392
N. Dursun et al.
Table I. Baseline characteristics, associated conditions and type
of adjunctive therapy
Baseline characteristics n = 118
Sex, male/female, n (%)
Age, months, mean (SD)
Type of hypertonia, n (%) 81 (68.6)/37 (31.4)
81.4 (38.9)
Spastic
Mixed
Type of involvement, n (%)
Unilateral
Table II. Mean dosages per muscle (U/kg) in onabotulinumtoxin-A
(OnaBoNT-A) and abobotulinumtoxin-A (AboBoNT-A) treatment
cycles
OnaBoNT-A
Dose per muscle in most
treatment cycle AboBoNT-A treatment
affected leg (n = OnaBoNT-A/ (n = 118)
cycle (n = 118)
AboBoNT-A)
Mean (SD)
Mean (SD)
65 (55.1)
Iliopsoas ( n = 74/68)
Hip adductors ( n = 43/43)
Rectus femoris ( n = 61/73)
Gracilis ( n = 64/77)
Hamstrings ( n = 93/102)
Gastrocnemius ( n = 111/117)
Soleus ( n = 85/99)
Tibialis posterior ( n = 65/60)
Peroneal muscles ( n = 32/34)
Flexor digitorum longus
( n = 41/54)
53 (44.9)
23 (19.5)
Bilateral
95 (80.5)
Gross Motor Function Classification System Level, n (%)
I 9 (7.6)
II 35 (29.7)
III 19 (16.1)
IV 50 (42.4)
V
Adjunctive therapies, n (%)
5 (4.2)
Intensive therapy 83 (70.3)
Serial casting 41 (34.7)
Hippotherapy 17 (14.4)
2.3
3.3
3.0
2.4
4.2
5.8
3.2
3.2
1.8
1.8
(0.9)
(1.3)
(1.6)
(1.1)
(2.2)
(2.9)
(1.6)
(1.8)
(0.9)
(0.7)
the distribution of treatment-related AEs between the
treatment cycles (p = 0.774).
Baseline clinical measurements (MAS, TS and OGS)
were generally well balanced between the 2 treatment
cycles. MAS and TS scores at the hip adductors (flexed
and extended knee), hamstrings and plantar flexors
(flexed and extended knee) similarly improved with
OnaBoNT-A and AboBoNT-A treatment with no sta-
tistically significant differences observed (Table IV).
Mean change from baseline in OGS total score to week
4–6 was also similar (4.1 (SD 2.2) with OnaBoNT-A
vs 3.8 (SD 2.1) with AboBoNT-A, p = 0.202). Change
in individual OGS items are shown in Table SI.
5 (4.2)
Abobotulinumtoxin-A:
Intensive therapy 67 (56.8)
Serial casting 33 (28.0)
Hippotherapy 13 (11.0)
Robotic rehabilitation 12 (10.2)
SD: standard deviation.
(0.3)
(0.5)
(0.8)
(0.5)
(1.0)
(1.2)
(0.8)
(0.7)
(0.3)
(0.3)
SD: standard deviation.
Onabotulinumtoxin-A:
Robotic rehabilitation
0.7
1.2
1.2
0.8
1.7
2.5
1.2
1.2
0.6
0.6
shows the mean doses per lower limb muscle in the
2 treatment cycles.
TEAEs were recorded in 41 (34.7%) patients in the
OnaBoNT-A treatment cycle vs 31 (26.3%) patients
in the AboBoNT-A treatment cycle (Table III). There
were no significant differences in the distribution of
TEAEs between the OnaBoNT-A and AboBoNT-A
treatment cycles (p = 0.286). Treatment-related AEs
were reported for 5 (4.1%) patients in the OnaBoNT-A
treatment cycle and 7 (5.8%) patients in the AboBoNT-
A treatment cycle; all were mild and resolved in less
than 4 weeks. There was no significant difference in
DISCUSSION
This retrospective study demonstrates that, in child-
ren with CP, switching BoNT-A formulations from
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1
Table III. Adverse events in onabotulinumtoxin-A (OnaBoNT-A) vs abobotulinumtoxin-A (AboBoNT-A) treatment cycles
Onabotulinumtoxin-A a (n = 118)
Upper respiratory tract infection
Raynauds phenomenon
Soft-tissue surgery for lower extremity
Injection site pain
Injection site ecchymosis
Epileptic seizures
Spinal surgery
Hip surgery
SDR
Tonsillitis
Oral ulceration
Injection site nodule
Eye surgery
Herpes infection
Spinal infection
Knee effusion
Falls
a
Abobotulinumtoxin-A b (n =118)
Frequency (%) Treatment-related sAE Frequency (%) Treatment-related sAE
25 (21.1)
1 (0.8)
1 (0.8)
1 (0.8)
3 (2.5)
3 (2.5)
2 (1.6)
2 (1.6)
1 (0.8)
1 (0.8)
1 (0.8)
1 (0.8)
1 (0.8)
–
–
–
– No
No
No
Yes
Yes
No
No
No
No
No
No
Yes
No
–
–
–
– No
No
Yes
No
No
No
Yes
Yes
Yes
No
No
No
Yes
–
–
–
– 19 (16.1)
1 (0.8)
1 (0.8)
3 (2.5)
3 (2.5)
–
–
–
–
–
–
–
–
1 (0.8)
1 (0.8)
1 (0.8)
1 (0.8) No
No
No
Yes
Yes
–
–
–
–
–
–
–
–
No
No
No
Yes No
No
Yes
No
No
–
–
–
–
–
–
–
–
No
Yes
No
No
Overlap of adverse events (AEs) in 2 patients; b 36 patients were not reinjected (continued follow-up).
SDR: selective dorsal rhizotomy; sAE: severe adverse events.
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