Longitudinal Goal Attainment With Repeat Injections of AbobotulinumtoxinA in Adults With Lower Limb Spasticity: Results From a Prospective Observational Study.

OBJECTIVE

To assess longitudinal goal attainment with repeat abobotulinumtoxinA (AboBoNT-A) injections for lower limb spasticity (LLS) over 16 months.

DESIGN

Prospective, longitudinal, international, multicenter, observational study (NCT04050527).

SETTING

Specialist neurorehabilitation centers.

PARTICIPANTS

Ambulatory adults with unilateral LLS able to take ≥5 steps with/without assistance (effectiveness population, N=384).

INTERVENTIONS

Participants received ≥1 AboBoNT-A treatment cycle administered in accordance with local prescribing guidelines to achieve individualized treatment goals.

MAIN OUTCOME MEASURES

The primary endpoint was goal attainment as assessed using the cumulated Goal Attainment Scaling-Leg (GAS-leg) T score, across all treatment cycles for each patient.

RESULTS

Overall, participants underwent a median of 5 lower limb injection cycles (median dose 600U, range 100-1475U) with a mean±SD injection interval of 18.3±6.1 weeks. Participants generally achieved their goals as expected over repeated cycles; the mean (95% CI) GAS-leg T score at cycle 1 baseline was 38.0 (37.7, 38.3) and the mean cumulated GAS-leg T score at 16 months was 48.2 (47.4, 48.9) (mean change from a baseline of 9.9 [9.1, 10.7]). Participants injected with a guidance technique at baseline were more likely to attain their cycle 1 primary treatment goals (odds ratio: 1.9 [95% CI 1.1, 3.1], P=.02). Overall, 56 (13.5%) participants reported ≥1 adverse event, of which 6 participants (1.4%) had a treatment-related adverse event.

CONCLUSIONS

Findings from this large, international study provide evidence for the benefit of repeated cycles of AboBoNT-A for LLS. Multivariate analyses indicated that goal attainment during the first cycle was better with those injected using injection guidance than those injected without guidance.