We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis.
- Authors
Berweck, Steffen; Banach, Marta; Gaebler-Spira, Deborah; Chambers, Henry G.; Schroeder, A. S.; Geister, Thorin L.; Althaus, Michael; Hanschmann, Angelika; Vacchelli, Matteo; Bonfert, Michaela V.; Heinen, Florian; Dabrowski, Edward
- 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.
- Subjects
DROOLING; IMMUNE response; CLINICAL trials; SPASTICITY; BOTULINUM A toxins; CEREBRAL palsy
- Publication
Toxins, 2022, Vol 14, Issue 9, p585
- ISSN
2072-6651
- Publication type
Article
- DOI
10.3390/toxins14090585