- Email: [email protected]
botulinum toxin treatment for spasticity: Clinical experience with changing from abobotulinumtoxina (DYSPORT) to incobotulinumtoxina (XEOMIN)
Abstracts / Toxicon 123 (2016) S2eS90
47. BOTULINUM TOXIN TREATMENT FOR SPASTICITY: CLINICAL EXPERIENCE WITH CHANGING FROM ABOBOTULINUMTOXINA (DYSPORT) TO INCOBOTULINUMTOXINA (XEOMIN) Martin Cossar*, Alastair Cozens. NHS Grampian, Specialist Rehabilitation Service, Woodend Hospital, Aberdeen, UK * Corresponding author: Loma Linda University School of Medicine, 11370 Anderson Street, Suite B-100, Loma Linda, CA 92354, USA. E-mail address:martin.cossar@ nhs.net.
Introduction and objectives: Our Posture and Movement Clinic provides botulinum toxin treatment for outpatients with spasticity of various etiologies. In 2013, we changed formulation from abobotulinumtoxinA (Dysport) to incobotulinumtoxinA (Xeomin). Here we review treatment outcomes with both formulations. Methods: Treatment intervals, dosing, muscles injected, treatment goals, goal attainment (yes, partial, or no), and occurrence of adverse reactions were recorded. Dosing was adjusted based on previous treatment outcomes and clinical need. However, the abobotulinumtoxinA (500 units [U]/ 2.5 milliliters [mL] saline) to incobotulinumtoxinA (100 U/2.0 mL saline) unit ratio was generally 4:1. Electrostimulation guidance was used routinely. Results: From September 2012 to February 2013, we treated 36 consecutive spasticity outpatients with abobotulinumtoxinA. Of these, 23 patients (ages 26 to 86 years; 9 male) required retreatment and were switched to incobotulinumtoxinA. Most patients had spasticity due to stroke (n¼16) or multiple sclerosis (n¼4). The most frequent treatment goal was to support the use of ankle-foot or wrist-hand orthoses (n¼14). All patients at least partially achieved their treatment goals after their last abobotulinumtoxinA treatment (mean [standard deviation; SD] dose, 819.3 [411.4] U; range, 150 to 1500 U). The first incobotulinumtoxinA treatment was given 8 to 38 weeks (mean, [SD] 21.6 [7.2] weeks) after abobotulinumtoxinA treatment, with a mean (SD) dose of 196.1 (106.1) U (range, 35 to 400 U). All patients at least partially achieved their treatment goals after their first incobotulinumtoxinA treatment without adverse reactions. IncobotulinumtoxinA retreatment was required by 16/23 patients after a mean (SD) of 24.3 (12.4) weeks (range, 12 to 56 weeks). Conclusions: In our clinic, abobotulinumtoxinA and incobotulinumtoxinA, given at an approximate 4:1 unit ratio, were similarly effective and well tolerated for the treatment of spasticity. Editorial support funded by: Merz Pharmaceuticals Keywords: AbobotulinumtoxinA; Botulinum toxin type A; IncobotulinumtoxinA; Spasticity; Treatment goals 48. PSEUDODYSTONIC UPPER LIMB SECONDARY TO THALAMIC LESIONS: USEFULNESS OF ULTRASOUND-GUIDED BOTULINUM TOXIN TREATMENT Cristina Costa*, Patrícia Pita Lobo. Department of Neurology, Hospital Prof Dr Fernando Fonseca, Amadora, Portugal * Corresponding author: Department of Neurology, Hospital Prof Dr Fernando Fonseca, EPE, 2720-176 Amadora, Portugal. E-mail address:[email protected].
Introduction: Botulinum toxin is used as first-line treatment for focal dystonias, but its usefulness in the treatment of pseudodystonia due to lesions involving the proprioceptive pathways is unknown. Methods: Patient #1: A 36-year-old man with abnormal movements of the left upper limb interfering with activities of daily living (ADLs). MRI showed a chronic lesion of the right dorsolateral thalamus. Examination revealed dystonic postures and choreatic movements, as well as a proprioceptive defect of the non-functional arm. Patient #2: A 54-year-old man with small vessel left thalamo-capsular stroke presenting with a right sensorimotor deficit and hemiataxia. Despite resolution of hemiparesis, clumsiness and abnormal postures of the right hand persisted, interfering with ADLs. Examination disclosed mild somatosensory and proprioceptive impairment, astereognosis, normal muscle strength, ataxia, mild spasticity and dystonia of the right
S19
hand. Botulinum toxin (Botox®, Allergan) was administered (3 sessions at 3-month intervals) using ultrasound guidance to both agonist and antagonist muscles of the affected upper arm. Total dose on last treatment was 305 U and 125 U for patients 1 and 2, respectively. Patients were assessed using Goal Attainment scaling (GAS) at baseline (P0-pretreatment) and 6 weeks after the 3rd treatment (P3). Results: Both patients reported complete relief of pain, as well as significant improvement in involuntary movement frequency and severity from P0 to P3, enabling or facilitating ADLs. GAS change score (P1 to P3) was 36.5 (patient 1) and 21.7 (patient 2). No significant change in muscle tone was noted between P0 and P3. Conclusions: Significant functional gains were obtained in these two patients with pseudodystonia, despite the somatosensory nature of their deficits. Botulinum toxin treatment may be a useful treatment option for patients with thalamic pseudodystonia of the upper limb. Keywords: Botulinum toxin; Dystonia; Pseudodystonia 49. EFFICACY AND SAFETY OF ONABOTULINUMTOXINA 100 U FOR TREATMENT OF URINARY INCONTINENCE DUE TO NEUROGENIC DETRUSOR OVERACTIVITY IN NONCATHETERIZING MULTIPLE SCLEROSIS PATIENTS Francisco Cruz a,*, Pierre Denys b, Veronique Keppenne c, Alfred Kohan d, Benjamin Brucker e, Blair Egerdie f, Andrew Magyar g, J.P. Nicandro h, Brenda Jenkins h, Emmanuel Chartier-Kastler i. a ~o & Universidade Do Porto, Porto, Portugal; b Ho ^pital Raymond Hospital S. Joa e de Li ege, Poincar e, Department of Neuro-urology, Garches, France; c Universit Department of Urology, Li ege, Belgium; d Advanced Urology Centers of New York, Bethpage, NY, USA; e New York University, Departments of Urology and Obstetrics & Gynecology, New York, NY, USA; f Urology Associates/Urologic Med Research, Kitchener, Ontario, Canada; g Allergan, plc, Bridgewater, NJ, e Paris-VI, Paris, Department USA; h Allergan, plc, Irvine, CA, USA; i Universit of Urology, France ~o & * Corresponding author: Department of Neurology and IBMC Hospital S. Joa ^ni Monteiro, Porto 4200-319, Portugal. Universidade Do Porto, Alameda Prof. Herna E-mail address:[email protected].
Introduction: A multicenter, double-blind study evaluated the efficacy and safety of onabotulinumtoxinA (onabotA) 100 U in patients (pts) with neurogenic detrusor overactivity due to multiple sclerosis (MS) who were not using clean intermittent catheterization (CIC) at baseline and were inadequately managed by 1 anticholinergic (ACH) agent. Methods: Eligible pts received 1 treatment of onabotA 100 U (n¼66) or placebo (pbo) (n¼78) given as 30 1-mL intradetrusor injections via cystoscopy. Pts could request 1 additional open-label onabotA treatment if they qualified for retreatment (12 weeks since first treatment, 2 urinary incontinence [UI] episodes, and 1 UI-free day over 3 days, and a postvoid residual volume <200 mL). Assessments were change from baseline at week 6 in UI episodes/day, maximum cystometric (bladder) capacity (MCC), maximum detrusor pressure (MDP) during first involuntary detrusor contraction (IDC), and Incontinence Quality of Life (I-QOL) total score. Also assessed were proportions of pts achieving 100% UI reduction at 6 weeks, duration of effect (DOE), adverse events (AEs), and CIC initiation. Results: OnabotA significantly improved UI episodes/day vs pbo (e3.3 vs e1.1; P<0.001), MCC (+127.2 vs e1.8 mL; P<0.001), and MDP during first IDC (e19.6 vs 3.7 cm H2O; P<0.01). A significantly greater proportion of onabotA pts achieved 100% UI reduction vs pbo (53.0% vs 10.3%; P<0.001). Improvements in I-QOL total score were significantly greater with onabotA vs pbo (40.4 vs 9.9; P<0.001) and approximately 3 times the minimally important difference (+11 points). DOE for onabotA was significantly longer vs pbo (11.9 vs 2.9 mos; P<0.001). Urinary tract infection was the most common AE. CIC rates (due to AE of urinary retention) were 15.2% vs 2.6% with onabotA vs pbo. Conclusions: In noncatheterizing MS pts who were inadequately managed by 1 ACH agent, onabotA treatment resulted in significant and clinically meaningful improvements in UI, MCC, MDP at first IDC, QOL, and DOE vs pbo and was well tolerated. Funding: Allergan.
47. BOTULINUM TOXIN TREATMENT FOR SPASTICITY: CLINICAL EXPERIENCE WITH CHANGING FROM ABOBOTULINUMTOXINA (DYSPORT) TO INCOBOTULINUMTOXINA (XEOMIN) Martin Cossar*, Alastair Cozens. NHS Grampian, Specialist Rehabilitation Service, Woodend Hospital, Aberdeen, UK * Corresponding author: Loma Linda University School of Medicine, 11370 Anderson Street, Suite B-100, Loma Linda, CA 92354, USA. E-mail address:martin.cossar@ nhs.net.
Introduction and objectives: Our Posture and Movement Clinic provides botulinum toxin treatment for outpatients with spasticity of various etiologies. In 2013, we changed formulation from abobotulinumtoxinA (Dysport) to incobotulinumtoxinA (Xeomin). Here we review treatment outcomes with both formulations. Methods: Treatment intervals, dosing, muscles injected, treatment goals, goal attainment (yes, partial, or no), and occurrence of adverse reactions were recorded. Dosing was adjusted based on previous treatment outcomes and clinical need. However, the abobotulinumtoxinA (500 units [U]/ 2.5 milliliters [mL] saline) to incobotulinumtoxinA (100 U/2.0 mL saline) unit ratio was generally 4:1. Electrostimulation guidance was used routinely. Results: From September 2012 to February 2013, we treated 36 consecutive spasticity outpatients with abobotulinumtoxinA. Of these, 23 patients (ages 26 to 86 years; 9 male) required retreatment and were switched to incobotulinumtoxinA. Most patients had spasticity due to stroke (n¼16) or multiple sclerosis (n¼4). The most frequent treatment goal was to support the use of ankle-foot or wrist-hand orthoses (n¼14). All patients at least partially achieved their treatment goals after their last abobotulinumtoxinA treatment (mean [standard deviation; SD] dose, 819.3 [411.4] U; range, 150 to 1500 U). The first incobotulinumtoxinA treatment was given 8 to 38 weeks (mean, [SD] 21.6 [7.2] weeks) after abobotulinumtoxinA treatment, with a mean (SD) dose of 196.1 (106.1) U (range, 35 to 400 U). All patients at least partially achieved their treatment goals after their first incobotulinumtoxinA treatment without adverse reactions. IncobotulinumtoxinA retreatment was required by 16/23 patients after a mean (SD) of 24.3 (12.4) weeks (range, 12 to 56 weeks). Conclusions: In our clinic, abobotulinumtoxinA and incobotulinumtoxinA, given at an approximate 4:1 unit ratio, were similarly effective and well tolerated for the treatment of spasticity. Editorial support funded by: Merz Pharmaceuticals Keywords: AbobotulinumtoxinA; Botulinum toxin type A; IncobotulinumtoxinA; Spasticity; Treatment goals 48. PSEUDODYSTONIC UPPER LIMB SECONDARY TO THALAMIC LESIONS: USEFULNESS OF ULTRASOUND-GUIDED BOTULINUM TOXIN TREATMENT Cristina Costa*, Patrícia Pita Lobo. Department of Neurology, Hospital Prof Dr Fernando Fonseca, Amadora, Portugal * Corresponding author: Department of Neurology, Hospital Prof Dr Fernando Fonseca, EPE, 2720-176 Amadora, Portugal. E-mail address:[email protected].
Introduction: Botulinum toxin is used as first-line treatment for focal dystonias, but its usefulness in the treatment of pseudodystonia due to lesions involving the proprioceptive pathways is unknown. Methods: Patient #1: A 36-year-old man with abnormal movements of the left upper limb interfering with activities of daily living (ADLs). MRI showed a chronic lesion of the right dorsolateral thalamus. Examination revealed dystonic postures and choreatic movements, as well as a proprioceptive defect of the non-functional arm. Patient #2: A 54-year-old man with small vessel left thalamo-capsular stroke presenting with a right sensorimotor deficit and hemiataxia. Despite resolution of hemiparesis, clumsiness and abnormal postures of the right hand persisted, interfering with ADLs. Examination disclosed mild somatosensory and proprioceptive impairment, astereognosis, normal muscle strength, ataxia, mild spasticity and dystonia of the right
S19
hand. Botulinum toxin (Botox®, Allergan) was administered (3 sessions at 3-month intervals) using ultrasound guidance to both agonist and antagonist muscles of the affected upper arm. Total dose on last treatment was 305 U and 125 U for patients 1 and 2, respectively. Patients were assessed using Goal Attainment scaling (GAS) at baseline (P0-pretreatment) and 6 weeks after the 3rd treatment (P3). Results: Both patients reported complete relief of pain, as well as significant improvement in involuntary movement frequency and severity from P0 to P3, enabling or facilitating ADLs. GAS change score (P1 to P3) was 36.5 (patient 1) and 21.7 (patient 2). No significant change in muscle tone was noted between P0 and P3. Conclusions: Significant functional gains were obtained in these two patients with pseudodystonia, despite the somatosensory nature of their deficits. Botulinum toxin treatment may be a useful treatment option for patients with thalamic pseudodystonia of the upper limb. Keywords: Botulinum toxin; Dystonia; Pseudodystonia 49. EFFICACY AND SAFETY OF ONABOTULINUMTOXINA 100 U FOR TREATMENT OF URINARY INCONTINENCE DUE TO NEUROGENIC DETRUSOR OVERACTIVITY IN NONCATHETERIZING MULTIPLE SCLEROSIS PATIENTS Francisco Cruz a,*, Pierre Denys b, Veronique Keppenne c, Alfred Kohan d, Benjamin Brucker e, Blair Egerdie f, Andrew Magyar g, J.P. Nicandro h, Brenda Jenkins h, Emmanuel Chartier-Kastler i. a ~o & Universidade Do Porto, Porto, Portugal; b Ho ^pital Raymond Hospital S. Joa e de Li ege, Poincar e, Department of Neuro-urology, Garches, France; c Universit Department of Urology, Li ege, Belgium; d Advanced Urology Centers of New York, Bethpage, NY, USA; e New York University, Departments of Urology and Obstetrics & Gynecology, New York, NY, USA; f Urology Associates/Urologic Med Research, Kitchener, Ontario, Canada; g Allergan, plc, Bridgewater, NJ, e Paris-VI, Paris, Department USA; h Allergan, plc, Irvine, CA, USA; i Universit of Urology, France ~o & * Corresponding author: Department of Neurology and IBMC Hospital S. Joa ^ni Monteiro, Porto 4200-319, Portugal. Universidade Do Porto, Alameda Prof. Herna E-mail address:[email protected].
Introduction: A multicenter, double-blind study evaluated the efficacy and safety of onabotulinumtoxinA (onabotA) 100 U in patients (pts) with neurogenic detrusor overactivity due to multiple sclerosis (MS) who were not using clean intermittent catheterization (CIC) at baseline and were inadequately managed by 1 anticholinergic (ACH) agent. Methods: Eligible pts received 1 treatment of onabotA 100 U (n¼66) or placebo (pbo) (n¼78) given as 30 1-mL intradetrusor injections via cystoscopy. Pts could request 1 additional open-label onabotA treatment if they qualified for retreatment (12 weeks since first treatment, 2 urinary incontinence [UI] episodes, and 1 UI-free day over 3 days, and a postvoid residual volume <200 mL). Assessments were change from baseline at week 6 in UI episodes/day, maximum cystometric (bladder) capacity (MCC), maximum detrusor pressure (MDP) during first involuntary detrusor contraction (IDC), and Incontinence Quality of Life (I-QOL) total score. Also assessed were proportions of pts achieving 100% UI reduction at 6 weeks, duration of effect (DOE), adverse events (AEs), and CIC initiation. Results: OnabotA significantly improved UI episodes/day vs pbo (e3.3 vs e1.1; P<0.001), MCC (+127.2 vs e1.8 mL; P<0.001), and MDP during first IDC (e19.6 vs 3.7 cm H2O; P<0.01). A significantly greater proportion of onabotA pts achieved 100% UI reduction vs pbo (53.0% vs 10.3%; P<0.001). Improvements in I-QOL total score were significantly greater with onabotA vs pbo (40.4 vs 9.9; P<0.001) and approximately 3 times the minimally important difference (+11 points). DOE for onabotA was significantly longer vs pbo (11.9 vs 2.9 mos; P<0.001). Urinary tract infection was the most common AE. CIC rates (due to AE of urinary retention) were 15.2% vs 2.6% with onabotA vs pbo. Conclusions: In noncatheterizing MS pts who were inadequately managed by 1 ACH agent, onabotA treatment resulted in significant and clinically meaningful improvements in UI, MCC, MDP at first IDC, QOL, and DOE vs pbo and was well tolerated. Funding: Allergan.