Abstract Details

Title Time to retreatment following abobotulinumtoxinA injections in children with upper-limb spasticity

Topic Child Neurology and Developmental Neurology

Presentation(s) Child Neurology and Developmental Neurology Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 020

Objective Describe the time to retreatment after abobotulinumtoxinA injections (Cycle 1) in a Phase 3 study of upper-limb spasticity due to cerebral palsy (CP).

Background Estimating when a child being treated with botulinum toxin for spasticity will require retreatment is relevant to clinical planning. The standard injection interval is 12 weeks; however previous data suggest longer intervals are frequently observed with abobotulinumtoxinA.

Design/Methods This was a double-blind, repeat-treatment study (NCT02106351). 212 children (2-17y) with upper-limb spasticity due to CP were randomized to abobotulinumtoxinA (2U/kg, 8U/kg, 16U/kg) into elbow or wrist flexors. Eligibility for the next cycle was assessed at Week 16. At this visit, children who had a Modified Ashworth Scale score of 0 or a primary Goal Attainment Scale score of +2 were not eligible for reinjection. Children who showed sustained benefit returned every 6±2 weeks until they required retreatment, or until Week 52.

Results Mean time from injection to retreatment was longer in the abobotulinumtoxinA 8U/kg and 16U/kg groups compared with the 2U/kg group, and injection intervals increased with dose. Overall analysis (8U/kg + 16U/kg) showed that 19.4% of children were retreated at Week 16, 28.8% were retreated at Week 22, 13.7% were retreated at Week 28 and 24.5% were retreated between Weeks 34-52. 19 children either did not need reinjection (n=13) or were withdrawn (n=6) across the 8 and 16 U/kg dose groups.

Conclusions Overall, less than half of the children treated with abobotulinumtoxinA at doses of 8U/kg or 16U/kg required retreatment before Week 22. Even at Week 28, approximately 7 months after their initial treatment, only 62% of children required re-treatment. Longer injection intervals may improve patient quality of life, diminish caregiver burden, provide cost savings, and offer clinicians more flexibility.

Authors/Disclosures
Ann H. Tilton, MD, F�鶹��ýӳ�� (LSUHSC and Childrens Hospital of New Orleans) PRESENTER	Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Tilton has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Up to Date.
	No disclosure on file
	No disclosure on file
Jorge Carranza, MD	Dr. Carranza has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IPSEN. Dr. Carranza has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for IPSEN.
	No disclosure on file
Mauricio R. Delgado, MD, FRCPC, F�鶹��ýӳ��	Dr. Delgado has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Delgado has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Delgado has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kashiv. The institution of Dr. Delgado has received research support from Ipsen.

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