Skip to main content
Top
Published in: Pain and Therapy 2/2021

Open Access 01-12-2021 | Migraine | Original Research

Effectiveness and Safety of CGRP-mAbs in Menstrual-Related Migraine: A Real-World Experience

Authors: Marcello Silvestro, Ilaria Orologio, Simona Bonavita, Fabrizio Scotto di Clemente, Carla Fasano, Alessandro Tessitore, Gioacchino Tedeschi, Antonio Russo

Published in: Pain and Therapy | Issue 2/2021

Login to get access

Abstract

Introduction

Migraine shows a significantly higher prevalence in women, especially during reproductive age when menstrual-related hormonal fluctuations represent the most common migraine trigger. Indeed, over 50% of patients report a higher occurrence of migraine attacks during the perimenstrual window. Menstrual migraine attacks are consistently referred to as more disabling, less responsive to symptomatic treatments, longer in duration, and more prone to relapse than non-menstrual migraine attacks. Evidence strongly suggests that estrogen fluctuations are involved in migraine attacks worsening during the perimenstrual window through several mechanisms directly or indirectly involving the CGRP pathway. We aimed to evaluate whether mAbs blocking CGRP-ligand or receptor (CGRP-mAbs) could represent an effective and safe preventive treatment for menstrual migraine attacks in patients with menstrual-related migraine (MRM) with previous treatment failures.

Methods

Forty patients with MRM with at least three previous treatment failures received monthly CGRP-mAbs. At the baseline and after six CGRP-mAbs administrations, patients underwent to extensive interviews to assess frequency, duration, intensity, and responsiveness to painkiller intake of migraine attacks occurring during the perimenstrual window.

Results

After six administrations of CGRP-mAbs we observed a reduction of median menstrual migraine frequency (from 5 to 2 days per month), pain intensity (from 8/10 to 6/10), and attacks duration (from 24 to 8 h) (p < 0.001). Nevertheless, a significant increase in the percentage of responding to migraine painkillers was observed from 42.5% at baseline to 95% at T1 (p < 0.001).

Conclusions

CGRP-mAbs could represent a safe and effective preventive therapeutic strategy able to reduce the disabling burden of menstrual migraine attack frequency, duration, intensity, and significantly improve the response to painkillers. These findings could be related to and further indirectly prove the greater influence of CGRP-mediated mechanisms in the pathophysiology of menstrual migraine attacks.
Appendix
Available only for authorised users
Literature
1.
go back to reference Vetvik KG, MacGregor EA. Sex differences in the epidemiology, clinical features, and pathophysiology of migraine. Lancet Neurol. 2017;16(1):76–87.CrossRef Vetvik KG, MacGregor EA. Sex differences in the epidemiology, clinical features, and pathophysiology of migraine. Lancet Neurol. 2017;16(1):76–87.CrossRef
2.
go back to reference Yeh WZ, Blizzard L, Taylor BV. What is the actual prevalence of migraine? Brain Behav. 2018;8(6):e00950.CrossRef Yeh WZ, Blizzard L, Taylor BV. What is the actual prevalence of migraine? Brain Behav. 2018;8(6):e00950.CrossRef
3.
go back to reference Allais G, Chiarle G, Sinigaglia S, Airola G, Schiapparelli P, Benedetto C. Gender-related differences in migraine. Neurol Sci. 2020;41(Suppl 2):429–36.CrossRef Allais G, Chiarle G, Sinigaglia S, Airola G, Schiapparelli P, Benedetto C. Gender-related differences in migraine. Neurol Sci. 2020;41(Suppl 2):429–36.CrossRef
4.
go back to reference Mannix LK, Calhoun AH. Menstrual Migraine. Curr Treat Options Neurol. 2004;6(6):489–98.CrossRef Mannix LK, Calhoun AH. Menstrual Migraine. Curr Treat Options Neurol. 2004;6(6):489–98.CrossRef
5.
go back to reference Allais G, Chiarle G, Sinigaglia S, et al. Treating migraine with contraceptives. Neurol Sci. 2017;38(Suppl 1):85–9.CrossRef Allais G, Chiarle G, Sinigaglia S, et al. Treating migraine with contraceptives. Neurol Sci. 2017;38(Suppl 1):85–9.CrossRef
6.
go back to reference Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211.
7.
go back to reference Hu Y, Guan X, Fan L, Jin L. Triptans in prevention of menstrual migraine: a systematic review with meta-analysis. J Headache Pain. 2013;14(1):7 (Published 2013 Jan 30).CrossRef Hu Y, Guan X, Fan L, Jin L. Triptans in prevention of menstrual migraine: a systematic review with meta-analysis. J Headache Pain. 2013;14(1):7 (Published 2013 Jan 30).CrossRef
8.
go back to reference MacGregor EA. Prevention and treatment of menstrual migraine. Drugs. 2010;70(14):1799–818.CrossRef MacGregor EA. Prevention and treatment of menstrual migraine. Drugs. 2010;70(14):1799–818.CrossRef
9.
go back to reference Allais G, Chiarle G, Sinigaglia S, Benedetto C. Menstrual migraine: a review of current and developing pharmacotherapies for women. Expert Opin Pharmacother. 2018;19(2):123–36.CrossRef Allais G, Chiarle G, Sinigaglia S, Benedetto C. Menstrual migraine: a review of current and developing pharmacotherapies for women. Expert Opin Pharmacother. 2018;19(2):123–36.CrossRef
10.
go back to reference Silberstein SD, Hutchinson SL. Diagnosis and treatment of the menstrual migraine patient. Headache. 2008;48(Suppl 3):S115–23.CrossRef Silberstein SD, Hutchinson SL. Diagnosis and treatment of the menstrual migraine patient. Headache. 2008;48(Suppl 3):S115–23.CrossRef
11.
go back to reference Lattanzi S, Brigo F, Trinka E, et al. Erenumab for preventive treatment of migraine: a systematic review and meta-analysis of efficacy and safety. Drugs. 2019;79(4):417–31.CrossRef Lattanzi S, Brigo F, Trinka E, et al. Erenumab for preventive treatment of migraine: a systematic review and meta-analysis of efficacy and safety. Drugs. 2019;79(4):417–31.CrossRef
12.
go back to reference Lionetto L, Curto M, Cisale GY, et al. Fremanezumab for the preventive treatment of migraine in adults. Expert Rev Clin Pharmacol. 2019;12(8):741–8.CrossRef Lionetto L, Curto M, Cisale GY, et al. Fremanezumab for the preventive treatment of migraine in adults. Expert Rev Clin Pharmacol. 2019;12(8):741–8.CrossRef
13.
go back to reference Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211–21.CrossRef Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211–21.CrossRef
14.
go back to reference Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018;75(9):1080 (1088 published correction appears in JAMA Neurol. 2019 Jul 1;76(7):872).CrossRef Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018;75(9):1080 (1088 published correction appears in JAMA Neurol. 2019 Jul 1;76(7):872).CrossRef
15.
go back to reference Pavlovic JM, Paemeleire K, Göbel H, et al. Efficacy and safety of erenumab in women with a history of menstrual migraine. J Headache Pain. 2020;21(1):95 (Published 2020 Aug 3).CrossRef Pavlovic JM, Paemeleire K, Göbel H, et al. Efficacy and safety of erenumab in women with a history of menstrual migraine. J Headache Pain. 2020;21(1):95 (Published 2020 Aug 3).CrossRef
16.
go back to reference Sacco S, Bendtsen L, Ashina M, 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(1):6 (2019 May 23;20(1):58 Published 2019 Jan 16).CrossRef Sacco S, Bendtsen L, Ashina M, 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(1):6 (2019 May 23;20(1):58 Published 2019 Jan 16).CrossRef
17.
go back to reference Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: figures and Trends From Government Health Studies. Headache. 2018;58(4):496–505.CrossRef Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: figures and Trends From Government Health Studies. Headache. 2018;58(4):496–505.CrossRef
18.
go back to reference Labastida-Ramírez A, Rubio-Beltrán E, Villalón CM, MaassenVanDenBrink A. Gender aspects of CGRP in migraine. Cephalalgia. 2019;39(3):435–44.CrossRef Labastida-Ramírez A, Rubio-Beltrán E, Villalón CM, MaassenVanDenBrink A. Gender aspects of CGRP in migraine. Cephalalgia. 2019;39(3):435–44.CrossRef
19.
go back to reference Gupta S, McCarson KE, Welch KM, Berman NE. Mechanisms of pain modulation by sex hormones in migraine. Headache. 2011;51(6):905–22.CrossRef Gupta S, McCarson KE, Welch KM, Berman NE. Mechanisms of pain modulation by sex hormones in migraine. Headache. 2011;51(6):905–22.CrossRef
20.
go back to reference Calhoun AH. Understanding menstrual migraine. Headache. 2018;58(4):626–30.CrossRef Calhoun AH. Understanding menstrual migraine. Headache. 2018;58(4):626–30.CrossRef
21.
go back to reference MacGregor EA, Frith A, Ellis J, Aspinall L, Hackshaw A. Incidence of migraine relative to menstrual cycle phases of rising and falling estrogen. Neurology. 2006;67(12):2154–8.CrossRef MacGregor EA, Frith A, Ellis J, Aspinall L, Hackshaw A. Incidence of migraine relative to menstrual cycle phases of rising and falling estrogen. Neurology. 2006;67(12):2154–8.CrossRef
22.
go back to reference Maasumi K, Tepper SJ, Kriegler JS. Menstrual migraine and treatment options: review. Headache. 2017;57(2):194–208.CrossRef Maasumi K, Tepper SJ, Kriegler JS. Menstrual migraine and treatment options: review. Headache. 2017;57(2):194–208.CrossRef
23.
go back to reference Downie J, Poyser NL, Wunderlich M. Levels of prostaglandins in human endometrium during the normal menstrual cycle. J Physiol. 1974;236(2):465–72.CrossRef Downie J, Poyser NL, Wunderlich M. Levels of prostaglandins in human endometrium during the normal menstrual cycle. J Physiol. 1974;236(2):465–72.CrossRef
25.
go back to reference Matsuda M, Huh Y, Ji RR. Roles of inflammation, neurogenic inflammation, and neuroinflammation in pain. J Anesth. 2019;33(1):131–9.CrossRef Matsuda M, Huh Y, Ji RR. Roles of inflammation, neurogenic inflammation, and neuroinflammation in pain. J Anesth. 2019;33(1):131–9.CrossRef
26.
go back to reference Ibrahimi K, Danser AHJ, Villalón CM, van den Meiracker AH, MaassenVanDenBrink A. Influence of varying estrogen levels on trigeminal CGRP release in healthy women. J Headache Pain. 2013;14(Suppl 1):P123.CrossRef Ibrahimi K, Danser AHJ, Villalón CM, van den Meiracker AH, MaassenVanDenBrink A. Influence of varying estrogen levels on trigeminal CGRP release in healthy women. J Headache Pain. 2013;14(Suppl 1):P123.CrossRef
27.
go back to reference Maleki N, Linnman C, Brawn J, Burstein R, Becerra L, Borsook D. Her versus his migraine: multiple sex differences in brain function and structure. Brain. 2012;135(Pt 8):2546–59.CrossRef Maleki N, Linnman C, Brawn J, Burstein R, Becerra L, Borsook D. Her versus his migraine: multiple sex differences in brain function and structure. Brain. 2012;135(Pt 8):2546–59.CrossRef
28.
go back to reference Mathew PG, Dun EC, Luo JJ. A cyclic pain: the pathophysiology and treatment of menstrual migraine. Obstet Gynecol Surv. 2013;68(2):130–40.CrossRef Mathew PG, Dun EC, Luo JJ. A cyclic pain: the pathophysiology and treatment of menstrual migraine. Obstet Gynecol Surv. 2013;68(2):130–40.CrossRef
29.
go back to reference Sullivan E, Bushnell C. Management of menstrual migraine: a review of current abortive and prophylactic therapies. Curr Pain Headache Rep. 2010;14(5):376–84.CrossRef Sullivan E, Bushnell C. Management of menstrual migraine: a review of current abortive and prophylactic therapies. Curr Pain Headache Rep. 2010;14(5):376–84.CrossRef
30.
go back to reference Silberstein S, Patel S. Menstrual migraine: an updated review on hormonal causes, prophylaxis and treatment. Expert Opin Pharmacother. 2014;15(14):2063–70.CrossRef Silberstein S, Patel S. Menstrual migraine: an updated review on hormonal causes, prophylaxis and treatment. Expert Opin Pharmacother. 2014;15(14):2063–70.CrossRef
31.
go back to reference Allais G, Sanchez del Rio M, Diener HC, et al. Perimenstrual migraines and their response to preventive therapy with topiramate. Cephalalgia. 2011;31(2):152–60.CrossRef Allais G, Sanchez del Rio M, Diener HC, et al. Perimenstrual migraines and their response to preventive therapy with topiramate. Cephalalgia. 2011;31(2):152–60.CrossRef
32.
go back to reference Ferrari MD, Goadsby PJ, Roon KI, Lipton RB. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia. 2002;22(8):633–58 (published correction appears in Cephalalgia. 2003 Feb;23(1):71.).CrossRef Ferrari MD, Goadsby PJ, Roon KI, Lipton RB. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia. 2002;22(8):633–58 (published correction appears in Cephalalgia. 2003 Feb;23(1):71.).CrossRef
33.
go back to reference Ornello R, Frattale I, Caponnetto V, De Matteis E, Pistoia F, Sacco S. Menstrual headache in women with chronic migraine treated with erenumab: an observational case series. Brain Sci. 2021;11(3):370.CrossRef Ornello R, Frattale I, Caponnetto V, De Matteis E, Pistoia F, Sacco S. Menstrual headache in women with chronic migraine treated with erenumab: an observational case series. Brain Sci. 2021;11(3):370.CrossRef
Metadata
Title
Effectiveness and Safety of CGRP-mAbs in Menstrual-Related Migraine: A Real-World Experience
Authors
Marcello Silvestro
Ilaria Orologio
Simona Bonavita
Fabrizio Scotto di Clemente
Carla Fasano
Alessandro Tessitore
Gioacchino Tedeschi
Antonio Russo
Publication date
01-12-2021
Publisher
Springer Healthcare
Published in
Pain and Therapy / Issue 2/2021
Print ISSN: 2193-8237
Electronic ISSN: 2193-651X
DOI
https://doi.org/10.1007/s40122-021-00273-w

Other articles of this Issue 2/2021

Pain and Therapy 2/2021 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.