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.

Department of Biomedical Metabolic and Neural Sciences School in Neurosciences University of Modena and Reggio Emilia Modena Italy

Department of Neurology Alfred Health Melbourne VIC Australia

Department of Neurology Charité Universitätsmedizin Berlin Berlin Germany

Department of Neurology F Renzetti Hospital Chieti Italy

Department of Neurology G Mazzini Hospital Teramo Italy

Department of Neurology Military University Hospital Prague 1st Faculty of Medicine Charles University Prague Czechia

Department of Neurology Motol University Hospital Prague 1st Faculty of Medicine Charles University Prague Czechia

Department of Neurology S Pio da Pietrelcina Hospital Chieti Italy

Department of Neurology West German Headache Center University Hospital Essen Essen Germany

Headache and Neurosonology Unit Policlinico Universitario Campus Bio Medico Rome Italy

Headache and Pain Unit Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Rome Italy

Headache Center Department of Medical Surgical Neurological Metabolic and Aging Sciences University of Campania Luigi Vanvitelli Naples Italy

Headache Center Geriatrics Clinic Department of Medicine and Science of Aging and Center for Advanced Studies and Technology G D'Annunzio University Chieti Italy

Headache Centre Division of Neurology and Stroke Unit A Cardarelli Hospital Naples Italy

Headache Centre Ospedale S Antonio Abate ASST Valle Olona Gallarate Italy

Istituto di Ricovero e Cura a Carattere Scientifico Istituto delle Scienze Neurologiche di Bologna Bologna Italy

Medical Toxicology Headache and Drug Abuse Research Center Department of Biomedical Metabolic and Neural Sciences University of Modena and Reggio Emilia Modena Italy

Neuroscience Section Department of Applied Clinical Sciences and Biotechnology University of L'Aquila L'Aquila Italy

Praxis Gendolla Essen Germany

San Raffaele University Rome Italy

Sechenov 1st Moscow State Medical University Moscow Russia

Southwest Neurology Audit and Research Group Department of Neurology Derriford Hospital Plymouth United Kingdom

The Headache Service Guy's and St Thomas' National Health Service Foundation Trust London United Kingdom

Universitätsmedizin Greifswald Greifswald Germany

Zobrazit více v PubMed

Collaborators GBDH. Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. (2018) 17:954–76. 10.1016/S1474-4422(18)30322-3 PubMed DOI PMC

Vetvik KG, MacGregor EA. Sex differences in the epidemiology, clinical features, and pathophysiology of migraine. Lancet Neurol. (2017) 16:76–87. 10.1016/S1474-4422(16)30293-9 PubMed DOI

Borsook D, Erpelding N, Lebel A, Linnman C, Veggeberg R, Grant PE, et al. . Sex and the migraine brain. Neurobiol Dis. (2014) 68:200–14. 10.1016/j.nbd.2014.03.008 PubMed DOI PMC

Edvinsson L. CGRP antibodies as prophylaxis in migraine. Cell. (2018) 175:1719. 10.1016/j.cell.2018.11.049 PubMed DOI

Edvinsson L, Haanes KA, Warfvinge K, Krause DN. CGRP as the target of new migraine therapies - successful translation from bench to clinic. Nat Rev Neurol. (2018) 14:338–50. 10.1038/s41582-018-0003-1 PubMed DOI

Tiseo C, Ornello R, Pistoia F, Sacco S. How to integrate monoclonal antibodies targeting the calcitonin gene-related peptide or its receptor in daily clinical practice. J Headache Pain. (2019) 20:49. 10.1186/s10194-019-1000-5 PubMed DOI PMC

Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F, et al. . A controlled trial of erenumab for episodic migraine. N Engl J Med. (2017) 377:2123–32. 10.1056/NEJMoa1705848 PubMed DOI

Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, et al. . Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. (2017) 16:425–34. 10.1016/S1474-4422(17)30083-2 PubMed DOI

Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, et al. . Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. (2018) 392:2280–7. 10.1016/S0140-6736(18)32534-0 PubMed DOI

Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD, et al. . European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. (2019) 20:6. 10.1186/s10194-018-0955-y PubMed DOI PMC

Cheng S, Jenkins B, Limberg N, Hutton E. Erenumab in chronic migraine: an australian experience. Headache. (2020) 60:2555–62. 10.1111/head.13968 PubMed DOI

De Matteis E, Ornello R, Sacco S. Real-world data, clinical practice so far. In: Monoclonal Antibodies in Headache. European Headache Federation. Springer: (2020).

Lambru G, Hill B, Murphy M, Tylova I, Andreou AP. A prospective real-world analysis of erenumab in refractory chronic migraine. J Headache Pain. (2020) 21:61. 10.1186/s10194-020-01127-0 PubMed DOI PMC

Ornello R, Casalena A, Frattale I, Gabriele A, Affaitati G, Giamberardino MA, et al. . Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J Headache Pain. (2020) 21:32. 10.1186/s10194-020-01102-9 PubMed DOI PMC

Pensato U, Favoni V, Pascazio A, Benini M, Asioli GM, Merli E, et al. . Erenumab efficacy in highly resistant chronic migraine: a real-life study. Neurol Sci. (2020) 41(Suppl. 2):457–9. 10.1007/s10072-020-04658-1 PubMed DOI

Raffaelli B, Kalantzis R, Mecklenburg J, Overeem LH, Neeb L, Gendolla A, et al. . Erenumab in chronic migraine patients who previously failed five first-line oral prophylactics and onabotulinumtoxina: a dual-center retrospective observational study. Front Neurol. (2020) 11:417. 10.3389/fneur.2020.00417 PubMed DOI PMC

Ranieri A, Alfieri G, Napolitano M, Servillo G, Candelaresi P, Di Iorio W, et al. . One year experience with erenumab: real-life data in 30 consecutive patients. Neurol Sci. (2020) 41(Suppl. 2):505–6. 10.1007/s10072-020-04677-y PubMed DOI

Russo A, Silvestro M, Scotto di Clemente F, Trojsi F, Bisecco A, Bonavita S, et al. . Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience. J Headache Pain. (2020) 21:69. 10.1186/s10194-020-01143-0 PubMed DOI PMC

Scheffler A, Messel O, Wurthmann S, Nsaka M, Kleinschnitz C, Glas M, et al. . Erenumab in highly therapy-refractory migraine patients: first German real-world evidence. J Headache Pain. (2020) 21:84. 10.1186/s10194-020-01151-0 PubMed DOI PMC

Valle ED, Di Falco M, Mancioli A, Corbetta S, La Spina I. Efficacy and safety of erenumab in the real-life setting of S. Antonio Abate Hospital's Headache Center (Gallarate). Neurol Sci. (2020) 41:465. 10.1007/s10072-020-04752-4 PubMed DOI

Barbanti P, Aurilia C, Egeo G, Fofi L, Cevoli S, Colombo B, et al. . Erenumab in the prevention of high-frequency episodic and chronic migraine: erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache. (2021) 61:363–72. 10.1111/head.14032 PubMed DOI

Talbot J, Stuckey R, Crawford L, Weatherby S, Mullin S. Improvements in pain, medication use and quality of life in onabotulinumtoxinA-resistant chronic migraine patients following erenumab treatment - real world outcomes. J Headache Pain. (2021) 22:5. 10.1186/s10194-020-01214-2 PubMed DOI PMC

Labastida-Ramirez A, Rubio-Beltran E, Villalon CM, MaassenVanDenBrink A. Gender aspects of CGRP in migraine. Cephalalgia. (2019) 39:435–44. 10.1177/0333102417739584 PubMed DOI PMC

Scher AI, Wang SJ, Katsarava Z, Buse DC, Fanning KM, Adams AM, et al. . Epidemiology of migraine in men: results from the chronic migraine epidemiology and outcomes (CaMEO) study. Cephalalgia. (2019) 39:296–305. 10.1177/0333102418786266 PubMed DOI

Warfvinge K, Krause DN, Maddahi A, Edvinsson JCA, Edvinsson L, Haanes KA. Estrogen receptors alpha, beta and GPER in the CNS and trigeminal system - molecular and functional aspects. J Headache Pain. (2020) 21:131. 10.1186/s10194-020-01197-0 PubMed DOI PMC

Gupta S, Villalon CM, Mehrotra S, de Vries R, Garrelds IM, Saxena PR, et al. . Female sex hormones and rat dural vasodilatation to CGRP, periarterial electrical stimulation and capsaicin. Headache. (2007) 47:225–35. 10.1111/j.1526-4610.2006.00526.x PubMed DOI

de Vries Lentsch S, Rubio-Beltran E, MaassenVanDenBrink A. Changing levels of sex hormones and calcitonin gene-related peptide (CGRP) during a woman's life: implications for the efficacy and safety of novel antimigraine medications. Maturitas. (2021) 145:73–7. 10.1016/j.maturitas.2020.12.012 PubMed DOI

Ashina M, Terwindt GM, Al-Karagholi MA, de Boer I, Lee MJ, Hay DL, et al. . Migraine: disease characterisation, biomarkers, and precision medicine. Lancet. (2021) 397:1496–504. 10.1016/S0140-6736(20)32162-0 PubMed DOI

Comparing the relative and absolute effect of erenumab: is a 50% response enough? Results from the ESTEEMen study