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

被引:15
作者
Ornello, Raffaele [1 ]
Baraldi, Carlo [2 ]
Guerzoni, Simona [3 ]
Lambru, Giorgio [4 ]
Fuccaro, Matteo [4 ]
Raffaelli, Bianca [5 ]
Gendolla, Astrid [6 ]
Barbanti, Piero [7 ,8 ]
Aurilia, Cinzia [7 ]
Cevoli, Sabina [9 ]
Favoni, Valentina [9 ]
Vernieri, Fabrizio [10 ]
Altamura, Claudia [10 ]
Russo, Antonio
Silvestro, Marcello
Dalla Valle, Elisabetta [11 ,12 ]
Mancioli, Andrea [11 ,12 ]
Ranieri, Angelo [13 ]
Alfieri, Gennaro [13 ]
Latysheva, Nina
Filatova, Elena [14 ]
Talbot, Jamie [14 ,15 ]
Cheng, Shuli [16 ]
Holle, Dagny [17 ]
Scheffler, Armin [17 ]
Nezadal, Tomas [18 ]
Ctrnacta, Dana [18 ]
Sipkova, Jitka [18 ]
Matousova, Zuzana [19 ]
Sette, Lucia [1 ]
Casalena, Alfonsina [20 ]
Maddestra, Maurizio [21 ]
Viola, Stefano [22 ]
Affaitati, Giannapia [23 ,24 ]
Giamberardino, Maria Adele [23 ,24 ]
Pistoia, Francesca [1 ]
Reuter, Uwe [4 ]
Sacco, Simona [1 ,25 ]
机构
[1] Univ Aquila, Neurosci Sect, Dept Appl Clin Sci & Biotechnol, Laquila, Italy
[2] Univ Modena & Reggio Emilia, Sch Neurosci, Dept Biomed Metab & Neural Sci, Modena, Italy
[3] Univ Modena & Reggio Emilia, Dept Biomed Metab & Neural Sci, Med Toxicol Headache & Drug Abuse Res Ctr, Modena, Italy
[4] Guys & St Thomas Natl Hlth Serv NHS Fdn Trust, Headache Serv, London, England
[5] Charite Univ Med Berlin, Dept Neurol, Berlin, Germany
[6] Praxis Gendolla, Essen, Germany
[7] Ist Ricovero & Cura Carattere Sci IRCCS San, Headache & Pain Unit, Rome, Italy
[8] San Raffaele Univ, Rome, Italy
[9] Ist Ricovero & Cura Carattere Sci IRCCS, Ist Sci Neurol Bologna, Bologna, Italy
[10] Policlin Univ Campus Bio Med, Headache & Neurosonol Unit, Rome, Italy
[11] Univ Campania Luigi Vanvitelli, Dept Med Surg Neurol Metab & Aging Sci, Headache Ctr, Naples, Italy
[12] Osped S Antonio Abate, Headache Ctr, ASST Valle Olona, Gallarate, Italy
[13] Cardarelli Hosp, Div Neurol & Stroke Unit, Headache Ctr, Naples, Italy
[14] Sechenov First Moscow State Med Univ, Sechenov Univ, Moscow, Russia
[15] Derriford Hosp, Dept Neurol, Southwest Neurol Audit & Res Grp, Plymouth, Devon, England
[16] Alfred Hlth, Dept Neurol, Melbourne, Vic, Australia
[17] Univ Hosp Essen, Dept Neurol, West German Headache Ctr, Essen, Germany
[18] Charles Univ Prague, Mil Univ Hosp Prague, Dept Neurol, Fac Med 1, Prague, Czech Republic
[19] Charles Univ Prague, Motol Univ Hosp Prague, Dept Neurol, Fac Med 1, Prague, Czech Republic
[20] G Mazzini Hosp, Dept Neurol, Teramo, Italy
[21] F Renzetti Hosp, Dept Neurol, Chieti, Italy
[22] S Pio Pietrelcina Hosp, Dept Neurol, Chieti, Italy
[23] Univ G dAnnunzio, Dept Med & Sci Aging, Headache Ctr, Geriatr Clin, Chieti, Italy
[24] Univ G dAnnunzio, Ctr Adv Studies & Technol, Headache Ctr, Geriatr Clin, Chieti, Italy
[25] Univ Med Greifswald, Greifswald, Germany
来源
FRONTIERS IN NEUROLOGY | 2021年 / 12卷
关键词
migraine; erenumab; gender; migraine treatment; men; real-world evidence; MIGRAINE; SEX; CGRP;
D O I
10.3389/fneur.2021.774341
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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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