Poster 203 Systematic Literature Review of AbobotulinumtoxinA in Randomized, Controlled Clinical Trials for Adult Lower Limb Spasticity

Objective: To review the evidence base for the efficacy, safety and tolerability of abobotulinumtoxinA treatment in the treatment of adult patients with lower limb spasticity (ALLS). Design: A systematic literature review (English) was performed to identify randomized controlled trials of abobotulinumtoxinA in the treatment of ALLS. Keywords were: abobotulinumtoxinA, botulinum toxin, Dysport, spasticity, and clinical trial. The review was first conducted in 2013 and was updated up to February 2016. Setting: All studies included in this review were conducted in specialist centers. Participants: Subjects with ALLS, irrespective of etiology. Interventions: Not applicable. Main Outcome Measures: Study methodology, patient, and treatment- level data were extracted from the full-text publications under predefined headings (efficacy, safety, dosing). Results: A total of 6 primary publications evaluating abobotulinumtoxinA in a total of 468 patients with ALLS due to stroke, TBI, or multiple sclerosis met inclusion criteria. A range of outcome measures were used including: muscle tone (assessed using the Modified Ashworth Scale), range of movement (passive and active), walking parameters, pain, and activities of daily living. Total abobotulinumtoxinA doses ranged between 500U and 2000U, depending on the lower limb muscles injected. All studies showed significant reductions in muscle tone. When assessed, abobotulinumtoxinA was consistently associated with significant effects on pain. Effects on walking parameters were less consistent but generally favored abobotulinumtoxinA injections. AbobotulinumtoxinA was generally welltolerated across the studies. Treatment-related adverse events included but were not limited to fatigue, local pain at injection site, hypertonia, weakness of the noninjected muscle, abnormal gait, and urinary tract infection. Conclusions: Based on the evidence from 6 randomized clinical studies reviewed, it can be concluded that abobotulinumtoxinA injections consistently reduce tone and can be effective in the management of ALLS. However, there was a relative lack of large trials of abobotulinumtoxinA in this indication. Ongoing studies in this area will add to this evidence base.