Efficacy of IncobotulinumtoxinA in Treatment of Lower Limb Spasticity in Adults (P4.035)

Objective: In this post-hoc analysis, the effectiveness of incobotulinumtoxinA for treating key clinical patterns of lower limb (LL) spasticity (eg, pes equinovarus) is assessed. Background: Botulinum toxin A formulations, including incobotulinumtoxinA, have been shown to be safe and effective for the treatment of upper limb (UL) spasticity. Design/Methods: In the TOWER study (NCT01603459), escalating fixed total doses of incobotulinumtoxinA (400, 600 and 600­–800U, respectively) were used to treat 155 adult subjects (18–80 years) with UL and LL spasticity. Muscle tone was assessed using the Ashworth Scale (AS); additional outcome measures included AS responder rates (defined as patients with ≥1 point improvement at 4-weeks) and Resistance to Passive Movement Scale (REPAS) Results: In treatment cycle 1, 109 subjects received LL treatment for any clinical pattern. Pes equinovarus was the most frequently treated pattern (N=100); however, a total of 9 different LL clinical patterns were treated during the study. The mean ± standard deviation [SD] dose for pes equinovarus was 166.3±94.9 U during the first cycle. At the 4-week follow-up visit, the mean improvement (± SD) in ankle joint AS score was −0.63±0.76 in subjects treated for pes equinovarus and −0.16±0.63 in subjects not treated for this pattern. A significant effect of pes equinovarus dose on AS improvement was revealed using multiple regression analysis, adjusting for AS baseline value ( P =0.0096). AS responder rates were 55.0% in treated subjects and 12.7% in untreated subjects ( P P =0.0022). Conclusions: Results support the safety and effectiveness of incobotulinumtoxinA for the treatment of LL spasticity. Study Supported by: Merz Pharmaceuticals GmbH Disclosure: Dr. Simpson has received personal compensation for activities with Merz, Allergan, Ipsen, Endo, Insys, MundiPharma, Takeda, and Teva CNS as a consultant. Dr. Wissel has received personal compensation for activities with Allergan, Ipsen, Merz, and Medtronic. Dr. Bensmail has received personal compensation for activities with Medtronic, Allergan, Ipsen, Merz, and Almirall as a consultant, member of a scientific advisory board, a speaker or other activities. Dr. Scheschonka has received personal compensation for activities with Merz as an employee. Dr. Faltau-Baque has received personal compensation for activities with Merz as an employee. Dr. Simon has received personal compensation for activities with Merz Pharmaceuticals as an employee.