abobotulinumtoxinA Injections Research Articles

Video enhanced visual analysis of hemiparetic gait muscle selection: A pilot study

This paper summarizes the use of video enhanced visual analysis (VEVA) as a muscle selection assistance method for abnormal foot postures in adults with upper motor neuron syndrome (UMNS) treated with botulinum neurotoxin (BoNT-A) in a real-world setting.This pilot study used a prospective treatment study design with persons in an outpatient, rehabilitation hospital. Participants had acquired brain injury (ABI) of >6-month duration who had a spastic ankle foot deformity amenable to treatment with botulinum toxin A and able to independently ambulate a minimum of 10 m. Participants were evaluated before abobotulinumtoxinA injection (500 U–1500 U) to the identified lower limb muscles and four to five weeks post injection. Main Outcome Measures: Temporal spatial data (self-selected and maximal walking velocities (SSWV/MWV); step length and stance time); Modified Ashworth Scale (MAS); Tardieu Scale (TS) and ankle Passive Range of Motion (PROM) change from baseline to follow-up (f/u).Data is presented on ten of the eleven consecutive participants enrolled in the study. One participant withdrew due to study unrelated opposite ankle pain before reassessment. Mean SSWV increased post treatment by 21% in the barefoot condition and 8% when walking with shoes. For the MWV condition, there was a 15% mean increase post treatment in the barefoot condition and 10% when walking with shoes. Participants showed improved symmetry in step length and stance time in both post-treatment walking conditions. Ankle MAS and TS improved with knee flexed or extended. Ankle PROM increased post treatment with knee flexed by 8° and knee extended by 11.7°. VEVA in addition to clinical evaluation appears to facilitate muscle identification and selection of ankle deformities for treatment with BoNT-A. Our findings show marked improvement in ankle MAS, TS and PROM as indicators of pharmacological activity and increase in SSWV as a marker of functional improvement.

Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Glabellar Lines in Chinese Patients: A Pivotal, Phase 3, Randomized, Double-Blind and Open-Label Phase Study

BackgroundVarious botulinumtoxinA formulations are approved for glabellar lines treatment worldwide, including abobotulinumtoxinA (Dysport®).ObjectivesAssess abobotulinumtoxinA superiority versus placebo and non-inferiority versus active comparator (onabotulinumtoxinA; Botox®), for the treatment of Chinese patients with moderate/severe glabellar lines.MethodsPhase 3, randomized study (NCT02450526) comprising a double-blind (cycle 1) phase and an open-label (cycles 2−5) phase. Patients received abobotulinumtoxinA 50 units or matching placebo (5:1), active comparator (onabotulinumtoxinA 20 units) or matching placebo (5:1). In cycles 2–5, eligible patients were retreated with abobotulinumtoxinA only. Responders had glabellar lines of none/mild severity. Primary endpoint: responder rates at cycle 1, day 29 at maximum frown with abobotulinumtoxinA versus placebo (for superiority; by investigator’s live assessment [ILA] and subject’s self-assessment [SSA]), and versus active comparator (for non-inferiority; by ILA). Treatment-emergent adverse events were recorded.ResultsOverall, 520 patients were randomized. Superiority and non-inferiority, respectively, were demonstrated for abobotulinumtoxinA versus placebo (ILA, SSA; both p < 0.0001) and abobotulinumtoxinA versus active comparator. AbobotulinumtoxinA efficacy was maintained over open-label cycles; median time to onset of efficacy was 2.0 days. After 6 months, 17% of patients treated with abobotulinumtoxinA remained responders. AbobotulinumtoxinA was well-tolerated. Safety results were in line with the known profile of abobotulinumtoxinA; adverse events rate decreased with repeated treatment.ConclusionsAfter a single injection, abobotulinumtoxinA demonstrated superiority versus placebo and non-inferiority versus onabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines in Chinese patients. Multiple injections of abobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar lines in Chinese patients.Level of Evidence IThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Evaluating the Effectiveness and Safety of AbobotulinumtoxinA in Pediatric Lower Limb Spasticity (PLLS)

<h3>Research Objectives</h3> To assess the longitudinal attainment of patient-centered, function-related goal attainment scale (GAS) T-score after repeated abobotulinumtoxinA (aboBoNT-A) injections. <h3>Design</h3> Phase IV, prospective, observational study. <h3>Setting</h3> 28 US-based centers. <h3>Participants</h3> Patients aged 2–17 years with PLLS. <h3>Interventions</h3> AboBoNT-A injections over ≤30 months (≤10 cycles). <h3>Main Outcome Measures</h3> Assessment of cumulated GAS T-scores across all cycles to measure progress of therapy goals; scores of ≥50 reflect goal achievement. <h3>Results</h3> Of 210 patients, 77.6% (n=163) were previously treated with botulinum neurotoxin. Available Gross Motor Function Classification System (GMFCS) levels showed that 31.3% (n=61/195) of patients were non-ambulatory (GMFCS IV/V). Mean±SD cumulated GAS T-score was 51.1±9.3. Overall, 75.2% of patients achieved their primary goals. Across all cycles, the number of muscles injected ranged from 5.5±2.9‒7.0±3.7; the number of injection points ranged from 8.1±2.7‒9.9±5.7, with gastrocnemius injections being most common (85.7%). Injection guidance techniques were used in >70% of patients in Cycles 1‒6; electrostimulation was most frequent (>50%). In the safety population (N=242), 102 patients (42.1%) reported 392 treatment-emergent AEs, which were mostly mild to moderate. Overall, a total of 35 AEs in 15 patients (6.2%) were deemed treatment-related. <h3>Conclusions</h3> Overall, goals were achieved as or better than expected in the majority of patients. AboBoNT-A was well tolerated, with a low incidence of treatment-related AEs. These results confirm aboBoNT-A as an effective treatment option, with a positive risk-benefit profile. <h3>Author(s) Disclosures</h3> MG: Received consultancy fees/research support from Ipsen; ED: Received consultancy fees and/or research support from Allergan, Ipsen, Solstice, Merz; AT: Received consultancy fees/research support from Ipsen; AC: Received research support from Ipsen; SHE: Received consultancy fees from Biogen and Ipsen; FCG and JG: Employees of Ipsen.

Long-term follow-up of intravesical abobotulinumtoxinA (Dysport®) injections in women with idiopathic detrusor overactivity

ObjectiveOnly a few numbers of studies have been published on the use of abobotulinumtoxinA (Dysport®) in idiopathic detrusor overactivity (IDO). This study reported the long-term follow-up of women with IDO who were treated with intravesical Dysport® injections. MethodsTwo hundred and thirty-six patients with IDO who had failed first-line conservative and antimuscarinic therapy received 500–900 units of Dysport® between April 2014 and July 2015. All patients were followed up for 5 years after their initial injection and interviewed on the phone. ResultsA total of 236 women with IDO aged from 18 years to 84 years (mean±standard deviation: 49.6±15.9 years) were included in our study. The median follow-up time for patients was 36.5 (range: 10–70) months, and the median recovery time after injection was 18.5 (range: 0–70) months. A total of 83 (35.2%) patients stated that they had subjective improvement of their symptoms whereas 84 (35.6%) patients did not report any improvement in symptoms. The initial International Consultation on Incontinence Questionnaire Overactive Bladder mean score was 6.9 (standard deviation 3.4). There was a positive association between the median recovery time and the components of the International Consultation on Incontinence Questionnaire Overactive Bladder questionnaire. ConclusionIn a sub-population of overactive bladder patients with IDO who have failed first-line therapy, a single intravesical Dysport® injection can resolve patient symptoms completely or reduce the symptoms to an acceptable level that can be controlled with antimuscarinics or re-injection on demands.

Modelling Long-Term Outcomes and Risk of Death for Patients with Post-Stroke Spasticity Receiving Abobotulinumtoxina Treatment and Rehabilitation Therapy.

ObjectiveStroke is associated with a high risk of death and cardiovascular events. Rehabilitation therapy is critical for functional recovery, to reduce hospital readmissions, all-cause and cardiovascular mortality, and stroke recurrence (long-term outcomes). Post-stroke spasticity may prevent effective recovery by restricting mobility. AbobotulinumtoxinA is an adjunctive therapy to physical therapy for post-stroke spasticity, but its long-term effects are unknown. The objective was to model the long-term clinical and economic outcomes of abobotulinumtoxinA for post-stroke spasticity.MethodsEffects of abobotulinumtoxinA on treating post-stroke spasticity and evidence linking functional outcomes with long-term outcomes were collected in a focused literature review. A model was developed to estimate health benefits on long-term outcomes, direct medical costs, life- and quality-adjusted life-years for abobotulinumtoxinA injections plus rehabilitation therapy compared with rehabilitation therapy alone, from a UK perspective over a 10-year time-period.ResultsAbobotulinumtoxinA + rehabilitation therapy led to a risk reduction of 8.8% for all-cause mortality, and an increase of 13% in life-years and 59% in quality-adjusted life-years compared with rehabilitation therapy alone. AbobotulinumtoxinA + rehabilitation therapy was considered cost-effective compared with rehabilitation therapy alone (incremental cost-effectiveness ratio: £24,602).ConclusionAbobotulinumtoxinA + rehabilitation therapy may improve long-term outcomes, including post-stroke survival, while being cost-effective for the treatment of post-stroke spasticity.LAY ABSTRACTHere we developed a model to explore and compare the long-term benefits and overall costs of two interventions for the treatment of post-stroke spasticity (PSS): abobotulinumtoxinA injections plus rehabilitation therapy (aboBoNT-A+RT) vs. RT alone. Stroke survivors are known to be at a higher risk of recurrent stroke and death, and more than 25% are affected by spasticity. PSS significantly reduces patients’ mobility, physical functioning, and subsequently their ability to recover after a stroke. AboBoNT-A+RT is an effective treatment for spasticity. This model is the first to highlight that combining aboBoNT-A injections with RT could improve the overall survival of stroke survivors with spasticity by 8.8% and their overall quality of life, while being considered good value for money by UK payers.

Effectiveness of Early AbobotulinumtoxinA Injections in Patients With Upper Limb Spastic Paresis After Traumatic Brain Injury in Real Clinical Practice: Results of a Multicenter Observational, Non-Interventional Prospective Study (Adults with post Traumatic Brain Injury (TBI) upper limb (UL) spasticity – APTULS)

Effectiveness of Early AbobotulinumtoxinA Injections in Patients With Upper Limb Spastic Paresis After Traumatic Brain Injury in Real Clinical Practice: Results of a Multicenter Observational, Non-Interventional Prospective Study (Adults with post Traumatic Brain Injury (TBI) upper limb (UL) spasticity – APTULS)

Assessing the Effectiveness of AbobotulinumtoxinA Injections for Adult Lower Limb Spasticity in Routine Clinical Practice: Methodology and Baseline Data for the AboLiSh Study

Assessing the Effectiveness of AbobotulinumtoxinA Injections for Adult Lower Limb Spasticity in Routine Clinical Practice: Methodology and Baseline Data for the AboLiSh Study

Factors associated with efficacy of botulinum toxin a injections in primary axillary hyperhidrosis: A retrospective study of ninety patients.

Primary focal hyperhidrosis (PFH) is a frequent condition which can seriously affect the quality of life. Intradermal injections of botulinum toxin A (BTA) is a safe temporary treatment. The objective was to assess the factors associated with the efficacy of the axillary injections of abobotulinumtoxinA in PFH. Among a cohort of 236 patients followed for axillary injections of BTA between 2001 and 2020 for severe PFH, we included patients treated with 150 units per armpit of abobotulinumtoxinA with a minimum follow-up of three years. We described the characteristics of the patients and then searched for association between variables (sex, age, multifocal PFH and duration of efficacy of the first injection [<6 or ≥6months]) and the number of injections received in three years, counted at the second injection date, by univariate and multivariate logistic regression. Ninety patients were included (62 women, median age of 29 years and 12.2% of multifocal PFH). The median duration of efficacy of the first injection was six months (interquartile range 3-9). The duration of efficacy of the first injection ≥6months was significantly associated with less injections during the 3-year follow-up in univariate (odds ratio [OR]: -1.18 [95% confidence interval (CI): -1.80 to -0.55]; p < 0.01) and multivariate (OR: -1.16 [95% CI: -1.79 to -0.53]; p < 0.01) logistic regression. There was no significant difference with female sex, age, or multifocal PFH. A duration of efficacy of the first injection greater than six months seems to indicate a better response profile to BTA.

Introducing a noninvasive, non-surgical, and reversible animal model for fecal incontinence using abobotulinumtoxinA in dogs.

The aim of this study was to introduce a new animal model of fecal incontinence (FI) by injecting abobotulinumtoxinA in the external anal sphincter (EAS) muscle of dogs which replaces models based on anal sphincter destructions that are invasive, mostly require surgical procedures, expensive, permanent, and painful to the animals. 4 healthy mongrel dogs were used in this study. First, they were received NaCl 0.09% (as control) injections in EAS muscle and effects were assessed by means of Electromyography (EMG) and clinically evaluated by sphincter pinch test and presence of leakage of feces for 2 weeks. Then, they received abobotulinumtoxinA in EAS muscle and reevaluated for 6 weeks to see short-term and medium-term effects of abobotulinumtoxinA injection. Saline had no significant changes in results obtained from EMG, however, there were significant decreases in amplitudes of action potentials after receiving abobotulinumtoxinA in comparison with no injection or saline injection in EAS muscle. Pinch tests were normal after saline injection assessment period, however, then started to be negative, ranging from two days after abobotulinumtoxinA injection to seven days after receiving abobotulinumtoxinA. Animals also had significant presentations of fecal incontinence (leakage of feces and cage contamination with feces) from the 1st week after receiving abobotulinumtoxinA until the 6th week after receiving abobotulinumtoxinA. AbobotulinumtoxinA caused paralysis in the EAS and producd FI conditions in dogs. This animal model was an appropriate substitute to the various invasive, expensive and also complicated procedures with an easy, feasible, noninvasive and non-painful single-stage abobotulinumtoxinA injection.

Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2)

BackgroundFor patients with neurogenic detrusor overactivity incontinence (NDOI), treatment with oral medications is often unsatisfactory. ObjectiveTo assess the efficacy and safety of abobotulinumtoxinA (aboBoNT-A) for NDOI. Design, setting, and participantsTwo randomized, double-blind phase 3 studies (CONTENT1, NCT02660138; CONTENT2, NCT02660359) enrolled patients with NDOI who were regularly performing clean intermittent catheterization (CIC) and were inadequately managed with oral therapy. Pooled results from the first placebo-controlled treatment cycle are reported. InterventionPatients received injections of aboBoNT-A 600 U (n = 162) or 800 U (n = 161) or placebo (n = 162) into the detrusor muscle. Outcome measurements and statistical analysisThe primary endpoint was the mean change from baseline in NDOI episodes per week at week 6. Secondary endpoints reported are the proportion of patients with no NDOI episodes, the volume per void, urodynamic parameters, and quality of life (QoL). Safety was also assessed. Statistical analyses were conducted for the pooled study populations (each aboBoNT-A dose vs placebo). Results and limitationsAt week 6, NDOI episodes per week were significantly reduced in each aboBoNT-A group versus placebo (both p < 0.001) and the volume per void had significantly increased. Approximately one-third of patients in each aboBoNT-A dose group reported no NDOI episodes versus 3% of patients in the placebo group. Reductions in urinary incontinence (UI) were reflected in significantly greater improvements in UI-related QoL in the aboBoNT-A groups versus placebo. Urodynamic parameters (bladder capacity and detrusor pressure) were significantly improved with each aboBoNT-A dose versus placebo. Each aboBoNT-A dose was well tolerated. Symptomatic urinary tract infection was the most frequent treatment-emergent adverse event, with incidence comparable across the aboBoNT-A and placebo groups. The studies were terminated prematurely owing to slow recruitment and were not designed for statistical comparison between the two aboBoNT-A doses. ConclusionsIntradetrusor aboBoNT-A is an effective treatment and alternative option for patients with NDOI who have an inadequate response to oral anticholinergics and are already performing CIC. Patient summaryIn patients with bladder muscle overactivity caused by neurological conditions (multiple sclerosis or spinal cord injury) and resulting in urinary incontinence, abobotulinumtoxinA injections improved their symptoms and bladder function, with no unexpected effects.

Efficacy of Intracavernosal Injections of 50-Unit Versus 100-Unit Doses of AbobotulinumtoxinA (Masport®) in Vasculogenic Erectile Dysfunction with Phosphodiesterase Type 5 Inhibitors Resistant

Background: We aimed to evaluate the safety and efficacy of 50-unit dose against 100-unit dose of intracavernosal injection (ICI) of AbobotulinumtoxinA (BTX-A) (Masport®) in patients with vascular erectile dysfunction (ED) resistant to first-line therapies, including phosphodiesterase type 5 inhibitors (PDE5I). Methods: In this double-blind randomized controlled trial (RCT), 40 patients with ED resistant to PDE5I were randomly divided into two groups: ICI of a single dose of Masport® 50 units and single dose of 100 units. Peak systolic velocity (PSV) confirmed arterial insufficiency vascular disorder. For all patients, International Index of Erectile Function (IIEF), Sexual Health Inventory for Men (SHIM), and Erection Hardness Score (EHS) questionnaires were completed. Six weeks after the treatment, the subjects were re-examined. Results: Our results showed an acceptable clinical efficacy and safety of ICI of Masport® six weeks after injection. No systemic complications in patients were seen. Three patients complained of brief penile pain shortly after injection, but there were no other local complications. The increase in mean PSV in the 100-unit group due to treatment was significant (P-value &lt; 0.0001). Also, there was a significant difference between the two groups of 50- and 100-unit (P-value &lt; 0.0001). In addition, the increase in mean IIEF-EF, SHIM score, and EHS due to treatment was significant between the two groups. For the 100-unit group, P-value &lt; 0.0001 and the difference between the two groups was also significant (P-value &lt; 0.0001), which indicated a better response to treatment in the 100-unit group. The mean increase of IIEF score (EF domain) was 4.3 (mean IIEF: 9.4 and 13.7 after and before, respectively) in the 100-unit group and (mean IIEF: 8.1 and 9.1 after and before, respectively) in the 50-unit group. Conclusions: The results of this study showed that ICI of AbobotulinumtoxinA, especially at a dose of 100 units, in patients with refractory vasculogenic ED is safe and effective in improving sexual function and ultrasound indices.

Muscle Selection and Dosing in a Phase 3, Pivotal Study of AbobotulinumtoxinA Injection in Upper Limb Muscles in Children With Cerebral Palsy.

Background: Guidelines recommend botulinum toxin-A in pediatric upper limb spasticity as part of routine practice. Appropriate dosing is a prerequisite for treatment success and it is important that injectors have an understanding on how to tailor dosing within a safe and effective range. We report upper limb dosing data from a phase 3 study of abobotulinumtoxinA injections in children with cerebral palsy.Methods: This was a double-blind, repeat-treatment study (NCT02106351). In Cycle 1, children were randomized to abobotulinumtoxinA at 2 U/kg control dose or clinically relevant 8 U/kg or 16 U/kg doses. Doses were divided between the primary target muscle group (PTMG, wrist or elbow flexors) and additional muscles tailored to clinical presentation. During Cycles 2–4, children received doses of 8 U/kg or 16 U/kg and investigators could change the PTMG and other muscles to be injected. Injection of muscles in the other upper limb and lower limbs was also permitted in cycles 2–4, with the total body dose not to exceed 30 U/kg or 1,000 U (whichever was lower) in the case of upper and lower limb treatment.Results: 212 children were randomized, of which 210 received ≥1 abobotulinumtoxinA injection. Per protocol, the elbow and wrist flexors were the most commonly injected upper limb muscles. Across all 4 cycles, the brachialis was injected in 89.5% of children (dose range 0.8–6 U/kg), the brachioradialis in 83.8% (0.4–3 U/kg), the flexor carpi ulnaris in 82.4% (0.5–3 U/kg) and the flexor carpi radialis in 79.5% (0.5–4 U/kg). Other frequently injected upper limb muscles were the pronator teres(70.0%, 0.3–3 U/kg). adductor pollicis (54.3%, 0.3-1 U/kg), pronator quadratus (44.8%, 0.1–2 U/kg), flexor digitorum superficialis (39.0%, 0.5-4 U/kg), flexor digitorum profundus (28.6%, 0.5–2 U), flexor pollicis brevis/opponens pollicis (27.6%, 0.3-1 U/kg) and biceps (27.1%, 0.5–6 U/kg). AbobotulinumtoxinA was well-tolerated at these doses; muscular weakness was reported in 4.3% of children in the 8 U/kg group and 5.7% in the 16 U/kg group.Conclusions: These data provide information on the pattern of injected muscles and dose ranges used in this study, which were well-tolerated. Per protocol, most children received injections into the elbow and wrist flexors. However, there was a wide variety of other upper limb muscles injected as physicians tailored injection patterns to clinical need.

Effectiveness of early abobotulinum toxin (Dysport&lt;sup&gt;®&lt;/sup&gt;) injections in patients with upper limb spastic paresis after traumatic brain injury in real clinical practice: results of a multicenter observational non-interventional prospective study (Adults with post Traumatic Brain Injury (TBI) upper limb (UL) spasticity – APTULS)

The article reveals results of the first russian prospective observational study, aimed at evaluating of the clinical results early using injections of abobotulinumtoxinA (Abo-BTA, Dysport®) in patients with upper limb spasticity (ULS), which is one of disabling consequence traumatic's brain injuries (TBI). Currently, botulinum therapy is an integral part of the complex treatment of patients with chronic spasticity, has a high level of evidence (level IA), is included in clinical recommendations, national guidelines in a lot of countries around the world countries. The article analyzes results of studies conducted in the world in recent years, which confirm the effectiveness of Abo-BTA injections in the treatment of spasticity, which developing in early period after acute brain injury. Presented data of their own observations are allowed to authors conclude, that using of Abo-BTA injections in the complex rehabilitation of patients with ULS in the early recovery period of TBI demonstrates its good tolerability and a high safety profile, contributes to improving the effectiveness of treatment by reducing muscle tone and spasticity, increasing the volume of movements in joints. Therefore, Abo-BTA injections can be considered as a necessary addition to standard early rehabilitation programs. However, it is necessary to conduct further large-scale studies to more accurately determine the timing of the start of botulinum therapy, the doses of Abo-BTA, the most effective combinations of rehabilitation methods in the creating of individual programs.

Efficacy of combination therapy of mid-urethral sling and low-dose Abobotulinumtoxin-A injection in mixed urinary incontinence.

To determine the outcome of combined transobturator tape sling (TOT) and low dose intradetrusor injection of Abobotulinumtoxin-A (Abobot-A, Dysport®) in women with mixed urinary incontinence (MUI). This randomized, active comparator-controlled, parallel-group, two-part clinical trial was conducted on women who had positive Valsalva leak point pressure (VLPP) + detrusor overactivity (DO), cough-associated DO. In Part 1, 20 women with MUI who had a failure of medical and behavioral therapies to cure MUI, randomized in two groups receiving TOT surgery alone, or in combination with Dysport® injection (n = 10 in each group), and then Part 2 was initiated as a prospective open-label on 40 more patients. We performed cystoscopy and injected 300 U of Dysport®in 20-30 intradetrusor injection sites in each patient. The patient's symptoms in both groups decreased significantly after treatment. The symptoms were improved significantly in the combination therapy group according to the International Consultation on Incontinence Questionnaire-overactive bladder (ICIQ-OAB) questionnaire (p < .001), and International Consultation on Incontinence Questionnaire-urinary Incontinence-short form (ICIQ-UI-SF) (p = .041) in comparing with the TOT group. In Part 2, the mean score was 17.10 (4.75) for ICIQ-UI-SF and 9.22 (2.89) for ICIQ-OAB before the treatment. Twelve weeks after the intervention, the median (interquartile range: IQR) of ICIQ-OAB symptoms (2.0 [3.0]; p < .001) and ICIQ-UI-SF decreased, too (1. 0 [2.0]; p < .001). Considering improvement using Patient Global Impression of Improvement scale, 46 (92.0%) stated that they had significant subjective improvement of their symptoms. Combination therapy was accompanied with a promising effect in the patients with MUI according to the results of standardized questionnaires. However, further studies with controlled arms are recommended.

Guided Self-rehabilitation Contracts Combined With AbobotulinumtoxinA in Adults With Spastic Paresis.

Guided self-rehabilitation contracts (GSCs) are a diary-based rehabilitation strategy, wherein specific muscles are identified for prescription of high-load, home self-stretching techniques. We assessed the effect of GSCs combined with simultaneous upper limb (UL) and lower limb (LL) abobotulinumtoxinA injections on composite active range of motion (CXA) in adults with chronic spastic paresis. This was an international, prospective, single-arm, open-label study (ENGAGE, NCT02969356). Personalized GSCs were monitored by phone every other week, alongside 2 consecutive abobotulinumtoxinA injections (1500 U) across UL and LL, over 6 to 9 months. Primary outcomes were responder rates (CXA improvement ≥35° [UL] or ≥5° [LL]) at week 6 cycle 2. Secondary outcomes were active function (UL: Modified Frenchay Scale [MFS]; LL: 10-m barefoot maximal walking speed [WS]) and quality of life (12-item Short Form Health Survey, SF-12). Of the 153 treated participants, 136 had primary endpoint data; 72.1% (95% confidence interval [CI], 64.0-78.9) were responders. Mean (SD) CXA changes from baseline to last study visit were +49.3° (63.4) for UL and +20.1° (27.6) for LL. Mean (95% CI) changes from baseline to week 12 cycle 2 were +0.55 (0.43-0.66) in MFS, +0.12 m/s (0.09-0.15) for WS, and +4.0 (2.8-5.2) for SF-12 physical scores. In the safety population (n = 157), 49.7% of participants reported treatment-emergent adverse events (AEs); 12.1% reported 25 serious AEs. GSC combined with simultaneous UL and LL abobotulinumtoxinA injections led to improvements in CXA and function in both limbs, and quality-of-life physical scores. These results suggest the beneficial effect of combined GSC and abobotulinumtoxinA therapy in the management of spastic paresis.Video Abstract available for more insight from the authors (see the Supplementary Video, available at: http://links.lww.com/JNPT/A346).

Time to retreatment following abobotulinumtoxinA injections in children with upper-limb spasticity (1409)

Time to retreatment following abobotulinumtoxinA injections in children with upper-limb spasticity (1409)

Corrigendum to AbobotulinumtoxinA injections in shoulder muscles to improve adult upper limb spasticity: Results from a phase 4 real-world study and a phase 3 open-label trial.

Botulinum toxins, such as abobotulinumtoxinA, are used to treat spasticity (muscle overactivity) in arm muscles. Spasticity in shoulder muscles occurs in many patients following a stroke. Shoulder spasticity can be painful and limit limb movement. This paper compares the results from patients who did and those who did not receive abobotulinumtoxinA injections in shoulder muscles (among other arm muscles) in 2 studies. In both studies, the results showed that more patients receiving treatment in shoulder muscles chose pain as a key goal for treatment and had reduced pain following treatment compared with patients not treated in the shoulder. In addition, patients receiving shoulder injections showed further improvement in arm movement compared with those not receiving shoulder injections. Overall, these results suggest that abobotulinumtoxinA treatment in shoulder muscles may improve outcomes for patients with arm spasticity involving the shoulder.

Assessment of the effects of abobotulinumtoxinA injections in patients with chronic migraine: A pilot study

Assessment of the effects of abobotulinumtoxinA injections in patients with chronic migraine: A pilot study

Evaluation of Therapeutic Effect of Intratrigonal Injection of AbobotulinumtoxinA(Dysport) and Hydrodistention in Refractory Interstitial Cystitis /Bladder Pain Syndrome.

There are two brands of BotulinumtoxinA(BTXA) that commonly used in treatment of Lower Urinary Tract Disease: OnabotolinumtoxinA(Ona-BTXA) and AbobotulinumtoxinA (Abo-BTXA). The present study was conducted to assess the potential therapeutic and adverse effect of Abo-BTXA or Dysport for IC/BPS. Twenty-two out of 52 women diagnosed with IC/BPS who were refractory or had a low response to oral treatments of IC/BPS after 6 months, were included in the study. The end-point was O'Leary-Sant Score (OSS) including "symptoms" and "problem" indexes (ICSI and ICPI respectively) assessment after 1,3and 6 months after Abo-BTXA injection. Each patient underwent cystoscopy and immediately after hydrodistention received intratrigonal injections of 300 IU of Abo-BTXA (Dysport®) in30sites. The effect and side effects of this treatment over time have been investigated. Complications including high post void residual urine (PVR), bladder rupture, and urinary tract infections (UTI) were also assessed. The mean age of patients was 46.2±13.7 years and median OSS was 27.8±5.8.: After single injection ICSI, ICPI and total OSS significantly reduced in 1, 3, and 6 months follow up; rate of decrease total OSS was 39.5%, 36%, 18%, respectively. Its effect lasted up to six months and started to decrease after 1 months (p-value<0.05). Complications included urinary retention (PVR>200ml), bladder rupture, and UTI in 13.5%, 4.3%, and 18% of the patients, respectively. intravesical injection of 300IU Abo-BTX(Dysport) could be a useful approach for the treatment of patients with refractory IC/BPS in a period of six months.

Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study.

AimTo assess the efficacy and safety of repeat abobotulinumtoxinA injections in reducing upper limb spasticity in children with cerebral palsy (CP).MethodThis was a double‐blind, repeat‐cycle study (NCT02106351) in children with CP (2–17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home‐exercise therapy program (HETP; minimum five 15min sessions/wk). Children received 8U/kg or 16U/kg plus HETP in cycles 2 to 4.ResultsDuring cycle 1, 210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2–17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP. At week 6 of cycle 1, children in the 8U/kg or 16U/kg groups had significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of –0.4 [p=0.012] and –0.7 [p<0.001] respectively). All groups improved on Physician Global Assessment and children in all groups achieved their treatment goals at least as expected. Therapeutic benefits were sustained during cycles 2 to 4; muscular weakness was the only treatment‐related adverse event reported in at least one child/group (4.3% and 5.7% vs 1.4% respectively).InterpretationTreatment with 8U/kg or 16U/kg abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose. Therapeutic benefits of abobotulinumtoxinA plus HETP were sustained with repeat treatment cycles.What this paper adds AbobotulinumtoxinA injections significantly reduced upper limb spasticity in children with cerebral palsy.Children treated with abobotulinumtoxinA and targeted home exercises showed global improvement and goal attainment.Benefits were sustained over 1 year with repeat cycles of abobotulinumtoxinA and home exercises.AbobotulinumtoxinA injections into the upper limb were well tolerated over 1 year.