Effectiveness of AbobotulinumtoxinA in Adults with Lower Limb Spasticity: Top Line Results from the AboLiSh Observational Study
Alberto Esquenazi1, Richard Zorowitz2, Stephen Ashford3, Anne-Sophie Grandoulier4, Pascal Maisonobe4, Christian Hannes4, Jorge Jacinto5
1Department of Physical Medicine and Rehabilitation, 2MedStar Health, Washington and Georgetown University School of Medicine, 3London North West University Healthcare NHS Trust, 4Ipsen, 5Centro de Medicina de Reabilitaçãode Alcoitão
Objective:

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.

Background:

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.

Design/Methods:

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.

Results:

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.

Conclusions:
This large, international study provides evidence for the benefit of repeated cycles of aboBoNT-A for lower limb spasticity, demonstrates the importance of appropriate injection guidance techniques, and points to the benefit of treating the upper-limb in combination with lower-limb when clinically indicated. Treatment with aboBoNT-A was generally well-tolerated and safe; no new safety issues were identified.
10.1212/WNL.0000000000204715