Fremanezumab for the preventive treatment of migraine in adults

References

• Goadsby PJ, Lipton RB, Ferrari MD. Migraine—current understanding and treatment. N Engl J Med. 2002;346(4):257–270.
   PubMed Web of Science ®Google Scholar
• 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. 21. 19(1):17.
   PubMed Web of Science ®Google Scholar
• Edvinsson L, Uddman R. Neurobiology in primary headaches. Brain Res Brain Res Rev. 2005;48(3):438–456.
   PubMedGoogle Scholar
• Edvinsson L, Eftekhari S, Salvatore CA, et al. Cerebellar distribution of calcitonin gene-related peptide (CGRP) and its receptor components calcitonin receptor-like receptor (CLR) and receptor activity modifying protein 1 (RAMP1) in rat. Mol Cell Neurosci. 2011;46(1):333–339.
   PubMed Web of Science ®Google Scholar
• Emeson RB, Hedjran F, Yeakley JM, et al. Alternative production of calcitonin and CGRP mRNA is regulated at the calcitoninspecific splice acceptor. Nature. 1989;341(6237):76–80.
   PubMed Web of Science ®Google Scholar
• Ho TW, Edvinsson L, Goadsby PJ. CGRP and its receptors provide new insights into migraine pathophysiology. Nat Rev Neurol. 2010;6(10):573–582.
   PubMed Web of Science ®Google Scholar
• Majima M, Ito Y, Hosono K, et al. CGRP/CGRP receptor antibodies: potential adverse effects due to blockade of neovascularization? Trends Pharmacol Sci. 2019;40(1):11–21.
   PubMed Web of Science ®Google Scholar
• Schou WS, Ashina S, Amin FM, et al. Calcitonin gene-related peptide and pain: a systematic review. J Headache Pain. 2017;18(1):34.
   PubMedGoogle Scholar
• Iyengar S, Ossipov MH, Johnson KW. The role of calcitonin gene-related peptide in peripheral and central pain mechanisms including migraine. Pain. 2017;158(4):543–559.
   PubMed Web of Science ®Google Scholar
• Carniglia L, Ramírez D, Durand D, et al. Neuropeptides and microglial activation in inflammation, pain, and neurodegenerative diseases. Mediators Inflamm. 2017;2017:5048616.
   PubMed Web of Science ®Google Scholar
• Lennerz JK, Ruhle V, Ceppa EP, et al. Calcitonin receptor-like receptor (CLR), receptor activity-modifying protein 1 (RAMP1), and calcitonin gene-related peptide (CGRP) immunoreactivity in the rat trigeminovascular system: differences between peripheral and central CGRP receptor distribution. J Comp Neurol. 2008;507(3):1277–1299.
   PubMed Web of Science ®Google Scholar
• Lee MJ, Lee SY, Cho S, et al. Feasibility of serum CGRP measurement as a biomarker of chronic migraine: a critical reappraisal. J Headache Pain. 2018. 13. 19(1):53.
   PubMedGoogle Scholar
• de Prado BM, Russo AF. CGRP receptor antagonists: A new frontier of anti-migraine medications. Drug Discov Today Ther Strateg. 2006;3(4):593–597.
   PubMedGoogle Scholar
• Tso AR, Goadsby PJ. Anti-CGRP monoclonal antibodies: the next era of migraine prevention? Curr Treat Options Neurol. 2017;19(8):27.
   PubMed Web of Science ®Google Scholar
• Hay DL, Garelja ML, Poyner DR, et al. Update on the pharmacology of calcitonin/CGRP family of peptides: IUPHAR Review 25. Br J Pharmacol. 2018;175(1):3–17.
   PubMed Web of Science ®Google Scholar
• Walker CS, Raddant AC, Woolley MJ, et al. CGRP receptor antagonist activity of olcegepant depends on the signalling pathway measured. Cephalalgia. 2018;38(3):437–451.
   PubMed Web of Science ®Google Scholar
• Russell FA, King R, Smillie SJ, et al. Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev. 2014;94(4):1099–1142.
   PubMed Web of Science ®Google Scholar
• Watson RE, DiPette DJ, Supowit SC, et al. Vasodilator peptides: CGRP, substance P, and adrenomedullin. In: Oparil S, Weber MA, editors. Hypertension, 2nd ed. A companion to Brenner & rector’s the kidney. Philadelphia: Elsevier; 2005. p. 193–202.
   Google Scholar
• Tajti J, Uddman R, Möller S, et al. Messenger molecules and receptor mRNA in the human trigeminal ganglion. J Auton Nerv Syst. 1999. 28. 76(2–3):176–183.
   PubMedGoogle Scholar
• Traub RJ, Allen B, Humphrey E, et al. Analysis of calcitonin gene-related peptide-like immunoreactivity in the cat dorsal spinal cord and dorsal root ganglia provide evidence for a multisegmental projection of nociceptive C-fiber primary afferents. J Comp Neurol. 1990. 15. 302(3):562–574.
   PubMed Web of Science ®Google Scholar
• Vause CV, Durham PL. CGRP stimulation of iNOS and NO release from trigeminal ganglion glial cells involves mitogen- activated protein kinase pathways. J Neurochem. 2009;110:811–821.
   PubMed Web of Science ®Google Scholar
• Thalakoti S, Patil VV, Damodaram S, et al. Neuron-glia signaling in trigeminal ganglion: implications for migraine pathology. Headache. 2007;47(7):1008–1023.
   PubMed Web of Science ®Google Scholar
• De Corato A, Lisi L, Capuano A, et al. Trigeminal satellite cells express functional calcitonin gene-related peptide receptors, whose activation enhances interleukin-1β pro-inflammatory effects. J Neuroimmunol. 2011 15;237(1–2):39–46.
   PubMed Web of Science ®Google Scholar
• Benarroch EE. CGRP: sensory neuropeptide with multiple neurologic implications. Neurology. 2011. 19. 77(3):281–287.
   PubMed Web of Science ®Google Scholar
• Shinohara K, Watabe AM, Nagase M, et al. Essential role of endogenous calcitonin gene-related peptide in pain-associated plasticity in the central amygdala. Eur J Neurosci. 2017;46(6):2149–2160.
   PubMed Web of Science ®Google Scholar
• Pawlik WW, Obuchowicz R, Biernat J, et al. Role of calcitonin gene related peptide in the modulation of intestinal circulatory, metabolic, and myoelectric activity during ischemia/reperfusion. J Physiol Pharmacol. 2000;51(4Pt2):933–942.
   PubMedGoogle Scholar
• Holzmann B. Modulation of immune responses by the neuropeptide CGRP. Amino Acids. 2013;45(1):1–7.
   PubMed Web of Science ®Google Scholar
• Bower RL, Hay DL. Amylin structure-function relationships and receptor pharmacology: implications for amylin mimetic drug development. Br J Pharmacol. 2016;173(12):1883–1898.
   PubMed Web of Science ®Google Scholar
• Poyner DR. Molecular pharmacology of receptors for calcitonin- gene-related peptide, amylin and adrenomedullin. Biochem Soc Trans. 1997;25(3):1032–1036.
   PubMed Web of Science ®Google Scholar
• Hay DL, Chen S, Lutz TA, et al. Amylin: pharmacology, physiology, and clinical potential. Pharmacol Rev. 2015;67(3):564–600.
   PubMed Web of Science ®Google Scholar
• Bell D, Schlüter KD, Zhou XJ, et al. Hypertrophic effects of calcitonin gene-related peptide (CGRP) and amylin on adult mammalian ventricular cardiomyocytes. J Mol Cell Cardiol. 1995;27(11):2433–2443.
   PubMed Web of Science ®Google Scholar
• llegaard M, Thorkildsen C, Petersen S, et al. Amylin(1–8) is devoid of anabolic activity in bone. Calcif Tissue Int. 2010;86(3):249–260.
   PubMed Web of Science ®Google Scholar
• May PC, Boggs LN, Fuson KS. Neurotoxicity of human amylin in rat primary hippocampal cultures: similarity to Alzheimer’s disease amyloid-beta neurotoxicity. J Neurochem. 1993;61(6):2330–2333.
   PubMed Web of Science ®Google Scholar
• Qiu WQ. Amylin and its G-protein-coupled receptor: A probable pathological process and drug target for Alzheimer’s disease. Neuroscience. 2017;25(356):44–51.
   Google Scholar
• Mietlicki-Baase EG. Amylin in Alzheimer’s disease: pathological peptide or potential treatment? Neuropharmacology. 2018. 1. 136(PtB):287–297.
   PubMedGoogle Scholar
• Hinson JP, Kapas S, Smith DM. Adrenomedullin, a multifunctional regulatory peptide. Endocr Rev. 2000;21(2):138–167.
   PubMed Web of Science ®Google Scholar
• Hattori Y, Nakanishi N, Gross SS, et al. Adrenomedullin augments nitric oxide and tetrahydrobiopterin synthesis in cytokine-stimulated vascular smooth muscle cells. Cardiovasc Res. 1999;44(1):207–214.
   PubMed Web of Science ®Google Scholar
• Miller MJ, Martínez A, Unsworth EJ, et al. Adrenomedullin expression in human tumor cell lines. Its potential role as an autocrine growth factor. J Biol Chem. 1996 20;271(38):23345–23351.
   PubMed Web of Science ®Google Scholar
• Kanazawa H, Kurihara N, Hirata K, et al. Adrenomedullin, a newly discovered hypotensive peptide, is a potent bronchodilator. Biochem Biophys Res Commun. 1994. 30. 205(1):251–254.
   PubMed Web of Science ®Google Scholar
• Hu W, Zhou PH, Zhang XB, et al. Pathophysiological functions of adrenomedullin and natriuretic peptides in patients with primary aldosteronism. Endocrine. 2015;48(2):661–668.
   PubMed Web of Science ®Google Scholar
• Takahashi K, Morimoto R, Hirose T, et al. Adrenomedullin 2/intermedin in the hypothalamo-pituitary-adrenal axis. J Mol Neurosci. 2011;43(2):182–192.
   PubMed Web of Science ®Google Scholar
• Chen TJ, Fu QY, Wu WQ. Plasma levels of adrenomedullin in patients with traumatic brain injury: potential contribution to prognosis. Peptides. 2014;56:146–150.
   PubMed Web of Science ®Google Scholar
• Nagaya N, Kangawa K. Adrenomedullin in the treatment of pulmonary hypertension. Peptides. 2004;25(11):2013–2018.
   PubMed Web of Science ®Google Scholar
• Vingolo EM, Fragiotta S, Mafrici M, et al. Vitreous and plasma changes of endothelin-1, adrenomedullin and vascular endothelium growth factor in patients with proliferative diabetic retinopathy. Eur Rev Med Pharmacol Sci. 2017;21(4):662–668.
   PubMed Web of Science ®Google Scholar
• Nishikimi T, Nakagawa Y. Adrenomedullin as a biomarker of heart failure. Heart Fail Clin. 2018;14(1):49–55.
   PubMed Web of Science ®Google Scholar
• Grieco P, Gomez-Monterrey I. Natural and synthetic peptides in the cardiovascular diseases: an update on diagnostic and therapeutic potentials. Arch Biochem Biophys. 2019;15(662):15–32.
   Google Scholar
• Negro A, Martelletti P. Chronic migraine plus medication overuse headache: two entities or not? J Headache Pain. 2011;12(6):593–601.
   PubMed Web of Science ®Google Scholar
• Öztürk V. Acute Treatment of Migraine. Noro Psikiyatr Ars. 2013;50(Suppl 1):S26–S29.
   PubMedGoogle Scholar
• 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(4):399–406.
   PubMed Web of Science ®Google Scholar
• Bendtsen L, Sacco S, Ashina M, et al. Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation. J Headache Pain. 2018 26;19(1):91.
   PubMed Web of Science ®Google Scholar
• Messina R, Goadsby PJ. CGRP - a target for acute therapy in migraine: clinical data. Cephalalgia. 2019;39(3):420–427.
   PubMed Web of Science ®Google Scholar
• Wu H, Dall’Acqua WF. Humanized antibodies and their applications. Methods. 2005;36(1):1–2.
   PubMed Web of Science ®Google Scholar
• Silberstein SD. Emerging target-based paradigms to prevent and treat migraine. Clin Pharmacol Ther. 2013;93(1):78–85.
   PubMed Web of Science ®Google Scholar
• Negro A, Lionetto L, Simmaco M, et al. CGRP receptor antagonists: an expanding drug class for acute migraine? Expert Opin Investig Drugs. 2012;21(6):807–818.
   PubMed Web of Science ®Google Scholar
• Voss T, Lipton RB, Dodick, et al. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. Cephalalgia. 2016;36(9):887–898.
   PubMed Web of Science ®Google Scholar
• Lambru G, Andreou AP, Guglielmetti M, et al. Emerging drugs for migraine treatment: an update. Expert Opin Emerg Drugs. 2018 Nov 28;23:301–318.
   PubMed Web of Science ®Google Scholar
• Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017 30;377(22):2113–2122.
   PubMed Web of Science ®Google Scholar
• Schuster NM, Rapoport AM. New strategies for the treatment and prevention of primary headache disorders. Nat Rev Neurol. 2016;12(11):635–650.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Reuter U, Hallstrom Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377(22):2123–2132.
   PubMed Web of Science ®Google Scholar
• Edvinsson L. The trigeminovascular pathway: role of CGRP and CGRP receptors in migraine. Headache. 2017;57(Suppl. 2):47–55.
   PubMed Web of Science ®Google Scholar
• Shi L, Lehto SG, Zhu DX, et al. Pharmacologic characterization of AMG 334, a potent and selective human monoclonal antibody against the calcitonin gene- related peptide receptor. J Pharmacol Exp Ther. 2016;356(1):223–231.
   PubMed Web of Science ®Google Scholar
• Kaplon H, Reichert JM. Antibodies to watch in 2019. MAbs. 2019;11(2):219–238.
   PubMed Web of Science ®Google Scholar
• [cited 2019 Apr 19th]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761089Orig1s000ChemR.pdf
   Google Scholar
• Ohlsson L, Kronvall E, Stratton J, et al. Fremanezumab blocks CGRP induced dilatation in human cerebral, middle meningeal and abdominal arteries. J Headache Pain. 2018 14;19(1):66.
   PubMed Web of Science ®Google Scholar
• Cohen-Barak O, Weiss S, Rasamoelisolo M, et al. A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects. Cephalalgia. 2018;38(13):1960–1971.
   PubMed Web of Science ®Google Scholar
• Lionetto L, Cipolla F, Guglielmetti M, et al. Fremanezumab for the prevention of chronic and episodic migraine. Drugs Today. 2019;55(4):1–12.
   Web of Science ®Google Scholar
• Bigal ME, Walter S. Monoclonal antibodies for migraine: preventing calcitonin gene-related peptide activity. CNS Drugs. 2014;28(5):389–399.
   PubMed Web of Science ®Google Scholar
• Taylor FR. CGRP, amylin, immunology and headache medicine. Headache. 2019;59(1):131–150.
   PubMed Web of Science ®Google Scholar
• Bigal ME, Dodick DW, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1081–1090.
   PubMed Web of Science ®Google Scholar
• Bigal ME, Edvinsson L, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1091–1100.
   PubMed Web of Science ®Google Scholar
• Bigal ME, Dodick DW, Krymchantowski AV, et al. TEV-48125 for the preventive treatment of chronic migraine: efficacy at early time points. Neurology. 2016 5;87(1):41–48.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Silberstein SD, Bigal ME, et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA. 2018 15;319(19):1999–2008.
   PubMed Web of Science ®Google Scholar
• Cohen JM, Dodick DW, Yang R, et al. Fremanezumab as add-on treatment for patients treated with other migraine preventive medicines. Headache. 2017 Oct;57(9):1375–1384.
   PubMed Web of Science ®Google Scholar
• [cited 2019 Jun 19]. Available from: https://clinicaltrials.gov/ct2/results?cond=&term=fremanezumab&cntry=&state=&city=&dist=
   Google Scholar
• VanderPluym J, Dodick DW, Lipton RB, et al. Fremanezumab for preventive treatment of migraine: functional status on headache-free days. Neurology. 2018. 18. 91(12):e1152–e1165.
   PubMed Web of Science ®Google Scholar