Assess longitudinal goal attainment after ≥1 abobotulinumtoxinA (aboBoNT-A) injection(s) in the lower-limb over 16-months using the cumulated Goal Attainment Scaling – Leg (GASleg) T score in a routine clinical setting.

While the efficacy and safety of aboBoNT-A in reducing lower-limb spasticity has been established in controlled clinical trials, there is a paucity of information on real-life clinical goal attainment in practice.

Prospective, 16-month, observational study (NCT04050527). Ambulatory patients (≥18 years able to take ≥5 steps with/without assistance) with unilateral lower-limb spasticity were treated with aboBoNT-A in accordance with local prescribing guidelines to achieve individualized treatment goals.

Overall, 430 participants were enrolled, of which 384 underwent ≥1 BoNT-A injection cycle and had ≥1 GAS-leg assessment (effectiveness population); 65.9% of patients also received treatment for upper-limb spasticity. Patients generally achieved their goals as expected over repeated cycles; the mean cumulated GAS-leg T score at 16 months (primary endpoint) was 48.2 [47.4, 48.9] (mean change from baseline of 9.9 [9.1, 10.7]). Patients injected without injection guidance at baseline were significantly less likely to attain their goals than those in whom guidance was used (odds ratio: 0.38 [0.25, 0.58], p<0.0001). Patients treated concomitantly for upper-limb spasticity were significantly more likely to attain their goals than those only injected in the lower-limb (odds ratio: 2.34 [1.30, 4.28], p=0.005). Adverse events were reported by 56 (13.5%) patients; most were mild-moderate and considered unrelated to study treatment. Six patients (1.4%) had an AE possibly/probably related to treatment.