Abstract
BackgroundIncobotulinumtoxinA (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.MethodsParticipants 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).ResultsSixty-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.ConclusionsOur clinical experience indicates that incobotulinumtoxinA is a well-tolerated treatment option for focal spasticity in children with cerebral palsy.Trial registrationAs 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.
Highlights
IncobotulinumtoxinA (Xeomin®) is a botulinum neurotoxin type A with established efficacy in the treatment of upper-limb spasticity in adults
Participants A total of 69 children with cerebral palsy were included in this study (Table 1)
The greatest proportion of participants presented with Gross Motor Functional Classification System (GMFCS) level II (28/68, 41.2%; data missing for 1 participant); 25/68 (36.8%) presented with GMFCS level IV or V
Summary
IncobotulinumtoxinA (Xeomin®) is a botulinum neurotoxin type A with established efficacy in the treatment of upper-limb spasticity in adults. Cerebral palsy represents a heterogeneous group of permanent movement and posture disorders attributed to non-progressive disturbances that occur in the developing fetal or infant brain [1]. It is one of the most common causes of physical disability in children, occurring in 2.11/1000 live births worldwide [2]. Botulinum neurotoxin (BoNT) type A is an effective and well-tolerated treatment option for focal spasticity in children with cerebral palsy [3, 7,8,9] It inhibits acetylcholine release from nerve terminals at the motor endplate, preventing synaptic transmission [10]. Reduction of spasticity after BoNT type A injection should open a therapeutic window for other interventions in cerebral palsy, by preventing contracture formation and enhancing both motor ability and functional skills
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