Neuropediatrics 2017; 48(S 01): S1-S45
DOI: 10.1055/s-0037-1603013
P – Poster
Georg Thieme Verlag KG Stuttgart · New York

Abobotulinumtoxin-A (DYSPORT) Injection Doses per Muscle in Pediatric Patients with Lower Limb Spasticity

N. Dursun
1   Kocaeli University Medical Faculty, Izmit, Turkey
,
A. Tilton
2   Louisiana State University Health Center and Children’s Hospital New Orleans, New Orleans, Louisiana, United States
,
M. Gormley
3   Gillette Children’s Specialty Healthcare, St Paul, Minnesota, United States
,
M. Bonikowski
4   LLC Neuro Rehabilitation Department Zagórze n. Warsaw, Mazovian Neuropsychiatry Center, Warsaw, Poland
,
J. C. Velez
5   Club De Leones Cruz Del Sur Rehabilitation Center, Punta Arenas, Chile
,
M. L. Rodriguez
6   Ipsen Pharma, Les Ulis, France
,
P. Picaut
6   Ipsen Pharma, Les Ulis, France
,
A. S. Grandoulier
6   Ipsen Pharma, Les Ulis, France
,
M. R. Delgado
7   Texas Scottish Rite Hospital for Children, Dallas, Texas, United States
› Author Affiliations
Further Information

Publication History

Publication Date:
26 April 2017 (online)

 

Introduction: The efficacy and safety of BoNT-A for the treatment in children with spastic cerebral palsy (CP) has been previously demonstrated. However, there is little guidance on dosing per muscle for this population.

Methods: We present the doses per muscle used from a multicenter, repeated treatment, open-label study of abobotulinumtoxinA (AboBoNT-A, Dysport) injections into the gastrosoleus complex (GSC) and subsequent injections, which allowed injections into the hamstrings and other leg muscles during the later treatment cycles in children with lower limb spasticity due to CP with aGMFCS levels I to III. During Cycle 1, all patients requiring treatment received a 10 U/kg/leg dose into the GSC (+ hamstrings if required). From Cycle 2 onwards, patients requiring re-treatment received a dose of 5 to 20 U/kg/leg; other lower limb muscles were injected as required (max total dose: 30 U/kg).

Results: During the open-label study, investigators chose to inject non-GSC muscles in approximately quarter of patients, according to the individual pattern of spasticity and treatment goals. [Table 1] gives the range of doses used per muscle in the four cycles. The only treatment-related adverse event (TRAE) reported by 32 patients was injection site pain (n = 10), and there were no serious TRAEs.

Table 1 Outcome data

Muscle/Muscle group; n (%)

Open label

Cycle 1 N = 201

Cycle 2N = 168

Cycle 3N = 80

Cycle 4N = 8

GSC; n (%)Dose (U/kg); Median [range]

200 (99.5%)10.0 [4.3–21.0]

168 (100%)14.0 [4.1–30.0]

80 (100%)15.0 [5.0–30.0]

8 (100%)16.6 [10–22.5]

Medial hamstrings; n (%)Dose (U/kg); Median [range]

34 (16.9%)5.4 [3.0–10.0]

41 (24.4%)10.0 [3.0–15.0]

15 (18.8%)7.5 [3.8–15.0]

1 (12.5%)15

Tibialis posterior; n (%)Dose (U/kg); Median [range]

–

17 (10.1%)5.0 [1.5–15.0]

8 (10.0%)4.1 [2.3–8.3]

–

Hip adductors; n (%)Dose (U/kg); Median [range]

–

3 (1.8%)5.0 [4.5–13.0]

1 (1.3%)7.5

–

Iliopsoas; n (%)Dose (U/kg); Median [range]

–

1 (0.6%)2.0

1 (1.3%)3.8

–

Other lower limb muscle; n (%)Dose (U/kg); Median [range]

–

2 (1.2%)7.0 [4.0–10.0]

–

-–

Conclusion: These data provide dosage ranges for AboBoNT-A injections into proximal and distal leg muscles that have shown a favorable safety profile and efficacy in children with lower limb spasticity due to CP with a GMFCS levels I–III.1

Keywords: abobotulinumtoxinA, disport, dosing muscle

 

  • Reference

  • 1 Delgado MR. , et al. American Academy for Cerebral Palsy & Developmental Medicine 2016, Florida, USA
    PubMed