Introduction Current care plans for stroke survivors typically focus on acute management, resulting in many stroke survivors being discharged to their communities without adequate follow-up, despite their often experiencing significant post-stroke complications, such as post-stroke spasticity (PSS). While studies have explored the incidence and prevalence of PSS, little is known about how early PSS develops and how many stroke survivors develop ‘problematic’ PSS that would benefit from pharmacological treatment.Methods and analysis EPITOME is a prospective, international, observational, epidemiological study of participants (aged 18–90 years) who develop paresis within days 3–14 of a first-ever stroke that occurred within the past 4 weeks. Participants at sites across seven different countries are monitored remotely at 2 weeks and 1, 2, 3, 6, 9 and 12 months post-stroke to detect the possible onset of PSS using the Post-stroke Spasticity Monitoring Questionnaire (PSMQ). If the PSMQ indicates the possible presence of PSS, participants undergo a full in-clinic assessment to confirm the presence of PSS. For participants with confirmed PSS, the severity and distribution of spasticity is documented, and the investigator assesses whether the participant has spasticity that could benefit from pharmacological therapy. Participants without clinically confirmed PSS return to remote monitoring.Ethics and dissemination Ethics approval was obtained in all seven participating countries. Results will be published at international meetings and in an international peer-reviewed journal. Lay summaries will be prepared to accompany the primary paper and will also be provided to study participants.Trial registration number ClinicalTrials.gov NCT06055725.

Research ObjectivesTo describe abobotulinumtoxinA (aboBoNT-A) dosing parameters for the most commonly targeted muscles in the routine management of lower limb spasticity (LLS).DesignAboLiSH (NCT04050527) is a prospective, longitudinal, observational study.SettingInternational, multicenter.ParticipantsAdults aged ≥18 years with unilateral LLS, who are able to take ≥5 steps with or without assistance and are either botulinum toxin naïve or non-naïve.InterventionsAboBoNT-A injections, in accordance with local prescribing guidelines (maximum dose 1500U). Prescription decisions were made prior to, and independently of study enrollment.Main Outcome MeasuresDocumentation of injection parameters made at every visit where aboBoNT-A is injected (including technique, injection intervals and rehabilitation interventions) over 16 months.ResultsThe baseline population includes 421 adults with LLS (mean±SD age 53.7±13.9 years; 65.1% male). The median total injected dose of aboBoNT-A was 600U, ranging from 100-1500U. A median of 4 muscles (range: 1-8) were injected, with most injections given under guidance (any 74.0%; EMG 41.0%, electrostimulation 32.3%, ultrasound 42.9%). The most commonly injected lower limb muscles (>20% patients) consisted of gastrocnemius medial head (injected in 82.7% of patients, median dose 150U), gastrocnemius lateral head (71.7%, 150U), soleus (66.5%, 200U), tibialis posterior (49.6%, 150U), flexor digitorum longus (39.0%, 100U), and flexor hallucis longus (22.1%, 100U). The use of injection guidance for these muscles ranged from 71.6% for the gastrocnemius medial head to 79.9% for the flexor digitorum longus.ConclusionsIn these baseline analyses, 6 muscles were identified as being most frequently injected in LLS. Injection practice was consistent with foot equinus and/or varus as the most common pattern of spasticity treated, in line with a key goal of improving mobility.Author(s) DisclosuresRDZ: Received research support from and is a consultant for BrainQ and Ipsen. AE: Received research support from and is a consultant for Abbvie/Allergan and Ipsen. SA: Received honoraria from Ipsen, Abbvie/Allergan, Merz, and Danone; and research support from Ipsen. PM and SP: Employees of Ipsen. JJ: Received honoraria from Abbvie/Allergan, Merz, and Ipsen.

Research ObjectivesTo evaluate the LegA sensitivity to change following treatment of lower limb spasticity (LLS) with a single cycle of abobotulinumtoxinA (aboBoNT-A) and rehabilitation in an ambulatory population.DesignAboLiSH (NCT04050527) is a prospective, longitudinal, observational study.SettingInternational, multicenter.ParticipantsAdults aged ≥18 years with unilateral LLS, who are able to take ≥5 steps with or without assistance.InterventionsAboBoNT-A injections, in accordance with local prescribing guidelines (maximum dose 1500U). Prescription decisions were made prior to, and independently of study enrollment.Main Outcome MeasuresLLS related treatment goals set by the participants at baseline. Where possible, goal outcome is supported by standardized measurement using the LegA.ResultsOf the 376 patients included in the interim Treatment Cycle 1 analysis, 278 had ≥1 assessment using the LegA. Part A assesses the patient's ability to care for the affected leg (passive function); mean±SD scores reduced (improved) from 8.8±7.2 at baseline to 7.6±6.2 at end of cycle (mean [95%CI] change of -1.4 [-1.8, -0.9], n=261). Part B assesses the patient's ability to independently complete activities using the affected leg (active function); mean±SD scores improved from 24.4±13.1 to 22.2±11.8 (mean [95%CI] change of -2.6 [-3.4, -1.9], n=261). Part C assesses the impact of spasticity on quality of life (QoL); mean±SD scores improved from 15.8±7.2 to 13.7±6.5 (mean [95%CI] change of -2.3 [-2.8, -1.7], n=258).ConclusionsFindings from this observational study of aboBoNT-A in the routine management of LLS confirm the sensitivity of the LegA for spasticity intervention and further support its use in the ambulatory population. For this cohort, improvements in active function and QoL were ≥2 absolute points, indicating clinically relevant improvement.Author(s) DisclosuresSA: Received honoraria from Ipsen, Abbvie/Allergan, Merz, and Danone; and research support from Ipsen. JJ: Received honoraria from Abbvie/Allergan, Merz, and Ipsen. RDZ: Received research support from and is a consultant for BrainQ and Ipsen. PM and CH: Employees of Ipsen. AE: Received research support from and is a consultant for Abbvie/Allergan and Ipsen.

Objective: Describe how people with lower limb spasticity present for treatment in routine clinical practice. Methods: Prospective, observational study (Clinicaltrials.gov: NCT04050527) of ambulatory adult patients (≥ 18 years) with unilateral lower limb spasticity (able to take ≥ 5 steps with or without assistance) presenting for routine spasticity management, including treatment with abobotulinumtoxinA. Results: The study population included 430 adults with lower limb spasticity. Despite their relatively young age (mean ± standard deviation 53.7 ± 13.9 years), only 20% of patients were employed. Most patients had an acquired brain injury due to cerebrovascular disease; 84.1% reported having concomitant upper limb spasticity. Using the Leg Activity Measure, most patients reported no or only mild difficulties in performing hygiene/positioning tasks, while 80.7% had at least mild difficulty with indoor ambulation and 90.5% had at least mild difficulty with walking outdoors. Sensory, communication and/or cognitive impairments were also common. At the first treatment cycle, 50.7% of patients set active function primary goals, including locomotion transferring or standing. Conclusion: These observations highlight the complexity of presentation that must be considered when setting treatment goals for lower limb spasticity and emphasize the types of impairment and activity (functional) limitations that treating teams may expect to encounter in their patients and should cover in their initial and follow-up assessments.

Understanding the use of botulinumtoxin (BoNT) in clinical practice is essential for improving clinical care. Real-world evidence for long-term persistence with BoNT therapy is limited. We conducted a retrospective longitudinal study to describe treatment dynamics and persistence with BoNT over 2 years.

Objective: To describe treatment dynamics and persistence with botulinumtoxin (BoNT) over 2 years in a retrospective longitudinal study. Background: Understanding the use of BoNT in clinical practice is essential for improving clinical care. Real-world evidence on long-term persistence with BoNT therapy is limited. Design/Methods: This study assessed medical claims data from the IBM MarketScan database among patients with a first medical claim for BoNT (not product specific) between October 2016 and October 2019. The index date was the day of the first BoNT administration, and a 1-year washout period before this date was used to identify incident BoNT use. On-label indications were defined as those approved for abobotulinumtoxinA. Six cohorts were analyzed: 1, all patients; 2, all patients, excluding those with off-label indications at the index date; 3, all patients with on-label diagnosis during the study period; and 4, 5 and 6, all patients with diagnosis of stroke, migraine and bladder dysfunction, respectively, before the index date. The number of treatments in the 2-year follow-up period and persistency (120-day look forward from treatment date; 80th percentile value of days to next treatment) were evaluated. Results: Across all cohorts (cohort [n]: 1 [19 711], 2 [5741], 3 [3238], 4 [611], 5 [7778] and 6 [1791]), 18.8–46.9% of patients received only one injection. Proportions of patients receiving three to eight injections remained consistent, with 0.3–15.7% receiving eight injections. Mean number of treatments across cohorts was 2.1–4.7, and time between treatments (80th percentile) was 105–319 days. Conclusions: In this retrospective longitudinal real-world study, there was a large drop-off in the proportion of patients receiving BoNT treatment after first injection, with few patients receiving eight injections over 2 years in accordance with the standard treatment regimen. These data are limited in providing the underlying reasons for the drop-off; further research is warranted. Disclosure: Dr. Simpson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Dr. Simpson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Mr. Bouchard has received personal compensation for serving as an employee of Ipsen. Mr. Bouchard has stock in Ipsen. Dr. Page has received personal compensation for serving as an employee of Ipsen. Dr. Page has received stock or an ownership interest from Ipsen. Dr. Spurden has received personal compensation for serving as an employee of IPSEN. Mr. Goldfarb has nothing to disclose. Atul T. Patel, 15908 has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Revance. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ipsen. Atul T. Patel, 15908 has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Atul T. Patel, 15908 has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for IPSEN. The institution of Atul T. Patel, 15908 has received research support from Allergan. The institution of Atul T. Patel, 15908 has received research support from Revance. The institution of Atul T. Patel, 15908 has received research support from IPSEN.

Objective: This exploratory analysis of a large, randomized, double-blind study (NCT02106351) describes the effect of treatment with abobotulinumtoxinA followed by a tailored home exercises therapy programme in enabling children with upper limb spasticity due to cerebral palsy to achieve their functional goals using goal attainment scaling (GAS).Methods: Children with cerebral palsy and spasticity in ≥ 1 upper limb received up to 4 injection cycles of abobotulinumtoxinA (2 U/kg (cycle 1 only), 8U/kg and 16U/kg) into the elbow and wrist flexors and other upper limb muscles selected to support individual treatment goals. Children followed a home exercises therapy programme, which included stretches and exercises specifically chosen to facilitate goal achievement and engagement in activities.Results: For cycle 1, most children had active function goals set as their primary goal (69.7% vs 19.2% passive function goals). GAS T- scores and goal responder rates at week 16 indicated that most types of primary goal were achieved at least as expected during cycle 1 (all groups). Primary goal GAS T-scores were generally maintained for the first 3 abobotulinumtoxinA treatment cycles.Conclusion: Most children with upper limb spasticity treated with repeat cycles of abobotulinumtoxinA supported by an individualized home exercises therapy programme achieved their functional goals. LAY ABSTRACTTreatment with botulinum toxins (such as abobotulinumtoxinA; aboBoNT-A) is often recommended to treat spasticity of the upper limb to help children with cerebral palsy improve their hand skills. In this large study, children with cerebral palsy were treated with up to 4 aboBoNT-A injection cycles followed by a home exercises programme that was specifically made for each child to help them meet their treatment goals. This study aimed to explore the types of goals the children wanted to achieve with this treatment and the factors that influence goal attainment. Most children in this study had “active function” goals set, including “involving the affected arm more in daily activities” and improving “reaching”, “use of limb as a helping hand” and “grasp and release”. Combined treatment with aboBoNT-A and the exercise programme helped most children achieve their goals, but it was difficult to discern any differences in efficacy between the aboBoNT-A doses used in the study. The authors suggest that the high rates of goal achievement in this study indicate that botulinum toxin should not usually be given without a physiotherapy programme.

We report baseline data from a preplanned interim analysis of patients receiving abobotulinumtoxinA (aboBoNT-A) treatment for lower limb spasticity in routine practice.

Secondary causes of diabetes are uncommon but early recognition is important so that patients receive appropriate diagnosis and treatment. Cushing’s syndrome is a rare disorder which is associated with weight gain, diabetes and hypertension. Since obesity is common in type 2 diabetes, a diagnosis of Cushing’s syndrome may be easily overlooked. Herein we describe resistant/refractory hypertension as a clinical clue to suspect Cushing’s syndrome in patients with diabetes.