Switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy treated for spasticity: A retrospective safety and efficacy evaluation

Abstract

In the absence of head-to-head clinical trials, a retrospective observational study of 118 children with cerebral palsy who had switched botulinum toxin formulation (from onabotulinumtoxin-A to abobotulinumtoxin-A) due to a change in hospital policy was performed. The safety and tolerability profile of both formulations were similar. Likewise, the efficacy of treatment (measured 4-6 weeks post-injection) was found to be similar for all clinical measures assessed. This study indicates that switching from onabotulinumtoxin-A to abobotulinumtoxin-A is generally well-tolerated and therapeutic efficacy is maintained. Objectives: To determine whether switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy is safe and whether therapeutic efficacy is maintained. Methods: This retrospective observational study of routine care included 118 children with cerebral palsy (mean age 81.4 months (standard deviation 38.9)) who had switched from onabotulinumtoxin-A to abobotulinumtoxin-A injections into their lower extremities due to a change in hospital policy. Analysis was limited to the final onabotulinumtoxin-A treatment-cycle prior to switch, and the first abobotulinumtoxin-A treatment-cycle following switch. The primary objective was to document the safety and tolerability of switching products. Efficacy endpoints included muscle tone, spasticity, and gait function based on Modified Ashworth Scale (MAS), Tardieu Scale (TS) and Observational Gait Scale (OGS) scores. Results: Treatment-emergent adverse events were recorded in 41 (34.7%) and 31 (26.3%) patients during the onabotulinumtoxin-A and abobotulinumtoxin-A treatment cycles, respectively. Treatment-related adverse events were reported in 5 patients in the onabotulinumtoxin-A treatment-cycle vs 7 in the abobotulinumtoxin-A treatment-cycle (p = 0.774). Treatment efficacy (4-6 weeks post-treatment) was similar in the onabotulinumtoxin-A and abobotulinumtoxin-A treatment-cycles for all variables (MAS, TS, OGS). Conclusion: In children with cerebral palsy, switching from onabotulinumtoxin-A to abobotulinumtoxin-A is safe and generally well-tolerated and therapeutic efficacy is maintained.

Cost effectiveness and impact on quality of life of abobotulinumtoxinA and onabotulinumtoxinA in the treatment of children with lower limb spasticity in Canada

“…The main conclusions above are consistent with findings from other economic studies in PLL. In real-world longitudinal studies, abobotulinumtoxinA has been reported to be similarly or more effective and less costly than onabotulinumtoxinA 35,[38][39][40][41] .…”

Safety and efficacy of Botulinum toxin type A preparations in cerebral palsy — an evidence-based review

“…There were no differences between the preparations in terms of efficacy and safety, but none of the studies compared them directly. Two other papers have described the transition from OnaBoNT-A to AboBoNT-A for economic or administrative reasons [36,37]. The authors found no differences in the efficacy or safety of the treatment.…”

AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol

“…Such information on the potential differences of each product is of great importance to inform treatment decisions. For example, a switch from one BoNT-A to the other might be necessary as per physician’s decision based on patient medical needs to optimize treatment outcomes or based on hospital/insurance budgetary directives for financial considerations [ 15 , 16 ]. Moreover, recent data from a patient survey in spasticity indicate that > 80% patients with spasticity are living with significant symptom re-emergence between injections [ 17 ], and an understanding of the duration of benefit will be important in ensuring this ‘rollercoaster’ of symptoms is reduced or avoided.…”