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Abstract Details

Efficacy and Safety of AbobotulinumtoxinA in Pediatric Lower Limb Spasticity: 2nd Interim Results From a Phase IV, Prospective, Observational, Multicenter Study
Movement Disorders
Movement Disorders Posters (7:00 AM-5:00 PM)
134

To assess subject-centered, function-related goal attainment (T-score) after repeated abobotulinumtoxinA (aboBoNT-A) injections. We report updated data after as many as 5 cycles, including long-term safety results assessed for ≤18 months.
AboBoNT-A is approved in the US for treatment of pediatric lower limb spasticity (PLLS) in children aged 2-17. Treatments and goals need to be individualized according to patient needs.

This phase IV study collects real-world data on the clinical use of aboBoNT-A in patients with PLLS, aged 2-17. Prescription decisions were made prior to/independent of study enrollment. Functional goals were identified at baseline by patient/parent/caregiver in consultation with investigators. Adverse events were reported.
This 2nd interim analysis included 201 patients, of which 78.1% (n=157) had received prior botulinum neurotoxin (BoNT) treatment. At enrollment, 69.2% were aged 2-9. Average time to the 2nd and 3rd treatments was 24.79 (SD 12.38) and 42.58 (12.85) weeks, respectively. The cumulative GAS T-score for the total population was 51.60 (9.69). By the last treatment assessed (in this 2nd interim analysis), mean T-score for the total population (N=201) was 48.14 (8.08); BoNT-naïve (n=44) had a T-score of 52.07 (3.58) vs 47.52 (8.47) in BoNT?non-naïve (n=157) patients aged 2-9; T-score was 46.66 (8.31) vs 52.07 (6.41), respectively, in patients aged 10-17. In the safety population (N=243), 44 TEAEs were reported in 26 patients; most were mild to moderate, with 1 severe. Extremity pain, limb discomfort, muscle swelling, and myalgia reported in 3 patients were deemed treatment related. No reported TEAEs led to study drug withdrawal or death.
Goal attainment outcomes reflect overachievement (T-score slightly higher than 50.0) for the overall PLLS population. AboBoNT-A was well tolerated, with a low incidence of TEAEs. These results support aboBoNT-A as an effective treatment option with a positive risk-benefit profile for patients with PLLS. 
Authors/Disclosures

PRESENTER 		No disclosure on file
Edward R. Dabrowski, MD Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merz. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Solstice. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alergan. Dr. Dabrowski 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. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ipsen. Dr. Dabrowski has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Allergan. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Solstice. Dr. Dabrowski has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alergan. The institution of Dr. Dabrowski has received research support from Ipsen. The institution of Dr. Dabrowski has received research support from Merz.
Ann H. Tilton, MD, FÂ鶹´«Ã½Ó³»­ (LSUHSC and Childrens Hospital of New Orleans) 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
Pascal Maisonobe Pascal Maisonobe has received personal compensation for serving as an employee of ipsen pharma. Pascal Maisonobe has received personal compensation for serving as an employee of Ipsen.
Stefan Wietek, PhD (Ipsen (former Employee)) Dr. Wietek has received personal compensation for serving as an employee of Ipsen.