- Email: [email protected]
110. Factors influencing goal attainment in patients with poststroke upper limb spasticity following treatment with botulinum neurotoxin A in real-life clinical practice: subanalyses from the Upper Limb International Spasticity (ULIS)-II Study
Abstracts / Toxicon 93 (2015) S2eS67
107. INFILTRATION WITH BOTULINUM NEUROTOXIN A (XEOMIN) IN FLEXIBLE INTERVALS TO REACH APPROPRIATE MODULATION OF SPASTICITY Giancarlo Ianieri*, E. Romanelli, L. Mastromauro, R. Marvulli, G.B. Marzo Neurorehabilitation, Policlinico of Bari, Bari, Puglia, Italy *Corresponding author: Neurorehabilitation, Policlinico of Bari, Bari, Puglia 70124, Italy. E-mail address: [email protected]
Introduction and Objectives: Current standard treatment for patients with spasticity includes botulinum toxin infiltrations at intervals of no less than 3 months. However, in clinical practice, some patients need more closely spaced treatments in order to adequately modulate spastic hypertonia and to ensure their satisfaction. The aim of this study was to investigate whether reduction of intervals between incobotulinumtoxin A (Xeomin) infiltrations results in a significant reduction of treatment clinical efficacy over time or a rise in adverse reactions. Methods: We evaluated the effects of flexible intervals of incobotulinumtoxin A infiltrations (6, 12, 16 weeks) in 28 patients with left spasticity treated for a period of 16 months. We analyzed 3 parameters: patient satisfaction (outcome), Modified Ashworth Scale (MAS), and myotonometry (MYO), which represents a noninvasive way to characterize the viscoelastic properties (tone, elasticity, stiffness) of skeletal muscles. Statistical analysis was performed using one-way ANOVA. Results: Therapeutic effect of infiltration at different time intervals was maintained constant in time (P<0.05). Conclusions: The opportunity to reduce the time between infiltrations is due to the pharmacologic properties of incobotulinumtoxin A, which is free from complexing proteins. Infiltrations administered at flexible intervals (6 to 16 weeks) were well tolerated by patients and modulated the spasticity satisfactorily, allowing a personalized treatment. Last, we found that the therapeutic effect of this new strategy remains constant over time.
S33
Animal studies indicate an analgesic effect for botulinum neurotoxins (BoNTs) via inhibition of pain mediator release, decreased inflammation, and other mechanisms. In the past 10 years, a number of high-quality studies have been published suggesting or indicating the efficacy of BoNTs in relieving different types of neuropathic pain. Using the efficacy criteria recommended by the Assessment Subcommittee of the American Academy of Neurology (French 2008), the use of BoNTs for neck pain of cervical dystonia, postherpetic neuralgia, and pain of chronic lateral epicondylitis meets the level of evidence established for a Level A recommendation (2 or more class I studies). For post-traumatic neuralgia, plantar fasciitis, trigeminal neuralgia, piriformis syndrome, and pain associated with total knee arthroplasty, the evidence supports a level B rating: probably effective based on availability of 1 class I or 2 class II studies. BoNTs are possibly effective (Level C) in allodynia of diabetic neuropathy, pelvic pain, painful knee osteoarthritis, low back pain, postoperative pain in children with cerebral palsy after adductor release surgery, anterior knee pain with vastus lateralis imbalance, postoperative pain after mastectomy, anal sphincter spasms, and pain after hemorrhoidectomy (1 class II study). For carpal tunnel syndrome and phantom pain, 1 class I study showed significant difference compared with placebo (Level B, probably ineffective). The positive results of BoNT therapy in postherpetic neuralgia, post-traumatic neuralgia, trigeminal neuralgia and plantar fasciitis is a major development in pain medicine, since these disorders are common and the patients are often not satisfied with their current level of pain relief. It is anticipated that careful future clinical trials aiming to find the optimum dose, injection sites, and primary outcomes will improve the level of evidence for BoNTs in other areas of human pain. Reference French J, Gronseth G. Lost in a jungle of evidence: We need a compass. Neurology. 2008;71:1634-1638. 110. FACTORS INFLUENCING GOAL ATTAINMENT IN PATIENTS WITH POSTSTROKE UPPER LIMB SPASTICITY FOLLOWING TREATMENT WITH BOTULINUM NEUROTOXIN A IN REAL-LIFE CLINICAL PRACTICE: SUBANALYSES FROM THE UPPER LIMB INTERNATIONAL SPASTICITY (ULIS)-II STUDY Jorge Jacinto a,*, Klemens Fheodoroff b, Stephen Ashford c, Pascal Maisonobe d, Jovita Balcaitiene d, Lynne Turner-Stokes c a ~o Center of Rehabilitation Medicine, Cascais, Portugal; b GailtalAlcoita Klinik, Hermagor, Austria; c Regional Rehabilitation Unit, Northwick Park Hospital, Middlesex, UK; d Ipsen Pharma, Boulogne-Billancourt, France ~o Center of Rehabilitation Medicine, Serviço de *Corresponding author: Alcoita ~o de Adultos 3, Rua Conde Bara ~o, Alcabideche, Cascais 2649-506, Reabilitaça Portugal. E-mail address: [email protected]
Ă
Keywords: New strategy; Spasticity References €mper P. Essential blepharospasm: Practice-oriented Wabbels B, Roggenka therapy with botulinum toxin employing reduced treatment intervals. Ophthalmologe. 2012;109(1):45-53. Bakheit AM, Liptrot A, Newton R, Pickett AM. The effect of total cumulative dose, number of treatment cycles, interval between injections, and length of treatment on the frequency of occurrence of antibodies to botulinum toxin type A in the treatment of muscle spasticity. Int J Rehabil Res. 2012 Mar;35(1):36-39. 108. MAXIMIZING OUTCOMES IN SPASTICITY USING BONT Cindy Ivanhoe Baylor College of Medicine, 1333 Moursund Avenue, D110, Houston, TX 77030, USA. E-mail address: [email protected] 109. PAIN OTHER THAN HEADACHES Bahman Jabbari Department of Neurology, Yale University, LCI 920 C, 15 York Street, New Haven, CT 06510, USA. E-mail address: [email protected]
Introduction and Objectives: In ULIS-II, botulinum neurotoxin A (BoNT/A) treatment of poststroke upper limb spasticity (ULS) had a clinically significant impact on attainment of person-centered primary goals of rehabilitation, as measured by goal attainment scaling. This post-hoc analysis aimed to determine factors that influenced goal setting and achievement in ULIS-II. Methods: Patients' (N¼456, from 84 centers in 22 countries) baseline characteristics, impairment severity, and achievement of primary goals were identified in relation to passive function, active function, or pain goals. Impact of time elapsed since stroke to BoNT/A in ULIS-II, presence of severe soft tissue shortening (STS), and intensity of therapeutic input (TI) on goal setting and achievement were also analyzed. Results: Patients who set passive-function primary goals had greater motor impairment (P<0.001), STS (P¼0.006), and spasticity (P¼0.02) than those who set other primary goals. Patients with active-function primary goals had less motor impairment (P<0.0001), STS (P<0.0001), and spasticity (P<0.001), and shorter time since stroke (P¼0.001). Patients with primary pain goals were older (P¼0.01), with more STS (P¼0.008). Primary-goal achievement rates were similar between patients with 1 year (medium) and >1 year (longer) time from stroke to inclusion in ULIS-II (76.6% vs 80.2%) and with or without STS (76.7% vs 80.6%). Patients with a longer interval after stroke (>1 year) were still capable of achieving their individual goal set (74%). Primary-goal achievement was greater in patients receiving high- compared with low-intensity TI (83.6% vs 74.6%; P<0.05) during the study. Primary-goal setting was influenced by
S34
Abstracts / Toxicon 93 (2015) S2eS67
impairment, age, and time since stroke. Overall primary goal achievement was mainly impacted by concomitant TI. Conclusions: Our findings resonate with clinical experience and may assist in establishing future guidelines for selecting patients and goals for treatment with BoNT/A in ULS. Keywords: Botulinum toxin A; Goal attainment scaling (GAS); Stroke; Upper limb spasticity 111. LONG-TERM EFFECTS OF BOTULINUM TOXIN INJECTIONS Joseph Jankovic Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, TX, USA. E-mail address: [email protected]
Local chemodenervation with botulinum toxin (BoNT) injections to relax abnormally contracting muscles has been shown to be an effective and well-tolerated treatment in a variety of movement disorders and other neurologic and non-neurologic disorders. Despite 3 decades of therapeutic use, there are only a few longitudinal studies of BoNT (Ramirez-Castaneda 2013). Placebo-controlled studies, which are required for evidence-based reviews, typically consist of short-term clinical trials (Hallett 2013). Besides a highly positive impact on the quality of life, repeat BoNT treatments may favorably modify the natural history of this disease by way of effects such as preventing contractures in patients with cervical dystonia. In 2005, we published longitudinal follow-up data on 45 patients who had received BoNT treatments continuously for a mean period of 15.8 years at Baylor College of Medicine Movement Disorders Clinic (Mejia 2005). In a more recent analysis of a total of 1636 patients initially treated with BoNT between September 1, 1981, and December 31, 1996, we identified 89 patients (67 female) treated with BoNT for dystonia (51 with cervical dystonia and the others with cranial dystonia) with at least 1 injection visit per year for at least 10 years for up to 26 years (mean follow-up period of 18.5 years) (Ramirez-Castaneda 2014). The total number of onabotulinumtoxinA (Botox) units received during the first injection visit was 140.3 vs 224.5 at the last injection visit (P<0.0001). The global response effect (assessed on a 0 to 4 scale where 4¼marked improvement in severity and function), which takes into account the peak benefit minus adverse effect, was 3.18 after the first injection session and 3.57 after the last injection (P<0.0001). The response latency decreased from 5.5 days after the first injection to 3.3 after the last injection (P<0.0001). The duration in weeks of response after the initial injection session and at the last injection was 16.33 weeks vs 19.42 weeks (P¼0.0037), respectively. Adverse events, typically related to the site of injection, were reported in 19% of visits. Ours and other published data clearly support the conclusion that BoNT provides safe and effective long-term relief of dystonia. The adverse events associated with chronic, periodic exposure to BoNT injections are generally minor and self-limiting. References Hallett M, Albanese A, Dressler D, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of movement disorders. Toxicon. 2013;67:94-114. Mejia NI, Vuong KD, Jankovic J. Long-term botulinum toxin efficacy, safety, and immunogenicity. Mov Disord. 2005;20(5):592-597. Ramirez-Castaneda J, Jankovic J. Long-term efficacy and safety of botulinum toxin injections in dystonia. Toxins (Basel). 2013;5(2):249-266. Ramirez-Castaneda J, Jankovic J. Long-term efficacy, safety, and side effect profile of botulinum toxin in dystonia: a 20-year follow-up. Toxicon. 2014;90:344-348. 112. BASELINE DEMOGRAPHICS AND EVALUATION OF HEALTH UTILITY IN MOVEMENT DISORDER PATIENTS RECEIVING ONABOTULINUMTOXINA (BOTOX) TREATMENT IN A PROSPECTIVE OBSERVATIONAL COHORT STUDY: MOBILITY Mandar Jog a, *, Meetu Bhogal b, Grace Trentin b London Health Sciences Centre, London, ON, Canada; b Allergan, Markham, ON, Canada a
*Corresponding author: London Health Sciences Centre, 339 Windermere Road, A10-026, London, ON N6A 5A5, Canada. E-mail address: [email protected]
Introduction and Objectives: OnabotulinumtoxinA (onabotA) is an important treatment option for patients with movement disorders (MD). While studies have reported on the clinical efficacy of onabotA, patientreported outcomes (PRO) data are limited. This analysis describes baseline demographics and health utility (HU) in MD patients treated with onabotA. Methods: MOBILITY is a Canadian multicenter, observational study in patients initiating (naive) or receiving ongoing (maintenance) onabotA treatment. HU was the primary outcome measure, obtained from the SF-12 Health Survey using the SF-6D at baseline, week 4 post-treatment and up to 5 subsequent injection visits. Mean and 95% confidence intervals were calculated for HU scores. The safety cohort included patients who received 1 treatment. Results: A total of 455 MD patients (blepharospasm [n¼83], cervical dystonia [CD; n¼250], and hemifacial spasm [HFS, N¼122]) were enrolled, with 266 completing. Patients were aged 17 to 91 years (mean¼60 years, SD¼12); 66% were female (n¼299); 90%, Caucasian (n¼410); 25%, naive (n¼114); and 75% (n¼341), maintenance. Highest mean baseline HU scores were seen in HFS patients. Greatest improvements in HU scores were generally observed in CD patients. Baseline scores were generally higher in maintenance vs naive patients; however, greatest changes from baseline were in naive patients. Overall, mean HU scores generally increased and/or were maintained over time in all cohorts. The MD safety cohort reported 137 adverse events (AEs) in 47 patients; 51 (37%) were serious in 22 (5%) patients, and 103 (75%) were considered unrelated to treatment. The most commonly reported AEs were dysphagia (n¼7; 5%) and falls (n¼7; 5%). Conclusions: The majority of MD patients in MOBILITY were female, Caucasian, and on maintenance onabotA treatment. Data indicate that onabotA treatment may improve HU in MD patients over time. Keywords: Blepharospasm; Botulinum toxins; Cervical dystonia; Hemifacial spasm; Movement disorders; Type A
113. TREATMENT OF HEAD TREMOR WITH BOTULINUM TOXIN Wolfgang Jost Department of Neurology, University of Freiburg, 79106 Freiburg, Germany. E-mail address: [email protected]
Botulinum toxin has been the treatment of choice for cervical dystonia for well over 2 decades now. While the initial indication was specifically for rotatory torticollis, all the many different subtypes have since been included. In cervical dystonia, we distinguish phasic and tonic elements. Forms of dystonia with accompanying tremor are the most difficult to treat, as this usually involves a spontaneous oscillatory, often inconstant rhythmic tremor after the appearance of the cervical dystonia and is often exacerbated by an attempt to maintain normal posture. The dystonic tremor may sometimes be difficult to distinguish from essential tremor. Basically, the specific form of cervical dystonia that is already present is treated first: antero-, retro-, latero-, and rotatory forms of torticaput and/ or torticollis. In cases presenting with a tremor, electromyography can prove useful for the diagnosis and the evaluation of the muscles directly involved, both initially and throughout the course of treatment. Because dystonic tremor frequently involves several muscles that are difficult to inject, the use of sonography may be necessary in many cases as a control over the injection, as in the case of the obliquus capitis inferior muscle. A concomitant treatment of contralateral muscles not directly involved in the dystonia, such as the splenius capitis muscle, may frequently be needed. Essential head tremor can also be treated with botulinum toxin. In these cases, the head tremor is primarily treated, usually involving muscles on both sides, but with a smaller dosage because the muscles are not dystonic. In such cases, electromyography for diagnosing the muscles concerned is recommended both at the start and during the course of treatment. Again, sonography can be useful for injection control. However, as this treatment has not yet been approved, it has not been widely used to date. Basically, the other forms of head tremor can be treated with botulinum toxin as well, although experience here is even more limited. Keywords: Botulinum toxin; Cervical dystonia; Tremor
107. INFILTRATION WITH BOTULINUM NEUROTOXIN A (XEOMIN) IN FLEXIBLE INTERVALS TO REACH APPROPRIATE MODULATION OF SPASTICITY Giancarlo Ianieri*, E. Romanelli, L. Mastromauro, R. Marvulli, G.B. Marzo Neurorehabilitation, Policlinico of Bari, Bari, Puglia, Italy *Corresponding author: Neurorehabilitation, Policlinico of Bari, Bari, Puglia 70124, Italy. E-mail address: [email protected]
Introduction and Objectives: Current standard treatment for patients with spasticity includes botulinum toxin infiltrations at intervals of no less than 3 months. However, in clinical practice, some patients need more closely spaced treatments in order to adequately modulate spastic hypertonia and to ensure their satisfaction. The aim of this study was to investigate whether reduction of intervals between incobotulinumtoxin A (Xeomin) infiltrations results in a significant reduction of treatment clinical efficacy over time or a rise in adverse reactions. Methods: We evaluated the effects of flexible intervals of incobotulinumtoxin A infiltrations (6, 12, 16 weeks) in 28 patients with left spasticity treated for a period of 16 months. We analyzed 3 parameters: patient satisfaction (outcome), Modified Ashworth Scale (MAS), and myotonometry (MYO), which represents a noninvasive way to characterize the viscoelastic properties (tone, elasticity, stiffness) of skeletal muscles. Statistical analysis was performed using one-way ANOVA. Results: Therapeutic effect of infiltration at different time intervals was maintained constant in time (P<0.05). Conclusions: The opportunity to reduce the time between infiltrations is due to the pharmacologic properties of incobotulinumtoxin A, which is free from complexing proteins. Infiltrations administered at flexible intervals (6 to 16 weeks) were well tolerated by patients and modulated the spasticity satisfactorily, allowing a personalized treatment. Last, we found that the therapeutic effect of this new strategy remains constant over time.
S33
Animal studies indicate an analgesic effect for botulinum neurotoxins (BoNTs) via inhibition of pain mediator release, decreased inflammation, and other mechanisms. In the past 10 years, a number of high-quality studies have been published suggesting or indicating the efficacy of BoNTs in relieving different types of neuropathic pain. Using the efficacy criteria recommended by the Assessment Subcommittee of the American Academy of Neurology (French 2008), the use of BoNTs for neck pain of cervical dystonia, postherpetic neuralgia, and pain of chronic lateral epicondylitis meets the level of evidence established for a Level A recommendation (2 or more class I studies). For post-traumatic neuralgia, plantar fasciitis, trigeminal neuralgia, piriformis syndrome, and pain associated with total knee arthroplasty, the evidence supports a level B rating: probably effective based on availability of 1 class I or 2 class II studies. BoNTs are possibly effective (Level C) in allodynia of diabetic neuropathy, pelvic pain, painful knee osteoarthritis, low back pain, postoperative pain in children with cerebral palsy after adductor release surgery, anterior knee pain with vastus lateralis imbalance, postoperative pain after mastectomy, anal sphincter spasms, and pain after hemorrhoidectomy (1 class II study). For carpal tunnel syndrome and phantom pain, 1 class I study showed significant difference compared with placebo (Level B, probably ineffective). The positive results of BoNT therapy in postherpetic neuralgia, post-traumatic neuralgia, trigeminal neuralgia and plantar fasciitis is a major development in pain medicine, since these disorders are common and the patients are often not satisfied with their current level of pain relief. It is anticipated that careful future clinical trials aiming to find the optimum dose, injection sites, and primary outcomes will improve the level of evidence for BoNTs in other areas of human pain. Reference French J, Gronseth G. Lost in a jungle of evidence: We need a compass. Neurology. 2008;71:1634-1638. 110. FACTORS INFLUENCING GOAL ATTAINMENT IN PATIENTS WITH POSTSTROKE UPPER LIMB SPASTICITY FOLLOWING TREATMENT WITH BOTULINUM NEUROTOXIN A IN REAL-LIFE CLINICAL PRACTICE: SUBANALYSES FROM THE UPPER LIMB INTERNATIONAL SPASTICITY (ULIS)-II STUDY Jorge Jacinto a,*, Klemens Fheodoroff b, Stephen Ashford c, Pascal Maisonobe d, Jovita Balcaitiene d, Lynne Turner-Stokes c a ~o Center of Rehabilitation Medicine, Cascais, Portugal; b GailtalAlcoita Klinik, Hermagor, Austria; c Regional Rehabilitation Unit, Northwick Park Hospital, Middlesex, UK; d Ipsen Pharma, Boulogne-Billancourt, France ~o Center of Rehabilitation Medicine, Serviço de *Corresponding author: Alcoita ~o de Adultos 3, Rua Conde Bara ~o, Alcabideche, Cascais 2649-506, Reabilitaça Portugal. E-mail address: [email protected]
Ă
Keywords: New strategy; Spasticity References €mper P. Essential blepharospasm: Practice-oriented Wabbels B, Roggenka therapy with botulinum toxin employing reduced treatment intervals. Ophthalmologe. 2012;109(1):45-53. Bakheit AM, Liptrot A, Newton R, Pickett AM. The effect of total cumulative dose, number of treatment cycles, interval between injections, and length of treatment on the frequency of occurrence of antibodies to botulinum toxin type A in the treatment of muscle spasticity. Int J Rehabil Res. 2012 Mar;35(1):36-39. 108. MAXIMIZING OUTCOMES IN SPASTICITY USING BONT Cindy Ivanhoe Baylor College of Medicine, 1333 Moursund Avenue, D110, Houston, TX 77030, USA. E-mail address: [email protected] 109. PAIN OTHER THAN HEADACHES Bahman Jabbari Department of Neurology, Yale University, LCI 920 C, 15 York Street, New Haven, CT 06510, USA. E-mail address: [email protected]
Introduction and Objectives: In ULIS-II, botulinum neurotoxin A (BoNT/A) treatment of poststroke upper limb spasticity (ULS) had a clinically significant impact on attainment of person-centered primary goals of rehabilitation, as measured by goal attainment scaling. This post-hoc analysis aimed to determine factors that influenced goal setting and achievement in ULIS-II. Methods: Patients' (N¼456, from 84 centers in 22 countries) baseline characteristics, impairment severity, and achievement of primary goals were identified in relation to passive function, active function, or pain goals. Impact of time elapsed since stroke to BoNT/A in ULIS-II, presence of severe soft tissue shortening (STS), and intensity of therapeutic input (TI) on goal setting and achievement were also analyzed. Results: Patients who set passive-function primary goals had greater motor impairment (P<0.001), STS (P¼0.006), and spasticity (P¼0.02) than those who set other primary goals. Patients with active-function primary goals had less motor impairment (P<0.0001), STS (P<0.0001), and spasticity (P<0.001), and shorter time since stroke (P¼0.001). Patients with primary pain goals were older (P¼0.01), with more STS (P¼0.008). Primary-goal achievement rates were similar between patients with 1 year (medium) and >1 year (longer) time from stroke to inclusion in ULIS-II (76.6% vs 80.2%) and with or without STS (76.7% vs 80.6%). Patients with a longer interval after stroke (>1 year) were still capable of achieving their individual goal set (74%). Primary-goal achievement was greater in patients receiving high- compared with low-intensity TI (83.6% vs 74.6%; P<0.05) during the study. Primary-goal setting was influenced by
S34
Abstracts / Toxicon 93 (2015) S2eS67
impairment, age, and time since stroke. Overall primary goal achievement was mainly impacted by concomitant TI. Conclusions: Our findings resonate with clinical experience and may assist in establishing future guidelines for selecting patients and goals for treatment with BoNT/A in ULS. Keywords: Botulinum toxin A; Goal attainment scaling (GAS); Stroke; Upper limb spasticity 111. LONG-TERM EFFECTS OF BOTULINUM TOXIN INJECTIONS Joseph Jankovic Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, TX, USA. E-mail address: [email protected]
Local chemodenervation with botulinum toxin (BoNT) injections to relax abnormally contracting muscles has been shown to be an effective and well-tolerated treatment in a variety of movement disorders and other neurologic and non-neurologic disorders. Despite 3 decades of therapeutic use, there are only a few longitudinal studies of BoNT (Ramirez-Castaneda 2013). Placebo-controlled studies, which are required for evidence-based reviews, typically consist of short-term clinical trials (Hallett 2013). Besides a highly positive impact on the quality of life, repeat BoNT treatments may favorably modify the natural history of this disease by way of effects such as preventing contractures in patients with cervical dystonia. In 2005, we published longitudinal follow-up data on 45 patients who had received BoNT treatments continuously for a mean period of 15.8 years at Baylor College of Medicine Movement Disorders Clinic (Mejia 2005). In a more recent analysis of a total of 1636 patients initially treated with BoNT between September 1, 1981, and December 31, 1996, we identified 89 patients (67 female) treated with BoNT for dystonia (51 with cervical dystonia and the others with cranial dystonia) with at least 1 injection visit per year for at least 10 years for up to 26 years (mean follow-up period of 18.5 years) (Ramirez-Castaneda 2014). The total number of onabotulinumtoxinA (Botox) units received during the first injection visit was 140.3 vs 224.5 at the last injection visit (P<0.0001). The global response effect (assessed on a 0 to 4 scale where 4¼marked improvement in severity and function), which takes into account the peak benefit minus adverse effect, was 3.18 after the first injection session and 3.57 after the last injection (P<0.0001). The response latency decreased from 5.5 days after the first injection to 3.3 after the last injection (P<0.0001). The duration in weeks of response after the initial injection session and at the last injection was 16.33 weeks vs 19.42 weeks (P¼0.0037), respectively. Adverse events, typically related to the site of injection, were reported in 19% of visits. Ours and other published data clearly support the conclusion that BoNT provides safe and effective long-term relief of dystonia. The adverse events associated with chronic, periodic exposure to BoNT injections are generally minor and self-limiting. References Hallett M, Albanese A, Dressler D, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of movement disorders. Toxicon. 2013;67:94-114. Mejia NI, Vuong KD, Jankovic J. Long-term botulinum toxin efficacy, safety, and immunogenicity. Mov Disord. 2005;20(5):592-597. Ramirez-Castaneda J, Jankovic J. Long-term efficacy and safety of botulinum toxin injections in dystonia. Toxins (Basel). 2013;5(2):249-266. Ramirez-Castaneda J, Jankovic J. Long-term efficacy, safety, and side effect profile of botulinum toxin in dystonia: a 20-year follow-up. Toxicon. 2014;90:344-348. 112. BASELINE DEMOGRAPHICS AND EVALUATION OF HEALTH UTILITY IN MOVEMENT DISORDER PATIENTS RECEIVING ONABOTULINUMTOXINA (BOTOX) TREATMENT IN A PROSPECTIVE OBSERVATIONAL COHORT STUDY: MOBILITY Mandar Jog a, *, Meetu Bhogal b, Grace Trentin b London Health Sciences Centre, London, ON, Canada; b Allergan, Markham, ON, Canada a
*Corresponding author: London Health Sciences Centre, 339 Windermere Road, A10-026, London, ON N6A 5A5, Canada. E-mail address: [email protected]
Introduction and Objectives: OnabotulinumtoxinA (onabotA) is an important treatment option for patients with movement disorders (MD). While studies have reported on the clinical efficacy of onabotA, patientreported outcomes (PRO) data are limited. This analysis describes baseline demographics and health utility (HU) in MD patients treated with onabotA. Methods: MOBILITY is a Canadian multicenter, observational study in patients initiating (naive) or receiving ongoing (maintenance) onabotA treatment. HU was the primary outcome measure, obtained from the SF-12 Health Survey using the SF-6D at baseline, week 4 post-treatment and up to 5 subsequent injection visits. Mean and 95% confidence intervals were calculated for HU scores. The safety cohort included patients who received 1 treatment. Results: A total of 455 MD patients (blepharospasm [n¼83], cervical dystonia [CD; n¼250], and hemifacial spasm [HFS, N¼122]) were enrolled, with 266 completing. Patients were aged 17 to 91 years (mean¼60 years, SD¼12); 66% were female (n¼299); 90%, Caucasian (n¼410); 25%, naive (n¼114); and 75% (n¼341), maintenance. Highest mean baseline HU scores were seen in HFS patients. Greatest improvements in HU scores were generally observed in CD patients. Baseline scores were generally higher in maintenance vs naive patients; however, greatest changes from baseline were in naive patients. Overall, mean HU scores generally increased and/or were maintained over time in all cohorts. The MD safety cohort reported 137 adverse events (AEs) in 47 patients; 51 (37%) were serious in 22 (5%) patients, and 103 (75%) were considered unrelated to treatment. The most commonly reported AEs were dysphagia (n¼7; 5%) and falls (n¼7; 5%). Conclusions: The majority of MD patients in MOBILITY were female, Caucasian, and on maintenance onabotA treatment. Data indicate that onabotA treatment may improve HU in MD patients over time. Keywords: Blepharospasm; Botulinum toxins; Cervical dystonia; Hemifacial spasm; Movement disorders; Type A
113. TREATMENT OF HEAD TREMOR WITH BOTULINUM TOXIN Wolfgang Jost Department of Neurology, University of Freiburg, 79106 Freiburg, Germany. E-mail address: [email protected]
Botulinum toxin has been the treatment of choice for cervical dystonia for well over 2 decades now. While the initial indication was specifically for rotatory torticollis, all the many different subtypes have since been included. In cervical dystonia, we distinguish phasic and tonic elements. Forms of dystonia with accompanying tremor are the most difficult to treat, as this usually involves a spontaneous oscillatory, often inconstant rhythmic tremor after the appearance of the cervical dystonia and is often exacerbated by an attempt to maintain normal posture. The dystonic tremor may sometimes be difficult to distinguish from essential tremor. Basically, the specific form of cervical dystonia that is already present is treated first: antero-, retro-, latero-, and rotatory forms of torticaput and/ or torticollis. In cases presenting with a tremor, electromyography can prove useful for the diagnosis and the evaluation of the muscles directly involved, both initially and throughout the course of treatment. Because dystonic tremor frequently involves several muscles that are difficult to inject, the use of sonography may be necessary in many cases as a control over the injection, as in the case of the obliquus capitis inferior muscle. A concomitant treatment of contralateral muscles not directly involved in the dystonia, such as the splenius capitis muscle, may frequently be needed. Essential head tremor can also be treated with botulinum toxin. In these cases, the head tremor is primarily treated, usually involving muscles on both sides, but with a smaller dosage because the muscles are not dystonic. In such cases, electromyography for diagnosing the muscles concerned is recommended both at the start and during the course of treatment. Again, sonography can be useful for injection control. However, as this treatment has not yet been approved, it has not been widely used to date. Basically, the other forms of head tremor can be treated with botulinum toxin as well, although experience here is even more limited. Keywords: Botulinum toxin; Cervical dystonia; Tremor