- Email: [email protected]
30. The durability of onabotulinumtoxinA for the treatment of chronic migraine: CLARITY Pilot Study
Abstracts / Toxicon 93 (2015) S2eS67
Jaw-closing dystonia: masseter, internal pterygoid, and temporalis muscles Jaw-opening dystonia: external pterygoid, anterior digastric, and anterior temporalis muscles Oromandibulolingual dystonia: limitations of lingual injections TMD clenching: masseter and temporalis muscles Bruxism: external pterygoid muscles Overlap of TMD and migraine headaches Review of the muscles, location of injections, and techniques for each injection will be presented with video; data is based on 30 years’ experience and over 600 patients. 29. A NEW, SYMPTOM-BASED APPROACH TO NEUROLOGIC GAIT DISORDERS Bastiaan R. Bloem Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. E-mail address: [email protected] Careful recognition of neurologic gait and balance disorders is important in clinical practice, for various reasons. First, gait and balance disorders impose significant disability on affected individuals. Second, difficulties with walking and maintaining balance force patients to reduce their physical activities, which in turn is associated with a host of negative consequences, including a worsening of disease symptoms, development of osteoporosis, sleep disorders, and reduced survival. The tendency to become physically less active is compounded by a fear of falling, which commonly develops in patients with gait and balance disorders, even among those who have never sustained an actual fall before. Third, specific features of gait and balance can offer important diagnostic clues in patients with an uncertain clinical diagnosis. To improve the recognition of gait disorders, several classification schemes have been proposed (Nutt 1993; Snijders 2007). In case of gait disorders, it is common to define the type of gait disorder according to the main presenting feature. Examples include ataxic gait, dystonic gait, and waddling gait. The typical approach to teaching students and residents about such gait disorders is to present a typical phenotype, listing all possible features associated with this specific type of neurologic gait disorder. However, this is not the way patients usually present to the doctor in clinical practice. Indeed, patients may display only one or at most a few abnormal gait or balance signs, and some of these may fit with different types of neurologic disorders. A proposed new approach to disorders of gait takes typical presenting features as the starting point for recognizing the associated neurologic syndrome and for building a differential diagnosis. References Nutt JG, Marsden CD, Thompson PD. Human walking and higher-level gait disorders, particularly in the elderly. Neurology. 1993;43:268-279. Snijders AH, van de Warrenburg BP, Giladi N, Bloem BR. Neurological gait disorders in elderly people: clinical approach and classification. Lancet Neurol. 2007;6:63-74. Keywords: Classification; Gait; Neurologic examination; Walking 30. THE DURABILITY OF ONABOTULINUMTOXINA FOR THE TREATMENT OF CHRONIC MIGRAINE: CLARITY PILOT STUDY Andrew M. Blumenfeld a, *, Andrew Inocelda a, Christopher Purdy b, Laura Dalfonso b, Raf Magar c a Headache Center of Southern California, Encinitas, CA, USA; b AHRM, Buffalo, NY, USA; c AHRM, Raleigh, NC, USA *Corresponding author: Headache Center of Southern California, 320 Santa Fe Drive, Suite 150, Encinitas, CA, USA. E-mail address: [email protected]
Introduction and Objectives: Limited data exist on the durability of benefit of onabotulinumtoxinA for chronic migraine (CM) beyond 5 cycles. The objective of this analysis was to evaluate the durability of benefit of 7 to 9 cycles of onabotulinumtoxinA for patients with CM. Methods: Medical records for patients with CM per International Classification of Headache Disorders, 3rd edition (beta) (ICHD-3b) criteria (15 headache days/month) were reviewed. Inclusion required a baseline visit,
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7 onabotulinumtoxinA injection cycles, 12±2 weeks between injections, and 155 to 195 U onabotulinumtoxinA dose using the PREEMPT injection paradigm (Blumenfed 2010). Abstracted data included dose, headache days, Migraine Disability Assessment (MIDAS) test, 6-item Headache Impact Test (HIT-6), and adverse events (AEs). Results: Of the 33 qualified patients, all received 7 cycles, 24 received 8 cycles, and 20 received 9 cycles. Mean headache days at baseline, cycle 7, cycle 8, and cycle 9 were 19.08, 6.25, 5.01, and 6.10, respectively. Mean headache-free days at baseline, cycle 7, cycle 8, and cycle 9 were 10.92, 23.75, 24.99, and 23.90, respectively. By cycles 7 and 9, 85% (cycle 7: 28/33; cycle 9: 17/20) of patients achieved >50% reduction in headache days. Mean (SD) MIDAS scores decreased from baseline across treatment cycles (baseline: 54.8 [±42.13; grade 4: severe]; cycle 9: 11.11 [±9.89; grade 2 to 3: mild/moderate]). Similarly, mean (SD) HIT-6 scores also decreased from baseline (baseline: 60.85 [±8.27]; cycle 9: 56.78 [±5.58]). No serious AEs were reported. Conclusions: Results from this series of patients demonstrated durable onabotulinumtoxinA benefit based on reduction in headache days after 7 to 9 treatments and long-term improvements in migraine-related disability as evaluated by MIDAS and HIT-6. Results warrant investigation in a larger study to better understand the durability of onabotulinumtoxinA benefit for CM in clinical practice. Reference Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010;50(9):1406-1418. Support: Allergan, Inc., supported the clinical study and medical writing for this abstract. Keywords: Chronic migraine; Headache; OnabotulinumtoxinA 31. STANDARD OF PRACTICE IN ANTICOAGULATED INDIVIDUALS REQUIRING DEEP COMPARTMENT BOTULINUM NEUROTOXIN INJECTIONS FOR SPASTICITY: A SURVEY Chris Boulias*, Farooq Ismail, Sinkar Trupti, Chetan P. Phadke West Park Healthcare Centre, Toronto, ON, Canada *Corresponding author: West Park Healthcare Centre, 82 Buttonwood Ave., Toronto, ON, M6M 2J5, Canada. E-mail address: [email protected]
Introduction and Objectives: There is no evidence that intramuscular injections cause excess bleeding. Botulinum neurotoxin type A (BoNT/A) injections involve multiple sites that may pose an additional risk of bleeding. In the absence of recommendations, a wide range of approaches exist relating to injecting patients on anticoagulant therapy. The purpose of this study was to understand physician preferences and guidelines in controlling bleeding risk and report of bleeding in their patients on anticoagulant therapy during intramuscular BoNT/A injections. Methods: Design: Prospective cross-sectional. Questionnaires were mailed to 138 physicians across Canada having a variable range of experience with BoNT/A. Results: Response rate was 38%, and 77% physicians had >5 years of experience with BoNT/A. About 44% were aware of the international normalized ratio (INR) value, and 44% were unaware. Of those who were unaware of INR, 53% still injected the toxin; 19% did not. Twenty-two percent inject regardless of INR, and 67% do not. Forty-four percent had the ability to measure INR; 46% did not. The INR comfort range for injections was <2 in 10%, 2 to 2.5 in ~35%, 2.6 to 3 in ~25%, and 3.1 to 3.5 in ~20% of physicians. Only 23% injected outside their comfort value, and 57% did not; 72% did not normalize the INR value before injections; 11% did. While 83% of physicians injected in the deep compartment, 92% said they had never encountered compartment syndrome in their practice; only 1% had. Conclusions: There is high variability in physician preferences in BoNT/A injection in anticoagulated patients in Canada. The majority (70%) take a conservative approach to controlling INR (<3), and 67% did not inject without INR values. The risk of bleeding and compartment syndrome appears to be extremely low. Guidelines are not available on how to approach patients on anticoagulation and the safe INR window to inject. Our results help understand preferences and INR levels used by
Jaw-closing dystonia: masseter, internal pterygoid, and temporalis muscles Jaw-opening dystonia: external pterygoid, anterior digastric, and anterior temporalis muscles Oromandibulolingual dystonia: limitations of lingual injections TMD clenching: masseter and temporalis muscles Bruxism: external pterygoid muscles Overlap of TMD and migraine headaches Review of the muscles, location of injections, and techniques for each injection will be presented with video; data is based on 30 years’ experience and over 600 patients. 29. A NEW, SYMPTOM-BASED APPROACH TO NEUROLOGIC GAIT DISORDERS Bastiaan R. Bloem Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. E-mail address: [email protected] Careful recognition of neurologic gait and balance disorders is important in clinical practice, for various reasons. First, gait and balance disorders impose significant disability on affected individuals. Second, difficulties with walking and maintaining balance force patients to reduce their physical activities, which in turn is associated with a host of negative consequences, including a worsening of disease symptoms, development of osteoporosis, sleep disorders, and reduced survival. The tendency to become physically less active is compounded by a fear of falling, which commonly develops in patients with gait and balance disorders, even among those who have never sustained an actual fall before. Third, specific features of gait and balance can offer important diagnostic clues in patients with an uncertain clinical diagnosis. To improve the recognition of gait disorders, several classification schemes have been proposed (Nutt 1993; Snijders 2007). In case of gait disorders, it is common to define the type of gait disorder according to the main presenting feature. Examples include ataxic gait, dystonic gait, and waddling gait. The typical approach to teaching students and residents about such gait disorders is to present a typical phenotype, listing all possible features associated with this specific type of neurologic gait disorder. However, this is not the way patients usually present to the doctor in clinical practice. Indeed, patients may display only one or at most a few abnormal gait or balance signs, and some of these may fit with different types of neurologic disorders. A proposed new approach to disorders of gait takes typical presenting features as the starting point for recognizing the associated neurologic syndrome and for building a differential diagnosis. References Nutt JG, Marsden CD, Thompson PD. Human walking and higher-level gait disorders, particularly in the elderly. Neurology. 1993;43:268-279. Snijders AH, van de Warrenburg BP, Giladi N, Bloem BR. Neurological gait disorders in elderly people: clinical approach and classification. Lancet Neurol. 2007;6:63-74. Keywords: Classification; Gait; Neurologic examination; Walking 30. THE DURABILITY OF ONABOTULINUMTOXINA FOR THE TREATMENT OF CHRONIC MIGRAINE: CLARITY PILOT STUDY Andrew M. Blumenfeld a, *, Andrew Inocelda a, Christopher Purdy b, Laura Dalfonso b, Raf Magar c a Headache Center of Southern California, Encinitas, CA, USA; b AHRM, Buffalo, NY, USA; c AHRM, Raleigh, NC, USA *Corresponding author: Headache Center of Southern California, 320 Santa Fe Drive, Suite 150, Encinitas, CA, USA. E-mail address: [email protected]
Introduction and Objectives: Limited data exist on the durability of benefit of onabotulinumtoxinA for chronic migraine (CM) beyond 5 cycles. The objective of this analysis was to evaluate the durability of benefit of 7 to 9 cycles of onabotulinumtoxinA for patients with CM. Methods: Medical records for patients with CM per International Classification of Headache Disorders, 3rd edition (beta) (ICHD-3b) criteria (15 headache days/month) were reviewed. Inclusion required a baseline visit,
S11
7 onabotulinumtoxinA injection cycles, 12±2 weeks between injections, and 155 to 195 U onabotulinumtoxinA dose using the PREEMPT injection paradigm (Blumenfed 2010). Abstracted data included dose, headache days, Migraine Disability Assessment (MIDAS) test, 6-item Headache Impact Test (HIT-6), and adverse events (AEs). Results: Of the 33 qualified patients, all received 7 cycles, 24 received 8 cycles, and 20 received 9 cycles. Mean headache days at baseline, cycle 7, cycle 8, and cycle 9 were 19.08, 6.25, 5.01, and 6.10, respectively. Mean headache-free days at baseline, cycle 7, cycle 8, and cycle 9 were 10.92, 23.75, 24.99, and 23.90, respectively. By cycles 7 and 9, 85% (cycle 7: 28/33; cycle 9: 17/20) of patients achieved >50% reduction in headache days. Mean (SD) MIDAS scores decreased from baseline across treatment cycles (baseline: 54.8 [±42.13; grade 4: severe]; cycle 9: 11.11 [±9.89; grade 2 to 3: mild/moderate]). Similarly, mean (SD) HIT-6 scores also decreased from baseline (baseline: 60.85 [±8.27]; cycle 9: 56.78 [±5.58]). No serious AEs were reported. Conclusions: Results from this series of patients demonstrated durable onabotulinumtoxinA benefit based on reduction in headache days after 7 to 9 treatments and long-term improvements in migraine-related disability as evaluated by MIDAS and HIT-6. Results warrant investigation in a larger study to better understand the durability of onabotulinumtoxinA benefit for CM in clinical practice. Reference Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010;50(9):1406-1418. Support: Allergan, Inc., supported the clinical study and medical writing for this abstract. Keywords: Chronic migraine; Headache; OnabotulinumtoxinA 31. STANDARD OF PRACTICE IN ANTICOAGULATED INDIVIDUALS REQUIRING DEEP COMPARTMENT BOTULINUM NEUROTOXIN INJECTIONS FOR SPASTICITY: A SURVEY Chris Boulias*, Farooq Ismail, Sinkar Trupti, Chetan P. Phadke West Park Healthcare Centre, Toronto, ON, Canada *Corresponding author: West Park Healthcare Centre, 82 Buttonwood Ave., Toronto, ON, M6M 2J5, Canada. E-mail address: [email protected]
Introduction and Objectives: There is no evidence that intramuscular injections cause excess bleeding. Botulinum neurotoxin type A (BoNT/A) injections involve multiple sites that may pose an additional risk of bleeding. In the absence of recommendations, a wide range of approaches exist relating to injecting patients on anticoagulant therapy. The purpose of this study was to understand physician preferences and guidelines in controlling bleeding risk and report of bleeding in their patients on anticoagulant therapy during intramuscular BoNT/A injections. Methods: Design: Prospective cross-sectional. Questionnaires were mailed to 138 physicians across Canada having a variable range of experience with BoNT/A. Results: Response rate was 38%, and 77% physicians had >5 years of experience with BoNT/A. About 44% were aware of the international normalized ratio (INR) value, and 44% were unaware. Of those who were unaware of INR, 53% still injected the toxin; 19% did not. Twenty-two percent inject regardless of INR, and 67% do not. Forty-four percent had the ability to measure INR; 46% did not. The INR comfort range for injections was <2 in 10%, 2 to 2.5 in ~35%, 2.6 to 3 in ~25%, and 3.1 to 3.5 in ~20% of physicians. Only 23% injected outside their comfort value, and 57% did not; 72% did not normalize the INR value before injections; 11% did. While 83% of physicians injected in the deep compartment, 92% said they had never encountered compartment syndrome in their practice; only 1% had. Conclusions: There is high variability in physician preferences in BoNT/A injection in anticoagulated patients in Canada. The majority (70%) take a conservative approach to controlling INR (<3), and 67% did not inject without INR values. The risk of bleeding and compartment syndrome appears to be extremely low. Guidelines are not available on how to approach patients on anticoagulation and the safe INR window to inject. Our results help understand preferences and INR levels used by