Formation of neutralizing antibodies in patients receiving botulinum toxin type a for treatment of poststroke spasticity: A pooled-data analysis of three clinical trials

Clinical Therapeutics

Volumn 29, Issue 4, 2007, Pages 683-690

  Yablon, Stuart A ^a   Brashear, Allison ^b   Gordon, Mark F ^c   Elovic, Elie P ^d   Turkel, Catherine C ^e   Daggett, Simon ^e   Liu, Jingyu ^e   Brin, Mitchell F ^e,f  

^a METHODIST REHABILITATION CENTER   (United States)

^b WAKE FOREST UNIVERSITY   (United States)

^c LONG ISLAND JEWISH MEDICAL CENTER   (United States)

^d KESSLER FOUNDATION   (United States)

^e ALLERGAN INC   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

botulinum toxin; neutralizing antibody; pooled analysis; poststroke spasticity; spasticity

Indexed keywords

BOTULINUM TOXIN A; NEUTRALIZING ANTIBODY; PLACEBO;

ADULT; ANTIBODY DETECTION; ANTIBODY PRODUCTION; ARTICLE; ASHWORTH SCALE; CLINICAL ASSESSMENT TOOL; CLINICAL TRIAL; DATA ANALYSIS; DRUG FORMULATION; ECCHYMOSIS; FEMALE; FINGER; HUMAN; INCIDENCE; INJECTION SITE PAIN; MALE; MOUSE PROTECTION ASSAY; MUSCLE CONTRACTURE; MUSCLE TONE; MUSCLE WEAKNESS; OUTCOMES RESEARCH; RATING SCALE; SAMPLING; SCORING SYSTEM; SERUM; SEX RATIO; SPASTICITY; STROKE; TREATMENT RESPONSE; WRIST;

ANTIBODIES; BOTULINUM TOXIN TYPE A; CEREBROVASCULAR ACCIDENT; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; HUMANS; MUSCLE SPASTICITY; NEUROMUSCULAR AGENTS;

EID: 34347353153     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2007.04.015     Document Type: Article

References (31)

1. Goldstein L.B., Adams R., Becker K., et al. Primary prevention of ischemic stroke: A statement for healthcare professionals from the Stroke Council of the American Heart Association. Circulation 103 (2001) 163-182
2. Sommerfeld D.K., Eek E.U., Svensson A.K., et al. Spasticity after stroke: Its occurrence and association with motor impairments and activity limitations. Stroke 35 (2004) 134-139
3. Leathley M.J., Gregson J.M., Moore A.P., et al. Predicting spasticity after stroke in those surviving to 12 months. Clin Rehabil. 18 (2004) 438-443
4. Watkins C.L., Leathley M.J., Gregson J.M., et al. Prevalence of spasticity post stroke. Clin Rehabil. 16 (2002) 515-522
5. Poster 268. Turkel C., and Sissins P. Functional activities affected by poststroke spasticity. Arch Phys Med Rehabil. 85 (2004) E52
6. Gracies J. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerv. 31 (2005) 552-571
7. Twitchell T.E. The restoration of motor function following hemiplegia in man. Brain. 74 (1951) 443-480
8. Mayer N.H., and Esquenazi A. Muscle overactivity and movement dysfunction in the upper motoneuron syndrome. Phys Med Rehabil Clin N Am. 14 (2003) 855-883
9. Yablon S.A. Botulinum neurotoxin intramuscular chemodenervation. Role in the management of spastic hypertonia and related motor disorders. Phys Med Rehab Clin North Am. 12 (2001) 833-874
10. Dolly O. Synaptic transmission: Inhibition of neurotransmitter release by botulinum toxins. Headache 43 Suppl 1 (2003) S16-S24
11. Brashear A., Gordon M.F., Elovic E., et al., 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. 347 (2002) 395-400
12. Childers M.K., Brashear A., Jozefczyk P., et al. Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke. Arch Phys Med Rehabil. 85 (2004) 1063-1069
13. Gordon M.F., Brashear A., Elovic E., et al., BOTOX Poststroke Spasticity Study Group. Repeated dosing of botulinum toxin type A for upper limb spasticity following stroke. Neurology 63 (2004) 1971-1973
14. Koman L.A., Mooney III J.F., Smith B.P., et al., BOTOX Study Group. Botulinum toxin type A neuromus cular blockade in the treatment of lower extremity spasticity in cerebral palsy: A randomized, double-blind, placebo-controlled trial. J Pediatr Orthop 20 (2000) 108-115
15. Turkel C.C., Bowen B., Liu J., and Brin M.F. Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity. Arch Phys Med Rehabil. 87 (2006) 786-792
16. Borodic G., Johnson E., Goodnough M., and Schantz E. Botulinum toxin therapy, immunologic resistance, and problems with available materials. Neurology 46 (1996) 26-29
17. Atassi M.Z. Basic immunological aspects of botulinum toxin therapy. Mov Disord 19 Suppl 8 (2004) S68-S84
18. Greene P., Fahn S., and Diamond B. Development of resistance to botulinum toxin type A in patients with torticollis. Mov Disord. 9 (1994) 213-217
19. Jankovic J., Vuong K.I.D., and Ahsan J. Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia. Neurology 60 (2003) 1186-1188
20. Yablon S., Daggett S., Lai F., et al. The development of toxin neutralizing antibodies with botulinum toxin type A (BoNTA) treatment. Neurorehabil Neural Repair. 20 (2006) 176-177
21. Herrmann J., Geth K., Mall V., et al. Clinical impact of antibody formation to botulinum toxin A in children. Ann Neurol 55 (2004) 732-735
22. Koman L.A., Brashear A., Rosenfeld S., et al. Botulinum toxin type A neuromuscular blockade in the treatment of equinus foot deformity in cerebral palsy: A multicenter, open-label clinical trial. Pediatrics 108 (2001) 1062-1071
23. Turkel C., Dru R., Liu J., and BOTOX Spasticity Study Group. Double-blind, randomized study of BOTOX® (botulinum toxin type A) purified neurotoxin complex for treating focal spasticity poststroke. Arch Pharmacol. 365 Suppl 2 (2002) R47
24. Rothwell P.M., Coull A.J., Giles M.F., et al., Oxford Vascular Study Group. Change in stroke incidence, mortality, case-fatality, severity, and risk factors in Oxfordshire, UK, from 1981 to 2004 (Oxford Vascular Study). Lancet 363 (2004) 1925-1933
25. Zahuranec D.B., Brown D.L., Lisabeth L.D., and Morgenstern L.B. Is it time for a large, collaborative study of pediatric stroke?. Stroke 36 (2005) 1825-1829
26. Giroud M., Lemesle M., Gouyon J.B., et al. Cerebrovascular disease in children under 16 years of age in the city of Dijon, France: A study of incidence and clinical features from 1985 to 1993. J Clin Epidemiol 48 (1995) 1343-1348
27. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects [WMA Web site]. Adopted by the 18th WMA General Assembly. Helsinki, Finland, June 1964 (2007). http://www.wma.net/e/policy/63.htm
28. Hanna P.A., and Jankovic J. Mouse bioassay versus Western blot assay for botulinum toxin antibodies: Correlation with clinical responses. Neurology 50 (1998) 1624-1629
29. Hanna P.A., Jankovic J., and Vincent A. Comparison of mouse bioassay and immunoprecipitation assay for botulinum toxin antibodies. J Neurol Neuro-surg Psychiatry. 66 (1999) 612-616
30. Rollnik J.D., Wohlfarth K., Dengler R., and Bigalke H. Neutralizing botulinum toxin type A antibodies: Clinical observations in patients with cervical dystonia. Neurol Clin Neurophysiol. 2001 (2001) 2-4
31. Jankovic J., and Schwartz K. Response and immunoresistance to botulinum toxin injections. Neurology 45 (1995) 1743-1746