Safety and efficacy of repeat long-term incobotulinumtoxinA treatment for lower limb or combined upper/lower limb spasticity in children with cerebral palsy.

Abstract

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.

• Authors: Petr Kaňovský, Florian Heinen, A Sebastian Schroeder, Henry G Chambers, Edward Dabrowski, Thorin L Geister, Angelika Hanschmann, Francisco J Martinez-Torres, Irena Pulte, Marta Banach, Deborah Gaebler-Spira
• Journal: Journal of pediatric rehabilitation medicine (J Pediatr Rehabil Med) Vol. 15 Issue 1 Pg. 113-127 ( 2022) ISSN: 1875-8894 [Electronic] Netherlands
• PMID: 34957963 (Publication Type: Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A
• incobotulinumtoxinA

Topics

• Adolescent
• Botulinum Toxins, Type A (adverse effects)
• Cerebral Palsy (complications, drug therapy)
• Child
• Humans
• Lower Extremity
• Muscle Spasticity (drug therapy, etiology)
• Neuromuscular Agents
• Treatment Outcome