Onabotulinumtoxin-A treatment in Greek patients with chronic migraine

Michail Vikelis, Andreas A Argyriou, Emmanouil V Dermitzakis, Konstantinos C Spingos, Dimos D Mitsikostas, Michail Vikelis, Andreas A Argyriou, Emmanouil V Dermitzakis, Konstantinos C Spingos, Dimos D Mitsikostas

Abstract

Background: Chronic migraine is a disabling condition, with limited treatment options. We conducted an open label, single arm, prospective clinical trial, to assess the efficacy and safety of onabotulinumtoxin-A in Greek patients with chronic migraine. Since recent evidence suggests that a meaningful clinical response may be delayed until after a third onabotulinumtoxin-A administration, we aimed at assessing outcomes at this time point.

Methods: A total of 119 patients with CM, scheduled to be treated with Onabotulinumtoxin-A (Botox ®) every 3 months, according to the approved indication and standard clinical practice, were prospectively enrolled. Data documenting changes from baseline (T0-trimester before Onabotulinumtoxin-A first administration) to the period after its third administration (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of >4/10 in a 0-10 numerical scale, and (iii) mean number of days with use of any acute headache medication, were collected from patients' headache diaries at each visit.

Results: Of the 119 patients, a total of 81 received 3 courses of onabotulinumtoxin-A and were included in the efficacy population. In those 81 patients, there was a significant decrease in mean headache days/month between T0 and T3 (21.3 ± 5.4 vs 7.7 ± 4.8; P < 0.001); a significant decrease in days with peak headache intensity of >4/10 (11.9 ± 5.5 vs 3.7 ± 3.3; P < 0.001) and finally, the change in days using acute headache medications per month between was also significant (16.2 ± 7.8 vs 5.2 ± 4.3; P < 0.001). Adverse events were few and of non- serious nature.

Conclusion: Our results strongly support the use of onabotulinumtoxin-A for the prophylaxis of CM, as this intervention proved effective, safe and well tolerated in our cohort of Greek patients.

Keywords: Chronic migraine; Migraine; Onabotulinumtoxin-A; Prevention; Prophylaxis; Treatment.

References

    1. Murray CJ, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2197–223. doi: 10.1016/S0140-6736(12)61689-4.
    1. No authors listed (2015) The Global Burden of Diseases: living with disability. Lancet 386:2118.
    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. doi: 10.1177/0333102413485658.
    1. Blumenfeld AM, Varon SF, Wilcox TK, Buse DC, Kawata AK, Manack A, Goadsby PJ, Lipton RB. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS) Cephalalgia. 2011;31:301–15. doi: 10.1177/0333102410381145.
    1. Bigal ME, Serrano D, Reed M, Lipton RB. Chronic migraine in the population: Burden, diagnosis, and satisfaction with treatment. Neurology. 2008;71:559–566. doi: 10.1212/01.wnl.0000323925.29520.e7.
    1. Stewart WF, Wood GC, Manack A, Varon SF, Buse DC, Lipton RB. Employment and work impact of chronic migraine and episodic migraine. J Occup Environ Med. 2010;52:8–14. doi: 10.1097/JOM.0b013e3181c1dc56.
    1. Buse DC, Manack A, Serrano D, Turkel C, Lipton RB. Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry. 2010;81:428–32. doi: 10.1136/jnnp.2009.192492.
    1. Mitsikostas DD, Thomas AM. Comorbidity of headache and depressive disorders. Cephalalgia. 1999;19:211–7. doi: 10.1046/j.1468-2982.1999.019004211.x.
    1. Natoli J, Manack A, Dean B, Butler Q, Turkel CC, Stovner L, Lipton RB. Global prevalence of chronic migraine: a systematic review. Cephalalgia. 2010;30:599–609.
    1. Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF, 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. doi: 10.1177/0333102410364676.
    1. Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, Silberstein SD, Brin MF, 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;30:804–14. doi: 10.1177/0333102410364677.
    1. Dodick DW, Turkel CC, DeGryse R, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF, 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;50:921–36. doi: 10.1111/j.1526-4610.2010.01678.x.
    1. Grazzi L. Onabotulinum toxin A for treatment of chronic migraine with medication overuse. Neurol Sci. 2013;34(Suppl 1):S27–8. doi: 10.1007/s10072-013-1381-1.
    1. Grazzi L, Usai S. Onabotulinum toxin A (Botox) for chronic migraine treatment: an Italian experience. Neurol Sci. 2015;36(Suppl 1):33–5. doi: 10.1007/s10072-015-2140-2.
    1. Pedraza MI, de la Cruz C, Ruiz M, López-Mesonero L, Martínez E, de Lera M, Guerrero ÁL. OnabotulinumtoxinA treatment for chronic migraine: experience in 52 patients treated with the PREEMPT paradigm. Springerplus. 2015;4:176. doi: 10.1186/s40064-015-0957-z.
    1. Russo M, Manzoni GC, Taga A, Genovese A, Veronesi L, Pasquarella C, Sansebastiano GE, Torelli P. The use of onabotulinum toxin A (Botox®) in the treatment of chronic migraine at the Parma Headache Centre: a prospective observational study. Neurol Sci. 2016;37:1127–31. doi: 10.1007/s10072-016-2568-z.
    1. Cernuda-Morollón E, Ramón C, Larrosa D, Alvarez R, Riesco N, Pascual J. Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: What happens after one year? Cephalalgia. 2015;35:864–8. doi: 10.1177/0333102414561873.
    1. The pharmaceutical catalogue . . Accessed 13 June 2016.
    1. Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010;50:1406–18. doi: 10.1111/j.1526-4610.2010.01766.x.
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. Fifth. Arlington: American Psychiatric Publishing; 2013.
    1. Whitcup SM, Turkel CC, DeGryse RE, Brin MF. Development of onabotulinumtoxinA for chronic migraine. Ann N Y Acad Sci. 2014;1329:67–80. doi: 10.1111/nyas.12488.
    1. Szok D, Csáti A, Vécsei L, Tajti J. Treatment of chronic migraine with OnabotulinumtoxinA: mode of action, efficacy and safety. Toxins. 2015;7:2659–73. doi: 10.3390/toxins7072659.
    1. Negro A, Curto M, Lionetto L, Martelletti P. 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. doi: 10.1186/s10194-016-0591-3.
    1. Khalil M, Zafar HW, Quarshie V, Ahmed F. Prospective analysis of the use of OnabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, U.K. J Headache Pain. 2014;15:54. doi: 10.1186/1129-2377-15-54.
    1. Negro A, Curto M, Lionetto L, Crialesi D, Martelletti P. OnabotulinumtoxinA 155 U in medication overuse headache: a two years prospective study. Springerplus. 2015;4:826. doi: 10.1186/s40064-015-1636-9.
    1. Ahmed F, Zafar HW, Buture A, Khalil M. Does analgesic overuse matter? Response to OnabotulinumtoxinA in patients with chronic. Springerplus. 2015;9:589.
    1. Burstein R, Zhang X, Levy D, Aoki KR, Brin MF. Selective inhibition of meningeal nociceptors by botulinum neurotoxin type A: therapeutic implications for migraine and other pains. Cephalalgia. 2014;34:853–69. doi: 10.1177/0333102414527648.
    1. Silberstein SD, Dodick DW, Aurora SK, Diener HC, DeGryse RE, Lipton RB, Turkel CC. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015;86:996–1001. doi: 10.1136/jnnp-2013-307149.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe