Switch from onabotulinumtoxin A to abobotulinumtoxin A
393
Table IV. Improvement from baseline for Modified Ashworth Scale (MAS) and Tardieu Scale (TS) at 4–6 weeks post-injection
Baseline
Mean change
OnaBoNT-A
Mean (SD) AboBoNT-A
Mean (SD) Hip adductors (patient in supine position with flexed knee)
3.0 (1.0)
MAS 2.9 (0.9) 0.712
p-value
OnaBoNT-A
Mean (SD) AboBoNT-A
Mean (SD) 1.7 (0.6) 1.9 (0.7) 0.070
p-value
Tardieu Scale
Angle of arrest, XV1 41.0 (12.9) 41.5 (14.3) 0.907 9.4 (9.5) 9.9 (10.6) 0.717
Angle of catch, XV3 22.5 (9.6) 23.4 (10.3) 0.663 15.6 (12.5) 16.6 (12.7) 0.194
Spasticity grade, X 18.4 (10.3) 17.9 (9.3) 0.810 8.9 (10.5) 9.9 (10.6) 0.326
2.0 (0.0) – 0.5 (0.9) 0.7 (0.9) 0.083
2.7 (0.9 0.071 1.3 (0.6) 1.4 (0.7) 0.642
2.0 (0.0)
Spasticity angle, Y
Hip adductors (patient in supine position with extended knee)
2.9 (1.0)
MAS
Tardieu Scale
Angle of arrest, XV1 30.8 (12.8) 35,7 (15.2) 0.544 9.8 (8.9) 7.7 (9.6) 0.657
Angle of catch, XV3 15.6 (8.3) 20,4 (11.8) 0.127 12.7 (12.5) 14.0 (12.7) 0.598
Spasticity grade, X 14.8 (8.1) 15,8 (7.8) 0.443 7.6 (9.2) 10.2 (8.8) 0.479
2.0 (0.0) 2.0 (0.0) – 0.3 (0.7) 0.6 (0.9) 0.183
2.9 (0.9) 3.0 (0.8) 0.306 1.5 (0.7) 1.6 (0.7 0.167
Spasticity angle, Y
Hamstrings (patient in supine position)
MAS
Tardieu Scale
Angle of arrest, XV1 135.4 (17.7) 133.9 (19.7) 0.000 20.1 (22.8) 18.5 (10.6) 0.467
Angle of catch, XV3 105.3 (21.7) 105.5 (23.0) 0.172 27.5 (15.1) 27.3 (14.3) 0.873
30.0 (12.3) 28.0 (14.2) 0.040 15.9 (23.6) 13.4 (10.5) 0.291
2.0 (0.1) 0.320 0.2 (0.7) 0.3 (0.7) 0.242
3.1 (0.7) 0.765 1.8 (0.7) 1.9 (0.7) 0.348
Spasticity grade, X
2.0 (0.1)
Spasticity angle, Y
Plantar flexors (patient in supine position with flexed knee)
3.1 (0.7)
MAS
Tardieu Scale
Angle of arrest, XV1 95.8 (11.2) 96.2 (11.2) 0.563 9.3 (6.9) 10.3 (6.8) 0.149
Angle of catch, XV3 74.0 (14.2) 74.0 (14.0) 0.830 18.8 (9.6) 19.1 (10.1) 0.796
Spasticity grade, X 22.3 (9.1) 23.0 (15.6) 0.700 10.7 (7.9) 9.4 (7.8) 0.071
2.1 (0.4) 0.408 0.3 (0.6) 0.3 (0.7) 0.251
3.4 (0.7) 0.566 1.7 (0.6) 1.7 (0.8) 0.278
2.1 (0.3)
Spasticity angle, Y
Plantar flexors (patient in supine position with extended knee)
3.4 (0.6)
MAS
Tardieu Scale
Angle of arrest, XV1 85.4 (11.1) 85.4 (11.7) 0.875 10.2 (6.8) 10.6 (6.8) 0.560
Angle of catch, XV3 62.6 (14.3) 62.9 (14) 0.684 20.0 (10.7) 20.5 (10.1) 0.623
Spasticity grade, X 22.6 (9.3) 22.5 (8.0) 0.664 10.9 (8.1 10.3 (7.4) 0.493
Spasticity angle, Y 2.1 (0.3) 2.1 (0.4) 0.368 0.2 (0.6) 0.070
0.1 (0.4)
For statistical analysis, Modified Ashworth Scale (MAS) scores are derived as: 0 = 0, 1 = 1, +1 = 2, 2 = 3, 3 = 4 and 4 = 5.
SD: standard deviation.
OnaBoNT-A to AboBoNT-A is safe and well-tolerated,
and efficacy is maintained. The safety profiles of both
OnaBoNT-A and AboBoNT-A were similar and con-
sistent with the previous literature (6–8).
Of note, almost half (46.6%) of the patients in this
analysis were GMFCS IV or V. Although there is little
direct evidence in the literature, these patients are gene-
rally considered to be at a higher risk for AEs (9, 10).
In their pragmatic retrospective study of 454 children
treated with BoNT-A, Papavasilou et al. showed that
adverse reactions were associated with GMFCS level
and presence of epilepsy, but were mostly mild even
for severely affected patients (11). Likewise, despite
the relatively high proportion of more severely affected
children in our data-set, treatment-related AEs were
uncommon before and after the switch. Across both
treatment cycles, treatment-related AEs were mostly
localized and minor injection site reactions with no
significant difference between OnaBoNT-A and Abo-
BoNT-A treatment. Overall, the most common TEAEs
were common childhood infections, such as upper
respiratory tract infection. Three patients with prior
history of epilepsy experienced seizures during the
OnaBoNT-A treatment cycle. Serious AEs occurred in
7 patients, and included various surgical operations in
the OnaBoNT-A treatment cycle, and spinal infection
and soft tissue surgery in the AboBoNT-A treatment
cycle. There was no treatment-related serious AE in
either treatment cycle.
At the doses used in this study, OnaBoNT-A and Abo-
BoNT-A were similarly effective in reducing hypertonia
and improving gait. On average, MAS scores typically
improved by at least one grade from baseline across the
different muscles injected, in both treatment cycles. Si-
milar improvements in TS scores were also observed for
both products. There was no loss of therapeutic benefit
following the switch from long-term use of one product
(children had received a mean of 3.7 OnaBoNT-A treat-
ment cycles) to the other. This is in line with the recent
Swedish study of children with CP that also followed
their switch from OnaBoNT-A to AboBoNT-A (12). As
in that study, we were obliged to switch products due to
J Rehabil Med 51, 2019