Dysport Injection Research Articles

Success Rate and Predicting Factors for Repeated High-Dose Intradetrusor Dysport Injections in Children With Neurogenic Bladder: A Retrospective Study.

Evaluating the effectiveness and safety of repeated high-dose intradetrusor abobotulinumtoxin A (Dysport®) injections for the treatment of pediatric neurogenic bladders refractory to medications. Retrospective interventional study. The cohort included 37 children (22 boys and 15 girls) of median age 9.2 years. Inclusion criteria were diagnosis of neurogenic bladder and failure to respond to medical treatment. Exclusion criteria were augmented bladder, insufficient data, and interval of > 11 months between video-urodynamic study and Dysport injection. All participants were treated with an intra-detrusor injection of Dysport 30 IU/kg (up to 1000 IU) under general anesthesia. Repeated (second and third) injections were scheduled (6-12 months) in patients who demonstrated an improvement in cystometric parameters. All participants underwent video urodynamic testing before onset of treatment and 4-5 months after subsequent injection. Success of treatment was defined as a decrease in end filling pressure (EFP) to < 40 cm H2O and/or a 20% increase in maximal cystometric capacity (MCC). These parameters along with initial bladder features were evaluated for ability to predict treatment success. No side effects of Dysport were observed or reported. The overall success rate was 62%. MCC increased by a median of 30% (IQR 200-300, p < 0.001), 37% (IQR 197-310, p = 0.001) and 45% (IQR 245-300, p = 0.025) after the first, second and third injections, respectively. Median EFP decreased from 45 cm H2O to 34 cm H2O (IQR 20-45, p = 0.029), 23 cm H2O (IQR 20-37, p = 0.004), and 20 cm H2O (IQR 12-32, p = 0.049) after the first, second, and third injections, respectively. No predicting factor of success of treatment were found; However, three of five cases of "end stage" bladder showed improvement. High-dose Dysport injection is safe and effective for the treatment of neurogenic bladder. Studies with larger cohort and a control group would further elucidate which bladders would benefit most. At present, we recommend treating also bladders with "end stage" features with botulinum toxin before considering augmentation.

Botulinum toxin injection in outpatients for chronic anal fissure

Objectives The aim of the study was to evaluate the effect of botulinum toxin (BT) injection on fissure healing in the treatment of chronic anal fissure (CAF) in outpatient conditions without any analgesia and sedation to the internal anal sphincter (IAS). The primary outcome measure was post-procedural pain. The secondary outcome measures were fissure healing and complications. Methods Prospectively preserved data of 67 patients who received BT injections for CAF were analyzed prospectively. Demographic data, duration of symptomatic improvement, fissure location and number, parity, post-procedural pain, complications, continence status, response to treatment, and duration of follow-up were examined. Participants received bilateral (50 + 50 units) BT injections into the internal anal sphincter (IAS) in an outpatient setting. Results Symptomatic improvement was observed in 58% of patients within 1 week. The complete response rate to treatment was 82% at a mean follow-up of 6 months. Patients with partial response to treatment (10%) were successfully treated with topical therapy, and patients with persisting fissures (8%) were successfully treated with partial lateral internal sphincterotomy (LIS). 14 patients (21%) reported some degree of transient incontinence at follow-up. Multiparous women experienced more symptoms of Incontinence (p = 0.00). Pre- and post-procedural Vas Score median values were 4. The 7th-week VAS score median value was 3. Conclusion Dysport injection under sedation-free outpatient conditions is an effective and safe alternative to LIS for the treatment of CAF, with tolerable procedural pain. All patients should be warned of transient incontinence.

079 Unmasking of motor neuron disease by botulinum toxin therapy

A 75 year-old male with a history of a right hemiparesis due to past h/o stroke sustained a T3 vertebral body compression fracture after a fall and was treated conservatively. Six months later, in a rehabilita- tion clinic he reported that following discharge there had been a gradual deterioration in his mobility and strength, particularly on the right side. His right upper limb had become more stiff and painful with decreased range of movements. Two months later he received Dysport injections to the right elbow flexors, right brachioradialis, soleus and right flexor carpi radialis. Four days later, he developed worsening right sided weakness, slurred quiet speech, head drop and difficulty swallowing and this persisted. On review in neurology clinic there was a head drop with neck extensor weakness, spasticity and severe weakness in his right upper and lower limbs. There were also upper and lower motor neuron signs in his left upper and lower limbs. Neurophysiology studies eventually revealed fasciculation potentials and active den- ervation changes in the left upper and lower limb raising ‘the strong suspicion of generalized anterior horn cell disease’. He continued to progress and eventually passed away with pneumonia a year after the original fall. We believe this is a case of incipient motor neuron disease unmasked by botulinum toxin treatment. This is not a recognized phenomenon though it has previously been reported.s.paluri@nhs.net

A novel technique of botulinum toxin injection around skull sutures for chronic migraine: A randomized controlled clinical trial.

Migraine is a chronic headache manifested with attacks. Here we aimed to evaluate and compare the efficacy of 15-point Dysport injection with 31-point Xeomin injections. This is a randomized clinical trial performed in 2020-2021 in Isfahan on patients with refractory chronic migraine. A total number of 60 patients entered the study. The pain of patients was also determined using headache impact test (HIT) questionnaire. Patients were randomized into two groups: Group 1 underwent 31-point Xeomin injection and Group 2 underwent 1 vial of Dysport injection into 15 points of the scalp. Our study revealed that the data regarding aura, nausea, vomit, photosensitivity, sensitivity to sounds and smells did not change significantly between two groups compared to the beginning of the study. Frequency, duration, intensity of headaches, and the mean HIT score of all patients improved significantly within 3 months after interventions. Comparing both groups showed no significant differences (P > 0.05). HIT score was decreased from 21.26 ± 3.58 before intervention to 15.51 ± 4.58 after 3 months in Group 1 and 22.23 ± 2.59-10.33 ± 2.26 in Group 2. In both groups, these changes were statistically significant (P < 0.001). Although we found more decrease of HIT score in Group 2 comparing with Group 1 (10.33 ± 2.26 vs. 15.51 ± 4.58), this difference was not statistically significant (P = 0.12). Although Xeomin and Dysport injections are both effective and reduced pain in patients with chronic migraine, our new technique is probably better than the standard technique. Because the injection points are halved, increase patients comfort and reduce overall cost.

Evaluation of the Clinical Effects of Abobotolinum Toxin A (Dysport) Injection in the Treatment of Neurogenic Lower Urinary Tract Dysfunction.

Neurogenic lower urinary tract dysfunction (NLUTD) is one of the most challenging problems in urology. In recent years, Onabotulinum toxin A (Botox) is considered a second-line treatment in these patients. This study aimed to evaluate the clinical effects of Abobotolinum toxin A (Dysport) into the bladder and urethra. We classified our patients with NLUTD into three groups: neurogenic detrusor overactivity (group 1), detrusor sphincter dyssynergia (group 2), and patients with both symptoms (group 3). The severity of the patient's symptoms was assessed using the Urinary Distress Inventory- Short form (UDI-6), urodynamic study, and post-void residual urine (PVR) at baseline. After injection of Dysport, the patients were evaluated by the change in UDI-6 score, PVR, and the patient's general satisfaction. In group 1, 500-900 U diluted Dysport injected intra-vesical. If associated with detrusor sphincter dyssynergia (group 3), 100 U diluted Dysport injected peri-urethral. In group 2, only 100 U diluted Dysport injected peri-urethral. Data from 52 women with NLUTD were analyzed. The mean age was 51.3 ± 21.6 years. The prevalence of detrusor overactivity and the value of Q max was more in group 1. However, the amount of PVR was more in groups 2 and 3. The overall success rate was acceptable in all three groups. In addition, there were significant improvements in UDI-6 parameters. Peri-urethral injection of Abobotolinum toxin A is effective and safe. However, the selection of the patients and the dose of toxin needs more studies.

Abobotulinum toxin A for periorbital facial rejuvenation: impact on ocular refractive parameters

ABSTRACT Clinical relevance Botulinum toxin is commonly used for cosmetic facial rejuvenation and can result in pain at the injected site, bruising and ecchymosis, erythema and oedema, headache, diplopia, blurred vision, focal facial weakness. This study evaluates the impact of botulinum toxin on refractive error and binocular vision. Background Botulinum toxin (trade name: Dysport) is a neurotoxic protein which is made from a Gram‐positive anaerobic bacterium known as Clostridium botulinum. In this study, we aimed to evaluate the impact of Dysport injection on refractive error, near point of accommodation and convergence, and palpebral fissure height. Methods Twenty‐eight subjects were treated for facial wrinkles, using Dysport. A 500‐unit vial of Dysport was diluted with 2.5-ml preserved normal saline, and injected doses were 30-units for crow’s feet, six units for lower eyelid wrinkles, 25 to 50-units for glabellar lines (five points), and 20 to 40 for forehead creases on four points. The refractive error, near point of accommodation and convergence and palpebral fissure heights were assessed before and two weeks after injection. Results The participants comprised 23 women and five men at a mean age of 53.51 ± 14.1-years. The means of the equivalent sphere before and after injection were −0.07 ± 1.34 and −0.08 ± 1.35 (p = 0.36). The means of near point of accommodation monocularly before and after injection were 29.75 ± 6.16-cm and 26.75 ± 6.00, respectively. The means of near point of convergence before and after injection were 16.03 ± 5.27-cm and 15.55 ± 6.14, respectively (p = 0.30). The means of palpebral fissure height before and after injection were 10.33 ± 1.69-mm and 10.20 ± 1.46-mm, respectively. The changes in equivalent spherical refractive error, binocular near point of accommodation and convergence were not statistically significant. Conclusion Dysport injection for the correction of upper face animation lines, if performed at the appropriate sites and the appropriate concentration, has no significant impact on refractive error, near point of accommodation and convergence, and palpebral fissure height.

Submandibular Gland Aesthetic Elimination With Neurotoxin

PURPOSE: Submandibular glands can be noticeable in some facelift and necklift patients. The current standard is to surgically remove them. The senior author has treated them with neuromodulators during necklift operative procedures and occasionally post-operatively with follow-up injections. We present a novel way to eliminate submandibular glands without the need for excision, achieving a smooth jawline contour post necklift surgery. METHODS AND MATERIALS: Before any lower facelift and necklift, assessment is done by visual inspection and palpation of the submandibular glands to determine if they require neuromodulator injection. During necklift, if the gland is prominent, then 50 units of Dysport (Galderma) is injected into each gland. Two injections are placed into each gland. Care is taken to inject with a 25-gauge needle under direct visualization. Six weeks after necklift, a postoperative visit with visual inspection and palpation of the submandibular gland is performed. If necessary, a repeat injection of 50 units of Dysport (Galderma) per gland is given. EXPERIENCE/DATA: A total of 12 patients underwent initial necklift with Dysport injection from 2016 to 2020. Out of these patients, a total of 1 patient/8% of patients required a second injection 6 weeks post surgery. No patient required a third injection. A postsurgical survey was performed with interpretation by 3 independent plastic surgeons as well as a patient satisfaction survey. Independent plastic surgeons who did not perform the actual necklift procedure were asked to grade the submandibular gland appearance from before and after photographs. Out of 12 patients, a total of 11 patients/92% were deemed “Total Correction,” 1 patient/8% was deemed “Incomplete Correction,” and a total of 0 patient/0% were deemed “No Correction.” All 12 patients were asked similar questions. A total of 11 patients/92% self reported “Total Correction,” 1 patient/8% self reported “Incomplete Correction,” and a total of 0 patient/0% self reported “No Correction.” One patient required a second injection due to continued palpability of the gland after surgery. She developed the sensation of “dry mouth,” which resolved 2 months after the second injection. No other sequelae were noted by the patient or Plastic Surgeon. No other sequelae were noted in any other patient, including excessive bleeding, pain at the submandibular gland size, irregular contour deformity, skin necrosis, or seroma formation. SUMMARY: Dysport (Galderm) injection directly into the submandibular gland, whether through an open technique or by palpation, resulted in substantially less prominent gland and a more aesthetically pleasing jawline. CONCLUSIONS: Direct submandibular gland excision has a risk of difficult to control bleeding due to the unique and random arterial supply of the gland. Having smaller exposure due to a necklift incision lateral to the gland does not aid in visualization of the gland and the blood supply. Direct neuromodulator injection into the gland is a safe and effective way to decrease the visibility and palpability of the gland on a long-term basis. We feel it is a useful alternative to surgical excision of the submandibular gland.

Ptosis following botulinum toxin injection in hemifacial spasm

Hemifacial spasm (HFS) is characterized by irregular involuntary tonic or clonic contractions of muscles innervated by the seventh cranial nerve. Patients usually need long-term treatment, as spontaneous remission is infrequent. Repeated botulinum toxin injection has been shown as a safe and successful treatment for symptomatic relief in patients with HFS.1 Side effects are usually mild and transient. Ptosis has been reported in about 24% of patients with HFS probably due to diffusion of toxin to levator palpebrae superioris muscle.2 However, the frequency of ptosis in patients with HFS has not been addressed yet, due to causes other than botulinum toxin side effect. Herein, we present a case of HFS who presented to our clinic with complaint of complete ptosis and progressive pain early after botulinum toxin injection. Despite initial negative evaluations, further work up revealed a compressive lesion. A 75-year-old man presented with left severe ptosis since 3 weeks ago (Figure 1). He was known case of left HFS since 4 years ago, and botulinum toxin had been regularly injected for his symptom relief in orbicularis oculi, corrugator, and procerus muscles. Figure 1. Left Blepharoptosis one week after botulinum toxin injection The patient stated that this new ptosis had begun within a week after his last Dysport (Ipsen, Ltd., Slough, Berkshire, UK) injection while he had no ptosis in his previous injections. In past medical history, he had ischemic heart disease, hypertension, cataract extraction of both eyes, and glaucoma surgery on his right eye. He had been admitted to the neurology ward of a general hospital.

Long-term Efficacy of Botulinum Neurotoxin-A Treatment for Essential Blepharospasm.

PurposeIn the present study, we investigated the treatment efficacy and clinical outcomes of botulinum neurotoxin-A (BoNT-A) administered for longer than 5 years to patients with essential blepharospasm.MethodsWe retrospectively reviewed 19 patients (male : female = 8 : 11) diagnosed with essential blepharospasm between March 2006 and July 2016 who underwent BoNT-A injections for over 5 years and were followed. Efficacy of 297 injections of Botox (n = 162), Meditoxin (n = 75), Hugel-tox (n = 40), or Dysport (n = 20) was based on the symptom improvement score at the final injection (−1, worse; 0, same; 1, better). Injection dose (botox unit), duration of efficacy (months), and adverse events were also investigated.ResultsBased on product type, significant differences in patient age (59.3 ± 9.8 years), disease period (5.0 ± 5.4 years), number of botulinum neurotoxin injections before visiting our clinic (1.6 ± 2.6), and follow-up period (7.2 ± 1.6 years) were not observed. Treatment efficacy score and injection dose of repetitive injections were 0.1 ± 0.5 and 39.1 ± 4.0 units, respectively, and did not show significant differences with repeated injections. Duration of response was 5.9 ± 5.4 months, but this significantly decreased as the injections were repeated (p < 0.01). Among the 297 injections, adverse events occurred 12 times (4.0%) with no severe sequelae.ConclusionsIn this study, we showed that repetitive, long-term BoNT-A injections are considered a stable and effective treatment for essential blepharospasm in terms of consistent injection dose and maintenance of treatment efficacy. However, the duration of long-term efficacy could be decreased in patients injected repetitively.

Time to Retreatment after AbobotulinumtoxinA (Dysport) Injections in Children with Dynamic Equinus Foot Deformity

Time to Retreatment after AbobotulinumtoxinA (Dysport) Injections in Children with Dynamic Equinus Foot Deformity

Phase 3 Trial to Evaluate AbobotulinumtoxinA (Dysport) Injections in Children with Upper Limb Spasticity Due to Cerebral Palsy: A Study Design

Phase 3 Trial to Evaluate AbobotulinumtoxinA (Dysport) Injections in Children with Upper Limb Spasticity Due to Cerebral Palsy: A Study Design

Switch to Abobotulinum toxin A may be useful in the treatment of neurogenic detrusor overactivity when intradetrusor injections of Onabotulinum toxin A failed.

To assess the outcomes of switching to a different brand of botulinum toxin A (BTA, from Botox® to Dysport®) in case of failure of intradetrusor injections (IDI) of Botox® in the treatment of neurogenic detrusor overactivity (NDO). The charts of all patients who underwent a switch to IDI of Dysport® after failure of an IDI of Botox® at six departments of neurourology were retrospectively reviewed. The main outcomes of interest were the bladder diary data and four urodynamic parameters: maximum cystometric capacity (MCC), maximum detrusor pressure (PDET max), and volume at first uninhibited detrusor contraction (UDC). Fifty-seven patients were included. After the first injection of Dysport®, no adverse events were reported. A significant decrease in number of urinary incontinence episodes per day was observed in 52.63% of patients (P < 0.001) and all patients experienced a reduction in PDET Max (-8.1 cmH20 on average; P = 0.003). MCC significantly increased by a mean of 41.2 (P = 0.02). The proportion of patients with no UDC increased significantly at week 6 after ATA injections (from 15.79% to 43.9%; P = 0.0002). Hence, 32 patients draw clinical and/or urodynamic benefits from the botulinum toxin switch from (56.14%). After a median follow up of 21 months, 87% of responders to BTA switch were still treated successfully with BTA. Most patients refractory to Botox® (56.14%) draw benefits from the switch to Dysport®.

A Case of Onychomycosis due to Aspergillus flavus in all Fingernails and Toenails of an Immunocompromised Patient

Background: Hallux Valgus is a kind of Toes aberration where the Metatarsophalangeal joint that connects the big toe to the foot, leading to the inner side and a protrusion on the inner surface of toe arise. This study aimed to determine the effect of botulinum toxin A Dysport injection to reduce pain and deviation angle of the thumb in Hallux Valgus and to increase outcomes of treatment as an adjuvant therapy. Material and methods: Randomized clinical study was performed on 18 patients at the Clinic of Physical Medicine and Rehabilitation, Isfahan University of Medical Sciences. In this study the Halgvs valgus angle (HVA) between the metatarsals (IMA) and cartilage distal metatarsal angle (DMAA) and pain was assessed before and after injection. Results: Average of Hallux Valgus angle before and after Botox injections were 28/89 ± 10/21 and 21/56 ± 8/22 degrees and the angle deviation in the 6 months after treatment was significantly improved (p<0.001). Conclusion: Injection of botulinum toxin A (Dysport) is a suitable and acceptable method to reform the skeleton deformities and also to reduce the pain in patients with Hallux valgus.

Time to retreatment after abobotulinumtoxina (Dysport) injections in children with dynamic equinus foot deformity

Time to retreatment after abobotulinumtoxina (Dysport) injections in children with dynamic equinus foot deformity

EEG beta and gamma powers when comparing certain psychophysiological states with normal and weakened electromyogram of facial muscles

The aim of the present study was to investigate EMG contamination on high-frequency scalp electroencephalogram (EEG) during comparisons of certain cognitive tasks performance. 19 healthy women who performed similar test tasks before and after cosmetic injections of Dysport in various face regions for reduction of facial muscles activity took part in the study. The test tasks were focused on induction of emotional states with different valences, on memory storing and extraction of verbal information. Default state of rest was uncluded too. During performance of the tasks, parallel registrations of EEG from a scalp surface(19 channels) and EMG from several facial muscles (6 channels) were carried out. Changes of spectral power in β2 and low γ frequency ranges (18-40 Hz) in EEG- and EMG-derivations after Dysport injections were analyzed. Changes of spectral power in the same derivations during comparisons of the different test tasks were analyzed before and after Dysport injections separately. It was demonstrated that Dysport injections lead to reduction of EMG power in regions of injections and to reduction of EEG power in frontal and temporal derivations. However, the EEG-correlates revealed when comparing different test tasks remain qualitatively invariable both after, and before Disports injections. These facts confirmed that EMG makes a noticeable contribution to the electric activity registered from a scalp in the frequency ranges more than 18-Hz. At the same time, it was shown that in certain experimental situations influence of EMG not necessarily interferes with identification of EEG-correlates of mental activity during EEG registration from a head surface in β2 and low γ frequency ranges.

When EMG contamination does not necessarily hide high-frequency EEG: scalp electrical recordings before and after Dysport injections

The main aim of the present study was to investigate effects of partial reductions of electromyogram (EMG) on high-frequency scalp electroencephalogram (EEG) at rest and during performance of certain cognitive tasks. Nineteen healthy women performed the same cognitive tasks before and after cosmetic injections of Dysport in certain sites of facial muscles. Scalp EEG and EMG were recorded. Impact of Dysport injections on changes of spectral power in β2 and low γ frequency ranges (18-40Hz) in EEG and EMG derivations was investigated. Also changes of spectral power in EEG and EMG derivations during comparisons of different cognitive states were calculated before and after Dysport injections separately. Dysport injections led to EMG decreases in facial muscles around the injection zones and also led to reductions of power of electric processes in scalp derivations. Along with it results of EEG power comparisons between the pairs of the cognitive states were qualitatively similar before and after Dysport injections. These facts to all appearance demonstrate that though scalp EEGs in the range above 15-40Hz are contaminated by EMG, in certain experimental situations EMG contamination does not preclude qualitative detections of electroencephalographic correlates of mental activities in β2 and low γ frequency ranges. Parallel EEG and EMG registrations can help not to overestimate EMG contamination in psychophysiological EEG studies.

Increasing the area and varying the dosage of Botulinum toxin a injections for effective treatment of hemifacial spasm

Conclusion: Wider-area botulinum toxin (BT) injection with the dosage depending on specific pathology is a promising approach for the treatment of hemifacial spasm (HFS), resulting in effective and long-lasting control of HFS with fewer side-effects. Objective: The aim of this study was to develop a BT injection strategy that minimizes complications by considering the causes, duration, and electrophysiologic features of the disease, as well as the patient’s age. Methods: From July 2011 to July 2015, 26 patients were included in the strategy. The mean age was 61.8 ± 14.6. In the case of essential HFS, 2 units/injection site was the standard dosage. If a patient was aged over 60 and had a reduced electromyogram (EMG) amplitude, the dosage was reduced by 0.5 units/site. In the case of post-paralytic and tumor-induced HFS, 1.5 units/site was the standard dosage. All cases were managed by alternating injections of Botox and Dysport with no physical therapy. Results: Most HFS patients treated with the injection strategy had complete remission of HFS within 1 week. The average number of BT injection sites was 22.6 ± 6.7. The mean total BT dosage on the affected side was 28.6 ± 4.9 units. The mean duration of BT efficacy was 28.6 ± 7.7 weeks.

Efficacy and safety of two administration modes of an intra‐detrusor injection of 750 units dysport® (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo‐controlled phase IIa study

Assess the efficacy and safety of abobotulinumtoxinA (Dysport®) in adult patients with neurogenic detrusor overactivity (NDO). This Phase IIa, international, multicentre, double-blind, randomised, placebo controlled, pilot study enrolled 47 patients with NDO and urinary incontinence resulting from spinal cord injury (SCI) or multiple sclerosis (MS). Patients were treated with 15 intra-detrusor injections of Dysport 750 U or the equivalent placebo (n = 16 and 7) or 30 injections of Dysport 750 U or the equivalent placebo (n = 17 and 7). Primary endpoint was change from baseline in mean number of daily incontinence episode frequency (IEF) at day 84. Secondary endpoints included change from baseline in urodynamic parameters and quality of life (QOL). A safety assessment was also conducted. Adjusted mean changes from baseline in IEF were -3.2 (-76%) and -1.7 (-15%) for 15 injections Dysport and placebo groups, respectively, (P = 0.1103) and -3.2 (-88%) and -2.6 (-73%) for 30 injections Dysport and placebo groups, respectively, (P = 0.0686). Statistically significant improvements in maximum cystometric capacity, maximum detrusor pressure and volume at first contraction were reported in the Dysport groups compared with placebo (P < 0.05). Improvements in QOL were reported. Three muscle weakness episodes were reported as serious adverse events in two tetraplegic and one paraplegic patient, all in the 15 injections Dysport group. Both 15 and 30 injections administration modes of Dysport decreased daily IEF and resulted in significant improvements in urodynamic parameters in NDO patients with MS or SCI. Reduction to 15 injection sites did not appear to be associated with any impact on efficacy. Neurourol. Urodynam. 36:457-462, 2017. © 2016 Wiley Periodicals, Inc.

Effect of abobotulinumtoxinA (Dysport) injections on functioning in children with dynamic equinus foot deformity due to cerebral palsy: analysis of treatment goals, gait and quality of life from a phase 3 study

Effect of abobotulinumtoxinA (Dysport) injections on functioning in children with dynamic equinus foot deformity due to cerebral palsy: analysis of treatment goals, gait and quality of life from a phase 3 study

The study of the efficacy of Botulinum toxin type A in patients with poststroke upper-limb spasticity ULIS-II: an analysis of Russian patients

To assess the efficacy of Botulinum toxin type A (BoNT-A) injections in routine practice. An international, post-marketing, multi-center, observational, prospective, longitudinal study included patients ≥18 years with poststroke upper-limb spasticity in whom a decision to inject BoNT-A had already been made, and who had no previous treatment with BoNT-A or BoNT-B within the last 12 weeks. The responder rate was assessed by the patient-centered goal attainment scaling (GAS). The study included 7Russian research centers (41 patients). Sixteen patients (39%) received BoNT-A injections prior to entering the study. During the treatment, 29 patients (70.7%) received dysport injections; 2 (4.9%) botox injections, 8 (19.5%) xeomin injections and 2 (4.9%) other BoNT-A agents. The primary treatment goals were successfully attained in 87.8%, secondary treatment goals in 88.3%. An improvement in passive function as primary goal and as secondary goal were achieved in 100%, in the range of movement in 94.9%, pain reduction in 82.4%, improvement in active function of the upper limb in 76.5%, reduction in involuntary movements (associated reactions) in 83.3% of cases. Investigators' global assessment of benefits revealed that 97.6% of patients showed positive effects from BoNT-A injections. Pateitnts' assessment of global benefits was slightly lower - 90,2% of patients reported positive treatment effects When assessed by patients, the rate of global benefits was 90.2%. Botulinum-toxin therapy is an effective treatment option. In the vast majority of patients, it allows both for reduction in muscle tone and functional benefits that could improve quality of life of the patients.