Пятилетний опыт применения нового класса препаратов для таргетной профилактической терапии мигрени
https://doi.org/10.30629/2658-7947-2021-26-3-4-14
Аннотация
Статья посвящена новому классу антимигренозных препаратов — моноклональным антителам (мАТ), нарушающим передачу сигнала кальцитонин-ген родственного пептида (КГРП). Кратко рассматриваются биологические эффекты КГРП в периферической и центральной нервной системе и его роль в патогенезе мигрени. Анализируются данные систематических обзоров рандомизированных клинических исследований эффективности и безопасности мАТ к КГРП (фреманезумаб, эптинезумаб и галканезумаб) и его рецептору (эренумаб) при эпизодической и хронической мигрени. Обсуждаются результаты пятилетнего применения эренумаба в рамках клинических исследований и реальной практики.
Об авторах
А. В. АмелинРоссия
Санкт-Петербург
А. Ю. Соколов
Россия
Санкт-Петербург
Ю. С. Ваганова
Россия
Санкт-Петербург
Список литературы
1. Russo A.F. CGRP-based Migraine Therapeutics: How Might They Work, Why So Safe, and What Next? ACS Pharmacol Transl Sci. 2019;2(1):2–8. https://doi.org/10.1021/acsptsci.8b00036. Epub 2018 Nov 5. PMID: 31559394; PMCID: PMC6761833.
2. Iyengar S., Johnson K.W., Ossipov M.H., Aurora S.K. CGRP and the Trigeminal System in Migraine. Headache. 2019;59(5):659–681. https://doi.org/10.1111/head.13529
3. Edvinsson L., Warfvinge K. Recognizing the role of CGRP and CGRP receptors in migraine and its treatment. Cephalalgia. 2019;39(3):366–373. https://doi.org/10.1177/0333102417736900
4. Edvinsson L. The CGRP Pathway in Migraine as a Viable Target for Therapies. Headache. 2018;58 Suppl 1:33-47. https://doi.org/10.1111/head.13305. PMID: 29697153
5. Messlinger K. The big CGRP fl ood — sources, sinks and signalling sites in the trigeminovascular system. J. Headache Pain. 2018;19(1):22. Published 2018 Mar 12. https://doi.org/10.1186/s10194-018-0848-0
6. Holland P.R., Saengjaroentham C., Vila-Pueyo M. The role of the brainstem in migraine: Potential brainstem eff ects of CGRP and CGRP receptor activation in animal models. Cephalalgia. 2019;39(3):390–402. https://doi.org/10.1177/0333102418756863
7. De Matteis E., Guglielmetti M., Ornello R., Spuntarelli V., Martelletti P., Sacco S. Targeting CGRP for migraine treatment: mechanisms, antibodies, small molecules, perspectives. Expert Rev. Neurother. 2020;20(6):627–641. https://doi.org/10.1080/14737175.2020.1772758
8. Levy D., Labastida-Ramirez A., Maassen Van Den Brink A. Current understanding of meningeal and cerebral vascular function underlying migraine headache. Cephalalgia. 2019;39(13):1606–1622. https://doi.org/10.1177/0333102418771350. Epub 2018 Jun 21. PMID: 29929378.
9. Ashina M., Hansen J.M., Do T.P., Melo-Carrillo A., Burstein R., Moskowitz M.A. Migraine and the trigeminovascular system-40 years and counting. Lancet Neurol. 2019;18(8):795–804. https://doi.org/10.1016/S1474-4422 (19)30185-1. Epub 2019 May 31. PMID: 31160203; PMCID: PMC7164539
10. Hoff mann J., Baca S.M., Akerman S. Neurovascular mechanisms of migraine and cluster headache. J. Cereb. Blood Flow Metab. 2019;39(4):573–594. https://doi.org/10.1177/0271678X17733655. Epub 2017 Sep 26. PMID: 28948863; PMCID: PMC6446418
11. Messlinger K., Russo A.F. Current understanding of trigeminal ganglion structure and function in headache. Cephalalgia. 2019;39(13):1661–1674. https://doi.org/10.1177/0333102418786261. Epub 2018 Jul 10. PMID: 29989427; PMCID: PMC7007999
12. Summ O., Charbit A.R., Andreou A.P., Goadsby P.J. Modulation of nocioceptive transmission with calcitonin gene-related peptide receptor antagonists in the thalamus. Brain. 2010;133(9):2540–8. https://doi.org/10.1093/brain/awq224. PMID: 20802202
13. Yu L.C., Weng X.H., Wang J.W., Lundeberg T. Involvement of calcitonin gene-related peptide and its receptor in anti-nociception in the periaqueductal grey of rats. Neurosci. Lett. 2003;349(1):1–4. https://doi.org/10.1016/s0304-3940 (03)00273-8. PMID: 12946572
14. Pozo-Rosich P., Storer R.J., Charbit A.R., Goadsby P.J. Periaqueductal gray calcitonin gene-related peptide modulates trigeminovascular neurons. Cephalalgia. 2015;35:1298–1307.
15. Zhang Y., Zhang Y., Tian K., Wang Y., Fan X., Pan Q. et al. Calcitonin gene-related peptide facilitates sensitization of the vestibular nucleus in a rat model of chronic migraine. J. Headache Pain. 2020;21(1):72. Published 2020 Jun 10. https://doi.org/10.1186/s10194-020-01145-y
16. Mason B.N., Kaiser E.A., Kuburas A., Loomis M.C., Latham J.A., Garcia-Martinez L.F. et al. Induction of Migraine-Like Photophobic Behavior in Mice by Both Peripheral and Central CGRP Mechanisms. J. Neurosci. 2017;37(1):204-216. https://doi.org/10.1523/JNEUROSCI.2967-16.2016
17. Close L.N., Eftekhari S., Wang M., Charles A.C., Russo A.F. Cortical spreading depression as a site of origin for migraine: Role of CGRP. Cephalalgia. 2019;39(3):428–434. https://doi.org/10.1177/0333102418774299
18. Melo-Carrillo A., Schain A.J., Stratton J., Strassman A.M., 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(5):1037–1043. https://doi.org/10.1097/j.pain.0000000000001791
19. Iyengar S., Ossipov M.H., Johnson K.W. The role of calcitonin gene-related peptide in peripheral and central pain mechanisms including migraine. Pain. 2017;158(4):543–559. https://doi.org/10.1097/j.pain.0000000000000831. PMID: 28301400; PMCID: PMC5359791
20. Hay D.L., Walker C.S. CGRP and its receptors. Headache. 2017;57(4):625–636. https://doi.org/10.1111/head.13064. Epub 2017 Feb 24. PMID: 28233915
21. Link A.S., Kuris A., Edvinsson L. Treatment of migraine attacks based on the interaction with the trigemino-cerebrovascular system. J. Headache Pain. 2008;9(1):5–12. https://doi.org/10.1007/s10194-008-0011-4. Epub 2008 Jan 23. PMID: 18217201; PMCID: PMC2245994
22. Negro A., Martelletti P. Gepants for the treatment of migraine. Expert Opin. Investig. Drugs. 2019;28(6):555–567. https://doi.org/10.1080/13543784.2019.1618830. Epub 2019 May 17. PMID: 31081399
23. Juhasz G., Zsombok T., Jakab B., Nemeth J., Szolcsanyi J., Bagdy G. Sumatriptan causes parallel decrease in plasma calcitonin gene-related peptide (CGRP) concentration and migraine headache during nitroglycerin induced migraine attack. Cephalalgia. 2005;25(3):179–83. https://doi.org/10.1111/j.1468-2982.2005.00836.x. PMID: 15689192
24. Ashina H., Schytz H.W., Ashina M. CGRP in Human Models of Migraine. Handb. Exp. Pharmacol. 2019;255:109–120. https://doi.org/10.1007/164_2018_128
25. Deng H., Li G.G., Nie H., Feng Y.Y., Guo G.Y., Guo W.L. et al. Effi cacy and safety of calcitonin-gene-related peptide binding monoclonal antibodies for the preventive treatment of episodic migraine — an updated systematic review and meta-analysis. BMC Neurol. 2020;20(1):57. https://doi.org/10.1186/s12883-020-01633-3. PMID: 32061264; PMCID: PMC7023812
26. Tso A.R., Goadsby P.J. Anti-CGRP Monoclonal Antibodies: the Next Era of Migraine Prevention? Curr. Treat. Options Neurol. 2017;19(8):27. https://doi.org/10.1007/s11940-017-0463-4. PMID: 28653227; PMCID: PMC5486583
27. Mitsikostas D.D., Reuter U. Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: comparisons across randomized controlled studies. Curr. Opin. Neurol. 2017;30(3):272–280. https://doi.org/10.1097/WCO.0000000000000438. PMID: 28240610
28. Goadsby P.J., Reuter U., Hallström Y., Broessner G., Bonner J.H., Zhang F. et al. A Controlled Trial of Erenumab for Episodic Migraine. N. Engl. J. Med. 2017;377(22):2123–2132. https://doi.org/10.1056/NEJMoa1705848. PMID: 29171821
29. Tepper S., Ashina M., Reuter U., Brandes J.L., Doležil D., Silberstein S. et al. Safety and effi cacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425–434. https://doi.org/10.1016/S1474-4422 (17)30083-2. Epub 2017 Apr 28. PMID: 28460892
30. Wen L., Badgett R., Cornell J. Number needed to treat: a descriptor for weighing therapeutic options. Am. J. Health Syst. Pharm. 2005;62(19):2031-6. https://doi.org/10.2146/ajhp040558. PMID: 16174840
31. Sun H., Dodick D.W., Silberstein S., Goadsby P.J., Reuter U., Ashina M. et al. Safety and effi cacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382–90. https://doi.org/10.1016/S1474-4422 (16)00019-3. Epub 2016 Feb 12. PMID: 26879279
32. Dodick D.W., Ashina M., Brandes J.L., Kudrow D., LanteriMinet M., Osipova V. et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38(6):1026–1037. https://doi.org/10.1177/0333102418759786. Epub 2018 Feb 22. PMID: 29471679
33. Goaj. et al. A Controlled Trial of Erenumab for Episodic Migraine. N. Engl. J. Med. 2017;377(22):2123–2132. https://doi.org/10.1056/NEJMoa1705848. PMID: 29171821
34. Reuter U., Goadsby P.J., Lanteri-Minet M., Wen S., HoursZesiger P., Ferrari M.D. et al. Effi cacy and tolerability of erenumab in patients with episodic migraine in whom two-tofour previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018;392(10161):2280–2287. doi: 10.1016/S0140-6736 (18)32534-0. Epub 2018 Oct 22. PMID: 30360965
35. Dodick D.W., Silberstein S.D., Bigal M.E., Yeung P.P., Goadsby P.J., Blankenbiller T. et al. Eff ect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018;319(19):1999–2008. https://doi.org/10.1001/jama.2018.4853. PMID: 29800211; PMCID: PMC6583237
36. Bigal M.E., Edvinsson L., Rapoport A.M., Lipton R.B., Spierings E.L., Diener H.C. et al. Safety, tolerability, and effi - cacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1091–100. https://doi.org/10.1016/S1474-4422 (15)00245-8. Epub 2015 Sep 30. PMID: 26432181
37. Dodick D.W., Goadsby P.J., Spierings E.L., Scherer J.C., Sweeney S.P., Grayzel D.S. Safety and effi cacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014;13(9):885–92. https://doi.org/10.1016/S1474-4422 (14)70128-0. Epub 2014 Aug 10. PMID: 25127173
38. Skljarevski V., Matharu M., Millen B.A., Ossipov M.H., Kim B.K., Yang J.Y. Effi cacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442–1454. https://doi.org/10.1177/0333102418779543. Epub 2018 May 31. PMID: 29848108
39. Stauff er V.L., Dodick D.W., Zhang Q., Carter J.N., Ailani J., Conley R.R. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018;75(9):1080–1088. https://doi.org/10.1001/jamaneurol.2018.1212. Erratum in: JAMA Neurol. 2019;76(7):872. PMID: 29813147; PMCID: PMC6143119
40. Skljarevski V., Oakes T.M., Zhang Q., Ferguson M.B., Martinez J., Camporeale A. et al. Eff ect of Diff erent Doses of Galcanezumab vs Placebo for Episodic Migraine Prevention: A Randomized Clinical Trial. JAMA Neurol. 2018;75(2):187–193. https://doi.org/10.1001/jamaneurol.2017.3859. Erratum in: JAMA Neurol. 2018;75(2):260. PMID: 29255900; PMCID: PMC5838630
41. Dodick D.W., Goadsby P.J., Silberstein S.D., Lipton R.B., Olesen J., Ashina M. et al. ALD403 study investigators. Safety and effi cacy 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(11):1100–1107. https://doi.org/10.1016/S1474-4422 (14)70209-1. Epub 2014 Oct 5. PMID: 25297013
42. Zhu Y., Liu Y., Zhao J., Han Q., Liu L., Shen X. The effi cacy and safety of calcitonin gene-related peptide monoclonal antibody for episodic migraine: a meta-analysis. Neurol. Sci. 2018;39(12):2097–2106. https://doi.org/10.1007/s10072-018-3547-3. Epub 2018 Sep 4. PMID: 30182284
43. Lattanzi S., Brigo F., Trinka E., Vernieri F., Corradetti T., Dobran M. et al. Erenumab for Preventive Treatment of Migraine: A Systematic Review and Meta-Analysis of Effi cacy and Safety. Drugs. 2019;79(4):417–431. https://doi.org/10.1007/s40265-019-01069-1. PMID: 30793254
44. Xu D., Chen D., Zhu L.N., Tan G., Wang H.J., Zhang Y. et al. Safety and tolerability of calcitonin-gene-related peptide binding monoclonal antibodies for the prevention of episodic migraine — a meta-analysis of randomized controlled trials. Cephalalgia. 2019;39(9):1164– 1179. https://doi.org/10.1177/0333102419829007. Epub 2019 Feb 21. PMID: 30789292
45. Ashina M., Saper J., Cady R., Schaeffl er B.A., Biondi D.M., Hirman J. et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020;40(3):241–254. https://doi.org/10.1177/0333102420905132. Epub 2020 Feb 19. PMID: 32075406; PMCID: PMC7066477
46. Ashina M., Goadsby P.J., Reuter U., Silberstein S., Dodick D.W, Fei Xue et al. Long‐term effi cacy and safety of erenumab in migraine prevention: Results from a 5‐year, open‐label treatment phase of a randomized clinical trial. Eur. J. Neurol. 2021;00:1–10. https://doi.org/10.1111/ene.14715
47. Espinoza Giacomozzi A.R., Vindas A.P., da Silva Jr. A.A., Bordini C.A., Buonanotte C.F., de Paula Roesler C.A. et al. Latin American consensus on guidelines for chronic migraine treatment. Arq. Neuro-Psiquiatr. [online]. 2013;71(7) [cited 2021-02-20]:478-486. Available from: < http://www.scielo.br/scielo.php?script = sci_arttext&pid = S0004-282X2013000700478&lng = en&nrm = iso > . ISSN 0004-282X. http://dx.doi.org/10.1590/0004-282X20130066
48. Deneris A., Rosati Allen P., Hart Hayes E., Latendresse G. Migraines in Women: Current Evidence for Management of Episodic and Chronic Migraines. J. Midwifery Womens Health. 2017;62(3):270–285. https://doi.org/10.1111/jmwh.12626. Epub 2017 May 31. PMID: 28561915
49. Deen M., Correnti E., Kamm K., Kelderman T., Papetti L., Rubio-Beltrán E. 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(1):96. doi: 10.1186/s10194-017-0807-1. PMID: 28948500; PMCID: PMC5612904
50. Messlinger K. The big CGRP fl ood — sources, sinks and signalling sites in the trigeminovascular system. J. Headache Pain. 2018;19(1):22. https://doi.org/10.1186/s10194-018-0848-0. PMID: 29532195; PMCID: PMC5847494
51. Detke H.C., Goadsby P.J., Wang S., Friedman D.I., Selzler K.J., Aurora S.K. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211–e2221. https://doi.org/10.1212/WNL.0000000000006640. Epub 2018 Nov 16. PMID: 30446596; PMCID: PMC6329331
52. Silberstein S.D., Dodick D.W., Bigal M.E., Yeung P.P., Goadsby P.J., Blankenbiller T. et al. Fremanezumab for the Preventive Treatment of Chronic Migraine. N. Engl. J. Med. 2017;377(22):2113–2122. https://doi.org/10.1056/NEJMoa1709038. PMID: 29171818
53. Hong P., Wu X., Liu Y. Calcitonin gene-related peptide monoclonal antibody for preventive treatment of episodic migraine: A meta analysis. Clin. Neurol. Neurosurg. 2017;154:74–78. https://doi.org/10.1016/j.clineuro.2017.01.009. Epub 2017 Jan 22. PMID: 28129635
Рецензия
Для цитирования:
Амелин А.В., Соколов А.Ю., Ваганова Ю.С. Пятилетний опыт применения нового класса препаратов для таргетной профилактической терапии мигрени. Российский неврологический журнал. 2021;26(3):4-14. https://doi.org/10.30629/2658-7947-2021-26-3-4-14
For citation:
Amelin A.V., Sokolov A.Yu., Vaganova Yu.S. Five-year experience of using a new class of drugs for targeted preventive therapy of migraine. Russian neurological journal. 2021;26(3):4-14. (In Russ.) https://doi.org/10.30629/2658-7947-2021-26-3-4-14