Objective: The ongoing ULIS-III study aims to describe real-life clinical practice and assess patient‑centered goal attainment with integrated upper limb spasticity (ULS) management that includes repeated botulinum toxin A (BoNT-A) injections. This interim analysis evaluates BoNT-A reinjection rates within rehabilitation management.

Background: ULIS-III is a 2-year longitudinal, prospective, observational, cohort study (NCT02454803), which is expected to involve 58 centers (14 countries) and to enroll >1000 adults with ULS receiving repeated BoNT-A injections.

Methods: This analysis involved 44 centers (13 countries) and 335 patients (reflective of ULIS-III recruitment stage). Primary endpoint of ULIS-III is goal attainment, using Goal Attainment Scaling─Evaluation of Outcome for ULS to evaluate change following BoNT‑A and concomitant treatments. BoNT-A preparation type, total dose, number of injections, and injection intervals will be recorded, as well as physical treatments, economic and quality-of-life data.

Results: Recruitment began January 2015. Patients with data for ≥2 injections (N=335), had a mean (SD) time between first and second injections of 154.9 (58.6), 137.8 (60.5), and 124.4 (41.0) days for abobotulinumtoxinA (n=203), onabotulinumtoxinA (n=94), and incobotulinumtoxinA (n=38), respectively.

Of these patients, 177 received ≥3 injections. Mean (SD) time between second and third injection was 146.4 (48.5), 131.8 (36.9), and 116.3 (32.3) days for abobotulinumtoxinA (n=110), onabotulinumtoxinA (n=48), and incobotulinumtoxinA (n=19), respectively. The mean (SD) change in time between first and second injection intervals for these 177 patients was –5.8 (68.1), 2.3 (37.9), and 0.9 (23.3) days for abobotulinumtoxinA, onabotulinumtoxinA, and incobotulinumtoxinA, respectively.

Conclusions: Initial ULIS-III injection-interval data suggest differences in time to retreatment with different BoNT-A preparations. Longer injection intervals may reduce patient and carer burden. However, the clinical significance and generalizability of the findings reported here are as yet undetermined and the current sample as well as other variables may influence reinjection. Further ULIS-III data will provide additional clarity to these preliminary analyses.

Previously submitted to AAPM&R 2017

Study sponsored by Ipsen

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MDS Abstracts - https://www.mdsabstracts.org/abstract/time-to-retreatment-with-botulinum-toxin-a-in-upper-limb-spasticity-management-initial-data-from-the-upper-limb-international-spasticity-ulis-iii-study/