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A Phase IV, Prospective, Observational, Multicenter Study Evaluating the Effectiveness and Safety of AbobotulinumtoxinA in Pediatric Lower Limb Spasticity (PLLS)

Mark Gormley, MD (Gillette Children's Specialty Healthcare, St. Paul, Minnesota); Asare Christian; Jumaah Goldberg; Sarah H. Evans, MD; Mauricio R. Delgado, MD; Francoise Calvi-Gries, BSc; Edward Dabrowski; Ann H. Tilton, MD

Meeting: AAPM&R Annual Assembly 2022

Categories: Pediatric Rehabilitation (2022)

Session Information

Session Title: AA 2022 Posters - Pediatric Rehabilitation

Session Time: None. Available on demand.

Disclosures: Mark Gormley, MD: Ipsen (Products/Services: No) (Consultant/Advisory Board, Research Grant or Support)

Objective: In view of the wide range of presentations and patient needs, it is becoming increasingly recognized that the treatment of spasticity needs to be individualized, including the assessment of treatment goals. This prospective study assessed the longitudinal attainment of patient-centered, function-related goal attainment scale (GAS) T-score after repeated abobotulinumtoxinA (aboBoNT-A) injections.

Design: Phase IV, prospective, observational, multicenter study.

Setting: 28 US-based centers.

Participants: Patients aged 2‒17 years with PLLS.

Interventions: AboBoNT-A injections over ≤30 months (≤10 cycles). Prescription decisions were made independent of study enrollment.

Main Outcome Measures: GAS T-scores were assessed for each injection cycle and goals could be redefined at each injection visit; scores of ≥50 reflect goal achievement. Adverse events (AEs) were reported.

Results: Of 210 patients, 77.6% (n=163) were previously treated with a botulinum neurotoxin. One third of the patients (n=61/195) were non-ambulatory (Gross Motor Function Classification System IV or V). Mean±SD cumulated GAS T-score was 51.1±9.3. Overall, 75.2% of patients achieved their primary goals. Across all cycles, the mean number of muscles injected ranged from 5.5±2.9 to 7.0±3.7 with gastrocnemius being the most common (85.7%). The mean number of total injection points per session ranged from 8.1±2.7 to 9.9±5.7. Injection guidance techniques were used in >70% of patients; electrostimulation was most frequently used (>50%). Regarding safety, 42.1% (n=102/242) reported 392 treatment-emergent AEs, which were mostly mild to moderate. A total of 35 AEs in n=15/242 patients (6.2%) were deemed treatment related.

Conclusions: Overall, the majority of patients treated with AboBoNT-A for spasticity in the lower limbs achieved their treatment goals as expected or better than expected. AboBoNT-A was well tolerated, with a low incidence of treatment-related AEs. These results confirm that aboBoNT-A is an effective treatment option, with a positive risk-benefit profile for PLLS.

Level of Evidence: Level II

To cite this abstract in AMA style:

Gormley M, Christian A, Goldberg J, Evans SH, Delgado MR, Calvi-Gries F, Dabrowski E, Tilton AH. A Phase IV, Prospective, Observational, Multicenter Study Evaluating the Effectiveness and Safety of AbobotulinumtoxinA in Pediatric Lower Limb Spasticity (PLLS) [abstract]. PM R. 2022; 14(S1)(suppl 1). https://pmrjabstracts.org/abstract/a-phase-iv-prospective-observational-multicenter-study-evaluating-the-effectiveness-and-safety-of-abobotulinumtoxina-in-pediatric-lower-limb-spasticity-plls/. Accessed May 17, 2025.
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