Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis.

Abstract

IncobotulinumtoxinA, a pure botulinumtoxinA formulation, is free of accessory proteins. This analysis provides pooled safety data from phase 3 trials of children/adolescents (2-17 years), investigating incobotulinumtoxinA for the treatment of spasticity associated with cerebral palsy (at doses ≤20 U/kg (max. 500 U) per injection cycle (IC) for ≤6 ICs; three trials) or sialorrhea associated with neurologic disorders (at total doses of 20-75 U per IC for ≤4 ICs; one trial) for ≤96 weeks. Safety endpoints included the incidences of different types of treatment-emergent adverse events (TEAEs) and immunogenicity. IncobotulinumtoxinA dose groups were combined. Of 1159 patients (mean age 7.3 years, 60.4% males) treated with incobotulinumtoxinA, 3.9% experienced treatment-related TEAEs, with the most common being injection site reactions (1.3%) (both indications), muscular weakness (0.7%) (spasticity), and dysphagia (0.2%) (sialorrhea). Two patients (0.2%) experienced a treatment-related treatment-emergent serious adverse event, and 0.3% discontinued the study due to treatment-related TEAEs. No botulinumtoxinA-naïve patients developed neutralizing antibodies (NAbs) after incobotulinumtoxinA. All children/adolescents with known pre-treatment status and testing positive for Nabs at final visit (n = 7) were previously treated with a botulinumtoxinA other than incobotulinumtoxinA. IncobotulinumtoxinA was shown to be safe, with very few treatment-related TEAEs in a large, diverse cohort of children/adolescents with chronic conditions requiring long-term treatment and was without new NAb formation in treatment-naïve patients.

• Authors: Steffen Berweck, Marta Banach, Deborah Gaebler-Spira, Henry G Chambers, A S Schroeder, Thorin L Geister, Michael Althaus, Angelika Hanschmann, Matteo Vacchelli, Michaela V Bonfert, Florian Heinen, Edward Dabrowski
• Journal: Toxins (Toxins (Basel)) Vol. 14 Issue 9 (08 25 2022) ISSN: 2072-6651 [Electronic] Switzerland
• PMID: 36136523 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Neutralizing
• Neuromuscular Agents
• Botulinum Toxins, Type A
• incobotulinumtoxinA

Topics

• Adolescent
• Antibodies, Neutralizing (therapeutic use)
• Botulinum Toxins, Type A (adverse effects)
• Child
• Child, Preschool
• Female
• Humans
• Male
• Muscle Spasticity (drug therapy, etiology)
• Neuromuscular Agents (adverse effects)
• Sialorrhea (drug therapy, etiology)
• Treatment Outcome