Migraine treatment tomorrow and the day after tomorrow. Impact on the CGRP pathway


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Migraine is a chronic neurological disease characterized by a high prevalence and a significant decrease in quality of life. The combination of these factors leads to a significant negative socio-economic impact. Recently, significant progress has been made in understanding the pathogenesis of migraine, which led to the emergence of new classes of drugs for the treatment of this disease. This review discusses the history of the study of calcitonin gene - related peptide (CGRP) in the pathogenesis of migraine, and the characteristics of new drugs that affect the pathway of CGRP receptor antagonists (“gepants") and monoclonal antibodies against CGRP/CGRP receptor.

Full Text

Restricted Access

About the authors

Kirill V. Skorobogatykh

University Headache Clinic

Email: post.kirill@gmail.com

Yu. E Azimova

University Headache Clinic

References

  1. Steiner T.J., et al. Migraine: the seventh disabler. J. Headache Pain. 2013;14:1. doi: 10.1186/11292377-14-1.
  2. Ayzenberg I., Katsarava Z., Sborowski A., et al.; Lifting the Burden. The prevalence of primary headache disorders in Russia: a countrywide survey. Cephalalgia. 2012;32(5):373-81. doi: 10.1177/0333102412438977.
  3. GBD 2016 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. 2018;17(11):954-76. doi: 10.1016/S1474- 4422(18)30322-3.
  4. Linde M., Gustavsson A., Stovner L.J., et al. The cost of headache disorders in Europe: the Eurolight project. Eur J. Neurol. 2011;19(5):703-11. doi: 10.1111/j.1468-1331.2011.03612.x.
  5. Ayzenberg I., Katsarava Z., Sborowski A., et al. Headache-attributed burden and its impact on productivity and quality of life in Russia: structured healthcare for headache is urgently needed. Eur J. Neurol. 2014;21(5):758-65. Doi: 10.1111/ ene.12380.
  6. Evers S., Afra J., Frese A., et al. European Federation of Neurological Societies. EFNS guideline on the drug treatment of migraine--revised report of an EFNS task force. Eur J. Neurol. 2009;16(9):968-81. doi: 10.1111/j.1468-1331.2009.02748.x.
  7. Marmura M.J., Silberstein S.D., Schwedt T.J. The Acute Treatment of Migraine in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. Headache. J. Head Face Pain. 2015;55(1):3-20. Doi: 10.1111/ head.12499.
  8. Silberstein S.D. Preventive Migraine Treatment. Continuum (Minneap Minn). 2015;21(4 Headache):973-89. Doi: 10.1212/ C0N.0000000000000199.
  9. Goadsby PJ., Holland PR., Martins-Oliveira M., et al. Pathophysiology of Migraine: A Disorder of Sensory Processing. Physiol Rev. 2017;97(2):553-622. doi: 10.1152/physrev.00034.2015.
  10. Ray B., Wolff H. Experimental studies on headache. Pain sensitive structures of the head and their significance in headache. Arch Surg. 1940;41:813-56.
  11. Moskowitz M.A., Reinhard J.F. Jr., Romero J., et ai. Neurotransmitters and the fifth cranial nerve: is there a relation to the headache phase of migraine? Lancet. 1474;2(-14-):--6--5. Doi: 10.1016/ s0140-6766(74)42642--
  12. Uddman R., Edvinsson L., Ekman R., et ai. Innervation of the feline cerebrai vasculature by nerve fibers containing caicitonin genereiated peptide: Trigeminal origin and co-existence with substance P. Neurosci Letters. 14-5;62(1):161-66. doi: 10.1016/0604-6440(-5)40246-4. doi: 10.1016/0604-6440(-5)40246-4.
  13. Скоробогатых К.В., Табеева ГР Кальцитонин-ген-родственный пептид в патогенезе первичных головных болей. Российский журнал боли. 2010;(1):1-52.
  14. Goadsby PJ., Edvinsson L., Ekman R. Release of vasoactive peptides in the extracerebral circulation of humans and the cat during activation of the trigeminovascular system. Ann Neurol. 14--);26(2):146-46. Doi:10.1002/ ana.410260214.
  15. Zagami A.S., Goadsby PJ., Edvinsson L. Stimulation of the superior sagittal sinus in the cat causes release of vasoactive peptides. Neuropept. 1440;16(2):64-75. doi: 10.1016/0146-4174(40)40114-e.
  16. Goadsby PJ., Edvinsson L., Ekman R. Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol. 1440;2-(2):1-6--7. Doi: 10.1002/ ana.4102-0216.
  17. Goadsby PJ., Edvinsson L. The trigeminovascular system and migraine: Studies characterizing cerebrovascular and neuropeptide changes seen in humans and cats. Ann Neurol. 1446);66(1):4--56. doi: 10.1002/ana.410660104. 1-. Lassen L., Haderslev P., Jacobsen V., et al. CGRP May Play A Causative Role in Migraine. Cephalalgia. 2002;22(1):54-61. doi: 10.1046/j.1468-2982.2002.00310.x.
  18. Warfvinge K., Edvinsson L. Distribution of CGRP and CGRP receptor components in the rat brain. Cephalalgia. 2017. 033310241772887. doi: 10.1177/0333102417728873.
  19. Edvinsson L. The Trigeminovascular Pathway: Role of CGRP and CGRP Receptors in Migraine. Headache. J. Head Face Pain. 2017;57:47-55. doi: 10.1111/head.13081.
  20. Olesen J., Diener H.-C., Husstedt I. W., et al. Calcitonin Gene-Related Peptide Receptor Antagonist BIBN 4096 BS for the Acute Treatment of Migraine. N. Engl J. Med. 2004;650(11):1104-
  21. doi: 10.1056/nejmoa030505.
  22. Edvinsson L., Linde M. New drugs in migraine treatment and prophylaxis: telcagepant and topiramate. Lancet. 2010;376(9741):645-55. doi: 10.1016/s0140-6736(10)60323-6.
  23. Ho T.W., Connor K.M., Zhang Y., et al. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurol. 2014;83:958-66. Doi: 10.1212/ WNL.0000000000000771.
  24. Marcus R., Goadsby PJ, Dodick D.W., et al. BMS-927711 for the acute treatment of migraine: A double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014;34:114-25. doi: 10.1177/0333102413500727.
  25. Voss T., Lipton R.B., Dodick D.W., et al. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. Cephalalgia. 2016;36:887-98. doi: 10.1177/0333102416653233.
  26. Lipton R.B., Croop R., Stock E.G., et al. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N. Engl J. Med. 2019;381(2):142-49. Doi: 10.1056/ nejmoa1811090.
  27. URL: https://clinicaltrials.gov/ct2/show/ NCT02848326
  28. Bigal M.E., Walter S., Rapoport A.M. Therapeutic antibodies against CGRP or its receptor. Br J. Clin Pharmacol. 2015;79(6):886-95. Doi: 10.1111/ bcp.12591.
  29. Silberstein S., Lenz R., Xu C. Therapeutic Monoclonal Antibodies: What Headache Specialists Need to Know. Headache. J. Head Face Pain. 2015;55(8):1171-82. Doi: 10.1111/ head.12642.
  30. Tepper S.J. History and Review of anti-Calcitonin Gene-Related Peptide (CGRP) Therapies: From Translational Research to Treatment. Headache. J. Head Face Pain. 2018;58( Suppl. 3):238-75. doi: 10.1111/head.13379.
  31. Sun H., Dodick D.W., Silberstein S., et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebocontrolled, phase 2 trial. Lancet. Neurol. 2016;15:382-90. doi: 10.1016/S1474-4422(16)00019-3.
  32. Dodick D.W., Ashina M., Brandes J.L., et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38:1026-37. doi: 10.1177/0333102418759786.
  33. Goadsby PJ, Reuter U., Hallstrm Y., et al. A controlled trial of erenumab for episodic migraine. N. Engl J. Med. 2017;377:2123-22. Doi: 10.1056/ NEJMoa1705848.
  34. Tepper SJ, Ashina M., Reuter U., et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, doubleblind, placebo-controlled phase 2 trial. Lancet. Neurol. 2017;16:425-34. doi: 10.1016/S1474-4422(17)30083-2.
  35. Bigal M.E., Dodick D.W., Rapoport A.M., et al. Safety, tolerability and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, doubleblind, placebo-controlled, phase 2b study. Lancet. Neurol. 2015;14:1081-90. Doi: 10.1016/ S1474-4422(15)00249-5.
  36. Dodick D.W., Silberstein S.D., Bigal M.E., et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA. 2018;319:1999-2008. doi: 10.1001/jama.2018.4853.
  37. Bigal M.E., Edvinsson L., Rapoport A.M., et al. Silberstein SD (2015a) 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;14:1091-100.
  38. Silberstein S.D., Dodick D.W., Bigal M.E., et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377:2113 22. Doi: https://doi.org/10.1056/ nejmoa1709038
  39. Dodick D.W., Goadsby PJ., Spierings E.L., et al. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin generelated peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014;13:885-92. doi: 10.1016/S1474-4422(14)70128-0.
  40. Skljarevski V., Oakes T.M., Zhang Q., et al. Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial. JAMA. Neurol. 2018;75:187-93. doi: 10.1001/jamaneurol.2017.3859.
  41. Stauffer V.L., Dodick D.W., Zhang Q., et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA. Neurol. 2018;75:1080-88. doi: 10.1001/jamaneurol.2018.1212.
  42. Detke H.C., Goadsby PJ., Wang S., et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebocontrolled REGAIN study. Neurol. 2018;91:1-11. Doi: https://doi. org/10.1212/ WNL.0000000000006640
  43. Dodick D.W., Goadsby PJ., Silberstein S.D., et al. ALD403 study investigators. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet. Neurol. 2014;13: 1100-107.
  44. A Multicenter Assessment of ALD403 in Frequent EpisodicMigraine(PROMISE 1)https://clinicaltrials. gov/ct2/show/NCT02559895 Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2) https:// clinicaltrials.gov/ct2/show/NCT02974153 Eptinezumab Alder Biopharmaceuticals https:// www.alderbio.rom
  45. Do T.P., Guo S., Ashina M. Therapeutic novelties in migraine: new drugs, new hope? J. Headache Pain. 2019;20(1). doi: 10.1186/s10194-019-0974-3.
  46. Ashina M., Goadsby PJ., Reuter U., et al. Longterm safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019;033310241985408. doi: 10.1177/0333102419854082.
  47. Ning X., Cohen J., Bennett N., et al. Long-Term Safety of Fremanezumab: Results of a 1-Year Study. Neurol. 2019;92(Suppl. 15).
  48. Schwedt T., Reuter U., Tepper S.J., et al. Early onset of efficacy with erenumab in patients with episodic and chronic migraine. J. Headache Pain. 2018;19(1):92. doi: 10.1186/s10194-018-0923-6.
  49. Bigal M.E., Dodick D.W., Krymchantowski A.VT, et al. TEV-48125 for the preventive treatment of chronic migraine: efficacy at early time points. Neurology. 2016;87:41-8. Doi: 10.1212/ WNL.0000000000002801.
  50. Kudrow D.B. Bigal, Eptinezumab Achieved Meaningful Reductions in Migraine Activity As Early As Day 1 and Were Sustained Through Week 12: Results From PROMISE-2 (Prevention Of Migraine via Intravenous eptinezumab Safety and Efficacy-2) Phase 3 Trial in Chronic Migraine. Neurology. 2016;87.
  51. Kudrow D., Lipton R., Silberstein S., et al. Eptinezumab for Prevention of Chronic Migraine: Results of 2 Infusions in the Phase 3 PROMISE-2 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy-2) Trial. Neurol. 2019;92(Suppl. 15).
  52. 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). doi: 10.1186/s10194-018-0955-y.
  53. Haanes K.A., Edvinsson L. Pathophysiological Mechanisms in Migraine and the Identification of New Therapeutic Targets. CNS Drugs. 2019. doi: 10.1007/s40263-019-00630-6.

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies