Open AccessSafety and efficacy of repeat long-term incobotulinumtoxinA treatment for lower limb or combined upper/lower limb spasticity in children with cerebral palsy
Author(s) -
Petr Kaňovský,
Florian Heinen,
Andreas Schröeder,
Henry G. Chambers,
Edward Dabrowski,
Thorin L. Geister,
Angelika Hanschmann,
Francisco Martinez-Torres,
Irena Pulte,
Marta Banach,
Deborah GaeblerSpira
Publication year - 2022
Publication title -
journal of pediatric rehabilitation medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.277
H-Index - 23
eISSN - 1875-8894
pISSN - 1874-5393
DOI - 10.3233/prm-210041
Subject(s) - cerebral palsy , spasticity , physical medicine and rehabilitation , medicine , lower limb , upper limb , term (time) , physical therapy , surgery , physics , quantum mechanics
PURPOSE: The open-label phase 3 “Treatment with IncobotulinumtoxinA in Movement Open-Label” (TIMO) study investigated longer-term safety and efficacy of incobotulinumtoxin A in children/adolescents with cerebral palsy (CP). METHODS: Patients on standard treatment, with unilateral or bilateral lower limb (LL) or combined upper limb (UL)/LL spasticity received four incobotulinumtoxinA injection cycles (16 or 20 Units/kg bodyweight total [maximum 400 or 500 Units] per cycle depending on ambulatory status/clinical pattern treated), each followed by 12–16 weeks’ observation. Treatment for pes equinus was mandatory; flexed knee or adducted thigh were options for unilateral treatment and/or ULs for unilateral/bilateral treatment. The primary endpoint was safety; changes in Ashworth Scale and Gross Motor Function Measure-66 scores, and Global Impression of Change Scale scores at week 4 of each injection cycle were also evaluated. RESULTS: IncobotulinumtoxinA (≤500 Units for ≤98 weeks) was safe, well-tolerated, and effective across all endpoints for multipattern treatment of LL and combined LL/UL spasticity in ambulant/nonambulant children/adolescents with CP. Treatment effects increased with each injection cycle. No new/unexpected safety concerns were identified. CONCLUSION: IncobotulinumtoxinA showed a good safety and tolerability profile, with efficacy over multiple clinical presentations. As an adjunct treatment, it offers an effective, individualized treatment option for pediatric CP-related spasticity.