Background: Primary results from the international ULIS-III study (Turner-Stokes et al, 2021) provided robust evidence for the benefit of repeated cycles of botulinum toxin-A (BoNT-A) for upper limb spasticity, with a (mean [95%CI]) cumulated GAS T-score of 49.5 [49.1, 49.9] at 2 years. Internationally, patients with active function goals tended to require more frequent injection, and we hypothesized that reimbursement restrictions in Australia (which typically limited the number of injections received) may have adversely impacted outcomes compared with the total cohort.
Aims: Report outcomes for the Australian subgroup of the ULIS-III study.
Methods: ULIS-III was a prospective, observational study (NCT02454803) following adults living with spasticity over 2 years of goal-directed upper limb spasticity management including repeated BoNT-A treatment.
Results: The Australian effectiveness subgroup included 115 patients (mean ± SD age 53.8 ± 16.9 years, 56% male, 79% stroke aetiology, median [IQR] duration of spasticity 5.3 [15.6] years), of whom 74% had previously been treated with BoNT-A. Compared with the total cohort, Australian participants (N=82 treated with same brand) had fewer injection cycles (mean 2.7 vs 4.0), with longer injection intervals (median 331 vs 213) days. Mean [95% CI] overall cumulated GAS T-scores were 47.9 [46.4, 49.4] at 2 years. Under-achievement was particularly marked for active function goals (mean cumulated GAS-T-score 43.6 vs 46.6 in total cohort), while goals for passive function and pain ranged between 48.9–50.9, indicating achievement as expected.
Conclusion: As anticipated, the Australian cohort had fewer injection cycles with longer injection intervals than the international cohort. Their overall goal attainment was lower, especially for active function goals. Amongst other possible factors, these data support the idea that restricted reimbursement may have impacted BoNT-A injection frequency, and consequently, patient outcomes.