OnabotulinumtoxinA in the treatment of patients with chronic migraine: clinical evidence and experience

Chia-Chun Chiang, Amaal J Starling, Chia-Chun Chiang, Amaal J Starling

Abstract

Chronic migraine is a debilitating neurobiological disorder that affects approximately 1.4-2.2% of the population worldwide. Patients with chronic migraine have 15 or more headache days per month, with at least 8 days per month that meet the criteria for migraine. Injection of onabotulinumtoxinA, using a standardized injection protocol, was approved by the US Food and Drug Administration in 2010 for the treatment of chronic migraine. The approval was made based on results from two large, randomized, double-blind placebo-controlled trials: the Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials. Since then, numerous studies have been performed investigating the short-term and long-term benefits, risks and complications of the use of onabotulinumtoxinA injections for the treatment of chronic migraine. The purpose of this narrative review is to describe the currently available clinical evidence for the use of onabotulinumtoxinA injections for treating patients with chronic migraine.

Keywords: botulinum toxins; humans; migraine disorders; type A.

Conflict of interest statement

Conflict of interest statement: Dr Chia Chun Chiang: None declared. Dr Amaal J. Starling: Amgen, Medical Advisory Board; Alder, Medical Advisory Board; Eli Lilly & Company, Medical Advisory Board; eNeura, Medical Advisory Board.

References

    1. Natoli JL, Manack A, Dean B, et al. Global prevalence of chronic migraine: A systematic review. Cephalalgia 2010; 30: 599–609.
    1. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia 2013; 33: 629–808.
    1. Bigal ME, Serrano D, Reed M, et al. Chronic migraine in the population: Burden, diagnosis, and satisfaction with treatment. Neurology 2008; 71: 559–566.
    1. Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: Results from the International Burden of Migraine Study (IBMS). Cephalalgia 2011; 31: 301–315.
    1. Wang SJ, Wang PJ, Fuh JL, et al. Comparisons of disability, quality of life, and resource use between chronic and episodic migraineurs: A clinic-based study in Taiwan. Cephalalgia 2013; 33: 171–181.
    1. Moon HJ, Seo JG, Park SP. Perceived stress in patients with migraine: A case-control study. J Headache Pain 2017; 18: 73.
    1. Dodick DW, Loder EW, Manack Adams A, et al. Assessing barriers to chronic migraine consultation, diagnosis, and treatment: Results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Headache. Epub ahead of print 3 May 2016. DOI: 10.1111/head.12774.
    1. 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: 968–981.
    1. Rizzoli PB. Acute and preventive treatment of migraine. Continuum (Minneap Minn) 2012; 18: 764–782.
    1. Starling AJ, Dodick DW. Best practices for patients with chronic migraine: Burden, diagnosis, and management in primary care. Mayo Clin Proc 2015; 90: 408–414.
    1. Starling AJ, Vargas BB. A narrative review of evidence-based preventive options for chronic migraine. Curr Pain Headache Rep 2015; 19: 49.
    1. Dodick DW, Turkel CC, DeGryse RE, et al. ; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: Pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache 2010; 50: 921–936.
    1. Aurora SK, Winner P, Freeman MC, et al. OnabotulinumtoxinA for treatment of chronic migraine: Pooled analyses of the 56-week PREEMPT clinical program. Headache 2011; 51: 1358–1373.
    1. Simpson DM, Hallett M, Ashman EJ, et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2016; 86: 1818–1826.
    1. Aurora SK, Dodick DW, Turkel CC, et al. ; PREEMPT 1 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 2010; 30: 793–803.
    1. 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: 804–814.
    1. Dodick DW, Turkel CC, DeGryse RE, et al. Assessing clinically meaningful treatment effects in controlled trials: Chronic migraine as an example. J Pain 2015; 16: 164–175.
    1. Lipton RB, Rosen NL, Ailani J, et al. OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program. Cephalalgia 2016; 36: 899–908.
    1. Pedraza MI, de la Cruz C, Ruiz M, et al. OnabotulinumtoxinA treatment for chronic migraine: Experience in 52 patients treated with the PREEMPT paradigm. Springerplus 2015; 4: 176.
    1. Khalil M, Zafar HW, Quarshie V, et al. Prospective analysis of the use of onabotulinumtoxinA (BOTOX) in the treatment of chronic migraine: Real-life data in 254 patients from Hull, UK. J Headache Pain 2014; 15: 54.
    1. Pascual J, Gaul C, Davies B, et al. Real-life use of onabotulinumtoxinA for symptom relief in patients with chronic migraine: 12-month REPOSE study interim analysis. Poster session presented at the 5th European Headache and Migraine Trust International Congress (EHMTIC); September 15–18, 2016; Glasgow, UK.
    1. Matharu M, Pascual J, Nilsson Remahl I, et al. Real-world utilisation and safety of onabotulinumtoxinA for chronic migraine from an observational study in the European Union. Poster session presented at European Headache and Migraine Trust (EHMTIC); September 15–18, 2016; Glasgow, UK.
    1. Maasumi K, Thompson NR, Kriegler JS, et al. Effect of onabotulinumtoxinA injection on depression in chronic migraine. Headache 2015; 55: 1218–1224. Erratum in: Headache 2016; 56(2): 449.
    1. Blumenfeld AM, Aurora SK, Laranjo K, et al. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol 2015; 15: 100.
    1. Magalhaes E, Menezes C, Cardeal M, et al. Botulinum toxin type A versus amitriptyline for the treatment of chronic daily migraine. Clin Neurol Neurosurg 2010; 112: 463–466.
    1. Diener HC, Bussone G, Van Oene JC, et al. ; TOPMAT-MIG-201(TOP-CHROME) Study Group. Topiramate reduces headache days in chronic migraine: A randomized, double-blind, placebo-controlled study. Cephalalgia 2007; 27: 814–823. Erratum in: Cephalalgia 2007; 27(8): 962.
    1. Hepp Z, Rosen NL, Gillard PG, et al. Comparative effectiveness of onabotulinumtoxinA versus oral migraine prophylactic medications on headache-related resource utilization in the management of chronic migraine: Retrospective analysis of a US-based insurance claims database. Cephalalgia 2016; 36: 862–874.
    1. Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: A randomized trial. Pain Physician 2012; 15: 245–253.
    1. Silberstein SD, Blumenfeld AM, Cady RK, et al. OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline. J Neurol Sci 2013; 331: 48–56.
    1. Chiang CC, Schwedt TJ, Wang SJ, et al. Treatment of medication-overuse headache: A systematic review. Cephalalgia 2016; 36: 371–386.
    1. Ahmed F, Zafar HW, Buture A, et al. Does analgesic overuse matter? Response to onabotulinumtoxinA in patients with chronic migraine with or without medication overuse. Springerplus 2015; 4: 589.
    1. Guerzoni S, Pellesi L, Baraldi C, et al. Increased efficacy of regularly repeated cycles with onabotulinumtoxinA in MOH patients beyond the first year of treatment. J Headache Pain 2015; 17: 48.
    1. Negro A, Curto M, Lionetto L, et al. OnabotulinumtoxinA 155 U in medication overuse headache: A two years’ prospective study. Springerplus 2015; 4: 826.
    1. 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.
    1. Rothrock JF, Bloudek LM, Houle TT, et al. Real-world economic impact of onabotulinumtoxinA in patients with chronic migraine. Headache 2014; 54: 1565–1573.
    1. Bratbak DF, Nordgard S, Stovner LJ, et al. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine. Cephalalgia 2017; 37: 356–364.
    1. Gadient PM, Smith JH, Ryan SJ. Herpes zoster ophthalmicus following onabotulinumtoxinA administration for chronic migraine: A case report and literature review. Cephalalgia 2015; 35: 443–448.
    1. Russo A, Silvestro M, Tessitore A, et al. The “Ram’s Horns Sign”: A case report of an unusual side effect of onabotulinumtoxinA in a chronic migraine patient. Headache 2016; 56: 1656–1658.

Source: PubMed

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