Skip to main content

AbobotulinumtoxinA: A Review in Pediatric Lower Limb Spasticity

Pediatric Drugs volume 19, pages 367–373 (2017)Cite this article

Abstract

AbobotulinumtoxinA (Dysport®) is currently the only botulinum toxin A formulation approved by the US FDA for the treatment of lower limb spasticity in pediatric patients aged ≥2 years. Intramuscular abobotulinumtoxinA was approved based on the results of a pivotal phase 3 trial in children with lower limb spasticity due to cerebral palsy. In this trial, a single treatment cycle with abobotulinumtoxinA 10–15 U/kg/leg injected into the gastrocnemius and soleus muscles significantly improved ankle plantar flexor muscle tone (primary endpoint), with abobotulinumtoxinA recipients showing a significant response to treatment relative to placebo. AbobotulinumtoxinA treatment also improved spasticity grade. The improvements in muscle tone and spasticity were associated with an improved ability to attain functional goals. Clinical benefits of abobotulinumtoxinA treatment lasted for 16–22 weeks in most patients, and were maintained with multiple treatment cycles during 1 year in an open-label extension study. AbobotulinumtoxinA was generally well tolerated, with a relatively low incidence of treatment-related adverse events. In summary, abobotulinumtoxinA is an effective and generally well tolerated treatment option for children with lower limb spasticity.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

USD 49.95

Price includes VAT (USA)
Tax calculation will be finalised during checkout.

References

  1. Moeini-Naghani I, Hashemi-Zonouz T, Jabbari B. Botulinum toxin treatment of spasticity in adults and children. Semin Neurol. 2016;36(1):64–72.

    Article  PubMed  Google Scholar 

  2. Koman LA, Paterson Smith B, Balkrishnan R. Spasticity associated with cerebral palsy in children: guidelines for the use of botulinum A toxin. Paediatr Drugs. 2003;5(1):11–23.

    Article  PubMed  Google Scholar 

  3. Dysport® (abobotulinumtoxinA) for injection: US prescribing information. 2016. https://www.dysport.com. Accessed 3 May 2017.

  4. Keam SJ, Muir VJ, Deeks ED. Botulinum toxin A (Dysport®): in dystonias and focal spasticity. Drugs. 2011;71(8):1043–58.

    CAS  Article  PubMed  Google Scholar 

  5. Thakker MM, Rubin PA. Pharmacology and clinical applications of botulinum toxins A and B. Int Ophthalmol Clin. 2004;44(3):147–63.

    Article  PubMed  Google Scholar 

  6. Tilton A, Russman B, Aydin R, et al. AbobotulinumtoxinA (Dysport®) improves function according to goal attainment in children with dynamic equinus due to cerebral palsy. J Child Neurol. 2017;32(5):482–7.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Park ES, Sim E, Rha DW. Architectural changes of the gastrocnemius muscle after botulinum toxin Type A injection in children with cerebral palsy. Yonsei Med J. 2014;55:1406–12.

    Article  PubMed  PubMed Central  Google Scholar 

  8. Colovic H, Dimitrijevic L, Stankovic I, et al. The effects of botulinum toxin type A on improvement and dynamic spastic equinus correction in children with cerebral palsy—preliminary results. Arch Med Sci. 2014;10(5):979–84.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  9. Colovic H, Dimitrijevic L, Stankovic I, et al. Estimation of botulinum toxin type A efficacy on spasticity and functional outcome in children with spastic cerebral palsy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2012;156(1):41–7.

    CAS  Article  PubMed  Google Scholar 

  10. Lee SJ, Sung IY, Jang DH, et al. The effect and complication of botulinum toxin Type A injection with serial casting for the treatment of spastic equinus foot. Ann Rehabil Med. 2011;35(3):344–53.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Bottos M, Benedetti MG, Salucci P, et al. Botulinum toxin with and without casting in ambulant children with spastic diplegia: a clinical and functional assessment. Dev Med Child Neurol. 2003;45(11):758–62.

    CAS  Article  PubMed  Google Scholar 

  12. Hesse S, Brandl-Hesse B, Seidel U, et al. Lower limb muscle activity in ambulatory children with cerebral palsy before and after the treatment with Botulinum toxin A. Restor Neurol Neurosci. 2000;17(1):1–8.

    CAS  PubMed  Google Scholar 

  13. Fazzi E, Maraucci I, Torrielli S, et al. Factors predicting the efficacy of botulinum toxin-A treatment of the lower limb in children with cerebral palsy. J Child Neurol. 2005;20(8):661–6.

    Article  PubMed  Google Scholar 

  14. Metaxiotis D, Siebel A, Doederlein L. Repeated botulinum toxin A injections in the treatment of spastic equinus foot. Clin Orthop Relat Res. 2002;394:177–85.

    Article  Google Scholar 

  15. Heinen F, Wissel J, Philipsen A, et al. Interventional neuropediatrics: treatment of dystonic and spastic muscular hyperactivity with botulinum toxin A. Neuropediatrics. 1997;28(6):307–13.

    CAS  Article  PubMed  Google Scholar 

  16. Frasson E, Dall’ora E, Bordignon M, et al. Spread of botulinum neurotoxin Type A at standard doses is inherent to the successful treatment of spastic equinus foot in cerebral palsy: short-term neurophysiological and clinical study. J Child Neurol. 2012;27(5):587–93.

    Article  PubMed  Google Scholar 

  17. Geva-Dayan K, Domenievitz D, Zahalka R, et al. Botulinum toxin injections for pediatric patients with hereditary spastic paraparesis. J Child Neurol. 2010;25(8):969–75.

    Article  PubMed  Google Scholar 

  18. Unlu E, Cevikol A, Bal B, et al. Multilevel botulinum toxin Type A as a treatment for spasticity in children with cerebral palsy: a retrospective study. Clinics. 2010;65(6):613–9.

    PubMed  PubMed Central  Google Scholar 

  19. Sätilä HK, Pietikainen T, Lehtonen-Raty P, et al. Treatment of spastic equinus gait with botulinum toxin A: does dose matter? Analysis of a clinical cohort. Neuropediatrics. 2006;37(6):344–9.

    Article  PubMed  Google Scholar 

  20. Dabrowski E, Bonikowski M, Gormley M, et al. Efficacy and safety of abobotulinumtoxinA (Dysport®) in children with dynamic equinus foot deformity previously treated with botulinum toxins. In: Annual meeting of the association of academic physiatrists. 2017.

  21. Delgado MR, Russman B, Gormley M, et al. Effect of abobotulinumtoxinA (Dysport®) injections on functioning in children with dynamic equinus foot deformity due to cerebral palsy: analysis of treatment goals, gait and quality of life from a phase 3 study [abstract]. Am J Phys Med Rehabil. 2016;95(Suppl 3):a5.

    Google Scholar 

  22. Delgado MR, Tilton A, Russman B, et al. AbobotulinumtoxinA for equinus foot deformity in cerebral palsy: a randomized controlled trial. Pediatrics. 2016;137(2):e20152830.

    Article  PubMed  Google Scholar 

  23. Tse A, Tilton A, Bonikowski M, et al. Goal selection using the Goal Attainment Scale in ambulatory patients with cerebral palsy according to GMFSC levels in a randomized, double-blind placebo-controlled study of abobotulinumtoxina (Dysport®) [abstract no. SP15]. Dev Med Child Neurol. 2014;56(Suppl 5):11.

    Google Scholar 

  24. Bonikowski M, Tilton A, Gormley M, et al. Abobotulinumtoxin A in children with lower limb spasticity due to cerebral palsy: safety and efficacy results of a phase III open-label extension study [abstract no. P78]. Gait Posture. 2016;49(Suppl 2):222.

    Google Scholar 

  25. Baker R, Jasinski M, Maciag-Tymecka I, et al. Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double-blind, placebo-controlled, dose-ranging study. Dev Med Child Neurol. 2002;44(10):666–75.

    CAS  Article  PubMed  Google Scholar 

  26. Ubhi T, Bhakta BB, Ives HL, et al. Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy. Arch Dis Child. 2000;83(6):481–7.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  27. Kanovsky P, Bares M, Severa S, et al. Long-term efficacy and tolerability of 4-monthly versus yearly botulinum toxin Type A treatment for lower-limb spasticity in children with cerebral palsy. Dev Med Child Neurol. 2009;51(6):436–45.

    Article  PubMed  Google Scholar 

  28. Moore AP, Ade-Hall RA, Smith CT, et al. Two-year placebo-controlled trial of botulinum toxin A for leg spasticity in cerebral palsy. Neurology. 2008;71(2):122–8.

    CAS  Article  PubMed  Google Scholar 

  29. Mall V, Heinen F, Siebel A, et al. Treatment of adductor spasticity with BTX-A in children with CP: a randomized, double-blind, placebo-controlled study. Dev Med Child Neurol. 2006;48(1):10–3.

    Article  PubMed  Google Scholar 

  30. Matthews D, Camba GC, Pascual-Pascual I, et al. Safety and tolerability of abobotulinumtoxina (Dysport®) in children (2–17 years) with lower limb spasticity due to cerebral palsy: a pooled analysis of 8 clinical trials [poster 485]. PM R. 2016;8(9):S318.

    Article  PubMed  Google Scholar 

  31. Dabrowski D, Bonikowski M, Gormley M, et al. Efficacy and safety of abobotulinumtoxinA (Dysport®) in children with dynamic equinus foot deformity previously treated with botulinum toxins [abstract no. 126]. Ann Neurol. 2016;80(Suppl 2):S368.

    Google Scholar 

  32. Delgado MR, Hirtz D, Aisen M, et al. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010;74(4):336–43.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

During the peer review process, the manufacturer of abobotulinumtoxinA was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Yahiya Y. Syed

Authors
  1. Yahiya Y. Syed
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Yahiya Y. Syed.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

Yahiya Syed is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/EA98F0602C1007A1.

Additional information

The manuscript was reviewed by: V. Binay Safer, Ankara Physical Medicine Rehabilitation Training and Research Hospital, Ankara, Turkey; P. Edwards, Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Bribane, QLD, Australia.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Syed, Y.Y. AbobotulinumtoxinA: A Review in Pediatric Lower Limb Spasticity. Pediatr Drugs 19, 367–373 (2017). https://doi.org/10.1007/s40272-017-0242-4

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40272-017-0242-4