#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

CGRP monoclonal antibodies in the treatment of migraine – indication criteria and therapeutic recommendations for the Czech Republic


Authors: T. Nežádal- 1 4;  J. Marková 4,5;  A. Bártková 4,6;  L. Klečka- 4 7
Authors place of work: Neurologické oddělení, ÚVN-VFN Praha 1;  Institut neuropsychiatrické péče, Praha 2;  Neurochirurgická klinika, 1. LF UK, Praha 3;  Sekce pro diagnostiku a léčbu bolesti, hlavy ČNS ČLS JEP 4;  Neurologická klinika 3. LF UK, a Thomayerovy nemocnice, Praha 5;  Neurologická klinika LF UP, a FN Olomouc 6;  Neurologické oddělení, Městská nemocnice Ostrava 7
Published in the journal: Cesk Slov Neurol N 2020; 83/116(4): 445-451
Category: Doporučené postupy
doi: https://doi.org/10.14735/amcsnn2020445

Summary

Current prophylactic treatment of frequent episodic and chronic migraine is often unsuccessful or associated with adverse events. Calcitonin gene-related peptide (CGRP) is a key peripheral and central patophysiological agent in migraine. Data emerging from trials with monoclonal antibodies suggest that specific blockade of the CGRP pathway may provide an effective and treatment in migraine. At present, precise indication criteria for the administration of these antibodies, required duration of their administration and methods of evaluating their effect, especially on the quality of life, are being determined.

Keywords:

Migraine – prophylactic treatment – antibodies CGRP – guidelines


Zdroje

1. Dodick DW. Migraine. Lancet 2018; 391 (10127): 1315–1330. doi: 10.1016/S0140-6736 (18) 30478-1.

2. GBD 2016 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 (10100): 1211–1159. doi: 10.1016/S0140-6736 (17) 32154-2.

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: 954–976.

4. Buse DC, Manack AN, Fanning KM et al. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache 2012; 52 (10): 1456–1470. doi: 10.1111/j.1526-4610.2012.02223.x.

5. Evers S, Afra J, Frese A et al. EFNS guideline on the drug treatment of migraine-revised report of an EFNS task force. Eur J Neurol 2009; 16 (9): 968–981. doi: 10.1111/j.1468-1331.2009.02748.x.

6. Silberstein SD, Holland S, Freitag F et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology 2012; 78 (17): 1337–1345. doi: 10.1212/WNL.0b013e3182535d20.

7. Araki N, Takeshima T, Igarashi H et al. Clinical practice guideline for chronic headache 2013. Neurol Clin Neurosci 2019; 7 (5): 231–259. doi: 10.1111/ncn3.12322.

8. Duncan C, Carod Artal FJ, Coulson A et al. Publication 155. Pharmacological management of migraine. A national clinical guideline. Edinburg, UK: SIGN 2018.

9. Dodick DW, Turkel CC, DeGryse RE et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo--controlled phases of the PREEMPT clinical program. Headache 2010; 50 (6): 921–936. doi: 10.1111/j.1526-4610.2010.01678.x.

10. Hepp, Z, Dodick DW, Varon SF et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia 2015; 35 (6): 478–488. doi: 10.1177/0333102414547138. J Headache Pain 2018;  19 (1): 13.

11. Blumenfeld AM, Stark RJ, Freeman MC et al. Long term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study.

12. Blumenfeld AM, Stark RJ, Freeman MC et al. Complicated decisions on new migraine-prevention therapies. Lancet Neurol 2018; 19 (1): 13. doi: 10.1186/s10194-018-0840-8.

13. Goadsby PJ, Edvinsson L, Ekman R. Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol 1990; 28 (2): 183–187. doi: 10.1002/ana.410280213.

14. Edvinsson L. The CGRP pathway in migraine as a viable target for therapies. Headache 2018; 58 (Suppl 1): 33–47. doi: 10.1111/head.13305.

15. Kamm K, Straube A, Ruscheweyh R. Calcitonin gene- -related peptide levels in tear fluid are elevated in migraine patients compared to healthy controls. Cephalalgia 2019; 39 (12): 1535–1543. doi: 10.1177/0333102419856640.

16. 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 (6): 338–350. doi: 10.1038/s41582-018-0003-1.

17. 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. doi: 10.1097/j.pain.0000000000000831.

18. Yu LC, Hansson P, Lundeberg T. The calcitonin gene--related peptide antagonist CGRP8-37 increases the latency to withdrawal responses in rats. Brain Res 1994; 653 (1–2): 223–230. doi: 10.1016/0006-8993 (94) 90393-x.

19. Hargreaves R, Olesen J. Calcitonin gene-related peptide modulators – the history and renaissance of a new migraine drug class. Headache 2019; 59 (6): 951–970. doi: 10.1111/head.13510.

20. Nežádal T. CGRP monoklonální protilátky v profylaktické léčbě migrény. Neurol praxi 2019; 20 (5): 356–360.

21. Goadsby PJ, Reuter U, Hallström Y et al. A controlled trial of erenumab for episodic migraine. N Engl J Med 2017; 377: 2123−2132. doi: 10.1056/NEJMoa1705 848.

22. Tepper S, Ashina M, Reuter U et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol 2017; 16 (6): 425–434. doi: 10.1016/S1474-4422 (17) 30083-2.

23. Brandes JL, Diener HC, Dolezil D et al. The spectrum of response to erenumab in patients with chronic migraine and subgroup analysis of patients achieving ≥50%, ≥75%, and 100% response. Cephalalgia 2020; 40 (1): 28–38. doi: 10.1177/0333102419894559.

24. Reuter U, Goadsby PJ, Lanteri-Minet M et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four 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.

25. Ornello R, Casalena A, Frattale I et al. Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J Headache Pain 2020; 21 (1): 32. doi: 10.1186/s10194-020-01102-9.

26. 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; 319 (19): 1999−2008. doi: 10.1001/jama.2018.4853.

27. Brandes JL, Kudrow D, Yeung PP et al. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia 2020; 40 (5): 470–477. doi: 10.1177/0333102419885905.

28. Silberstein SD, Dodick DW, Bigal ME et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 2017; 377 (22): 2113–2122. doi: 10.1056/NEJMoa1709038.

29. Silberstein SD, McAllister P, Ning X et al. Safety and tolerability of fremanezumab for the prevention of migraine: a pooled analysis of phases 2b and 3 clinical trials. Headache 2019; 59 (6): 880–890. doi: 10.1111/head.13534.

30. VanderPluym J, Dodick DW, Lipton RB et al. Fremanezumab for preventive treatment of migraine: functional status on headache-free days. Neurology 2018; 91 (12): e1152–e1165. doi: 10.1212/01.wnl.0000544321.19316.40.

31. Ferrari MD, Diener HC, Ning X et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet 2019; 394 (10203): 1030–1040. doi: 10.1016/S0140-6736 (19) 31946-4.

32. Stauffer VL, Dodick DW, Zhang Q et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol 2018; 75 (9): 1080–1088. doi: 10.1001/jamaneurol.2018.1212.

33. Skljarevski V, Matharu, M, Millen, BA et al. Efficacy 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. doi: 10.1177/0333102418779543.

34. Camporeale A, Kudrow D, Sides R et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol 2018; 18 (1): 188. doi: 10.1186/s12883-018-1193-2.

35. Detke HC, Millen BA, Zhang Q et al. Rapid Onset of effect of galcanezumab for the prevention of episodic migraine: analysis of the EVOLVE studies. Headache 2020; 60 (2): 348–359. doi: 10.1111/head.13691.

36. Ruff DD, Ford JH, Tockhorn-Heidenreich A et al. Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials. Eur J Neurol 2020; 27 (4): 609–618. doi: 10.1111/ene.14114.

37. Detke HC, Goadsby PJ, Wang S et al. Galcanezumab in chronic migraine. The randomized, double-blind, placebo-controlled REGAIN study. Neurology 2018; 91 (24): e2211–e2221. doi: 10.1212/WNL.0000000000006640.

38. Ailani J, Pearlman E, Zhang Q et al. Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of three randomized double-blind studies. Eur J Neurol 2020; 27 (3): 542–549. doi: 10.1111/ene.14102.

39. Goadsby PJ, Dodick DW, Leone M et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med 2019; 381 (2): 132–141. doi: 10.1056/NEJMoa1813440.

40. Baker B, Schaeffler B, Cady R et al. Rational design of a monoclonal antibody inhibiting calcitonin gene-related peptide, ALD403 (eptinezumab), to provide early onset, high efficacy, extended duration of action, and desired safety for the prevention of migraine. Cephalalgia 2017; 37 (Suppl 1): 109.

41. Saper J, Lipton RB, Kudrow DB et al. A phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of eptinezumab in frequent episodic migraine prevention: primary results of the PROMISE-1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy–1) trial. Cephalalgia 2017; 37 (Suppl 1): 337.

42. Lipton RB, Goadsby PJ, Smith J et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology 2020; 94 (13): e1365–e1377. doi: 10.1212/WNL.0000000000009169.

43. Dodick DW, Lipton RB, Silberstein S et al. Eptinezumab for prevention of chronic migraine: a randomized phase 2b clinical trial. Cephalalgia 2019; 39 (9): 1075–1085. doi: 10.1177/0333102419858355.

44. 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 (5): 715–723. doi: 10.1111/head.13316.

45. Kudrow D, Pascual J, Winner PK et al. Vascular safety of erenumab for migraine prevention. Neurology 2020; 94 (5): e497–e510. doi: 10.1212/WNL.0000000000008743.

46. Bigal ME, Walter S, Bronson M et al. Cardiovascular and hemodynamic parameters in women following prolonged CGRP inhibition using LBR-101, a monoclonal antibody against CGRP. Cephalalgia 2014; 34: 968–976. doi: 10.1177/0333102414527646.

47. Hargreaves R, Olesen J. Calcitonin gene-related peptide modulators – the history and renaissance of a new migraine drug class. Headache 2019; 59 (6): 951–970. doi: 10.1111/head.13510.

48. Oakes TM, Kovacs R, Rosen N et al. Evaluation of cardiovascular outcomes in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3, randomized, double-blind, placebo--controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. Headache 2020; 60 (1): 110–123. doi: 10.1111/head.13684.

49. 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): 6. doi: 10.1186/s10194-018- 0955-y.

50. American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practise. Headache 2019; 59 (1): 1–18. doi: 10.1111/head.13456.

51. Nežádal T, Marková J, Bártková A et al. Mezinárodní klasifikace bolestí hlavy (ICHD-3) – oficiální český překlad. Cesk Slov Neurol N 2020; 83/116 (2): 145–152. doi: 10.14735/amcsnn2020145.

52. Ziegeler C, May A. Non-responders to treatment with antibodies to the CGRP-receptor may profit from a switch of antibody class. Headache 2020; 60 (2): 469–470. doi: 10.1111/head.13729.

Štítky
Detská neurológia Neurochirurgia Neurológia
Článek Editorial

Článok vyšiel v časopise

Česká a slovenská neurologie a neurochirurgie

Číslo 4

2020 Číslo 4
Najčítanejšie tento týždeň
Najčítanejšie v tomto čísle
Kurzy

Zvýšte si kvalifikáciu online z pohodlia domova

Aktuální možnosti diagnostiky a léčby litiáz
nový kurz
Autori: MUDr. Tomáš Ürge, PhD.

Všetky kurzy
Prihlásenie
Zabudnuté heslo

Zadajte e-mailovú adresu, s ktorou ste vytvárali účet. Budú Vám na ňu zasielané informácie k nastaveniu nového hesla.

Prihlásenie

Nemáte účet?  Registrujte sa

#ADS_BOTTOM_SCRIPTS#