Clinical comparisons of botulinum neurotoxin formulations

Neurologist

Volumn 14, Issue 5, 2008, Pages 289-298

  Brashear, Allison ^a  

^a WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

Bioequivalence; Blepharospasm; Botulinum toxin; Cervical dystonia; Dose ratio; Hemifacal spasm; Spasticity, hyperhidrosis

Indexed keywords

ACETYLCHOLINE; BONTA; BONTB; BOTULINUM TOXIN A; BOTULINUM TOXIN B; PLACEBO; UNCLASSIFIED DRUG;

ACETYLCHOLINE RELEASE; BIOEQUIVALENCE; BIOLOGICAL ACTIVITY; BLEPHAROSPASM; BLURRED VISION; CEREBRAL PALSY; CHEMICAL STRUCTURE; CLINICAL ASSESSMENT; CLINICAL TRIAL; DIPLOPIA; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FORMULATION; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRY EYE; DYSPHAGIA; DYSTONIA; HEMATOMA; HEMIFACIAL SPASM; HUMAN; HYPERHIDROSIS; LACRIMATION; LAGOPHTHALMOS; MUSCLE HYPOTONIA; MUSCLE WEAKNESS; NEUROTRANSMISSION; NONHUMAN; PHYSICAL CHEMISTRY; PRESYNAPTIC NERVE; PRIORITY JOURNAL; PTOSIS; REVIEW; SEROTYPE; SIDE EFFECT; SPASTICITY; STRABISMUS; WRINKLE; XEROSTOMIA;

ANIMALS; BOTULINUM TOXINS; CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS AS TOPIC; COSMETIC TECHNIQUES; HUMANS; MUSCLE SPASTICITY; THERAPEUTIC EQUIVALENCY;

EID: 53549097062     PISSN: 10747931     EISSN: None     Source Type: Journal    
DOI: 10.1097/NRL.0b013e31816f2cdd     Document Type: Review

References (87)

1. BOTOX® [package insert]. Irvine, CA: Allergan, Inc.; 2004.
2. BOTOX® Cosmetic [package insert]. Irvine, CA: Allergan, Inc.; 2005.
3. Dysport® [package insert]. Slough, UK: Ipsen Ltd.; 2005.
4. Merz Web site. Xeomin®. Available at: http://www.xeomin.com. Accessed August 7, 2006.
5. Myobloc® [package insert]. South San Francisco, CA: Solstice Neurosciences, Inc.; 2004. Available at: http://www.myobloc.com/hp_about/ PI_7-19-05.pdf. Accessed January 16, 2007.
6. Hatheway CL. Bacterial sources of clostridial neurotoxins. In: Simpson LL, ed. Botulinum Neurotoxin and Tetanus Toxin. New York, NY: Academic Press, Inc.; 1989:3-24.
7. Sakaguchi G. Clostridium botulinum toxins. Pharmacol Ther. 1982; 19: 165-194.
8. Aoki KR. Pharmacology and immunology of botulinum neurotoxins. Int Ophthalmol Clin. 2005;45:25-37.
9. Dolly O. Synaptic transmission: inhibition of neurotransmitter release by botulinum toxins. Headache. 2003;43(suppl 1):S16-S24.
10. Rossetto O, Seveso M, Caccin P, et al. Botulinum neurotoxins are metalloproteases specific for SNARE proteins involved in neuroexocy-tosis. Curr Probl Dermatol. 2002;30:117-125.
11. Pearce LB, First ER, MacCallum RD, et al. Pharmacologic characterization of botulinum toxin for basic science and medicine. Toxicon. 1997;35:1373-1412.
12. Foster KA, Bigalke H, Aoki KR. Botulinum neurotoxin-from laboratory to bedside. Neurotox Res. 2006;9:133-140.
13. First ER, Pearce LB, Borodic GE. Dose standardisation of botulinum toxin. Lancet. 1994;343:1035.
14. Pearce LB, Borodic GE, Johnson EA, et al. The median paralysis unit: a more pharmacologically relevant unit of biologic activity for botulinum toxin. Toxicon. 1995;33:217-227.
15. Aoki KR. A comparison of safety margins of botulinum neurotoxin serotypes A, B and F in mice. Toxicon. 2001;39:1815-1820.
16. Atassi MZ. Basic immunological aspects of botulinum toxin therapy. Mov Disord. 2004;19(suppl 8):S68-S84.
17. Dressler D, Hallett M. Immunological aspects of Botox®, Dysport® and Myobloc™/NeuroBloc® Eur J Neurol. 2006;13(suppl 1):S11-S15.
18. 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.
19. Borodic G, Johnson E, Goodnough M, et al. Botulinum toxin therapy, immunologic resistance, and problems with available materials. Neurology. 1996;46:26-29.
20. Greene P, Fahn S, Diamond B. Development of resistance to botulinum toxin type A in patients with torticollis. Mov Disord. 1994;9:213-217.
21. Jankovic J. Botulinum toxin: clinical implications of antigenicity and immunoresistance. In: Brin M, Jankovic J, Hallett M, eds. Scientific and Therapeutic Aspects of Botulinum Toxin. Philadelphia, PA: Lippincott, Williams & Wilkins; 2002:409-415.
22. Kessler KR, Skutta M, Benecke R; for the German Dystonia Study Group. Long-term treatment of cervical dystonia with botulinum toxin type A: efficacy, safety and antibody frequency. J Neurol. 1999;246: 265-274.
23. Truong D, Duane DD, Jankovic J, et al. Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord. 2005; 20:783-791.
24. Comella CL, Jankovic J, Daggett S, et al. Interim results of an observational study of neutralizing antibody formation with the current preparation of botulinum toxin type A treatment for cervical dystonia [abstract P06.141]. Neurology. 2004;62(7 suppl 5):A511. Abstract presented at: American Academy of Neurology 56th Annual Meeting; April 2004; San Francisco, CA.
25. Yablon SA, Brashear A, Gordon MF, et al. Formation of neutralizing antibodies in patients receiving botulinum toxin type A for treatment of poststroke spasticity: a pooled analysis of three clinical trials. Clin Ther. 2007;29:683-690.
26. Zuber M, Sebald M, Bathien N, et al. Botulinum antibodies in dystonic patients treated with type A botulinum toxin: frequency and significance. Neurology. 1993;43:1715-1718.
27. Bakheit AMO, Fedorova NV, Skoromets AA, et al. The beneficial antispasticity effect of botulinum toxin type A is maintained after repeated treatment cycles. J Neurol Neurosurg Psychiatry. 2004;75: 1558-1561.
28. Jankovic J, Hunter C, Dolimbek BZ, et al. Clinico-immunologic aspects of botulinum toxin type B treatment of cervical dystonia. Neurology. 2006;67:2233-2235.
29. Dressier 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.
30. Aoki KR. Botulinum neurotoxin serotypes A and B preparations have different safety margins in preclinical models of muscle weakening efficacy and systemic safety. Toxicon. 2002;40:923-928.
31. Nussgens Z, Roggenkamper P. Comparison of two botulinum-toxin preparations in the treatment of essential blepharospasm. Graefes Arch Clin Exp Ophthalmol. 1997;235:197-199.
32. Simonetta Moreau M, Cauhepe C, Magues JP, et al. A double-blind, randomized, comparative study of Dysport® vs. Botox® in primary palmar Hyperhidrosis. Br J Dermatol. 2003;149:1041-1045.
33. Sampaio C, Ferreira JJ, Simoes F, et al. DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A-Dysport and Botox-assuming a ratio of 4:1. Mov Disord. 1997;12:1013-1018.
34. Odergren T, Hjaltason H, Kaakkola S, et al. A double blind, randomised, parallel group study to investigate the dose equivalence of Dysport® and Botox® in the treatment of cervical dystonia. J Neurol Neurosurg Psychiatry. 1998;64:6-12.
35. Bihari K. Safety, effectiveness, and duration of effect of BOTOX after switching from Dysport for blepharospasm, cervical dystonia, and hemifacial spasm. Curr Med Res Opin. 2005;21:433-438.
36. Ranoux D, Gury C, Fondarai J, et al. Respective potencies of Botox and Dysport: a double blind, randomised, crossover study in cervical dystonia. J Neurol Neurosurg Psychiatry. 2002;72:459-462.
37. Lowe P, Patnaik R, Lowe N. Comparison of two formulations of botulinum toxin type A for the treatment of glabellar line: a double-blind, randomized study. J Am Acad Dermatol. 2006;55:975-980.
38. Durif F. Clinical bioequivalence of the current commercial preparations of botulinum toxin. Eur J Neurol.1995;2(suppl 3):S17-S18.
39. Talarico-Filho S, Mendonca DO, Nascimento M, et al. A double-blind, randomized, comparative study of two type A botulinum toxins in the treatment of primary axillary hyperhidrosis. Dermatol Surg. 2007; 33(suppl 1):S44-S50.
40. Marchetti A, Magar R, Findley L, et al. Retrospective evaluation of the dose of Dysport and BOTOX in the management of cervical dystonia and blepharospasm: the REAL DOSE study. Mov Disord. 2005;20:937-944.
41. Sampaio C, Costa J, Ferreira JJ. Clinical comparability of marketed formulations of botulinum toxin. Mov Disord. 2004; 19(suppl 8):S129-S136.
42. Mathew NT. The prophylactic treatment of chronic daily headache. Headache. 2006;46:1552-1564.
43. Sheean G. Botulinum toxin for the treatment of musculoskeletal pain and spasm. Curr Pain Headache Rep. 2002;6:460-469.
44. Jabbari B. Treatment of chronic lower back pain with botulinum neurotoxins. Curr Pain Rep. 2007;4:352-358.
45. Moore C, Rackley R, Goldman H. Urologic applications of botox. Curr Urol Rep. 2005;6:419-423.
46. Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990;40:277-280.
47. Jankovic J, Schwartz KS. Longitudinal experience with botulinum toxin injections for treatment of blepharospasm and cervical dystonia. Neurology. 1993;43:834-836.
48. Meija NI, Vuong KD, Jankovic J. Long-term botulinum toxin efficacy, safety, and immunogenicity. Mov Disord. 2005;20:592-597.
49. Brashear A, Hogan P, Wooten-Watts M, et al. Longitudinal assessment of the dose consistency of botulinum toxin type A (BOTOX®) for cervical dystonia. Adv Ther. 2005;22:49-55.
50. Poewe W, Deuschl G, Nebe A, et al; for the German Dystonia Study Group (GDSG). What is the optimal dose of botulinum toxin A in the treatment of cervical dystonia? Results of a double blind, placebo controlled, dose ranging study using Dysport®. J Neurol Neurosurg Psychiatry. 1998;64:13-17.
51. Haussermann P, Marczoch S, Klinger C, et al. Long-term follow-up of cervical dystonia patients treated with botulinum toxin A. Mov Disord 2004;19:303-308.
52. Lew MF, Adornato BT, Duane DD, et al. Botulinum toxin type B: a double-blind, placebo-controlled, safety and efficacy study in cervical dystonia. Neurology. 1997;49:701-707.
53. Brashear A, Lew MF, Dykstra DD, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-responsive cervical dystonia. Neurology. 1999;53:1439-1446.
54. Brin MF, Lew MF, Adler CH, et al. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999;53:1431-1438.
55. Benecke R, Jost WH, Kanovsky P, et al. A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia. Neurol-ogy. 2005;64:1949-1951.
56. Brashear A, Gordon MF, ElovicE, et al; for the BOTOX Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002;347:395-400.
57. Richardson D, Sheean G, Werring D, et al. Evaluating the role of botulinum toxin in the management of focal hypertonia in adults. J Neurol Neurosurg Psychiatry. 2000;69:499-506.
58. Simpson DM, Alexander DN, O'Brien CF, et al. Botulinum toxin type A in the treatment of upper extremity spasticity: a randomized, double-blind, placebo-controlled trial. Neurology. 1996;46:1306-1310.
59. Gordon MF, Brashear A, Elovic E, et al; for the BOTOX Poststroke Spasticity Study Group. Repeated dosing of botulinum toxin type A for upper limb spasticity following stroke. Neurology. 2004;63:1971-1973.
60. Bakheit AM, Thilmann AF, Ward AB, et al. A randomized, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke. 2000;31:2402-2406.
61. Bakheit AM, Pittock S, Moore AP, et al. A randomized, double-blind, placebo-controlled study of the efficacy and safety of botulinum toxin type A in upper limb spasticity in patients with stroke. Eur J Neurol. 2001;8:559-565.
62. Bhakta BB, Cozens JA, Chamberlain MA, et al. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry. 2000;69:217-221.
63. Suputtitada A, Suwanwela NC. The lowest effective dose of botulinum A toxin in adult patients with upper limb spasticity. Disabil Rehabil. 2005;27:176-184.
64. Brashear A, McAfee AL, Kuhn ER, et al. Botulinum toxin type B in upper-limb poststroke spasticity: a double-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2004;85:705-709.
65. Taylor JD, Kraft SP, Kazdan MS, et al. Treatment of blepharospasm and hemifacial spasm with botulinum A toxin: a Canadian multicentre study. Can J Ophthalmol. 1991;26:133-138.
66. Defazio G, Abbruzzese G, Girlanda P, et al. Botulinum toxin A treatment for primary hemifacial spasm: a 10-year multicenter study. Arch Neurol. 2002;59:418-420.
67. Tsai CP, Chiu MC, Yen DJ, et al. Quantitative assessment of efficacy of Dysport (botulinum toxin type A) in the treatment of idiopathic blepharospasm and hemifacial spasm. Acta Neurol Taiwan. 2005;14: 61-68.
68. 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. 2006;113:303-312.
69. Carruthers A, Carruthers J. Prospective, double-blind, randomized, parallel-group, dose-ranging study of botulinum toxin type A in men with glabellar rhytids. Dermatol Surg. 2005;31:1297-1303.
70. Carruthers JA, Lowe NJ, Menter MA, et al. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002;46:840-849.
71. Carruthers JD, Lowe NJ, Menter MA, et al; for the Botox Glabellar Lines II Study Group. Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. Plast Reconstr Surg. 2003;112:1089-1098.
72. Rzany B, Ascher B, Fratila A, et al; for the GLADYS Study Group. Efficacy and safety of 3- and 5-injection patterns (30 and 50 U) of botulinum toxin A (Dysport) for the treatment of wrinkles in the glabella and the central forehead region. Arch Dermatol. 2006;142:320-326.
73. Ascher B, Zakine B, Kestemont P, et al. A multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of 3 doses of botulinum toxin A in the treatment of glabellar lines. J Am Acad Dermatol. 2004;51:223-233.
74. Monheit G, Carruthers A, Brandt F, et al. A randomized, double-blind, placebo-controlled study of botulinum toxin type A for the treatment of glabellar lines: determination of optimal dose. Dermatol Surg. 2007; 33(suppl 1):S51-S59.
75. Rzany B, Dill-Muller D, Grablowitz D, et al; on behalf of the German-Austrian Retrospective Study Group. Repeated botulinum toxin A injections for the treatment of lines in the upper face: a retrospective study of 4,103 treatments in 945 patients. Dermatol Surg. 2007;33 (1 Spec No.):S18-S25.
76. Baumann L, Slezinger A, Vujevich J, et al. A double-blinded, randomized, placebo-controlled pilot study of the safety and efficacy of Myobloc (botulinum toxin type B)-purified neurotoxin complex for the treatment of crow's feet: a double-blinded, placebo-controlled trial. Dermatol Surg. 2003;29:508-515.
77. Sadick NS. Prospective open-label study of botulinum toxin type B (Myobloc) at doses of 2,400 and 3,000 U of the treatment of glabellar wrinkles. Dermatol Surg. 2003;29:501-507.
78. Carruthers A, Carruthers J, Corcoran Flynn T, et al. Dose-finding, safety, and tolerability study of botulinum toxin type B for the treatment of hyperfunctional glabellar lines. Dermatol Surg. 2007;33(suppl 1):S60-S68.
79. Naumann M, Lowe NJ; on behalf of the Hyperhidrosis Clinical Study Group. Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial. BMJ. 2001;323:1-4.
80. Naumann M, Lowe NJ, Kumar CR, et al; for the Hyperhidrosis Clinical Investigators Group. Botulinum toxin type A is a safe and effective treatment for axillary hyperhidrosis over 16 months: a prospective study. Arch Dermatol. 2003;139:731-736.
81. Naumann MK, Hamm H, Lowe NJ; on behalf of the BOTOX® Hyperhidrosis Clinical Study Group. Effect of botulinum toxin type A on quality of life measures in patients with excessive axillary sweating: a randomized controlled trial. Br J Dermatol. 2002;147:1218-1226.
82. Schnider P, Moraru E, Kittler H, Voller B, Auff E. High-dose botulinum toxin type A for axillary hyperhidrosis. Arch Dermatol. 2000:136:1567.
83. Schnider P, Binder M, Kittler H, et al. A randomized, double-blind, placebo-controlled trial of botulinum A toxin for severe axillary hyperhidrosis. Br J Dermatol. 1999;140:677-680.
84. Dressler D, Benecke R. Autonomic side effects of botulinum toxin type B treatment of cervical dystonia and hyperhidrosis. Eur Neurol. 2003 ; 49:34-38.
85. Baumann L, Slezinger A, Halem M, et al. Pilot study of the safety and efficacy of Myobloc™ (botulinum toxin type B) for treatment of axillary hyperhidrosis. Int J Dermatol. 2005;44:418-424.
86. Cornelia CL, Jankovic J, Shannon KM, et al; and the Dystonia Study Group. Comparison of botulinum toxin serotypes A and B for the treatment of cervical dystonia. Neurology. 2005;65:1423-1429.
87. Matarasso SL. Comparison of botulinum toxin types A and B: a bilateral and double-blind randomized evaluation in the treatment of canthal rhytides. Dermatol Surg. 2003;29:7-13.