Neues zur Botulinum Neurotoxin A Therapie bei Spastik und fokaler Dystonie

Zusammenfassung

Die Injektion mit Botulinum Neurotoxin A ist fester Bestandteil in der Behandlung von Erkrankungen, welche mit einer fokalen Spastik oder Dystonie einhergehen. In den letzten Jahren hat es in Deutschland neue Zulassungen für die Behandlung der Armspastik unabhängig von der Ätiologie und auch für die Behandlung der Beinspastik nach einem Schlaganfall gegeben. Daher haben sich die therapeutischen Möglichkeiten im Rahmen der Zulassungen deutlich erweitert. Die Anwendung von pathoanatomischen Konzepten zur Behandlung der zervikalen Dystonie insbesondere der Injektion in kleinere und tiefer gelegene Muskeln wird erläutert. Andere Aspekte der Behandlung wie Injektionsintervalle oder die aktuell diskutierte Hochdosistherapie werden dargestellt.

Abstract

The treatment of diseases associated with spasticity and focal dystonia with injection of Botulinum Neurotoxin A is well established. During the past years, Botulinum Neurotoxin A was licensed in Germany for treatment of lower limb post-stroke spasticity and for upper limb spasticity of any etiological origin. Hence, the therapeutic possibilities with Botulinum Neurotoxin A have increased. In this study, new pathoanatomical concepts in the treatment of smaller or deeper located muscles in cervical dystonia will be discussed. Further aspects relevant for treatment such as high-dose therapy will be presented.

Schlüsselwörter

Botulinum Neurotoxin - Spastik - Dystonie - Therapie

Keywords

spasticity - dystonia - treatment - Botulinum Neurotoxin

• Literatur

• 1 Dressler D, Bigalke H. Botulinum toxin type B de novo therapy of cervical dystonia: frequency of antibody induced therapy failure. J Neurol 2005; 252: 904-907
• 2 Frevert J. Pharmaceutical, biological, and clinical properties of botulinum neurotoxin type A products. Drugs in R&D 2015; 15: 1-9
• 3 Whitemarsh RC, Tepp WH, Bradshaw M et al. Characterization of botulinum neurotoxin A subtypes 1 through 5 by investigation of activities in mice, in neuronal cell cultures, and in vitro. Infect Immun 2013; 81: 3894-3902
• 4 Blasi J, Chapman ER, Link E et al. Botulinum neurotoxin A selectively cleaves the synaptic protein SNAP-25. Nature 1993; 365: 160-163
• 5 Kull S, Schulz KM, Weisemann J et al. Isolation and functional characterization of the novel Clostridium botulinum neurotoxin A8 subtype. PLoS One 2015; 10: e0116381
• 6 Defazio G, Abbruzzese G, Livrea P et al. Epidemiology of primary dystonia. Lancet Neurol 2004; 3: 673-678
• 7 Volkmann J, Ceballos-Baumann AO, Kupsch A et al. Dystonie. Leitlinien der DGN 2012;
• 8 Brans JW, Lindeboom R, Snoek JW et al. Botulinum toxin versus trihexyphenidyl in cervical dystonia: a prospective, randomized, double-blind controlled trial. Neurology 1996; 46: 1066-1072
• 9 Snaith A, Wade D, Dystonia BMJ. Clinical Evidence. 2014 2014
• 10 LeDoux MS, Vemula SR, Xiao J et al. Clinical and genetic features of cervical dystonia in a large multicenter cohort. Neurol Genet 2016; 2: 1-11
• 11 Maia FM, Kanashiro AK, Chien HF et al. Clinical changes of cervical dystonia pattern in long-term botulinum toxin treated patients. ParkinsonismRelat Disord 2010; 16: 8-11
• 12 Ramirez-Castaneda J, Jankovic J. Long-term efficacy, safety, and side effect profile of botulinum toxin in dystonia: a 20-year follow-up. Toxicon 2014; 90: 344-348
• 13 Misra VP, Ehler E, Zakine B et al. Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia. results from an international observational study. BMJ Open 2012; 2
• 14 Bhidayasiri R. Treatment of complex cervical dystonia with botulinum toxin: involvement of deep-cervical muscles may contribute to suboptimal responses. Parkinsonism & related disorders 2011; 17 (Suppl. 01) S20-S24
• 15 Sung DH, Choi JY, Kim DH et al. Localization of dystonic muscles with 18F-FDG PET/CT in idiopathic cervical dystonia. J Nucl Med 2007; 48: 1790-1795
• 16 Lee IH, Yoon YC, Sung DH et al. Initial experience with imaging-guided intramuscular botulinum toxin injection in patients with idiopathic cervical dystonia. AJR 2009; 192: 996-1001
• 17 Reichel G, Stenner A, Jahn A. The phenomenology of cervical dystonia. Fortschr Neurol Psychiatr 2009; 77: 272-277
• 18 Dressler D. Electromyographic evaluation of cervical dystonia for planning of botulinum toxin therapy. Eur J Neurol 2000; 7: 713-718
• 19 Dressler D, Rothwell JC. Electromyographic quantification of the paralysing effect of botulinum toxin in the sternocleidomastoid muscle. Eur Neurol 2000; 43: 13-16
• 20 Munchau A, Filipovic SR, Oester-Barkey A et al. Spontaneously changing muscular activation pattern in patients with cervical dystonia. Mov Disord 2001; 16: 1091-1107
• 21 Werdelin L, Dalager T, Fuglsang-Frederiksen A et al. The utility of EMG interference pattern analysis in botulinum toxin treatment of torticollis: a randomised, controlled and blinded study. Clin Neurophysiol 2011; 122: 2305-2309
• 22 Nijmeijer SW, Koelman JH, Kamphuis DJ et al. Muscle selection for treatment of cervical dystonia with botulinum toxin – a systematic review. ParkinsonismRelat Disord 2012; 18: 731-736
• 23 Schramm A, Mobius C, Stark D et al. Involvement of the obliquus capitis inferior muscle in dystonic head tremor. Movement Disord 2014; 29: S572-S641
• 24 Fujimoto H, Mezaki T, Yokoe M et al. Sonographic guidance provides a low-risk approach to the longus colli muscle. Mov Disord 2012; 27: 928-929
• 25 Hong JS, Sathe GG, Niyonkuru C et al. Elimination of dysphagia using ultrasound guidance for botulinum toxin injections in cervical dystonia. Muscle Nerve 2012; 46: 535-539
• 26 Schramm A, Baumer T, Fietzek U et al. Relevance of sonography for botulinum toxin treatment of cervical dystonia: an expert statement. J Neural Transm (Vienna) 2015; 122: 1457-1463
• 27 Marsden CD, Sheehy MP. Writer’s cramp. Trends Neurosci 1990; 13: 148-153
• 28 Lungu C, Karp BI, Alter K et al. Long-term follow-up of botulinum toxin therapy for focal hand dystonia: outcome at 10 years or more. Mov Disord 2011; 26: 750-753
• 29 Wissel J, Kabus C, Wenzel R et al. Botulinum toxin in writer’s cramp: objective response evaluation in 31 patients. J Neurol Neurosurg Psychiatry 1996; 61: 172-175
• 30 Kruisdijk JJ, Koelman JH, Ongerboer de Visser BW et al. Botulinum toxin for writer’s cramp: a randomised, placebo-controlled trial and 1-year follow-up. J Neurol Neurosurg Psychiatry 2007; 78: 264-270
• 31 Goldman JG. Writer’s cramp. Toxicon 2015; 107: 98-104
• 32 Cole R, Hallett M, Cohen LG. Double-blind trial of botulinum toxin for treatment of focal hand dystonia. Mov Disord 1995; 10: 466-471
• 33 Dashtipour K, Chen JJ, Frei K et al. Systematic literature Review of AbobotulinumtoxinA in Clinical Trials for Blepharospasm and Hemifacial Spasm. Tremor Other Hyperkinet Move 2015; 5: 338
• 34 Esposito M, Fasano A, Crisci C et al. The combined treatment with orbital and pretarsal botulinum toxin injections in the management of poorly responsive blepharospasm. Neurol Sci 2014; 35: 397-400
• 35 Liepert J, Curt A, Heise K et al. Therapie des spastischen Syndroms. Leitlinien der DGN 2012;
• 36 Simpson DM, Gracies JM, Yablon SA et al. Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo-controlled study. J Neurol Neurosurg Psychiatry 2009; 80: 380-385
• 37 Tilton AH. Evidence-based review of safety and efficacy in cerebral palsy. Toxicon 2015; 107: 105-108
• 38 Kaji R, Osako Y, Suyama K et al. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol 2010; 257: 1330-1337
• 39 Gracies JM, Brashear A, Jech R et al. Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial. Lancet Neurol 2015;
• 40 Kaku M, Simpson DM. Spotlight on botulinum toxin and its potential in the treatment of stroke-related spasticity. Drug Des Develop Therapy 2016; 10: 1085-1099
• 41 Shaw L, Rodgers H, Price C et al. BoTULS: a multicentre randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A. Health Technol Assess 2010; 14: 1-113 iii–iv
• 42 Kwakkel G, Meskers CG. Botulinum toxin A for upper limb spasticity. Lancet Neurol 2015;
• 43 Wissel J, auf dem Brinke M, Hecht M et al. Botulinum toxin in the treatment of adult spasticity. An interdisciplinary German 10-point consensus 2010. Nervenarzt 2011; 82: 481-495
• 44 Bensmail D, Hanschmann A, Wissel J. Satisfaction with botulinum toxin treatment in post-stroke spasticity: results from two cross-sectional surveys (patients and physicians). Journal of medical economics 2014; 17: 618-625
• 45 Demetrios M, Khan F, Turner-Stokes L et al. Multidisciplinary rehabilitation following botulinum toxin and other focal intramuscular treatment for post-stroke spasticity. Cochrane Database Syst Rev 2013; 6: CD009689
• 46 Turner-Stokes L, Fheodoroff K, Jacinto J et al. Results from the Upper Limb International Spasticity Study-II (ULISII): a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management. BMJ open 2013; 3
• 47 Ashford S, Turner-Stokes L, Siegert R et al. Initial psychometric evaluation of the Arm Activity Measure (ArmA): a measure of activity in the hemiparetic arm. Clinical rehabilitation 2013; 27: 728-740
• 48 Ashford S, Turner-Stokes L. Systematic review of upper-limb function measurement methods in botulinum toxin intervention for focal spasticity. Physiotherapy research international: the journal for researchers and clinicians in physical therapy 2013; 18: 178-189
• 49 Urban PP, Wolf T, Uebele M et al. Occurence and clinical predictors of spasticity after ischemic stroke. Stroke 2010; 41: 2016-2020
• 50 Opheim A, Danielsson A, Alt Murphy M et al. Early prediction of long-term upper limb spasticity after stroke: part of the SALGOT study. Neurology 2015; 85: 873-880
• 51 Tao W, Yan D, Li JH et al. Gait improvement by low-dose botulinum toxin A injection treatment of the lower limbs in subacute stroke patients. Journal of physical therapy science 2015; 27: 759-762
• 52 Fietzek UM, Kossmehl P, Schelosky L et al. Early botulinum toxin treatment for spastic pes equinovarus – a randomized double-blind placebo-controlled study. Eur J Neurol 2014; 21: 1089-1095
• 53 Hesse S, Mach H, Frohlich S et al. An early botulinum toxin A treatment in subacute stroke patients may prevent a disabling finger flexor stiffness six months later: a randomized controlled trial. Clinical rehabilitation 2012; 26: 237-245
• 54 Cousins E, Ward A, Roffe C et al. Does low-dose botulinum toxin help the recovery of arm function when given early after stroke? A phase II randomized controlled pilot study to estimate effect size. Clinical rehabilitation 2010; 24: 501-513
• 55 Dressler D, Adib Saberi F, Kollewe K et al. Safety aspects of incobotulinumtoxinA high-dose therapy. J Neural Transm 2015; 122: 327-333
• 56 Intiso D, Simone V, Di Rienzo F et al. High doses of a new botulinum toxin type A (NT-201) in adult patients with severe spasticity following brain injury and cerebral palsy. NeuroRehabilitation 2014; 34: 515-522
• 57 Goldstein EM. Safety of high-dose botulinum toxin type A therapy for the treatment of pediatric spasticity. J Child Neurol 2006; 21: 189-192
• 58 Varghese-Kroll E, Elovic EP. Contralateral weakness and fatigue after high-dose botulinum toxin injection for management of poststroke spasticity. Am J Phys Med Rehabil 2009; 88: 495-499
• 59 Thomas AM, Simpson DM. Contralateral weakness following botulinum toxin for poststroke spasticity. Muscle Nerve 2012; 46: 443-448
• 60 ClinicalTrials.gov. A service of the U. S. National Institutes of Health. Available from: https://www.clinicaltrials.gov/
• 61 FDA . FDA Requires Boxed Warning for All Botulinum Toxin Products. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm
• 62 Saad J, Gourdeau A. A direct comparison of onabotulinumtoxina (Botox) and IncobotulinumtoxinA (Xeomin) in the treatment of benign essential blepharospasm: a split-face technique. J Neuroophthalmol 2014; 34: 233-236
• 63 Ravenni R, De Grandis D, Mazza A. Conversion ratio between Dysport and Botox in clinical practice: an overview of available evidence. Neurol Sci 2013; 34: 1043-1048
• 64 Hexsel D, Brum C, do Prado DZ et al. Field effect of two commercial preparations of botulinum toxin type A: a prospective, double-blind, randomized clinical trial. J Am Acad Dermatol 2012; 67: 226-232
• 65 Yun JY, Kim JW, Kim HT et al. Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. Mov Disord 2015; 30: 206-213
• 66 Scaglione F. Conversion Ratio between Botox((R)), Dysport((R)), and Xeomin((R)) in Clinical Practice. Toxins 2016; 8
• 67 Dressler D, Tacik P, Saberi FA. Botulinum toxin therapy of cervical dystonia: duration of therapeutic effects. J Neural Transm (Vienna) 2015; 122: 297-300
• 68 Lange O, Bigalke H, Dengler R et al. Neutralizing antibodies and secondary therapy failure after treatment with botulinum toxin type A: much ado about nothing?. Clin Neuropharmacol 2009; 32: 213-218
• 69 Greene P, Fahn S, Diamond B. Development of resistance to botulinum toxin type A in patients with torticollis. Mov Disord 1994; 9: 213-217
• 70 Tsui JK, Eisen A, Stoessl AJ et al. Double-blind study of botulinum toxin in spasmodic torticollis. Lancet 1986; 2: 245-247
• 71 Stell R, Thompson PD, Marsden CD. Botulinum toxin in spasmodic torticollis. J Neurol Neurosurg Psychiatry 1988; 51: 920-923
• 72 Jankovic J, Vuong KD, Ahsan J. Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology 2003; 60: 1186-1188
• 73 Roggenkamper P, Jost WH, Bihari K et al. Efficacy and safety of a new Botulinum Toxin Type A free of complexing proteins in the treatment of blepharospasm. J Neural Transm (Vienna) 2006; 113: 303-312
• 74 Evidente VG, Truong D, Jankovic J et al. IncobotulinumtoxinA (Xeomin(R)) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci 2014; 346: 116-120
• 75 Evidente VG, Fernandez HH, LeDoux MS et al. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna) 2013; 120: 1699-1707
• 76 Kaji R. Clinical differences between A1 and A2 botulinum toxin subtypes. Toxicon 2015; 107: 85-88