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Review

Patient selection for migraine preventive treatment with anti-CGRP(r) monoclonal antibodies

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Pages 769-776 | Received 02 Apr 2019, Accepted 17 May 2019, Published online: 29 May 2019

References

  • GBD. Disease and injury incidence and prevalence collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet. 2017;390:1211–1259.
  • GBD. Headache collaborators. 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. 2016;17:954–976.
  • Steiner TJ, Stovner LJ, Vos T, et al. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018;19:17.
  • Serrano D, Lipton RB, Scher AI, et al. Fluctuations in episodic and chronic migraine status over the course of 1 year: implications for diagnosis, treatment and clinical trial design. J Headache Pain. 2017;18:101.
  • Headache classification committee of the International Headache Society (IHS) the international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38:1–211.
  • Negro A, Martelletti P. Chronic migraine plus medication overuse headache: two entities or not? J Headache Pain. 2011;12:593–601.
  • Negro A, Rocchietti-March M, Fiorillo M, et al. Chronic migraine: current concepts and ongoing treatments. Eur Rev Med Pharmacol Sci. 2011;15:1401–1420.
  • Negro A, D’Alonzo L, Martelletti P. Chronic migraine: comorbidities, risk factors, and rehabilitation. Intern Emerg Med. 2010;Suppl 1:S13–9.
  • Martelletti P, Katsarava Z, Lampl C, et al. Refractory chronic migraine: a consensus statement on clinical definition from the European headache federation. J Headache Pain. 2014;28:47.
  • Goadsby PJ, Holland PR, Martins-Oliveira M, et al. Pathophysiology of migraine: A disorder of sensory processing. Physiol Rev. 2017;97:553–622.
  • May A. Understanding migraine as a cycling brain syndrome: reviewing the evidence from functional imaging. Neurol Sci. 2017;38:125–130.
  • Noseda R, Burstein R. Migraine pathophysiology: anatomy of the trigeminovascular pathway and associated neurological symptoms, cortical spreading depression, sensitization, and modulation of pain. Pain. 2013;154(Suppl 1):S44–53.
  • Eftekhari S, Salvatore CA, Johansson S, et al. Localization of CGRP, CGRP receptor, PACAP and glutamate in trigeminal ganglion. Relation to the blood-brain barrier. Brain Res. 2015;1600:93–109.
  • Lundblad C, Haanes KA, Grände G, et al. Experimental inflammation following dural application of complete Freund’s adjuvant or inflammatory soup does not alter brain and trigeminal microvascular passage. J Headache Pain. 2015;16:91.
  • Liu Y, Broman J, Zhang M, et al. Brainstem and thalamic projections from a craniovascular sensory nervous centre in the rostral cervical spinal dorsal horn of rats. Cephalalgia. 2009;29:935–948.
  • Malick A, Strassman RM, Burstein R. Trigeminohypothalamic and reticulohypothalamic tract neurons in the upper cervical spinal cord and caudal medulla of the rat. J Neurophysiol. 2000;84:2078–2112.
  • Williams MN, Zahm DS, Jacquin MF. Differential foci and synaptic organization of the principal and spinal trigeminal projections to the thalamus in the rat. Eur J Neurosci. 1994;6:429–453.
  • Liu Y, Zhang M, Broman J, et al. Central projections of sensory innervation of the rat superficial temporal artery. Brain Res. 2003;966:126–133.
  • Liu Y, Broman J, Edvinsson L. Central projections of sensory innervation of the rat superior sagittal sinus. Neuroscience. 2004;129:431–437.
  • Liu Y, Broman J, Edvinsson L. Central projections of sensory innervation of middle meningeal artery of rat. Brain Res. 2008;1208:103–110.
  • Edvinsson L, Haanes KA, Warfvinge K, et al. CGRP as the target of new migraine therapies - successful translation from bench to clinic. Nat Rev Neurol. 2018;14:338–350.
  • Vécsei L, Tuka B, Tajti J. Role of PACAP in migraine headaches. Brain. 2014;137:650–651.
  • Schytz HW, Birk S, Wienecke T, et al. PACAP38 induces migraine-like attacks in patients with migraine without aura. Brain. 2009;132:16–25.
  • Tuka B, Helyes Z, Markovics A, et al. Alterations in PACAP-38-like immunoreactivity in the plasma during ictal and interictal periods of migraine patients. Cephalalgia. 2013;33:1085–1095.
  • Edvinsson L, Villalón CM, MaassenVanDenBrink A. Basic mechanisms of migraine and its acute treatment. Pharmacol Ther. 2012;136:319–333.
  • Messlinger K. Migraine: where and how does the pain originate? Exp Brain Res. 2009;196:179–193.
  • Pietrobon D, Moskowitz MA. Pathophysiology of migraine. Annu Rev Physiol. 2013;75:365–391.
  • Raddant AC, Russo AF. Calcitonin gene-related peptide in migraine: intersection of peripheral inflammation and central modulation. Expert Rev Mol Med. 2011;13:e36.
  • Messlinger K. The big CGRP flood - sources, sinks and signalling sites in the trigeminovascular system. J Headache Pain. 2018;19(1):22.
  • Barwell J, Wootten D, Simms J, et al. RAMPs and CGRP receptors. Adv Exp Med Biol. 2012;744:13–24.
  • Russell FA, King R, Smillie SJ, et al. Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev. 2014;94:1099–1142.
  • Taylor FR. CGRP, amylin, immunology, and headache medicine. Headache. 2019;59:131–150.
  • Hay DL. Amylin. Headache. 2017;57(Suppl. 2):89–96.
  • Edvinsson L. Functional role of perivascular peptides in the control of cerebral circulation. Trends Neurosci. 1985;8:126–131.
  • Goadsby PJ. The vascular theory of migraine—a great story wrecked by the facts. Brain. 2009;132:6–7.
  • Amin FM, Asghar MS, Hougaard A, et al. Magnetic resonance angiography of intracranial and extracranial arteries in patients with spontaneous migraine without aura: a cross-sectional study. Lancet Neurol. 2013;12:454–461.
  • Wienecke T, Olesen J, Ashina M. Discrepancy between strong cephalic arterial dilatation and mild headache caused by prostaglandin D2 (PGD2). Cephalalgia. 2011;31:65–76.
  • Gallai V, Sarchielli P, Floridi A, et al. Vasoactive peptide levels in the plasma of young migraine patients with and without aura assessed both interictally and ictally. Cephalalgia. 1995;15:384–390.
  • Cernuda-Morollón E, Larrosa D, Ramón C, et al. Interictal increase of CGRP levels in peripheral blood as a biomarker for chronic migraine. Neurology. 2013;81:1191–1196.
  • Juhasz G, Zsombok T, Jakab B, et al. Sumatriptan causes parallel decrease in plasma calcitonin gene-related peptide (CGRP) concentration and migraine headache during nitroglycerin induced migraine attack. Cephalalgia. 2005;25:179–183.
  • Hansen JM, Hauge AW, Olesen J, et al. Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura. Cephalalgia. 2010;30:1179–1186.
  • Lassen LH, Jacobsen VB, Haderslev PA, et al. Involvement of calcitonin gener-elated peptide in migraine: regional cerebral blood flow and blood flow velocity in migraine patients. J Headache Pain. 2008;9:151–157.
  • Recober A, Kuburas A, Zhang Z, et al. Role of calcitonin gene-related peptide in light aversive behavior: implications for migraine. J Neurosci. 2009;29:8798–8804.
  • Cho SJ, Song TJ, Chu MK. Treatment update of chronic migraine. Curr Pain Headache Rep. 2017;21:26.
  • Dodick DW, Turkel CC, DeGryse RE, et al. PREEMPT chronic migraine study group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the doubleblind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010;50:921–936.
  • Lipton RB, Serrano D, Holland S, et al. Barriers to the diagnosis and treatment of migraine: effects of sex, income, and headache features. Headache. 2013;53:81–92.
  • Dodick DW, Loder EW, Manack Adams A, et al. Assessing barriers to chronic migraine consultation, diagnosis, and treatment: results from the chronic migraine epidemiology and outcomes (CaMEO) study. Headache. 2016;56:821–834.
  • Lionetto L, Borro M, Curto M, et al. Choosing the safest acute therapy during chronic migraine prophylactic treatment: pharmacokinetic and pharmacodynamic considerations. Expert Opin Drug Metab Toxicol. 2016;12:399–406.
  • Guerzoni S, Pellesi L, Baraldi C, et al. Long-term treatment benefits and prolonged efficacy of onabotulinumtoxinA in patients affected by chronic migraine and medication overuse headache over 3? Years of therapy. Front Neurol. 2017;8:586.
  • Negro A, Curto M, Lionetto L, et al. A two years open-label prospective study of onabotulinumtoxinA 195 U in medication overuse headache: a real-world experience. J Headache Pain. 2015;17:1.
  • Hepp Z, Dodick DW, Varon SF, et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015;35:478–488.
  • Blumenfeld AM, Bloudek LM, Becker WJ, et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache. 2013;53:644–655.
  • Hepp Z, Bloudek LM, Varon SF, et al. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20:22–33.
  • Lupi C, Benemei S, Guerzoni S, et al. Pharmacokinetics and pharmacodynamics of new acute treatments for migraine. Expert Opin Drug Metab Toxicol. 2019;15:189–198.
  • Negro A, Koverech A, Martelletti P. Serotonin receptor agonists in the acute treatment of migraine: a review on their therapeutic potential. J Pain Res. 2018;11:515–526.
  • Capi M, de Andrés F, Lionetto L, et al. Lasmiditan for the treatment of migraine. Expert Opin Investig Drugs. 2017;26:227–234.
  • Negro A, Curto M, Luana L, et al. Chronic migraine treatment: from onabotulinumtoxinA onwards. Expert Rev Neurother. 2016;16:1217–1227.
  • Safety and efficacy study in adult subjects with acute migraines. [Last accessed 2019 May 12th]. Available from: https://clinicaltrials.gov/show/NCT03235479
  • Safety and efficacy in adult subjects with acute migraines. [Last accessed 2019 May 12th]. Available from: https://clinicaltrials.gov/show/NCT03237845
  • Trial in Adult Subjects With Acute Migraines. [Last accessed 2019 May 12th]. Available from: https://clinicaltrials.gov/show/NCT03461757
  • Open label safety study in acute treatment of migraine. [Last accessed 2019 May 12th]. Available from: https://clinicaltrials.gov/show/NCT03266588
  • Efficacy, safety, and tolerability of oral ubrogepant in the acute treatment ofmigraine. [Last accessed 2019 May 12th]. Available from: https://clinicaltrials.gov/show/NCT02867709
  • Efficacy, safety, and tolerability study of oral ubrogepant in the acute treatment of migraine. [Last accessed 2019 May 12th]. Available from: https://clinicaltrials.gov/show/NCT02828020
  • An extension study to evaluate the long-term safety and tolerability of ubrogepant in the treatment of migraine. [Last accessed 2019 May 12th]. Available from: https://clinicaltrials.gov/show/NCT02873221
  • Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral AGN-241689 in Episodic Migraine Prevention. [Last accessed 2019 May 12th]. Available from: https://clinicaltrials.gov/show/NCT02848326
  • Allergan. Allergan’s Oral CGRP Receptor Antagonist Atogepant Demonstrates Robust Efficacy and Safety in Episodic Migraine Prevention in a Phase 2b/3 Clinical Trial. [Last accessed 2019 May 12th]. Available from: https://www.allergan.com/News/News/Thomson-Reuters/Allergan-s-Oral-CGRP-Receptor-Antagonist-Atogepant
  • Reuter U. A review of monoclonal antibody therapies and other preventative treatments in migraine. Headache. 2018;58(suppl 1):48–59.
  • Kielbasa W, Helton DL. A new era for migraine: pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody. Cephalalgia. 2019 Mar;27:333102419840780.
  • American Headache Society. The American Headache society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(1):1–18.
  • 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;20:6.
  • National Institute for health and Care Excellence. Appraisal consultation document Erenumab for preventing migraine. [Last accessed 2019 Mar 29] Available from: https://www.nice.org.uk/guidance/gid-ta10302/documents/appraisal-consultation-document
  • Giamberardino MA, Affaitati G, Curto M, et al. Anti-CGRP monoclonal antibodies in migraine: current perspectives. Intern Emerg Med. 2016;11:1045–1057.
  • Schwedt T, Reuter U, Tepper S, et al. Early onset of efficacy with erenumab in patients with episodic and chronic migraine. J Headache Pain. 2018;19:92.
  • Förderreuther S, Zhang Q, Stauffer VL, et al. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018;19:121.
  • Favoni V, Giani L, Al-Hassany L, et al. European headache federation school of advanced studies (EHF-SAS). CGRP and migraine from a cardiovascular point of view: what do we expect from blocking CGRP? J Headache Pain. 2019;20:27.
  • Negro A, Delaruelle Z, Ivanova TA, et al. European headache federation school of advanced studies (EHF-SAS). Headache and pregnancy: a systematic review. J Headache Pain. 2017;18:106.
  • Depre C, Antalik L, Starling A, et al. A randomized, double-blind, placebo-controlled study to evaluate the effect of erenumab on exercise time during a treadmill test in patients with stable angina. Headache. 2018;58:715–723.
  • Eftekhari S, Edvinsson L. Possible sites of action of the new calcitonin gene-related peptide receptor antagonists. Ther Adv Neurol Disord. 2010;3:369–378.
  • Pauza AG, Rysevaite-Kyguoliene K, Malinauskas M, et al. Alterations in enteric calcitonin gene-related peptide in patients with colonic diverticular disease: CGRP in diverticular disease. Auton Neurosci. 2019;216:63–71.
  • Ohno T, Hattori Y, Komine R, et al. Roles of Calcitonin gene-related peptide in maintenance of gastric mucosal integrity and in enhancement of ulcer healing and angiogenesis. Gastroenterology. 2008;134:215–225.
  • Sample SJ, Heaton CM, Behan M, et al. Role of calcitonin gene-related peptide in functional adaptation of the skeleton. PLoS One. 2014;9:e113959.
  • Wimalawansa SJ, El-Kholy AA. Comparitive study of distribution and biochemical characterization of brain calcitonin gene-related peptide receptors in five different species. Neuroscience. 1993;54:513–519.
  • Tanaka H, Kashiwagi R, Koizumi T. Inhibition of calcitonin gene-related peptide (CGRP) has the potential to extend first-phase insulin secretion. Exp Clin Endocrinol Diabetes. 2013;121:280–285.
  • Deen M, Correnti E, Kamm K, et al. European headache federation school of advanced studies (EHF-SAS). Blocking CGRP in migraine patients - a review of pros and cons. J Headache Pain. 2017;18:96.
  • Linde M, Gustavsson A, Stovner LJ, et al. The cost of headache disorders in Europe: the eurolight project. Eur J Neurol. 2012;19:703–711.
  • Reuter U. GBD 2016: still no improvement in the burden of migraine. Lancet Neurol. 2018;17:929–930.
  • Stovner LJ, Haimanot RT. Epidemiology of common headache disorders. In: Martelletti P, Steiner TJ, editors. Handbook of headache. Milan Heidelberg Dordrecht London New York: Springer; 2011. p. 17–25. SBN 978-88-470-2009-2.
  • Martelletti P. The application of CGRP(r) monoclonal antibodies in migraine spectrum: needs and priorities. BioDrugs. 2017;31:483–485.
  • Christensen CE, Younis S, Deen M, et al. Migraine induction with calcitonin gene-related peptide in patients from erenumab trials. J Headache Pain. 2018;19:105.

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