords: erenumab; gender; men; migraine; migraine treatment; real-world evidence.

Conflict of interest statement

RO reported personal fees from Novartis, Teva, and Eli Lilly, and had non-financial relationships with Allergan/AbbVie, Novartis, and Teva. SS reported personal fees and non-financial support from Allergan, Abbott, Eli Lilly, Novartis, and Teva; personal fees from Medscape; and others from Bayer, Pfizer, Medtronic, Starmed, Bristol–Myers Squibb, and Daiichi Sankyo. BR reported research grants from Novartis, and personal fees from Allergan, Lilly, Novartis, and Teva. UR received honoraria for consulting and lectures from Amgen, Allergan, Abbvie, Eli Lilly, Lundbeck, Novartis, electroCore, Medscape, StreaMedUp, and Teva, and research funding from the German Federal Ministry of Education and Research and Novartis. GAf reported competing interests with Novartis. MG reported competing interests with Helsinn Healthcare and Uriach Italy. GL received speaker honoraria, funding for travel, and honoraria for participation in advisory boards sponsored by Allergan, TEVA, Lilly, and Novartis; he also received speaker honoraria and funding for travel from electroCore, Nevro Corp, and Autonomic Technologies. NL reported personal fees from Novartis and Allergan. EF reported personal fees from Novartis and Teva. CB and SG received honoraria from Allergan, Teva, Eli Lilly, and Novartis. DH reported personal fees from Novartis, Teva, Eli Lilly, Allergan, Hormosan, Zuellig Pharma, and Bayer. ARa received speaker honoraria from Novartis, Teva, and Eli Lilly. SCe received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Novartis, Teva, Lilly, Allergan, Ibsa, Amgen, and Lundbeck. VF received honoraria as a speaker or for participating in advisory boards from Eli Lilly, Novartis, and Teva. ARu received speaker honoraria from Allergan, Lilly, Novartis, and Teva. MS received speaker honoraria from Lilly, Novartis, and Teva. FV received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Allergan, Eli-Lilly, Novartis, and Teva. PB received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Alder, Allergan, Bayer, ElectroCore, Eli Lilly, GSK, Lusofarmaco, MSD, Novartis, Stx-Med, Teva, and Visufarma. CAu received travel grants from Eli Lilly, FB-Health, Lusofarmaco, and Teva. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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.

Figures

Figure 1

Categories of decrease in monthly migraine days at weeks 9–12 compared with baseline in men and women. The P-value refers to the gender comparison in category distribution.

Figure 2

Change in monthly headache days, monthly migraine days, acute medication use, and Headache Impact Test-6 (HIT-6) score from baseline to weeks 9–12 of erenumab use in men and women. Each dot represents a patient. Blue dots indicate men, while red dots indicate women.