Incobotulinumtoxina treatment improves quality of life of patients with upper- and lower-limb spasticity

Abstract

The safety and efficacy of botulinum neurotoxin treatment for limb spasticity are well established. However, reports on the effect of treatment on quality of life (QoL) are inconclusive. Here we report QoL outcomes following incobotulinumtoxinA treatment of upper- and lower-limb spasticity in the TOWER study ( NCT01603459 ). This open-label study assessed the safety and efficacy of escalating incobotulinumtoxin A doses (400 U, 600 U and 600–800 U) in patients (18–80 years) with upper- and lower-limb spasticity on the same body side due to stroke or other cerebral causes. QoL was assessed using the EuroQoL-5 dimensions (EQ-5D) questionnaire, which includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and a visual analogue scale (VAS) on which patients rate their current state of health from 0 (worst) to 100 (best). In total, 155 patients were enrolled and received incobotulinumtoxin A. For all EQ-5D dimensions, the proportion of patients with improvements from the study baseline to the end of injection cycle (IC) 3 was higher than the proportion with worsening: Mobility, 11.4% vs. 2.9%; Self-care, 21.4% vs. 7.1%; Usual activities, 24.3% vs. 5.0%; Pain/discomfort, 30.7% vs. 9.3%; Anxiety/depression, 25.0% vs. 9.3%. The mean (SD) change in EQ-5D VAS score from the study baseline to 4 weeks post-treatment was 6.7 (14.1) points, 9.6 (16.3) points and 8.6 (17.0) points in IC1, IC2 and IC3, respectively ( P < 0.0001 for all, t -test). The mean (SD) EQ-5D VAS score improved from 59.9 (18.9) at baseline to 70.5 (16.7) at the end of IC3, corresponding to a mean (SD) change of 10.5 (17.5) points ( P < 0.0001, t -test). Treatment of upper- and lower-limb spasticity with increasing incobotulinumtoxin A doses (up to 800 U) improved QoL over the study duration (three treatments). Data encourage the further evaluation of the impact of botulinum neurotoxin A treatment on QoL in patients with spasticity.