open access

Vol 56, No 1 (2022)
Review Article
Submitted: 2021-03-23
Accepted: 2021-07-09
Published online: 2021-09-03
Get Citation

Onabotulinumtoxin A (ONA-BoNT/A) in the treatment of chronic migraine

Izabela Domitrz1, Jarosław Sławek23, Agnieszka Słowik4, Magdalena Boczarska-Jedynak5, Adam Stępień6, Konrad Rejdak7, Jakub Gierczyński8, Jacek Rożniecki9
·
Pubmed: 34477213
·
Neurol Neurochir Pol 2022;56(1):39-47.
Affiliations
  1. Department of Neurology, Faculty of Medical Sciences, Medical University of Warsaw, Poland
  2. Division of Neurological and Psychiatric Nursing, Faculty of Health Sciences, Medical University of Gdansk, Poland
  3. Department of Neurology & Stroke, St. Adalbert Hospital, “Copernicus” Ltd., Gdansk, Poland
  4. Department of Neurology, Jagiellonian University, Medical College, Kraków, Poland
  5. Health Institute - Neurology and Restorative Medicine, Oświęcim, Poland
  6. Department of Neurology, Military Institute of Medicine, Warsaw, Poland,
  7. Department of Neurology; Medical University of Lublin, Poland
  8. Healthcare Management Institute and Center of Value Based Healthcare, Łazarski University, Warsaw, Poland
  9. Department of Neurology, Stroke and Neurorehabilitation, Medical University of Lodz, Poland

open access

Vol 56, No 1 (2022)
Review articles
Submitted: 2021-03-23
Accepted: 2021-07-09
Published online: 2021-09-03

Abstract

Migraine is a common primary headache disease, which reduces quality of life. About 8% of migraineurs suffer from chronic migraine (CM), which is the most severe and troublesome type. It has been proven that onabotulinumtoxinA (ONA-BoNT/A) significantly improves CM, presumably inhibiting the release of calcitonin gene-related peptide (CGRP) and other neurotransmitters from c-fibres endings, and thus decreasing activation of nociceptive pathways and transmission of pain. The aim of this position paper was to assess the place of ONA-BoNT/A for the prophylaxis of CM in adults. The authors have compared the efficacy, safety and tolerance of the toxin to those of classical oral preventive therapies as well as to recently introduced anti-CGRP-pathway monoclonal antibodies. The results of randomised controlled studies of ONA-BoNT/A have been compared to open label (real world practice) trials.

Abstract

Migraine is a common primary headache disease, which reduces quality of life. About 8% of migraineurs suffer from chronic migraine (CM), which is the most severe and troublesome type. It has been proven that onabotulinumtoxinA (ONA-BoNT/A) significantly improves CM, presumably inhibiting the release of calcitonin gene-related peptide (CGRP) and other neurotransmitters from c-fibres endings, and thus decreasing activation of nociceptive pathways and transmission of pain. The aim of this position paper was to assess the place of ONA-BoNT/A for the prophylaxis of CM in adults. The authors have compared the efficacy, safety and tolerance of the toxin to those of classical oral preventive therapies as well as to recently introduced anti-CGRP-pathway monoclonal antibodies. The results of randomised controlled studies of ONA-BoNT/A have been compared to open label (real world practice) trials.

Get Citation

Keywords

chronic migraine, botulinum toxin type A, onabotulinumtoxin A, prophylactic treatment, monoclonal antibodies, CGRP

About this article
Title

Onabotulinumtoxin A (ONA-BoNT/A) in the treatment of chronic migraine

Journal

Neurologia i Neurochirurgia Polska

Issue

Vol 56, No 1 (2022)

Article type

Review Article

Pages

39-47

Published online

2021-09-03

Page views

6037

Article views/downloads

1181

DOI

10.5603/PJNNS.a2021.0061

Pubmed

34477213

Bibliographic record

Neurol Neurochir Pol 2022;56(1):39-47.

Keywords

chronic migraine
botulinum toxin type A
onabotulinumtoxin A
prophylactic treatment
monoclonal antibodies
CGRP

Authors

Izabela Domitrz
Jarosław Sławek
Agnieszka Słowik
Magdalena Boczarska-Jedynak
Adam Stępień
Konrad Rejdak
Jakub Gierczyński
Jacek Rożniecki

References (65)
  1. Linde M, Gustavsson A, Stovner LJ, et al. The cost of headache disorders in Europe: the Eurolight project. Eur J Neurol. 2012; 19(5): 703–711.
  2. GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016; 388(10053): 1545–1602.
  3. Chądzyński P, Kacprzak A, Domitrz W, et al. Migraine headache facilitators in a population of Polish women and their association with migraine occurrence - preliminary results. Neurol Neurochir Pol. 2019; 53(5): 377–383.
  4. Begasse de Dhaem O, Gharedaghi MH, Bain P, et al. Identification of work accommodations and interventions associated with work productivity in adults with migraine: A scoping review. Cephalalgia. 2021; 41(6): 760–773.
  5. Linde M, Mulleners WM, Chronicle EP, et al. Antiepileptics other than gabapentin, pregabalin, topiramate, and valproate for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013; 2013(6): CD010608.
  6. https://ichd-3.org/1-migraine/1-3-chronic-migraine.
  7. Pozo-Rosich P, Coppola G, Pascual J, et al. How does the brain change in chronic migraine? Developing disease biomarkers. Cephalalgia. 2021; 41(5): 613–630.
  8. Natoli JL, Manack A, Dean B, et al. Global prevalence of chronic migraine: a systematic review. Cephalalgia. 2010; 30(5): 599–609.
  9. 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.
  10. May A, Schulte L. Chronic migraine: risk factors, mechanisms and treatment. Nature Reviews Neurology. 2016; 12(8): 455–464.
  11. Gazerani P, Staahl C, Drewes AM, et al. The effects of Botulinum Toxin type A on capsaicin-evoked pain, flare, and secondary hyperalgesia in an experimental human model of trigeminal sensitization. Pain. 2006; 122(3): 315–325.
  12. Mazzocchio R, Caleo M. More than at the neuromuscular synapse: actions of botulinum neurotoxin A in the central nervous system. Neuroscientist. 2015; 21(1): 44–61.
  13. Shen B, Wang L. Impact of the botulinum-A toxin on prevention of adult migraine disorders. J Integr Neurosci. 2020; 19(1): 201–208.
  14. Herd CP, Tomlinson CL, Rick C, et al. Cochrane systematic review and meta-analysis of botulinum toxin for the prevention of migraine. BMJ Open. 2019; 9(7): e027953.
  15. GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019; 18(5): 459–480.
  16. GBD 2016 Neurology Collaborators, 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): 954–976.
  17. Saylor D, Steiner TJ. The global burden of headache. Semin Neurol. 2018; 38(2): 182–190.
  18. Lyngberg AC, Rasmussen BK, Jørgensen T, et al. Incidence of primary headache: a Danish epidemiologic follow-up study. Am J Epidemiol. 2005; 161(11): 1066–1073.
  19. Społeczne znaczenie migreny z perspektywy zdrowia publicznego i systemu ochrony zdrowia. Opracowanie: Zakład Analiz Ekonomicznych i Systemowych Narodowy Instytut Zdrowia Publicznego –Państwowy Zakład Higieny, 2018. https://www.pzh.gov.pl/wp-content/uploads/2019/06/RAPORT-MIGRENA-ca%C5%82y.pdf.
  20. Bigal ME, Lipton RB. The epidemiology, burden, and comorbidities of migraine. Neurol Clin. 2009; 27(2): 321–334.
  21. Jette N, Patten S, Williams J, et al. Comorbidity of migraine and psychiatric disorders--a national population-based study. Headache. 2008; 48(4): 501–516.
  22. Rapoport AM, Adelman JU. Cost of migraine management: a pharmacoeconomic overview. Am J Manag Care. 1998; 4(4): 531–545.
  23. Walley T. Pharmacoeconomics for migraine and headache researchers: basic concepts, methods and terminology. The Journal of Headache and Pain. 2004; 5(4): 217–223.
  24. Stokes M, Becker WJ, Lipton RB, et al. Cost of health care among patients with chronic and episodic migraine in Canada and the USA: results from the International Burden of Migraine Study (IBMS). Headache. 2011; 51(7): 1058–1077.
  25. Bloudek LM, Stokes M, Buse DC, et al. Cost of healthcare for patients with migraine in five European countries: results from the International Burden of Migraine Study (IBMS). J Headache Pain. 2012; 13(5): 361–378.
  26. Portal Statystyczny ZUS. https://www.zus.pl/baza-wiedzy/statystyka.
  27. Domitrz I, Lipa A, Rożniecki J, et al. Treatment and management of migraine in neurological ambulatory practice in Poland by indicating therapy with monoclonal anti-CGRP antibodies. Neurol Neurochir Pol. 2020; 54(4): 337–343.
  28. Domitrz I, Lipa A, Rożniecki J, et al. Migraine diagnosis and treatment in Poland: survey of primary care practitioners. Neurol Neurochir Pol. 2021 [Epub ahead of print].
  29. FDA Drug Safety Communication. Children born to mothers who took valproate products while pregnant may have impaired cognitive development. https://www.fda.gov/Drugs/DrugSafety/ucm261543.htm (October 26, 2018).
  30. Product Information: Depakote Oral Tablets, Divalproex Sodium Oral Tablets. AbbVie Inc.
  31. Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010; 30(7): 793–803.
  32. Matak I, Bölcskei K, Bach-Rojecky L, et al. Mechanisms of Botulinum Toxin type A action on pain. Toxins (Basel). 2019; 11(8).
  33. Do TP, Hvedstrup J, Schytz HW. Botulinum toxin: A review of the mode of action in migraine. Acta Neurol Scand. 2018; 137(5): 442–451.
  34. Ramachandran R, Yaksh TL. Therapeutic use of botulinum toxin in migraine: mechanisms of action. Br J Pharmacol. 2014; 171(18): 4177–4192.
  35. Luvisetto S, Gazerani P, Cianchetti C, et al. Botulinum Toxin type a as a therapeutic agent against headache and related disorders. Toxins (Basel). 2015; 7(9): 3818–3844.
  36. Szok D, Csáti A, Vécsei L, et al. Treatment of chronic migraine with onabotulinumtoxinA: Mode of action, efficacy and safety. Toxins (Basel). 2015; 7(7): 2659–2673.
  37. Gazerani P, Pedersen N, Staahl C, et al. Subcutaneous ONA-BoNT/A type A reduces capsaicin-induced trigeminal pain and vasomotor reactions in human skin. Pain. 2009; 141(1-2): 60–69.
  38. Tajti J, Kuris A, Vécsei L, et al. Organ culture of the trigeminal ganglion induces enhanced expression of calcitonin gene-related peptide via activation of extracellular signal-regulated protein kinase 1/2. Cephalalgia. 2011; 31(1): 95–105.
  39. Zychowska M, Rojewska E, Makuch W, et al. Participation of pro- and anti-nociceptive interleukins in botulinum toxin A-induced analgesia in a rat model of neuropathic pain. European Journal of Pharmacology. 2016; 791: 377–388.
  40. Diener HC, Dodick DW, Aurora SK, et al. PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010; 30(7): 804–814.
  41. 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. J Headache Pain. 2018; 19(1): 13.
  42. 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.
  43. Blumenfeld AM, Tepper SJ, Robbins LD, et al. Effects of onabotulinumtoxinA treatment for chronic migraine on common comorbidities including depression and anxiety. J Neurol Neurosurg Psychiatry. 2019; 90(3): 353–360.
  44. Minen MT, Begasse De Dhaem O, Kroon Van Diest A, et al. Migraine and its psychiatric comorbidities. J Neurol Neurosurg Psychiatry. 2016; 87(7): 741–749.
  45. Breslau N, Lipton RB, Stewart WF, et al. Comorbidity of migraine and depression: investigating potential etiology and prognosis. Neurology. 2003; 60(8): 1308–1312.
  46. Ahmed F, Gaul C, García-Moncó JC, et al. REPOSE Principal Investigators. An open-label prospective study of the real-life use of onabotulinumtoxinA for the treatment of chronic migraine: the REPOSE study. J Headache Pain. 2019; 20(1): 26.
  47. Vikelis M, Argyriou AA, Dermitzakis EV, et al. Onabotulinumtoxin-A treatment in Greek patients with chronic migraine. J Headache Pain. 2016; 17(1): 84.
  48. Santoro A, Fontana A, Miscio AM, et al. Quarterly repeat cycles of onabotulinumtoxinA in chronic migraine patients: the benefits of the prolonged treatment on the continuous responders and quality-of-life conversion rate in a real-life setting. Neurol Sci. 2017; 38(10): 1779–1789.
  49. Yalinay Dikmen P, Kosak S, Ilgaz Aydinlar E, et al. A single-center retrospective study of onabotulinumtoxinA for treatment of 245 chronic migraine patients: survey results of a real-world experience. Acta Neurol Belg. 2018; 118(3): 475–484.
  50. Stark C, Stark R, Limberg N, et al. Real-world effectiveness of onabotulinumtoxinA treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study. J Headache Pain. 2019; 20(1): 81.
  51. Santoro A, Copetti M, Miscio AM, et al. Chronic migraine long-term regular treatment with onabotulinumtoxinA: a retrospective real-life observational study up to 4 years of therapy. Neurol Sci. 2020; 41(7): 1809–1820.
  52. Canlas K, Macalintal-Canlas R, Sakai F. Efficacy of calcitonin gene-related peptide antagonists in the treatment of acute migraine: A systematic review and meta-analysis. Acta Medica Philippina. 2019; 53(1).
  53. Herd CP, Tomlinson CL, Rick C, et al. ONA-BoNT/A injections for preventing migraine in adults. Cochrane Database of Systematic Reviews 2018, Issue 6, Art No. : CD011616.
  54. Sacco S, Bendtsen L, Ashina M, et al. Correction to: 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): 58.
  55. Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of CM: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017; 16(6): 425–34.
  56. Tepper SJ, Ashina M, Reuter U, et al. Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study. Cephalalgia. 2020; 40(6): 543–553.
  57. Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the preventive treatment of CM. N Engl J Med. 2017; 377: 2113–22.
  58. Lipton R, Goadsby P, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine. Neurology. 2020; 94(13): e1365–e1377.
  59. Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in CM. The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11. ; 91(24): e2211–e2221.
  60. Ferrari M, Diener H, 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. The Lancet. 2019; 394(10203): 1030–1040.
  61. Raffaelli B, Kalantzis R, Mecklenburg J, et al. Erenumab in chronic migraine patients who previously failed five first-line oral prophylactics and onabotulinumtoxinA: A dual-center retrospective observational study. Frontiers in Neurology. 2020; 11.
  62. Wollmer MA, Magid M, Kruger THC, et al. The use of Botulinum Toxin for treatment of depression. Handb Exp Pharmacol. 2021; 263: 265–278.
  63. https://www.nice.org.uk/guidance/ta260/chapter/3-The-manufacturers-submission.
  64. Stępień A, Kozubski W, Rożniecki JJ, et al. Migraine treatment recommendations developed by an Expert Group of the Polish Headache Society, the Headache Section of the Polish Neurological Society, and the Polish Pain Society. Neurol Neurochir Pol. 2021; 55(1): 33–51.
  65. Pellesi L, Thien P, Ashina H, et al. Dual therapy with anti‐CGRP monoclonal antibodies and ONA-BoNT/A for migraine prevention: is there a rationale? Headache. 2020; 60(6): 1056–1065.

Regulations

Important: This website uses cookies. More >>

The cookies allow us to identify your computer and find out details about your last visit. They remembering whether you've visited the site before, so that you remain logged in - or to help us work out how many new website visitors we get each month. Most internet browsers accept cookies automatically, but you can change the settings of your browser to erase cookies or prevent automatic acceptance if you prefer.

By VM Media Group sp. z o.o., ul. Świętokrzyska 73, 80–180 Gdańsk, Poland
tel.:+48 58 320 94 94, fax:+48 58 320 94 60, e-mail: viamedica@viamedica.pl