Limb International Spasticity Research Articles

Predictors of real-world response in adults treated with botulinumtoxin-A for upper limb spasticity

Background: To explore predictors of treatment response in adults receiving botulinumtoxin-A (BoNT-A) for upper limb spasticity (ULS) and to describe the association between response and concomitant medication, professional physical therapy, and quality of life (QoL). Methods: This was a secondary analysis of the longitudinal Upper Limb International Spasticity study (ULIS-III) data set. Eligible patients were adults receiving/initiating BoNT-A treatment for ULS in clinical practice. The treatment response was a goal attainment scaling (GAS) T score change of ≥10 points from baseline to follow-up for each cycle. Concomitant medication was recorded. Time spent on professional physical therapy and self-management was recorded using the Upper Limb Focal Spasticity Therapy Recording (ULSTR) schedule. QoL was assessed using the EQ-5D-5L questionnaire. Baseline patient and clinical characteristics were described. Factors predictive of treatment response were explored using stepwise multivariable regression modeling (linear or logistic as appropriate for the outcome) and backward elimination (α=0.1). Results: Overall, 828/981 patients had response data; 71.9% responded to BoNT-A therapy. Potential predictors of response identified were the use of injection guidance techniques (P=0.001), female sex (P=0.031), and abobotulinumtoxin-A therapy (vs. onabotulinumtoxin-A; P<0.001). Compared with nonresponders, responders had marginally lower use of concomitant medication, received marginally more professional physical therapy and (subgroup only) had improved QoL. Age, duration/distribution, severity of impairment, and previous BoNT-A had no predictive value. Conclusions: Future analyses of ULIS-III data will aim to validate these findings and further explore determinants of treatment response and the interplay between care modalities.

Impact of integrated upper limb spasticity management including repeat botulinum toxin type A (BoNT-A) injections on patient-centred goal attainment in real-life practice: results from the prospective, observational Upper Limb International Spasticity cohort study (ULIS-III) in a Russian subpopulation

To assess the longitudinal attainment of patient-centred and function related goals after integrated spasticity management including repeated cycles of botulinum toxin A type A (BoNT-A) injections in real life settings over a period of 2 years. The article presents analysis of the results within the subpopulation of patients from Russia. This international, multicentre, observational, prospective, longitudinal cohort study (registered at clinicaltrials.gov as NCT02454803) included patients ≥18 years old with upper-limb spasticity of any aetiology in whom a decision had already been made to inject any BoNT-A formulation commercially available in the Russi. The treatment outcomes were evaluated using the Upper Limb Spasticity Index, which combines the patient-centred Goal Attainment Scaling (GAS) with a set of targeted standardised measures to assess the neurological impairment. The extent of functional impairment was assessed using the DAS. 168 Russian patients from 7 sites with a mean age of 49.8 years participated in the study. The Russian subpopulation had some differences from the overall study population in baseline characteristics of patients and injection practices of BoNT-A treatment. During the study period, the majority of Russian patients received AboBoNT-A (Dysport) injections - 142 (85%) patients at cycle 1, while OnaBoNT-A (Botox) was used in 14 (8%) patients, and IncoBoNT-A (Xeomin) - in 12 (7%) patients. Higher doses of AboBoNT-A were observed compared to the overall population, mean doses of AboBoNT-A between cycles 1 and 4 were 909-934 U in the Russian patients and 814-859 U in the overall population. In general, patients of the Russian subpopulation successfully achieved their treatment goals. The mean cumulated GAS T-score over the study was 51.1±3.0, marginally exceeding the same parameter in the overall population (49.5±5.9). Across the 6 goal domains, cumulated GAS T-scores in Russian subpopulation were highest for the goals related to passive function and pain relief, with mean scores of 51.8±4.2 and 51.6±4.8, respectively. In the overall population cumulated GAS T-scores were highest for involuntary movements (mean 50.5±5.6) and pain relief (mean 50.4±6.2). The lowest GAS T-scores were for the treatment goals related to active function in both Russian subpopulation and overall population, the mean scores were 48.3±5.5 and 46.6±7.4 respectively. The study results also showed significant improvement in in terms of reduction of muscle tone according to MAS (Modified Ashworth Scale) and the extent of functional impairment according to DAS (Disability Assessment Scale). The results of this subgroup analysis on patients from Russia showed high effectiveness of repeated cycles of BoNT-A injections as part of the integrated upper limb spasticity management conducted in real life settings, both in terms of reduction of muscle tone and correction of functional impairment, which contributes to the successful achievement of the treatment goals. The right choice of individual patient-centred treatment goals and methods for assessing their achievement are important components of the treatment and rehabilitation process for patients with spastic paresis of the upper limb.

Longitudinal goal attainment with integrated upper limb spasticity management including repeat injections of botulinum toxin A: Findings from the prospective, observational Upper Limb International Spasticity (ULIS-III) cohort study.

ObjectiveTo assess the longitudinal effects of integrated spasticity management incorporating repeated cycles of botulinum toxin A type A (BoNT-A) over 2 years.MethodsThe Upper Limb International Spasticity study was a prospective, observational, cohort study following adult patients over 2 years of integrated upper-limb spasticity management including repeat botulinum toxin (BoNT-A) treatment (any commercially-available product).ResultsA total of 1,004 participants from 14 countries were enrolled, of which 953 underwent ≥ 1 BoNT-A injection cycle (median 4 cycles) and had ≥ 1 goal attainment scaling assessment. Most participants (55.9–64.6% across cycles 1–6) saw a therapist after BoNT-A treatment; the most frequent therapy intervention was passive stretch (70.1–79.8% across cycles 1–6). Patients achieved their goals as expected over repeated cycles; mean cumulated goal attainment scaling T-score at 2 years was 49.5 (49.1, 49.9). Mean goal attainment scaling change scores of ≥ 10 were maintained across up to 7 cycles. Higher rates of goal achievement were seen for primary goals related to passive vs active function (86.6% vs 71.4% achievement). Standardized measures of spasticity, pain, involuntary movements, active and passive function improved significantly over the study.CONCLUSIONThis large, international study provides evidence for benefit of repeated cycles of BoNT-A, over 2 years captured through person-centred goal attainment and standardized measures.LAY ABSTRACTThis paper presents the primary efficacy results from the Upper Limb International Spasticity (ULIS-III) study, a large international longitudinal study that explored real-life clinical practice in the integrated management of upper-limb spasticity, using botulinum toxin-A (BoNT-A) in conjunction with physical therapies. The study provides evidence for the sustained functional benefit of repeated cycles of BoNT-A. In particular, those patients who continued to receive repeated injections for up to 7 cycles in 2 years showed relevant goal attainment. Standard outcome measures generally supported the rates of goal achievement; ratings of pain, involuntary movements, active and passive function all improved significantly over each treatment cycle. The successful results from ULIS-III highlight the importance of accurate and clear goal-setting during BoNT-A treatment to help target clinical intervention and the use of focused outcome measurement.

ULIS (Upper Limb International Spasticity), a 10-year Odyssey

Homer's Odyssey, one of the major Greek epic poems, tells the story of the hero Odysseus (or Ulysses in Roman versions) and his journey home to his wife Penelope. An epic poem is a long, narrative poem that is usually about heroic deeds and events that are significant to the culture of the poet. In keeping with this classic storytelling style, we describe the journey that the Upper Limb International Spasticity Study (ULIS) program has taken. The program was started in 2008 and has encountered a number of trials and obstacles along the way. This article sets out the history of development through its 10-year “Odyssey.” We use the benefit of hindsight to discuss how conducting large-scale, international observational studies can inform and influence routine practice in an area as diverse and complex as spasticity rehabilitation. We focus on the clinical pearls found within the now extensive ULIS dataset and how continually building upon the insights from each study can provide a real impetus for change.

Management of upper limb spasticity with botulinum toxin A: Baseline data from the Italian cohort of the upper limb international spasticity (ULIS)-III study

Management of upper limb spasticity with botulinum toxin A: Baseline data from the Italian cohort of the upper limb international spasticity (ULIS)-III study

Time to retreatment with botulinum toxin A in upper limb spasticity management: Upper limb international spasticity (ULIS)-III study interim analysis

Time to retreatment with botulinum toxin A in upper limb spasticity management: Upper limb international spasticity (ULIS)-III study interim analysis

PND86 - ECONOMIC BENEFITS ON ADULT UPPER LIMB SPASTICITY TREATMENT WITH ABOBOTULINUMTOXIN-A COMPARED TO ONABOTULINUMTOXIN-A OR INCOBOTULINUMTOXIN-A: ANALYSES IN A REAL-LIFE SETTING IN FRANCE

Assess economic costs associated with botulinum toxin-A (BoNT-A) treatment of adult patients with upper limb (AUL) spasticity in a real-life setting in France. Pharmaco-economic analysis comparing annual treatment costs of AUL spasticity with different BoNT-As: abobotulinumtoxinA (aboBoNT-A), onabotulinumtoxinA (onaBoNT-A) and incobotulinumtoxinA (incoBoNT-A). Analysis considered BoNT-A unit costs, injection intervals, and dosing data. Unit costs were estimated from retail prices (2018), without commercial offer. Average BoNT-A injection interval was estimated from published real-world evidence (ULIS-III study). Doses of BoNT-As of interest were estimated as real-life average administered doses based on practice-specific market research. BoNT-A products have non-interchangeable potency units. Real-life average administered doses per injection were: aboBoNT-A=463U (95% CI 413, 513), onaBoNT-A=223U (95% CI 195, 251), and incoBoNT-A=207U (95% CI 178, 236). Applying estimated unit costs, cost per injection was: aboBoNT-A=€259.2, onaBoNT-A and incoBoNT-A =€529.6. Accounting for BoNT-A injections intervals (22, 19 and 17 weeks for aboBoNT-A, onaBoNT-A and incoBoNT-A, respectively (Turner-Stokes et al. 2017)), overall annual injection cost per patient was: aboBoNT-A=€614.0, onaBoNT-A=€1,453.5, and incoBoNT-A=€1,624.5. The estimated annual treatment costs with aboBoNT-A was therefore 2.4 times lower than with onaBoNT-A and 2.6 times lower than incoBoNT-A in the average administered doses scenario. Considering administered doses, treating AUL spasticity with aboBoNT-A appears cost-saving in comparison to alternative treatment options (onaBoNT-A/incoBoNT-A). This can be explained by both aboBoNT-A unit costs and a long duration of response (Gracies 2018), associated with less frequent reinjections. REFERENCES: Lynne Turner-Stokes, Stephen Ashford, Jorge Jacinto, Klemens Fheodoroff, Gustavo Suarez, Pascal Maisonobe. Time to retreatment with botulinum toxin A in upper limb spasticity management: initial data from the Upper Limb International Spasticity (ULIS)-III study. Poster presented at MDS 2017 Gracies JM et al. Effects Of Repeated AbobotulinumtoxinA Injections In Upper Limb Spasticity Muscle Nerve 57: 245–254, 2018.

Poster 52: Botulinum Toxin A in Upper Limb Spasticity Management: Baseline Data from the Upper Limb International Spasticity (ULIS)-III Study

PM&RVolume 10, Issue 9S1 p. S25-S25 Poster 52: Botulinum Toxin A in Upper Limb Spasticity Management: Baseline Data from the Upper Limb International Spasticity (ULIS)-III Study Atul T. Patel MD, MHSA, FAAPMR, Atul T. Patel MD, MHSA, FAAPMR Kansas City Bone and Joint Clinic, Overland Park, KS, United StatesSearch for more papers by this authorStephen Ashford PhD, Stephen Ashford PhDSearch for more papers by this authorJorge Jacinto MD, Jorge Jacinto MDSearch for more papers by this authorKlemens Fheodoroff MD, Klemens Fheodoroff MDSearch for more papers by this authorAllison Brashear MD, Allison Brashear MDSearch for more papers by this authorPascal Maisonobe MSc, Pascal Maisonobe MScSearch for more papers by this authorJovita Balcaitiene MD, Jovita Balcaitiene MDSearch for more papers by this authorLynne Turner-Stokes DM FRCP, Lynne Turner-Stokes DM FRCPSearch for more papers by this author Atul T. Patel MD, MHSA, FAAPMR, Atul T. Patel MD, MHSA, FAAPMR Kansas City Bone and Joint Clinic, Overland Park, KS, United StatesSearch for more papers by this authorStephen Ashford PhD, Stephen Ashford PhDSearch for more papers by this authorJorge Jacinto MD, Jorge Jacinto MDSearch for more papers by this authorKlemens Fheodoroff MD, Klemens Fheodoroff MDSearch for more papers by this authorAllison Brashear MD, Allison Brashear MDSearch for more papers by this authorPascal Maisonobe MSc, Pascal Maisonobe MScSearch for more papers by this authorJovita Balcaitiene MD, Jovita Balcaitiene MDSearch for more papers by this authorLynne Turner-Stokes DM FRCP, Lynne Turner-Stokes DM FRCPSearch for more papers by this author First published: 26 September 2018 https://doi.org/10.1016/j.pmrj.2018.08.085Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume10, Issue9S12018 AAPM&R Annual Assembly AbstractsSeptember 2018Pages S25-S25 RelatedInformation

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

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.

AbobotulinumtoxinA injections in shoulder muscles: Results from a real world (ULIS-II) and a phase 3 (AUL) study

Shoulder spasticity post-stroke or -traumatic brain injury (TBI) may cause pain and restrict joint range of motion (ROM). Few studies have investigated botulinum toxin injections into shoulder muscles for spasticity treatment. Here we present data for sub-populations of patients receiving shoulder injections of abobotulinumtoxinA (aboBoNT-A) in two international, multicentre clinical studies: phase-4 Upper Limb International Spasticity Study-II (ULIS-II; post-stroke spasticity; NCT01020500 ), and phase-3 AUL open-label study (Adult Upper Limb; post-stroke or -TBI spasticity; NCT01313299 ). ULIS-II: selection and achievement of patient-centred primary goals. AUL study: Tardieu scale for passive ROM (X V1 ), angle of catch (X V3 ) and spasticity angle (X) for shoulder muscles; and Modified Frenchay Scale (MFS) for active function. In ULIS-II, 82 patients receiving aboBoNT-A in shoulder muscles selected pain treatment goal three times more often than those without ( Fig. 1 ), with high goal achievement (85.7 and 85.0%, respectively). In AUL study, 96 patients received ≥1 injection cycle in shoulder muscles, of which 84 received ≥ 2 shoulder injections. In patients with 1 shoulder injection, improved shoulder muscle spasticity (Tardieu) at last injection cycle: mean change from baseline at Week 4 was +12.3° and −8.2° for X V3 , and X, respectively ( Fig. 2 ). Patients with ≥ 2 shoulder injections had an improvements of +17.9° in X V3 . Concomitant improvements were also observed in active function (Week 4 Cycle 4, ≥ 2 shoulder injections: MFS: +0.71 [0.48]) ( Fig. 3 ). A trend towards lower injection doses in proximal compared with distal muscles was seen. Post-stroke or -TBI patients receiving abobotulinumtoxinA in shoulders, in addition to other proximal muscle groups, reached high levels of goal achievement, particularly relating to pain and showed improvement in active function (MFS).

Relief of spasticity-related pain with botulinum neurotoxin-A (bont-A) in real life practice. Post-hoc analysis from a large international cohort series

Pain is a common treatment goal for upper limb spasticity (ULS). Whilst clinical trials of botulinum toxin A (BoNT-A) show variable results for spasticity-related pain, here we describe treatment in real-life clinical practice. This post-hoc analysis compares patients whose primary treatment goal is pain relief, with primary goals in other areas. The Upper Limb International Spasticity (ULIS) programme is a series of observational cohort studies across > 30 countries, examining local clinical practice and patient-centred outcomes in ULS treatment with BoNT-A/concomitant therapies. ULIS-II ( NCT01020500 ) examined a single treatment cycle in stroke patients. ULIS-III ( NCT02454803 ) examines repeated cycles in all neurological conditions. Baseline data are recently available. Outcome measures: goal achievement, goal attainment scaling (GAS), Neurological Impairment Scale, Modified Ashworth Scale. In ULIS-II ( n = 456), pain was the fourth most common primary goal area, expressed by 13% of patients (pain group), whilst 87% had other primary goal areas, (e.g. function, mobility, involuntary movements). At baseline, the pain group showed significant differences in age (61 years vs. 56 years; P = 0.014) and contracture severity (5.9 vs. 4.5; P = 0.008), compared with others ( Table 1 ). Time since stroke, sex, motor impairment and spasticity were comparable between groups. The pain group showed somewhat better primary goal achievement (84% vs. 79%) and mean [standard deviation] GAS-T score (54.3 [9.4] vs. 52.5 [9.5]). Pain group goal attainment was significantly associated with improved pain visual analogue scale (Spearman rho = 0.65; P < 0.001), proximal spasticity (rho = 0.40, P = 0.002) and patient-reported global benefit (rho = 0.41; P = 0.001), but unrelated spasticity duration (rho = 0.15; P = 0.298). ULIS-III baseline data showed pain was the second most common primary goal area, identified by 25% of patients. Pain reduction is an important goal in patient-centred spasticity management, irrespective of chronicity or presence of contractures. It is increasingly identified by clinicians and patients as a primary treatment goal.

Time to retreatment with botulinum toxin A in upper limb spasticity management: Initial data from the Upper Limb International Spasticity (ULIS)-III study

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. 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. 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. 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. 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. This is an encore of the original abstract submitted to AAPM&R 2017 (Turner-Stokes et al.).

Poster 57: Time to Retreatment with Botulinum Toxin A in Upper Limb Spasticity Management: Initial Data from the Upper Limb International Spasticity (ULIS)-III Study

Poster 57: Time to Retreatment with Botulinum Toxin A in Upper Limb Spasticity Management: Initial Data from the Upper Limb International Spasticity (ULIS)-III Study

A comparison of goal selection and achievement between botulinum toxin A (BoNT-A) naïve and non-naïve patients in the upper limb international spasticity (ULIS)-II study

A comparison of goal selection and achievement between botulinum toxin A (BoNT-A) naïve and non-naïve patients in the upper limb international spasticity (ULIS)-II study

Relationship between abobotulinumtoxina injections into shoulder muscles and patient-centered primary goal selection and achievement: Subanalyses from the upper limb international spasticity (ULIS)-II study

Relationship between abobotulinumtoxina injections into shoulder muscles and patient-centered primary goal selection and achievement: Subanalyses from the upper limb international spasticity (ULIS)-II study

A comparison of goal selection and achievement according to patient sex in the upper limb international spasticity (ULIS)-Ii study

A comparison of goal selection and achievement according to patient sex in the upper limb international spasticity (ULIS)-Ii study

Poster 313 Relationship Between AbobotulinumtoxinA Injections into Shoulder Muscles and Patient Centred Primary Goal Selection and Achievement: Sub-Analyses from the Upper Limb International Spasticity (ULIS)-II Study

PM&RVolume 8, Issue 9S p. S262-S262 Practice Management & Leadership Poster 313 Relationship Between AbobotulinumtoxinA Injections into Shoulder Muscles and Patient Centred Primary Goal Selection and Achievement: Sub-Analyses from the Upper Limb International Spasticity (ULIS)-II Study Jorge Jacinto MD, Jorge Jacinto MDSearch for more papers by this authorJovita Balcaitiene MD, Jovita Balcaitiene MDSearch for more papers by this authorPascal Maisonobe MSc, Pascal Maisonobe MScSearch for more papers by this authorKlemens Fheodoroff MD, Klemens Fheodoroff MDSearch for more papers by this authorStephen Ashford, Stephen AshfordSearch for more papers by this authorLynne Turner-Stokes, Lynne Turner-StokesSearch for more papers by this author Jorge Jacinto MD, Jorge Jacinto MDSearch for more papers by this authorJovita Balcaitiene MD, Jovita Balcaitiene MDSearch for more papers by this authorPascal Maisonobe MSc, Pascal Maisonobe MScSearch for more papers by this authorKlemens Fheodoroff MD, Klemens Fheodoroff MDSearch for more papers by this authorStephen Ashford, Stephen AshfordSearch for more papers by this authorLynne Turner-Stokes, Lynne Turner-StokesSearch for more papers by this author First published: 24 September 2016 https://doi.org/10.1016/j.pmrj.2016.07.483Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume8, Issue9S2016 AAPM&R Annual Assembly AbstractsSeptember 2016Pages S262-S262 RelatedInformation

Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III)

ObjectivesDescribe the rationale and protocol for the Upper Limb International Spasticity (ULIS)-III study, which aims to evaluate the impact of integrated spasticity management, involving multiple botulinum toxin A (BoNT-A) injection...

Economic modeling of the use of botulinum toxin A in a homogenous patient population based on real-life clinical practice: ULIS-II (The Upper Limb International Spasticity Study); the French perspective

To evaluate the real life practice of the use of botulinum toxin A (BoNT-A) in post-stroke upper limb spasticity and the economic consequences of fair comparisons of the dosing between either abobotulinumtoxinA (Dysport ® ) or onabotulinumtoxinA (Botox ® ) or incobotulinumtoxinA (Xeomin ® ) in France. ULIS-II is an 18-month, observational, prospective study, conducted in 84 centers in 22 countries. France was the major contributor with 14 centers. Of 456 adults with post-stroke upper limb spasticity presenting for treatment with BoNT-A, 193 patients with the same injected limb segments “upper arm and lower arm” were analyzed for the dose injected for one cycle of BoNT-A. Treatment and concomitant interventions were in accordance with routine local clinical practice. Sample size, mean (SD)/median dose (min–max) in Unit for each BoNT-A and annual cost per patient were calculated using the median dose administered and considering no vial sharing. An injection interval of 12 weeks was simulated for all BoNT-A treatments and the France listed public price was used to ascertain annual cost. For the abobotulinumtoxinA group ( n = 141) a mean (SD)/median (min–max) dose of 665 U (280)/500 U (150–1500) was injected, for the onabotulinumtoxinA group ( n = 37) a mean (SD)/median dose of 183 U (99)/200 U (50–500) was injected and for incobotulinumtoxinA ( n = 15), a mean (SD)/median dose of 235 U (108)/200 U (100-440) was injected. Based on a BoNT-A injection interval of 12 weeks, the annual cost per patient in France would be 1123 € for abobotulinumtoxinA, 1784 € for onabotulinumtoxinA and 1784 € for incobotulinumtoxinA (based on median doses). Considering the real life practice of BoNT-A injections and the comparison of treatment groups treated for the same limb segment, this analysis suggests that the use of abobotulinumtoxinA would result potentially in a reduction in the healthcare cost for the treatment of spasticity (−37%) and that more patients could be treated with abobotulinumtoxinA with a given budget.

Factors influencing goal attainment in patients with post-stroke upper limb spasticity following treatment with botulinum toxin A in real-life clinical practice: sub-analyses from the Upper Limb International Spasticity (ULIS)-II Study.

In this post-hoc analysis of the ULIS-II study, we investigated factors influencing person-centred goal setting and achievement following botulinum toxin-A (BoNT-A) treatment in 456 adults with post-stroke upper limb spasticity (ULS). Patients with primary goals categorised as passive function had greater motor impairment (p < 0.001), contractures (soft tissue shortening [STS]) (p = 0.006) and spasticity (p = 0.02) than those setting other goal types. Patients with goals categorised as active function had less motor impairment (0.0001), contracture (p < 0.0001), spasticity (p < 0.001) and shorter time since stroke (p = 0.001). Patients setting goals for pain were older (p = 0.01) with more contractures (p = 0.008). The proportion of patients achieving their primary goal was not impacted by timing of first-ever BoNT-A injection (medium-term (≤1 year) vs. longer-term (>1 year)) post-stroke (80.0% vs. 79.2%) or presence or absence of severe contractures (76.7% vs. 80.6%), although goal types differed. Earlier BoNT-A intervention was associated with greater achievement of active function goals. Severe contractures impacted negatively on goal achievement except in pain and passive function. Goal setting by patients with ULS is influenced by impairment severity, age and time since stroke. Our findings resonate with clinical experience and may assist patients and clinicians in selecting realistic, achievable goals for treatment.