https://doi.org/10.4081/cc.2024.15762
Prospective evaluation of aura during anti-calcitonin gene-related peptide monoclonal antibody therapy after 52 weeks of treatment
Submitted: 20 March 2024
Accepted: 10 April 2024
Published: 7 May 2024
Accepted: 10 April 2024
Abstract Views: 2609
PDF: 269
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Background: Clinical studies have shown the efficacy and safety of monoclonal antibodies (mAbs) against calcitonin gene-related peptide (anti-CGRP) in migraine patients with and without aura. Early evidence from post hoc and small subgroup analyses suggests that anti-CGRP mAbs reduce the frequency and intensity of aura. Herein, we prospectively assessed the changes in aura after 12 months of anti-CGRP mAb treatment and performed a literature review.
Methods: All outpatients treated with anti-CGRP mAbs for one year in two tertiary Headache Centers and who experienced ≥1 episode of aura/month were enrolled. The study reports data from one month before (baseline) and the last three months (months 10, 11, 12) of treatment.
Results: Data from 13 patients with a diagnosis of migraine with and without aura were collected. The mean duration from aura onset was 17.8±7.9 years. At baseline nine patients (69.2%) reported visual aura, and four (30.8%) visual and sensory aura. Mean duration of aura episodes was of 34.2±15.7 minutes. At baseline, the mean number of monthly migraine days (MMDs) was 22.3±7.5, and the mean number of MMDs preceded by aura was 9.15±9.0. At month 12 of treatment, there was a significant reduction of MMDs (6.2±9.0, p=0.002) and MMDs with aura (2.6±2.7, p=0.015). Three patients reported episodes of aura without subsequent headache, a phenomenon that was absent prior to treatment. We identified 14 studies that reported changes in aura during anti-CGRP mAbs treatment.
Conclusions: This prospective study shows that anti-CGRP mAbs reduce the number of migraine attacks with aura consistently with the reduction of MMDs. Randomized studies with anti-CGRP mAbs specifically assessing migraine aura are required.
Burch RC, Buse DC, Lipton RB. Migraine: epidemiology, burden, and comorbidity. Neurol Clin 2019;37:631-49.
DOI: https://doi.org/10.1016/j.ncl.2019.06.001
Ferrari MD, Goadsby PJ, Burstein R, Kurth T, Ayata C, Charles A, et al. Migraine. Nat Rev Dis Primers 2022;8:2.
DOI: https://doi.org/10.1038/s41572-021-00328-4
Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd ed. Cephalalgia 2018;38:1-211.
DOI: https://doi.org/10.1177/0333102417738202
Goadsby PJ, Holland PR, Martins-Oliveira M, Hoffmann J, Schankin C, Akerman S. Pathophysiology of migraine: a disorder of sensory processing. Physiol Rev 2017;97:553-622.
DOI: https://doi.org/10.1152/physrev.00034.2015
Geppetti P, Capone JG, Trevisani M, Nicoletti P, Zagli G, Tola MR. CGRP and migraine: neurogenic inflammation revisited. J Headache Pain 2005;6:61-70.
DOI: https://doi.org/10.1007/s10194-005-0153-6
Brain SD, Williams TJ. Substance P regulates the vasodilator activity of calcitonin gene-related peptide. Nature 1988;335:73-5.
DOI: https://doi.org/10.1038/335073a0
De Logu F, Nassini R, Hegron A, Landini L, Jensen DD, Latorre R, et al. Schwann cell endosome CGRP signals elicit periorbital mechanical allodynia in mice. Nat Commun 2022;13:646.
DOI: https://doi.org/10.1038/s41467-022-28204-z
Dalkara T, Zervas NT, Moskowitz MA. From spreading depression to the trigeminovascular system. Neurol Sci 2006;27:S86-90.
DOI: https://doi.org/10.1007/s10072-006-0577-z
Mehnert J, Fischer-Schulte L, May A. Aura phenomena do not initiate migraine attacks. Findings from neuroimaging. Headache 2023;6:1040-4.
DOI: https://doi.org/10.1111/head.14597
Al-Hassany L, Goadsby PJ, Danser AHJ, Maassen Van Den Brink A. Calcitonin gene-related peptide-targeting drugs for migraine: how pharmacology might inform treatment decisions. Lancet Neurol 2022;21:284-94.
DOI: https://doi.org/10.1016/S1474-4422(21)00409-9
Iannone LF, Fattori D, Benemei S, Chiarugi A, Geppetti P, De Cesaris F. Long-term effectiveness of three anti-CGRP monoclonal antibodies in resistant chronic migraine patients based on the MIDAS score. CNS Drugs 2022;36:191-202.
DOI: https://doi.org/10.1007/s40263-021-00893-y
Raffaelli B, De Icco R, Corrado M, Terhart M, Ailani J. Open-label trials for CGRP-targeted drugs in migraine prevention: a narrative review. Cephalalgia 2023;43:3331024221137091.
DOI: https://doi.org/10.1177/03331024221137091
Haghdoost F, Puledda F, Garcia-Azorin D, Huessler EM, Messina R, Pozo-Rosich P. Evaluating the efficacy of CGRP mAbs and gepants for the preventive treatment of migraine: a systematic review and network meta-analysis of phase 3 randomised controlled trials. Cephalalgia 2023;43:3331024231159366.
DOI: https://doi.org/10.1177/03331024231159366
Ashina M, McAllister P, Cady R, Hirman J, Ettrup A. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia 2022;42:696-704.
DOI: https://doi.org/10.1177/03331024221077646
Ashina S, Melo-Carrillo A, Toluwanimi A, Bolo N, Szabo E, Borsook D, et al. Galcanezumab effects on incidence of headache after occurrence of triggers, premonitory symptoms, and aura in responders, non-responders, super responders, and super nonresponders. J Headache Pain 2023;24:26.
Iannone LF, De Cesaris F, Ferrari A, Benemei S, Fattori D, Chiarugi A. Effectiveness of anti-CGRP monoclonal antibodies on central symptoms of migraine. Cephalalgia 2022;42:1323-30.
DOI: https://doi.org/10.1177/03331024221111526
Hauge AW, Asghar MS, Schytz HW, Christensen K, Olesen J. Effects of tonabersat on migraine with aura: a randomised, double-blind, placebo-controlled crossover study. Lancet Neurol 2009;8:718-23.
DOI: https://doi.org/10.1016/S1474-4422(09)70135-8
Albanese M, Mercuri NB. Could the new anti-CGRP monoclonal antibodies be effective in migraine aura? Case reports and literature review. J Clin Med 2022;11.
DOI: https://doi.org/10.3390/jcm11051228
Straube A, Stude P, Gaul C, Schuh K, Koch M. Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany. J Headache Pain 2021;22:133.
DOI: https://doi.org/10.1186/s10194-021-01344-1
Danno D, Ishizaki K, Kikui S, Takeshima T. Treatment of hemiplegic migraine with anti-calcitonin gene-related peptide monoclonal antibodies: a case series in a tertiary-care headache center. Headache 2023;63:984-9.
DOI: https://doi.org/10.1111/head.14591
Scheffler A, Schenk H, Wurthmann S, Nsaka M, Kleinschnitz C, Glas M, et al. CGRP antibody therapy in patients with drug resistant migraine and chronic daily headache: a real-world experience. J Headache Pain 2021;22:111.
DOI: https://doi.org/10.1186/s10194-021-01323-6
Matteo E, Pensato U, Favoni V, Giannini G, Pierangeli G, Cevoli S. Do anti-CGRP drugs have a role in migraine aura therapy? J Neurol 2021;268:2273-4.
DOI: https://doi.org/10.1007/s00415-021-10546-1
Kearney E, Collins T, Sengupta S. De novo visual aura onset in a migraineur on galcanezumab-gnlm. Headache 2020;60:1435-7.
DOI: https://doi.org/10.1111/head.13855
Mahović D, Bračić M, Jakuš L, Vukovic Cvetkovic V, Krpan M. Effectiveness and safety of erenumab in chronic migraine: a Croatian real-world experience. Clin Neurol Neurosurg 2022;214:107169.
DOI: https://doi.org/10.1016/j.clineuro.2022.107169
Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, et al. Assessment of erenumab safety and efficacy in patients with migraine with and without aura: a secondary analysis of randomized clinical trials. JAMA Neurol 2022;79:159-68.
DOI: https://doi.org/10.1001/jamaneurol.2021.4678
Igarashi H, Shibata M, Ozeki A, Matsumura T. Galcanezumab effects on migraine severity and symptoms in japanese patients with episodic migraine: secondary analysis of a phase 2 randomized trial. Neurol Ther 2023;12:73-87.
DOI: https://doi.org/10.1007/s40120-022-00410-3
Braca S, Miele A, Stornaiuolo A, Cretella G, De Simone R, Russo CV. Are anti-calcitonin gene-related peptide monoclonal antibodies effective in treating migraine aura? A pilot prospective observational cohort study. Neurol Sci 2024;45:1655-60.
DOI: https://doi.org/10.1007/s10072-023-07241-6
Cresta E, Bellotti A, Rinaldi G, Corbelli I, Sarchielli P. Effect of anti-CGRP-targeted therapy on migraine aura: results of an observational case series study. CNS Neurosci Ther 2024;30:e14595.
DOI: https://doi.org/10.1111/cns.14595
Costa C, Tozzi A, Rainero I, Cupini LM, Calabresi P, Ayata C, et al. Cortical spreading depression as a target for anti migraine agents. J Headache Pain 2013;14:62.
DOI: https://doi.org/10.1186/1129-2377-14-62
Close LN, Eftekhari S, Wang M, Charles AC, Russo AF. Cortical spreading depression as a site of origin for migraine: role of CGRP. Cephalalgia 2019;39:428-34.
DOI: https://doi.org/10.1177/0333102418774299
Russo AF, Hay DL. CGRP physiology, pharmacology, and therapeutic targets: migraine and beyond. Physiol Rev 2023;103:1565-644.
DOI: https://doi.org/10.1152/physrev.00059.2021
Tozzi A, de Iure A, Di Filippo M, Costa C, Caproni S, Pisani A, et al. Critical role of calcitonin gene-related peptide receptors in cortical spreading depression. Proc Natl Acad Sci USA 2012;109:18985-90.
DOI: https://doi.org/10.1073/pnas.1215435109
Eftekhari S, Kechechyan GM, Faas G, Charles A. The CGRP receptor antagonist olcegepant modulates cortical spreading depression in vivo. Cephalalgia 2017;37:295-6.
Piper RD, Edvinsson L. Cortical spreading depression does not increase VIP and CGRP in the external jugular blood of the cat. Cephalalgia 1991;11:50-1.
DOI: https://doi.org/10.1177/0333102491011S1127
Hansen JM, Hauge AW, Olesen J, Ashina M. Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura. Cephalalgia 2010;30:1179-86.
DOI: https://doi.org/10.1177/0333102410368444
Al-Khazali HM, Ashina H, Christensen RH, Wiggers A, Rose K, Iljazi A, et al. An exploratory analysis of clinical and sociodemographic factors in CGRP-induced migraine attacks: a REFORM study. Cephalalgia 2023;43:3331024231206375.
DOI: https://doi.org/10.1177/03331024231206375
Filiz A, Tepe N, Eftekhari S, Boran HE, Dilekoz E, Edvinsson L, et al. CGRP receptor antagonist MK-8825 attenuates cortical spreading depression induced pain behavior. Cephalalgia 2019;39:354-65.
DOI: https://doi.org/10.1177/0333102417735845
Melo-Carrillo A, Schain AJ, Stratton J, Strassman AM, Burstein R. Fremanezumab and its isotype slow propagation rate and shorten cortical recovery period but do not prevent occurrence of cortical spreading depression in rats with compromised blood-brain barrier. Pain 2020;161:1037-43.
DOI: https://doi.org/10.1097/j.pain.0000000000001791
Noseda R, Schain AJ, Melo-Carrillo A, Tien J, Stratton J, Mai F, et al. Fluorescently-labeled fremanezumab is distributed to sensory and autonomic ganglia and the dura but not to the brain of rats with uncompromised blood brain barrier. Cephalalgia 2020;40:229-40.
DOI: https://doi.org/10.1177/0333102419896760
Johnson KW, Morin SM, Wroblewski VJ, Johnson MP. Peripheral and central nervous system distribution of the CGRP neutralizing antibody [(125)I] galcanezumab in male rats. Cephalalgia 2019;39:1241-8.
DOI: https://doi.org/10.1177/0333102419844711
Basedau H, Sturm LM, Mehnert J, Peng KP, Schellong M, May A. Migraine monoclonal antibodies against CGRP change brain activity depending on ligand or receptor target - an fMRI study. Elife 2022;11.
DOI: https://doi.org/10.7554/eLife.77146
Damodaram S, Thalakoti S, Freeman SE, Garrett FG, Durham PL. Tonabersat inhibits trigeminal ganglion neuronal satellite glial cell signaling. Headache 2009;49:5-20.
DOI: https://doi.org/10.1111/j.1526-4610.2008.01262.x
Read SJ, Hirst WD, Upton N, Parsons AA. Cortical spreading depression produces increased cGMP levels in cortex and brain stem that is inhibited by tonabersat (SB-220453) but not sumatriptan. Brain Res 2001;891:69-77.
DOI: https://doi.org/10.1016/S0006-8993(00)03191-7
Ashina S, Melo-Carrillo A, Toluwanimi A, Bolo N, Szabo E, Borsook D, et al. Galcanezumab effects on incidence of headache after occurrence of triggers, premonitory symptoms, and aura in responders, non-responders, super responders, and super nonresponders. J Headache Pain 2023;24:26.
DOI: https://doi.org/10.1186/s10194-023-01560-x
How to Cite
1.
Romozzi M, Burgalassi A, Vollono C, Albanese M, Vigani G, De Cesaris F, et al. Prospective evaluation of aura during anti-calcitonin gene-related peptide monoclonal antibody therapy after 52 weeks of treatment. Confinia Cephalal [Internet]. 2024 May 7 [cited 2024 Dec. 22];34(1). Available from: https://www.confiniacephalalgica.com/site/article/view/15762
Copyright (c) 2024 the Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
Most read articles by the same author(s)
- Selene Attorre, Andrea Burgalassi, Giulia Vigani, Francesco De Cesaris, Marina Romozzi, Luigi Francesco Iannone, Sex and gender differences in the epidemiology, clinical features, and pathophysiology of trigeminal autonomic cephalalgias , Confinia Cephalalgica: Vol. 34 No. 2 (2024)
Similar Articles
- Luis Horacio Parodi, Franco Lucchese, Un modelo genetico-ambiental para un estudio prospectivo del estado de salud de los ciudadanos Italianos en la Argentina. Parte 3 - Estadísticas analíticas con enfoque en tipos de enfermedades , Confinia Cephalalgica: Vol. 29 No. 1 (2019)
- Editorial office, Expert consensus document on criteria for assessing disability and invalidity in chronic primary headache. From the law to the implementation of diagnostic-therapeutic pathways , Confinia Cephalalgica: Vol. 33 No. 1 (2023)
- Paolo Rossi, Harald Muller, Miguel Angel de Pascual, Patrick Little, Elena Ruiz De La Torre, on the Behalf of the EMHA Cluster Headache Special Interest Group, Cluster Headache (CH) and work life in the European Union: a survey from the european migraine and headache alliance , Confinia Cephalalgica: Vol. 29 No. 1 (2019)
You may also start an advanced similarity search for this article.
