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Absence Of Neutralizing Antibody Formation During Incobotulinumtoxina Treatement Of Spasticity In Botulinum Toxin-Naive Children With Cerebral Palsy: Pooled Analysis Of Three Phase 3 Studies, Henry Chambers, Petr Kanovsky, A Sebastian Schroeder, Edward Dabrowski, Thorin Geister, Angelika Hanschmann, Irena Pulte, Michael Althaus, Marta Banach, Deborah Gaebler-Spira, Florian Heinen
Absence Of Neutralizing Antibody Formation During Incobotulinumtoxina Treatement Of Spasticity In Botulinum Toxin-Naive Children With Cerebral Palsy: Pooled Analysis Of Three Phase 3 Studies, Henry Chambers, Petr Kanovsky, A Sebastian Schroeder, Edward Dabrowski, Thorin Geister, Angelika Hanschmann, Irena Pulte, Michael Althaus, Marta Banach, Deborah Gaebler-Spira, Florian Heinen
Conference Presentation Abstracts
Introduction: The development of neutralizing antibodies (NAbs) has been linked to secondary non-response to botulinum neurotoxin type A (BoNT-A) injections. This may be of special concern when treating conditions like pediatric spasticity. We investigated NAb formation in three large Phase 3 studies with incobotulinumtoxinA, a BoNT-A lacking complexing proteins, in children/adolescents with cerebral palsy (CP).
Patients and methods: Patients with lower-limb (LL), upper-limb (UL), or combined LL/UL spasticity (2–17 years; uni- or bilateral CP; Ashworth Scale score ≥2 in clinical patterns for treatment) received total body weight incobotulinumtoxinA ≤16–20 U/kg (max. 400–500 U) depending on the study (TIM: NCT01893411; TIMO: …