Journal of Rehabilitation Medicine 51-5 | Page 74

J Rehabil Med 2019; 51: 390–394 SHORT COMMUNICATION SWITCHING FROM ONABOTULINUMTOXIN-A TO ABOBOTULINUMTOXIN-A IN CHILDREN WITH CEREBRAL PALSY TREATED FOR SPASTICITY: A RETROSPECTIVE SAFETY AND EFFICACY EVALUATION* Nigar DURSUN, MD, Melike AKARSU, MSc, Tugba GOKBEL, MD, Merve AKYUZ, MD, Cagla KARACAN, PhD and Erbil DURSUN, MD From the Kocaeli University Faculty of Medicine Department of Physical Medicine and Rehabilitation, Kocaeli University Medical Faculty Umuttepe, Kocaeli, Izmit, Turkey Objectives: To determine whether switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy is safe and whether th- erapeutic 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. Ana- lysis was limited to the final onabotulinumtoxin-A treatment-cycle prior to switch, and the first abobo- tulinumtoxin-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 ba- sed 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 abobotulinumt- oxin-A treatment cycles, respectively. Treatment-re- lated 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 abobotuli- numtoxin-A treatment-cycles for all variables (MAS, TS, OGS). Conclusion: In children with cerebral palsy, swit- ching from onabotulinumtoxin-A to abobotulinumt- oxin-A is safe and generally well-tolerated and th- erapeutic efficacy is maintained. Key words: botulinum toxin; cerebral palsy; spasticity; abobotulinumtoxin-A; onabotulinumtoxin-A; Dysport; Botox. Accepted Mar 22, 2019; Epub ahead of print Apr 1, 2019 J Rehabil Med 2019; 51: 390–394 Correspondence address: Nigar Dursun, Kocaeli University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Kocaeli University Medical Faculty Umuttepe, Kocaeli, 41380 Izmit, Turkey. E- mail: [email protected] *Presented as an e-poster at 12 th International Society of Physical and Rehabilitation Medicine (ISPRM)World Congress 2018. Presented as an oral free paper in 72 nd of American Academy of Cerebral Palsy and Developmental Medicine (AACPDM) Annual Meeting 2018.. LAY ABSTRACT In the absence of head-to-head clinical trials, a retro- spective observational study of 118 children with cere- bral 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 abobotulinum- toxin-A is generally well-tolerated and therapeutic ef- ficacy is maintained. H ypertonia is the most common motor disorder seen in cerebral palsy (CP) and, if inadequately managed, can result in slowly developing secondary problems, including soft-tissue contractures and bone deformities that further complicate effective long- term management. Lower limb problems in CP range from difficulties with gait, balance and endurance, to problems with hygiene, care and pain. As the child grows and develops, difficulties can evolve, with significant impact on the quality of life of the child and their family. Clinical guidelines recommend the use of botuli- num neurotoxin-A (BoNT-A) for localized/segmental spasticity that causes pain, compromises care and hygiene, impedes motor function, impedes tolerance to other treatment modalities, such as orthoses, and/ or causes cosmetic problems in this population (1–4). Moreover, the use of repeat BoNT-A treatments in an integrated approach has enabled a prevention or delay in the development of contractures and bone deformi- ties, thereby reducing the need for orthopaedic surgery and lessening the complexity of surgery when still required (5). Several BoNT-A products are available, but there are no controlled head to head clinical trials comparing the efficacy and safety of the different for- mulations in patients with CP and other neurological conditions. In clinical practice there are often many factors that impact the choice of product, from the clinician’s own experience and preferences to hospital formulary decisions. Usually, a patient will continue This is an open access article under the CC BY-NC license. www.medicaljournals.se/jrm doi: 10.2340/16501977-2550 Journal Compilation © 2019 Foundation of Rehabilitation Information. ISSN 1650-1977