300 Section - Goal Attainment and Ambulation With Increasing Doses of IncobotulinumtoxinA: A Post Hoc Analysis of the TOWER Study

Brain injury and cerebral lesions are an important cause of upper and lower limb spasticity, with over 40% of stroke patients estimated to be affected by post-stroke spasticity. Increasing doses of incobotulinumtoxin (incoA) proved effective and well tolerated in patients with upper- and lower-limb spasticity due to cerebral lesions in the TOWER study. In this post hoc analysis, we aimed to evaluate goal attainment and ambulation in a subpopulation of patients treated with incoA.

 

Design:

TOWER was a trial of 155 patients with spasticity due to cerebral causes who received three escalating doses (400U, 600U, and up to 800U [off-label]) of incoA injected into upper and/or lower limbs.

Goal attainment scale (GAS) ratings were measured at the end of each cycle and absolute and changes from study baseline in functional ambulation classification (FAC) scale scores at week 4 of cycles 1 and 2, and at the end of cycle 3.
 

Results:

This analysis included 70 patients (64.3% male; mean age 53.7 years). Considering upper and lower limbs together, 25.7% (18/70) of patients achieved ≥3 (of 4 possible) treatment goals (GAS score ≥0) at the end of cycle 1 (400U incoA), compared with 51.4% (36/70) and 71.9% (46/64) at the end of cycle 2 (600U incoA) and cycle 3 (≤800U incoA), respectively. The proportion of ambulatory independent patients (FAC score=5) increased from 28.6% (20/70) at study baseline to 35.7% at week 4 in cycle 1, 44.3% at week 4 in cycle 2, 46.9% at week 4 of cycle 3, and 50% (32/64) at the end of cycle 3. IncoA proved well tolerated across all cycles.

Conclusion:

As the number of injection cycles and dosage increased, the tolerability of incoA was maintained and an increasing proportion of patients achieved more key treatment goals and were able to walk independently.