Botulinum toxin a in upper limb spasticity management: Baseline data from the upper limb international spasticity (ULIS)–III study

Abstract

ULIS-III describes real-life clinical practice in upper limb spasticity (ULS) management using licensed botulinum toxin A (BoNT-A) products and concomitant therapies. ULIS-III assesses long-term impact on patient-centred outcomes and identifies best practice strategies according to patient needs. Baseline data are presented for patients enrolled by June 2017. This longitudinal, prospective, observational, cohort study of integrated ULS management in adults ( NCT02454803 ) examines impact of repeated BoNT-A injections over 2 years. Person-centred outcomes are assessed using the Upper Limb Spasticity Index, combining individual goal setting with targeted standardised measures, using patient-selected goal areas. Injection practices and physical treatments are recorded, alongside economic and quality-of-life data. Baseline data were analysed for 975 patients across 57 sites (14 countries; 5 continents). Table 1 presents baseline characteristics; 82% of patients had spasticity post-stroke; two-thirds had received previous BoNT-A for ULS (< 5 injections, 46%; > 10 injections, 28%). Median time from diagnosis to first injection and enrolment was 1.0 and 3.4 years, respectively. Baseline muscle tone and disability measures are shown in Table 1 . Upper arm and forearm muscles were most commonly injected; 34% received concomitant BoNT-A for lower limb spasticity ( Table 2 ). Shoulder injection frequency increased since ULIS-II (e.g. pectoralis major: 34 vs. 19%). Instrumental injection guidance techniques were used in 73% of patients. Most common primary goal areas were passive function (31%) and pain (25%), showing notable changes in goal selection since ULIS-II ( Fig. 1 ). ULIS-III contributes to greater understanding of achievable treatment goals and developing practice with improved clinical reasoning, as reflected in ULIS-III baseline data. ULIS-III will improve understanding of treatment and outcomes for long-term ULS management. Final data are expected in 2019.