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01-05-2016 | Neurology and Preclinical Neurological Studies - Original Article

Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting

Authors: Katja Kollewe, Claus M. Escher, Dirk U. Wulff, Davood Fathi, Lejla Paracka, Bahram Mohammadi, Matthias Karst, Dirk Dressler

Published in: Journal of Neural Transmission | Issue 5/2016

Abstract

Botulinum toxin was shown to be effective in treatment of chronic migraine. We wanted to explore its efficacy and tolerability in chronic application under real-life conditions. For this, 27 consecutive patients (age 45.6 ± 10.8 years, 25 females, 2 males) received altogether 176 injection series (IS) with 189.7 ± 45.8MU onabotulinumtoxinA (Botox^®) according to the PREEMPT scheme. During the study period altogether 6.5 ± 2.9 (min 4, max 13) IS were applied per patient (total treatment time of 73.1 ± 36.9 weeks). 96 % of the patients reported benefit. Monthly headache days were reduced from 18.9 ± 3.9 to 8.7 ± 4.5 (p < 0.001, −53.7 %), migraine days from 16.8 ± 4.9 to 7.4 ± 4.6 (p < 0.001, −55.1 %), autonomic days from 8.6 ± 7.5 to 2.7 ± 4.2 (p < 0.001, −71.9 %) and medication days from 14.2 ± 4.6 to 8.3 ± 4.2 (p < 0.001, −71.1 %). Health-related quality of life improved by 0.6–1.5 standard deviations (SD) (Short Form Health Survey), migraine-related quality of life by 1.4–2.0 SD (Migraine-Specific Quality of Life Questionnaire) and by 1.9 SD (Headache Impact Test), depression by 1.1 SD (Beck Depression Inventory). Subjective global clinical improvement was 2.6 ± 0.6 (Global Clinical Improvement Scale). All improvements were stable throughout the entire study period. Adverse effects were infrequent, mild and transient. Botulinum toxin provides highly effective and safe long-term treatment of chronic migraine.

Aoki KR (2003) Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache 43(Suppl 1):S9–S15CrossRefPubMed

Aurora S et al (2010) OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 30:793–803. doi:10.1177/0333102410364676 CrossRefPubMed

Aurora SK et al (2011) OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache J Head Face Pain 51:1358–1373. doi:10.1111/j.1526-4610.2011.01990.x CrossRef

Aurora SK, Dodick DW, Diener HC, DeGryse RE, Turkel CC, Lipton RB, Silberstein SD (2014) OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program. Acta Neurol Scand 129:61–70. doi:10.1111/ane.12171 CrossRefPubMedPubMedCentral

Bagley CL, Rendas-Baum R, Maglinte GA, Yang M, Varon SF, Lee J, Kosinski M (2012) Validating migraine-specific quality of life questionnaire v2.1 in episodic and chronic migraine. Headache J Head Face Pain 52:409–421. doi:10.1111/j.1526-4610.2011.01997.x CrossRef

Bigal ME, Rapoport AM, Sheftell FD, Tepper SJ, Lipton RB (2004) Transformed migraine and medication overuse in a tertiary headache centre–clinical characteristics and treatment outcomes. Cephalalgia 24:483–490CrossRefPubMed

Bigal ME, Serrano D, Reed M, Lipton RB (2008) Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Neurology 71:559–566. doi:10.1212/01.wnl.0000323925.29520.e7 CrossRefPubMed

Binder W, Brin M, Blitzer A, Schoenrock L, Pogoda J (2000) Botulinum toxin type A (BOTOX) for treatment of migraine headaches: an open-label study. Otolaryngol Head Neck Surg 123:669–676. doi:10.1067/mhn.2000.110960 CrossRefPubMed

Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ (2010) Method of injection of OnabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program: October 2010. Headache J Head Face Pain 50:1406–1418. doi:10.1111/j.1526-4610.2010.01766.x CrossRef

Blumenfeld A et al (2011) Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the international burden of migraine study (IBMS). Cephalalgia 31:301–315. doi:10.1177/0333102410381145 CrossRefPubMed

Buse DC, Manack A, Serrano D, Turkel C, Lipton RB (2010) Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry 81:428–432. doi:10.1136/jnnp.2009.192492 CrossRefPubMed

Buse DC, Manack AN, Fanning KM, Serrano D, Reed ML, Turkel CC, Lipton RB (2012) Chronic Migraine Prevalence. Headache J Head Face Pain 52:1456–1470. doi:10.1111/j.1526-4610.2012.02223.x CrossRef

Cady RK, Schreiber CP, Porter JAH, Blumenfeld AM, Farmer KU (2011) A multi-center double-blind pilot comparison of OnabotulinumtoxinA and topiramate for the prophylactic treatment of chronic migraine. Headache J Head Face Pain 51:21–32. doi:10.1111/j.1526-4610.2010.01796.x CrossRef

Castillo J, Muñoz P, Guitera V, Pascual J (1999) Epidemiology of chronic daily headache in the general population. Headache J Head Face Pain 39:190–196CrossRef

Cernuda-Morollon E, Ramon C, Larrosa D, Alvarez R, Riesco N, Pascual J (2014) Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: what happens after 1 year? Cephalalgia. doi:10.1177/0333102414561873

Cohen J (1992) A power primer. Psychol Bull 112:155–159CrossRefPubMed

Conway S, Delplanche C, Crowder J, Rothrock J (2005) Botox therapy for refractory chronic migraine. Headache 45:355–357CrossRefPubMed

Cui M, Khanijou S, Rubino J, Aoki KR (2004) Subcutaneous administration of botulinum toxin a reduces formalin-induced pain. Pain 107:125–133CrossRefPubMed

Diener HC, Weimar C (2012) Therapie der Migräne. In: Leitlinien für Diagnostik und Therapie in der Neurologie. Thieme Verlag, Stuttgart

Diener HC, Bussone G, Van Oene J, Lahaye M, Schwalen S, Goadsby P, Group* T-M-S (2007) Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Cephalalgia 27:814–823. doi:10.1111/j.1468-2982.2007.01326.x CrossRefPubMed

Diener H et al (2010) OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia 30:804–814. doi:10.1177/0333102410364677 CrossRefPubMed

Dodick D, Mauskop A, Elkind A, DeGryse R, Brin M, Silberstein S (2005) Botulinum toxin type a for the prophylaxis of chronic daily headache: subgroup analysis of patients not receiving other prophylactic medications: a randomized double-blind, placebo-controlled study. Headache 45:315–324CrossRefPubMed

Dressler D, Tacik P, Adib Saberi F (2014) Botulinum toxin therapy of cervical dystonia: comparing onabotulinumtoxinA (Botox^®) and incobotulinumtoxinA (Xeomin^®). J Neural Transm 121:29–31. doi:10.1007/s00702-013-1076-z CrossRefPubMedPubMedCentral

Durham PL, Cady R, Cady R (2004) Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: implications for migraine therapy. Headache 44:35–42. doi:10.1111/j.1526-4610.2004.04007.x (discussion 42–3) CrossRefPubMed

Evers S, Rahmann A, Vollmer-Haase J, Husstedt IW (2002) Treatment of headache with botulinum toxin A—a review according to evidence-based medicine criteria. Cephalalgia 22:699–710CrossRefPubMed

Finzi E, Rosenthal NE (2014) Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo controlled trial. J Psychiatr Res 52:1–6. doi:10.1016/j.jpsychires.2013.11.006 CrossRefPubMed

Freitag FG, Diamond S, Diamond M, Urban G (2008) Botulinum toxin type A in the treatment of chronic migraine without medication overuse. Headache 48:201–209. doi:10.1111/j.1526-4610.2007.00963.x PubMed

Guitera V, Munoz P, Castillo J, Pascual J (2002) Quality of life in chronic daily headache: a study in a general population. Neurology 58:1062–1065. doi:10.1212/wnl.58.7.1062 CrossRefPubMed

Headache Classification Committee of the International Headache S (2013) The international classification of headache disorders, 3rd edition (beta version). Cephalalgia 33:629–808. doi:10.1177/0333102413485658 CrossRef

Jackson JL, Kuriyama A, Hayashino Y (2012) Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: a meta-analysis. Jama 307:1736–1745CrossRefPubMed

Jhingran P, Osterhaus JT, Miller DW, Lee JT, Kirchdoerfer L (1998) Development and validation of the migraine-specific quality of life questionnaire. Headache J Head Face Pain 38:295–302CrossRef

Katsarava Z, Buse DC, Manack AN, Lipton RB (2012) Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep 16:86–92. doi:10.1007/s11916-011-0233-z CrossRefPubMedPubMedCentral

Khalil M, Zafar H, Quarshie V, Ahmed F (2014) 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 15:54. doi:10.1186/1129-2377-15-54 CrossRefPubMedPubMedCentral

Kollewe K, Mohammadi B, Dengler R, Dressler D (2010) Hemifacial spasm and reinnervation synkinesias: long-term treatment with either Botox^® or Dysport®. J Neural Transm 117:759–763. doi:10.1007/s00702-010-0409-4 CrossRefPubMed

Kollewe K, Mohammadi B, Kohler S, Pickenbrock H, Dengler R, Dressler D (2015) Blepharospasm: long-term treatment with either Botox(R), Xeomin(R) or Dysport(R). J Neural Transm 122:427–431. doi:10.1007/s00702-014-1278-z CrossRefPubMed

Kosinski M et al (2003) A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res Int J Qual Life Asp Treat Care Rehabil 12:963–974CrossRef

Kühner C, Bürger C, Keller F, Hautzinger M (2007) Reliabilität und Validität des revidierten Beck-Depressionsinventars (BDI-II): befunde aus deutschsprachigen Stichproben. Der Nervenarzt 78:651–656. doi:10.1007/s00115-006-2098-7 CrossRefPubMed

Lipton RB et al (2011) OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. Neurology 77:1465–1472. doi:10.1212/WNL.0b013e318232ab65 CrossRefPubMed

Magalhães E, Menezes C, Cardeal M, Melo A (2010) Botulinum toxin type A versus amitriptyline for the treatment of chronic daily migraine. Clin Neurol Neurosurg 112:463–466. doi:10.1016/j.clineuro.2010.02.004 CrossRefPubMed

Magid M, Reichenberg JS, Poth PE, Robertson HT, LaViolette AK, Kruger TH, Wollmer MA (2014) Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry 75:837–844CrossRefPubMed

Manack AN, Buse DC, Lipton RB (2011) Chronic Migraine: Epidemiology and Disease Burden. Curr Pain Headache Rep 15:70–78. doi:10.1007/s11916-010-0157-z CrossRefPubMed

Matak I, Lackovic Z (2014) Botulinum toxin A, brain and pain. Prog Neurobiol 119–120:39–59. doi:10.1016/j.pneurobio.2014.06.001 CrossRefPubMed

Mohammadi B, Kollewe K, Wegener M, Bigalke H, Dengler R (2009) Experience with long-term treatment with albumin-supplemented botulinum toxin type A. J Neural Transm 116:437–441. doi:10.1007/s00702-009-0200-6 CrossRefPubMed

Natoli JL, Manack A, Dean B, Butler Q, Turkel CC, Stovner L, Lipton RB (2010) Global prevalence of chronic migraine: a systematic review. Cephalalgia 30:599–609. doi:10.1111/j.1468-2982.2009.01941.x PubMed

Petri S, Tölle TT, Straube A, Pfaffenrath V, Stefenelli U, Ceballos-Baumann A (2009) Botulinum toxin as preventive treatment for migraine: a randomized double-blind study. Eur Neurol 62:204–211. doi:10.1159/000228987 CrossRefPubMed

Rollnik JD, Tanneberger O, Schubert M, Schneider U, Dengler R (2000) Treatment of tension-type headache with botulinum toxin type A: a double-blind Placebo-Controlled Study. Headache J Head Face Pain 40:300–305CrossRef

Sandrini G, Perrotta A, Tassorelli C, Torelli P, Brighina F, Sances G, Nappi G (2011) Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multicenter, double-blind, randomized, placebo-controlled, parallel group study. J Headache Pain 12:427–433. doi:10.1007/s10194-011-0339-z CrossRefPubMedPubMedCentral

Schwedt TJ (2014) Chronic migraine. BMJ 348:g1416. doi:10.1136/bmj.g1416 CrossRefPubMed

Silberstein et al (2000) Botulinum toxin type A as a migraine preventive treatment. Headache 40:445–450CrossRefPubMed

Welch MJ, Purkiss JR, Foster KA (2000) Sensitivity of embryonic rat dorsal root ganglia neurons to Clostridium botulinum neurotoxins. Toxicon 38:245–258CrossRefPubMed

Wollmer MA et al (2012) Facing depression with botulinum toxin: a randomized controlled trial. J Psychiatr Res 46:574–581. doi:10.1016/j.jpsychires.2012.01.027 CrossRefPubMed

Yang M, Rendas-Baum R, Varon SF, Kosinski M (2011) Validation of the Headache Impact Test (HIT-6™) across episodic and chronic migraine. Cephalalgia 31(3):357–367. doi:10.1177/0333102410379890 CrossRefPubMedPubMedCentral

Title: Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting
Authors: Katja Kollewe
Claus M. Escher
Dirk U. Wulff
Davood Fathi
Lejla Paracka
Bahram Mohammadi
Matthias Karst
Dirk Dressler
Publication date: 01-05-2016
Publisher: Springer Vienna
Published in: Journal of Neural Transmission / Issue 5/2016
Print ISSN: 0300-9564
Electronic ISSN: 1435-1463
DOI: https://doi.org/10.1007/s00702-016-1539-0

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Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting

Abstract

Keynote webinar | Spotlight on sleep in brain health

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Abstract

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