IncobotulinumtoxinA for the treatment of spasticity in children with cerebral palsy - a retrospective case series focusing on dosing and tolerability.

Abstract

BACKGROUND:

IncobotulinumtoxinA (Xeomin®) is a botulinum neurotoxin type A with established efficacy in the treatment of upper-limb spasticity in adults. This retrospective case series in a university hospital setting aimed to elucidate the safety and tolerability of incobotulinumtoxinA for treatment of spasticity in children with cerebral palsy.

METHODS:

Participants received incobotulinumtoxinA injections up to a maximum total dose of 600 U, 24 U/kg body weight. Medical records were reviewed for key demographic information, incobotulinumtoxinA exposure, and adverse effects (AEs).

RESULTS:

Sixty-nine children were included (mean age [SD], 8.3 [3.9] years; 44/69 [63.8%] male). One-hundred-and-ninety-one injections were administered, with mean (SD) of 2.8 (1.5) treatment cycles/participant and dosing interval of 6.0 (1.7) months. The number of muscles injected increased from 2.4 (1.2) at cycle 1 to 4.2 (1.9) at cycle 6. The mean (SD) total incobotulinumtoxinA dose increased from 191.7 (126.2) U, (8.5 [5.4] U/kg body weight) at cycle 1 to 368.0 (170.1) U, (9.9 [5.5] U/kg body weight) at cycle 6. Seventy four adverse effects (37.5% of injections) were reported, the most frequent was injection pain (93.2% of AEs). Only three AEs were considered directly treatment-related by injectors: muscle weakness, generalized weakness, and fever.

CONCLUSIONS:

Our clinical experience indicates that incobotulinumtoxinA is a well-tolerated treatment option for focal spasticity in children with cerebral palsy.

TRIAL REGISTRATION:

As the study was observational and retrospective, no EudraCT registration number was requested. The internal code assigned to the study in the administrative resolution was: 1143-N-15.

• Authors: Angel León-Valenzuela, Juan Sánchez Palacios, Rogelio Del Pino Algarrada
• Journal: BMC neurology (BMC Neurol) Vol. 20 Issue 1 Pg. 126 (Apr 08 2020) ISSN: 1471-2377 [Electronic] England
• PMID: 32268880 (Publication Type: Journal Article)

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A
• incobotulinumtoxinA

Topics

• Adolescent
• Botulinum Toxins, Type A (administration & dosage)
• Cerebral Palsy (drug therapy)
• Child
• Child, Preschool
• Female
• Humans
• Infant
• Male
• Muscle Spasticity (drug therapy)
• Muscle Weakness (chemically induced)
• Neuromuscular Agents (therapeutic use)
• Retrospective Studies
• Treatment Outcome