incobotulinumtoxinA Injections Research Articles

IncobotulinimtoxinA (Xeomin) for the treatment of adductor laryngeal dystonia: A prospective, open-label clinical trial

ObjectivesDemonstrate an understanding of incobotulinumtoxinA efficacy in the treatment of adductor spasmodic dysphonia (SD). Understand that incobotulinumtoxinA can successfully be used as an alternative to onabotulinumtoxinA and for secondary non-responders. MethodsWe conducted a prospective open-label trial from 2016 until 2019 regarding the use of incobotulinimtoxinA for the treatment of adductor spasmodic dysphonia. Exclusion criteria included pregnant/nursing women, botulinum toxin for other indications, known allergy, neuromuscular or systemic diseases, use of aminoglycoside antibiotics, substance abuse, litigation regarding prior therapy, or other confounding conditions. Sixty-four injection sessions with completed with sixteen patients who were enrolled in the study and underwent EMG-guided incobotulinumtoxinA injections to the thyroarytenoid (TA) muscle using a hollow monopolar Teflon-coated needle via a trans-cricothyroid membrane approach. Dosages to each TA muscle were recorded and patients completed a Voice Handicap Index-10 (VHI-10), a validated worksheet regarding their perceived percent of normal function (PNF) following treatment, and a side effect profile. Outcomes were analyzed using the paired t-test. ResultsFor primary transitioners to incobotulinimtoxinA, VHI-10 scores and best percent normal function did not significantly change. For non-responders, VHI-10 decreased from 32.5 on Botox to 19.5 on incobotulinimtoxinA and best PNF increased from 37.6 to 90 %, which was statistically significant. Transient side effects included breathiness. ConclusionsOur study demonstrates that incobotulinimtoxinA may be used successfully for adductor SD either as first line treatment or in secondary non-responders to onabotulinumtoxinA.

Injections of IncobotulinumtoxinA at Intervals Less Than 10 weeks Are Effective and Safe for Cervical Dystonia Patients With Inadequate Benefit From Standard Injection Intervals

Injections of IncobotulinumtoxinA at Intervals Less Than 10 weeks Are Effective and Safe for Cervical Dystonia Patients With Inadequate Benefit From Standard Injection Intervals

Improvements in Upper Limb Spasticity-Related Pain in Children/Adolescents With Cerebral Palsy After IncobotulinumtoxinA Injections

Improvements in Upper Limb Spasticity-Related Pain in Children/Adolescents With Cerebral Palsy After IncobotulinumtoxinA Injections

Improvements in Lower Limb Spasticity-Related Pain in Children/Adolescents With Cerebral Palsy After IncobotulinumtoxinA Injections

Improvements in Lower Limb Spasticity-Related Pain in Children/Adolescents With Cerebral Palsy After IncobotulinumtoxinA Injections

Treatment of Cervical Dystonia Using Shorter IncobotulinumtoxinA Injection Intervals Improves Patient-Reported Outcomes in Those With Inadequate Benefits From Standard Intervals

Treatment of Cervical Dystonia Using Shorter IncobotulinumtoxinA Injection Intervals Improves Patient-Reported Outcomes in Those With Inadequate Benefits From Standard Intervals

Pain Reduction in Adult Patients With Limb Spasticity Following a Single IncobotulinumtoxinA Injection: An analysis of Pooled Data From Phase 2 and 3 Studies

Pain Reduction in Adult Patients With Limb Spasticity Following a Single IncobotulinumtoxinA Injection: An analysis of Pooled Data From Phase 2 and 3 Studies

Benefit of Multiple IncobotulinumtoxinA Injections for Pain Reduction in Adult Patients With Limb Spasticity: An Analysis of Pooled Data From Phase 2 and 3 Studies

Benefit of Multiple IncobotulinumtoxinA Injections for Pain Reduction in Adult Patients With Limb Spasticity: An Analysis of Pooled Data From Phase 2 and 3 Studies

Injections Of Incobotulinumtoxina at Intervals Less Than 10 Weeks are Effective and Safe for Cervical Dystonia Patients with Inadequate Benefit from Standard Injection Intervals (P1-1.Virtual)

Injections Of Incobotulinumtoxina at Intervals Less Than 10 Weeks are Effective and Safe for Cervical Dystonia Patients with Inadequate Benefit from Standard Injection Intervals (P1-1.Virtual)

Treatment of Cervical Dystonia Using Shorter IncobotulinumtoxinA Injection Intervals Improves Patient-reported Outcomes in Those With Inadequate Benefits from Standard Intervals (P1-1.Virtual)

Treatment of Cervical Dystonia Using Shorter IncobotulinumtoxinA Injection Intervals Improves Patient-reported Outcomes in Those With Inadequate Benefits from Standard Intervals (P1-1.Virtual)

Efficacy and safety of two incobotulinumtoxinA injection intervals in cervical dystonia patients with inadequate benefit from standard injection intervals of botulinum toxin: Phase 4, open-label, randomized, noninferiority study

IntroductionSome patients with cervical dystonia (CD) receiving long-term botulinum neurotoxin (BoNT) therapy report early waning of treatment benefit before the typical 12-week reinjection interval. MethodsThis phase 4, open-label, randomized, noninferiority study (CD Flex; NCT01486264) compared 2 incobotulinumtoxinA injection schedules (Short Flex: 8 ± 2 weeks; Long Flex: 14 ± 2 weeks) in CD patients. Previous BoNT-responsive subjects who reported acceptable clinical benefit lasting < 10 weeks were recruited. Efficacy and safety were evaluated after 8 injection cycles. The primary endpoint was change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale 4 weeks after the eighth injection. Secondary endpoints included TWSTRS total and subscale scores. Immunogenicity was assessed in a subset of patients. ResultsTwo hundred eighty-two CD patients were randomized and treated (Short Flex, N = 142; Long Flex, N = 140), and 207 completed the study. Significant improvements in TWSTRS severity from study baseline to 4 weeks after cycle 8 were observed in both the Short Flex (4.1 points; P < 0.0001) and Long Flex (2.4 points; P = 0.002) groups; Short Flex was noninferior to Long Flex (LS mean difference = 1.4 points; 95% CI = [−2.9, 0.1] < Δ = 2.0). Key secondary endpoints favored Short Flex intervals. Adverse events (AEs) were comparable between groups. There was no secondary loss of treatment effect. ConclusionInjection cycles < 10 weeks for incobotulinumtoxinA are effective (and noninferior to longer intervals) for treating CD patients with early waning of clinical benefit. Shorter injection intervals did not increase AEs or lead to loss of treatment effect.

Real Life Experience with Individualized Doses of Incobotulinumtoxina in Patients with Severe Spasticity Due to Acquired Brain Injury

The objective of the present study was to evaluate the effectiveness and tolerability of incobotulinumtoxinA, at doses according to individual needs, in 10 patients with acquired brain injury and severe upper and lower limb spasticity. Patients received a multipattern periodic treatment with ultrasound-guided injections of incobotulinumtoxinA at doses of 800-900 U in the upper and lower limbs. The mean number of injection cycles per patient was 4.2. The 0-10 visual analogue scale for pain score decreased significantly from pre-injection (mean: 4.7) to four-week post-injection (mean: 0.7). Similarly, the mean Ashworth Scale score (muscular tone assessment) at four-week post-injection (mean: 1.4) was significantly lower than at injection (mean: 2.5). Except for two patients in one pattern, all cases showed an improvement in passive range of motion assessments using goniometry. All patients reported maximum satisfaction with the treatment, all reporting “much improved” after the treatment. No treatment-related adverse effects were observed during the study. Individualized doses of incobotulinumtoxinA are effective and well-tolerated for this type of patients and allow better management of their severe spasticity. Therefore, individualization of doses should be taken into account for optimizing clinical outcomes and improving the patients’ treatment satisfaction.

Dose selection of Incobotulinumtoxin A for the treatment of spasticity and sialorrhea in cerebral palsy: results of a retrospective multicenter study

Introduction. In patients with infantile cerebral palsy (CP), botulinum therapy is used to treat both muscle tone disorders and sialorrhea. Therefore, it is logical to use one preparation of botulinum toxin type A to treat spasticity and sialorrhea in one injection procedure. The aim of the work is to conduct a retrospective analysis of data from 15 centres that treat patients with cerebral palsy and use the botulinum therapy method to determine the optimal doses of IncobotulinumtoxinA (IBTA) for the treatment of spasticity and chronic sialorrhea in real clinical practice. Materials and methods. The treatment results of 389 children with cerebral palsy (including 211 (54.2%) boys) with IBTA were analyzed. The majority were children with bilateral forms of cerebral palsy - 312 (80.2%). The average age of the patients was 5.27 ± 3.71 years, the average weight of the patients was 18.8 ± 10.9 kg. Results. The total dose of IBTA in the group of 389 patients with cerebral palsy for the treatment of spasticity was 163.74 ± 80.65 U (25-550; 95% CI 155.7-171.7) and 10.4 ± 5.4 U/kg body weight (1,25-29.7; 95% CI 9.8-10.9). The total dose of IBTA in the group of patients with cerebral palsy with simultaneous treatment of spasticity and chronic sialorrhea (n = 16) was significantly higher: 267.18 ± 124.57 U (115-570; 95% CI 200.8-333.6) and 13, 0 ± 7.1 U/kg (5.8-24.6; 95% CI 9.2-16.8). In the lower extremities, the most frequent target muscles were the gastrocnemius (55.0% of cases; 95% CI 49.9-60.0) and semitendinosus / semimembranous muscle (46.3% of cases; 95% CI 41.2-51.4 ), and in the upper limbs - pronator teres (48.6% of cases; 95% CI 43.5-53.7) and biceps brachii (28.8% of cases; 95% CI 24.3-33.6). Limitations of the study. The limitations of our work are the use of an open retrospective study format, a relatively small sample of patients with chronic sialorrhea, the absence of long-term follow-up of patients and the results of repeated IBTA injections. Conclusion. If it is necessary to use botulinum therapy for the treatment of spasticity and sialorrhea in a child with CP, it is optimal to use the product IncobotulinumtoxinA, which will allow correction of two pathological manifestations in one procedure and can shorten the intervals between repeated injection cycles.

IncobotulinumtoxinA in the treatment of sialorrhea in patients with infantile cerebral palsy

Sialorrhea is a severe medical problem that is difficult to treat, which can lead to serious complications. In almost all cases, chronic sialorrhea is accompanied by a restriction of the child's contacts with peers, socialization difficulties, and a significant decrease in the quality of life. Nowadays, botulinum therapy can be an effective tool that significantly reduces sialorrhea manifestation.Oblective: to evaluate the effectiveness of Xeomin (incobotulinumtoxinA) in the treatment of sialorrhea in patients with spastic infantile cerebral palsy (ICP).Patients and methods. We enrolled 24 children with ICP (14 (58.3%) females, and 10 (41.7%) males) with various disease forms: 4 (16.6%) — with spastic hemiparesis, 6 (25.0%) — with spastic diplegia, and 14 (58.3%) — with spastic quadriparesis. IncobotulinumtoxinA injections were performed bilaterally in the parotid and submandibular salivary glands under ultrasound control at a total dose of 40-100 U (min 1.3, max 4.5 U/kg of body weight). IncobotulinumtoxinA. The Drooling Impact (DIS) and the Global Impression of Change Scale (GICS) were used 1, 3 and 6 months after IncobotulinumtoxinA injections to assess treatment effectiveness.Results and discussion. Botulinum toxin therapy resulted in a significant decrease in saliva discharge from the oral cavity 1 and 3 months after IncobotulinumtoxinA injections, which was demonstrated by a reduction in mean DIS score from 78.6±9.6 (min 62, max 95 points; 95% CI 74.6—82.7) to 48.7±6.7(min 25, max 61 points; 95% CI45.8—51.6) and 52.7±8.5points (min 22, max 65; 95% CI49.1—56.3), respectively, as well as an increase in delta GICSscore up to +1.3+0.8(min 0, max 3points; 95% CI 1.0—1.6) and +1.0+0.7points (min 0, max 3points; 95% CI 0.8—1.3), respectively. Adverse events were observed in 4patients (16.6%), which were classified as mild in 3 patients (did not require special treatment and completely stopped within six days) and moderate in 1 patient (also did not require special treatment and completely stopped within three weeks).Conclusion. In the majority (79.1%) of patients with ICP, it is possible to achieve high efficiency in reducing sialorrhea and this effect persists for at least 3 months.

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children: SIPEXI.

Background and ObjectivesTo investigate the efficacy and safety of repeated injections of incobotulinumtoxinA (incoBoNT/A) for treatment of chronic sialorrhea (drooling) associated with neurologic disorders (e.g., cerebral palsy, traumatic brain injury) or intellectual disability in children and adolescents in a prospective phase III study (SIPEXI [Sialorrhea Pediatric Xeomin Investigation]).MethodsThe study enrolled 2- to 17-year-old patients with sialorrhea due to neurologic disorders or intellectual disability. Patients received body weight–dependent doses of incoBoNT/A (20–75 U). A main period with 1 injection cycle (placebo-controlled, double-blind, 6- to 17-year-olds) was followed by an open-label extension with up to 3 further cycles. An additional cohort of 2- to 5-year-olds received active treatment throughout the study. Coprimary endpoints were the change in unstimulated salivary flow rate (uSFR) from baseline to week 4 and the carers' Global Impression of Change Scale (GICS) rating at week 4. Adverse events were recorded.ResultsIn the main period, 220 patients aged 6–17 years were randomized and treated (148 patients in incoBoNT/A group, 72 patients in placebo group). A total of 35 patients aged 2–5 years received incoBoNT/A (no placebo). A total of 214 patients aged 6–17 years and 33 patients aged 2–5 years continued treatment in the open-label extension period. For the 6- to 17-year-olds, a significant difference between incoBoNT/A and placebo was seen in mean uSFR decrease (difference −0.06 g/min; p = 0.0012) and the carers' GICS rating (difference 0.28 points; p = 0.032) at week 4, in favor of active treatment. The secondary endpoints consistently supported these results. A sustained benefit was observed during the extension. Incidences of adverse events were comparable between incoBoNT/A and placebo and did not increase notably with repeated injections. The most common adverse events were respiratory infections. Efficacy and safety were also favorable in the uncontrolled cohort of 2- to 5-year-olds.DiscussionBoth co–primary efficacy endpoints were reached and superiority of incoBoNT/A over placebo was confirmed. IncoBoNT/A (up to 75 U, up to 4 cycles) is an effective and well-tolerated treatment for sialorrhea associated with neurologic disorders in children.Trial Registration InformationClinicaltrials.gov: NCT02270736 (clinicaltrials.gov/ct2/show/results/NCT02270736); EU Clinical Trials Register: 2013-004532-30 (clinicaltrialsregister.eu/ctr-search/search?query=2013-004532-30).Classification of EvidenceThis study provides Class I evidence that injection of incobotulinumtoxinA decreases drooling in children aged 6 to 17 years with neurologic disorders.

The One21 Technique: An Individualized Treatment for Glabellar Lines Based on Clinical and Anatomical Landmarks.

PurposeBotulinum toxin type A is an effective treatment for glabellar dynamic wrinkles. As the muscular group involved in the contraction of the glabella varies among people, individualized treatment can achieve optimal results. This study evaluates a customized assessment for the treatment of glabellar lines with Incobotulinumtoxin-A, leading to an individualized points distribution and dosage.Patients and MethodsA single-center, evaluator-blinded, therapeutic cohort study enrolled 130 women with moderate or severe glabellar wrinkles. They underwent Incobotulinumtoxin-A injection following the standard 5-point injection at the glabellar muscles (n = 65) or an individualized assessment and scheme treatment based on anatomical references of contraction, the One21 technique (n = 65). All the patients were photographed under maximum contraction before treatment (T0) and after 4 weeks (T28). The photos were randomly assessed by two blinded, experienced raters to consensually grade the severity according to the Merz Aesthetics Scales (MAS). The primary clinical efficacy was defined as a 2-point reduction in the MAS score, on Day 28.ResultsThe groups were homogeneous regarding age, phototype, and baseline MAS scores. On Day 28 (T28), 64 (98.5%) patients from the One21 group and 52 (80%) from the 5-point group reduced the MAS score by at least two points (p < 0.01). When adjusted by age and phototype, both groups reduced the MAS score at T28 (p < 0.01); nevertheless, patients from the One21 group significantly performed better (p < 0.01), with a much higher rate response rate at T28, in comparison to the 5-point group. Of patients enrolled in the 5-point group, 83.1% utilized muscle groups other than the procerus and corrugator in glabellar wrinkle formation, and 17 (24.6%) presented asymmetrical contraction. Patients from the 5-point group with glabellar asymmetry and those who utilized the frontalis and orbicularis presented inferior performance (p < 0.05), reinforcing the importance of an individualized assessment and treatment plan.ConclusionThe One21 technique yielded better results than the standard 5-point treatment in reducing glabellar dynamic lines with Incobotulinumtoxin-A, especially for asymmetric lines of the glabella or the involvement of muscle groups other than the procerus and corrugator.

Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis.

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.

Tailored eyebrow shape and positioning using incobotulinumtoxinA injection in the upper face

Tailored eyebrow shape and positioning using incobotulinumtoxinA injection in the upper face

Comparison of two incobotulinumtoxinA injection techniques for treating axillary hyperhidrosis

Comparison of two incobotulinumtoxinA injection techniques for treating axillary hyperhidrosis

IncobotulinumtoxinA injection for sebum control, face lifting, and pore size improvement

IncobotulinumtoxinA injection for sebum control, face lifting, and pore size improvement

Duration of treatment effect using incobotulinumtoxinA for upper-limb spasticity: A post hoc analysis

The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12-20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.