- Email: [email protected]
Therapeutic assessment of Botulinum toxin in the treatment of hemifacial spasm
e138
Abstracts / Parkinsonism and Related Disorders 22 (2016) e87ee141
4. Vaughan CJ, Delanty N, Harrington H, Murphy MB. Treatment of spastic dystonia with transdermal nicotine. Lancet 1997;9077:565. P 3.077. A CROSS-SECTIONAL STRUCTURED SURVEY OF PATIENTS RECEIVING BOTULINUM TOXIN TYPE A TREATMENT FOR BLEPHAROSPASM Daniel Truong 1, John Fezza 2, John Burns 3, Julie Woodward 4, Thomas Hedges 5, Amit Verma 6. 1 The Parkinson’s and Movement Disorder Institute, Fountain Valley, United States; 2 Center for Sight, Sarasota, United States; 3 Ophthalmic Surgeons and Consultants of Ohio, Columbus, United States; 4 Duke University, Office of Research Administration, Durham, United States; 5 Tufts Medical Center, New England Eye Center, Boston, United States; 6 Merz North America, Inc., Raleigh, United States Objectives: This cross-sectional, structured survey characterized satisfaction with current standard-of-care BoNT/A and preferences for treatment intervals. Methods: Subjects with blepharospasm, who had received 2 BoNT/A cycles, were interviewed immediately before scheduled re-injection to evaluate treatment satisfaction, time course of treatment effects, preferred injection intervals, the Blepharospasm Disability Index (BSDI) and Jankovic Rating Scale (JRS). Baseline characteristics, medical history and reasons for treatment intervals were collected from medical records. Results: Subjects (n¼114) had received onabotulinumtoxinA (n¼78), incobotulinumtoxinA (n¼35) or abobotulinumtoxinA (n¼1) as their last treatment. The most frequent injection interval was 12 weeks (46.5% subjects); 30.7% had an interval >12 weeks. However, 36.6% reported that treatment effects usually declined within 8 weeks; 69.6% within 10 weeks. From medical records, the main rationale for interval choice was “to maintain treatment efficacy” (44.7%). BSDI and JRS scores indicated reemergence of symptoms before re-injection. 70% and 74% of patients reported difficulties to drive and read, respectively. Overall, treatment satisfaction was high, but declined significantly at the end of the cycle. Many subjects (52.3%) would prefer an injection interval of <12 weeks; 30.6% of <10 weeks. Conclusions: Subjects surveyed indicated that BoNT/A treatment effects declined from 8 weeks and particularly within 10 weeks of last injection as symptoms such as difficult reading and driving reemerged. More than half of those questioned (52.3%) would prefer more frequent injections, suggesting that flexible, individualized treatment intervals may improve treatment satisfaction and outcomes. P 3.078. THERAPEUTIC ASSESSMENT OF BOTULINUM TOXIN IN THE TREATMENT OF HEMIFACIAL SPASM Helio Teive, Jean Pierre Batisti, Natalia Galli, Alais Daine Kleinfelder. Neurology Service, Internal Medicine Department, Federal University of Parana, Curitiba, Brazil Objectives: To evaluate the long-term effect of botulinum toxin type A (BTX-A) in the treatment of hemifacial spasm (HFS) in 100 Brazilian patients. Methods: The study was carried out with patients seen in the Movement Disorders Outpatient Unit in the Neurology Department, Hospital de (HC/UFPR), between January 2009 Clínicas, Federal University of Parana and December 2013. Epidemiological data were collected from each patient’s medical records and included date of birth (age), gender and the side of the face affected by HFS. Information about each injection session, such as date and dose of each injection, latency and duration of the effect of BTX-A, were also collected. The efficacy of each injection session was assessed with a subjective functional improvement scale (Columbia University Rating Scale)13. Patients assigned values to the results of the treatment between 0% and 100%, where 0% corresponded to no improvement and 100% to complete improvement and a return to normal function. The patients being followed up during this period used onabotulinumtoxinA, Botox® (Allergan Pharmaceuticals, CA, USA), a specific formulation of BTX-A. The protocol used to administer BTX-A in our service is the protocol advocated by the Brazilian Ministry of Health.
Results: In all, 550 BTX injections were administered to 100 patients with HFS. Mean duration of improvement following each injection session was 3.14 months, mean latency 7.10 days and mean success rate 94.73%. Patients were evaluated by a physician at an interval of 5.76 months after each application. Adverse effects, which were mostly minor, were observed in 37% of the patients at least once during follow-up. The most frequent was ptosis (35.14%). Conclusions: Treatment of HFS with BTX-A was effective, sustainable and safe and had minimal, well-tolerated side effects. References: 1. Abbruzzese G, Berardelli A. Hemifacial spasm. Handb Clin Neurol 2011;100:675e680. 2. Sorgun MH, Yilmaz R, Akin YA, Mercan FN, Akbostanci MC. Botulinum toxin injections for the treatment of hemifacial spasm over 16 years. J Clin Neurosci 2015. pii: S0967-5868 (15)00168-X. http://dx.doi.org/10.1016/j. jocn.2015.02.032. [Epub ahead of print] 3. Yaltho TC, Jankovic J. The many faces of hemifacial spasm: differential diagnosis of unilateral facial spasms. Mov Disord 2011;26:1582e1592. 4. Wang A, Jankovic J. Hemifacial spasm: clinical findings and treatment. Muscle Nerve 1998;21:1740e1747. 5. Hallett M, Albanese A, Dressler D, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of movement disorders. Toxicon 2013;67:94e114. P 3.079. ACUTE ALLERGIC REACTION FOLLOWING INJECTION OF GENERIC, GOVERNMENT-PROVIDED, BOTULINUM TOXIN (GGP-BTA) FOR HEMIFACIAL SPASM Helio Teive 1, Helio Teive 1, Francisco Manoel Branco Germiniani 1, Rosana H. Scola 1, Ricardo N. Brito 1, Gustavo Ribas 1, Laura Fiuza Parolin 1, Valeria Scavasine 1, Mariana Canever 1, Conrado M. € lken 2, Sergio Zuneda Serafini 2. 1 Neurology Borges 1, Karisa F. Miska Tho , Curitiba, Service, Hospital de Clínicas, Universidade Federal do Parana Brazil; 2 Dermatology Service, Hospital de CLínicas, Universidade Federal do , Curitiba, Brazil Parana Objectives: To report the case of a patient who developed facial angioedema one hour after receiving intramuscular Generic, Government-provide Bitulinum Toxin A (GGP-BTA). Methods: Case report. Results: A patient with left hemifacial spasm, who had already been treated with commercially available BTA (Botox®) with no significant sideeffects,was treated with intramuscular injections of GGP-BTA on the affected muscles o the left side and additional injections in the periocular region of the right side for aesthetic symmetry. About one hour following the procedure he developed a purplish-red oedema of the eyelids, as well as the left nasolabial fold (Figure). He was treated at first with IV Methylprednisolone, followed by oral 60 mg qd of Prednisone. As there was minor improvement with corticosteroids, following evaluation by the Dermatology team, he received intramuscular Adrenaline and was started on oral Diphenhydramine with resolution of the angioedema (Figure). Allergic reactions after administration of Botulinum Toxin A are rare, unpredictable complications and may vary from rash to anaphylaxis. These have been reported with the use of commercially available formulations, but not with generic formulations. These are probably due to allergic reactions to albumin, lactose or gelatin use in the formulation of BTA. Conclusions: Although rare, allergic reactions to commercially available BTA may vary from rash to life-threatening anaphylaxis. We reported a case of facial angioedema following injection of GGP-BTA, with resolution after adequate systemic treatment with anti-allergic medications. References: 1. Ricciardi L, Bove F, Fasano A. Xeomin use in patients with systemic immune reactions to other botulinum toxins type A. Eur J Neurol 2013;20:e45-46. LC, Rodrigues CJ. Allergic reactions to Botulinum Toxin: 2. Tamura BM, Cuce positive intradermal test. Dermatol Surg 2008;34:1117-1119. 3. Brueggemann N, Doegnitz L, Harms L, Moser A, Hagenah JM. Skin reactions after intramuscular injections of Botulinum toxin A: a rare side effect. J. Neurol Neurosurg Psychiatry 2008;79:231-232.
Abstracts / Parkinsonism and Related Disorders 22 (2016) e87ee141
4. Vaughan CJ, Delanty N, Harrington H, Murphy MB. Treatment of spastic dystonia with transdermal nicotine. Lancet 1997;9077:565. P 3.077. A CROSS-SECTIONAL STRUCTURED SURVEY OF PATIENTS RECEIVING BOTULINUM TOXIN TYPE A TREATMENT FOR BLEPHAROSPASM Daniel Truong 1, John Fezza 2, John Burns 3, Julie Woodward 4, Thomas Hedges 5, Amit Verma 6. 1 The Parkinson’s and Movement Disorder Institute, Fountain Valley, United States; 2 Center for Sight, Sarasota, United States; 3 Ophthalmic Surgeons and Consultants of Ohio, Columbus, United States; 4 Duke University, Office of Research Administration, Durham, United States; 5 Tufts Medical Center, New England Eye Center, Boston, United States; 6 Merz North America, Inc., Raleigh, United States Objectives: This cross-sectional, structured survey characterized satisfaction with current standard-of-care BoNT/A and preferences for treatment intervals. Methods: Subjects with blepharospasm, who had received 2 BoNT/A cycles, were interviewed immediately before scheduled re-injection to evaluate treatment satisfaction, time course of treatment effects, preferred injection intervals, the Blepharospasm Disability Index (BSDI) and Jankovic Rating Scale (JRS). Baseline characteristics, medical history and reasons for treatment intervals were collected from medical records. Results: Subjects (n¼114) had received onabotulinumtoxinA (n¼78), incobotulinumtoxinA (n¼35) or abobotulinumtoxinA (n¼1) as their last treatment. The most frequent injection interval was 12 weeks (46.5% subjects); 30.7% had an interval >12 weeks. However, 36.6% reported that treatment effects usually declined within 8 weeks; 69.6% within 10 weeks. From medical records, the main rationale for interval choice was “to maintain treatment efficacy” (44.7%). BSDI and JRS scores indicated reemergence of symptoms before re-injection. 70% and 74% of patients reported difficulties to drive and read, respectively. Overall, treatment satisfaction was high, but declined significantly at the end of the cycle. Many subjects (52.3%) would prefer an injection interval of <12 weeks; 30.6% of <10 weeks. Conclusions: Subjects surveyed indicated that BoNT/A treatment effects declined from 8 weeks and particularly within 10 weeks of last injection as symptoms such as difficult reading and driving reemerged. More than half of those questioned (52.3%) would prefer more frequent injections, suggesting that flexible, individualized treatment intervals may improve treatment satisfaction and outcomes. P 3.078. THERAPEUTIC ASSESSMENT OF BOTULINUM TOXIN IN THE TREATMENT OF HEMIFACIAL SPASM Helio Teive, Jean Pierre Batisti, Natalia Galli, Alais Daine Kleinfelder. Neurology Service, Internal Medicine Department, Federal University of Parana, Curitiba, Brazil Objectives: To evaluate the long-term effect of botulinum toxin type A (BTX-A) in the treatment of hemifacial spasm (HFS) in 100 Brazilian patients. Methods: The study was carried out with patients seen in the Movement Disorders Outpatient Unit in the Neurology Department, Hospital de (HC/UFPR), between January 2009 Clínicas, Federal University of Parana and December 2013. Epidemiological data were collected from each patient’s medical records and included date of birth (age), gender and the side of the face affected by HFS. Information about each injection session, such as date and dose of each injection, latency and duration of the effect of BTX-A, were also collected. The efficacy of each injection session was assessed with a subjective functional improvement scale (Columbia University Rating Scale)13. Patients assigned values to the results of the treatment between 0% and 100%, where 0% corresponded to no improvement and 100% to complete improvement and a return to normal function. The patients being followed up during this period used onabotulinumtoxinA, Botox® (Allergan Pharmaceuticals, CA, USA), a specific formulation of BTX-A. The protocol used to administer BTX-A in our service is the protocol advocated by the Brazilian Ministry of Health.
Results: In all, 550 BTX injections were administered to 100 patients with HFS. Mean duration of improvement following each injection session was 3.14 months, mean latency 7.10 days and mean success rate 94.73%. Patients were evaluated by a physician at an interval of 5.76 months after each application. Adverse effects, which were mostly minor, were observed in 37% of the patients at least once during follow-up. The most frequent was ptosis (35.14%). Conclusions: Treatment of HFS with BTX-A was effective, sustainable and safe and had minimal, well-tolerated side effects. References: 1. Abbruzzese G, Berardelli A. Hemifacial spasm. Handb Clin Neurol 2011;100:675e680. 2. Sorgun MH, Yilmaz R, Akin YA, Mercan FN, Akbostanci MC. Botulinum toxin injections for the treatment of hemifacial spasm over 16 years. J Clin Neurosci 2015. pii: S0967-5868 (15)00168-X. http://dx.doi.org/10.1016/j. jocn.2015.02.032. [Epub ahead of print] 3. Yaltho TC, Jankovic J. The many faces of hemifacial spasm: differential diagnosis of unilateral facial spasms. Mov Disord 2011;26:1582e1592. 4. Wang A, Jankovic J. Hemifacial spasm: clinical findings and treatment. Muscle Nerve 1998;21:1740e1747. 5. Hallett M, Albanese A, Dressler D, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of movement disorders. Toxicon 2013;67:94e114. P 3.079. ACUTE ALLERGIC REACTION FOLLOWING INJECTION OF GENERIC, GOVERNMENT-PROVIDED, BOTULINUM TOXIN (GGP-BTA) FOR HEMIFACIAL SPASM Helio Teive 1, Helio Teive 1, Francisco Manoel Branco Germiniani 1, Rosana H. Scola 1, Ricardo N. Brito 1, Gustavo Ribas 1, Laura Fiuza Parolin 1, Valeria Scavasine 1, Mariana Canever 1, Conrado M. € lken 2, Sergio Zuneda Serafini 2. 1 Neurology Borges 1, Karisa F. Miska Tho , Curitiba, Service, Hospital de Clínicas, Universidade Federal do Parana Brazil; 2 Dermatology Service, Hospital de CLínicas, Universidade Federal do , Curitiba, Brazil Parana Objectives: To report the case of a patient who developed facial angioedema one hour after receiving intramuscular Generic, Government-provide Bitulinum Toxin A (GGP-BTA). Methods: Case report. Results: A patient with left hemifacial spasm, who had already been treated with commercially available BTA (Botox®) with no significant sideeffects,was treated with intramuscular injections of GGP-BTA on the affected muscles o the left side and additional injections in the periocular region of the right side for aesthetic symmetry. About one hour following the procedure he developed a purplish-red oedema of the eyelids, as well as the left nasolabial fold (Figure). He was treated at first with IV Methylprednisolone, followed by oral 60 mg qd of Prednisone. As there was minor improvement with corticosteroids, following evaluation by the Dermatology team, he received intramuscular Adrenaline and was started on oral Diphenhydramine with resolution of the angioedema (Figure). Allergic reactions after administration of Botulinum Toxin A are rare, unpredictable complications and may vary from rash to anaphylaxis. These have been reported with the use of commercially available formulations, but not with generic formulations. These are probably due to allergic reactions to albumin, lactose or gelatin use in the formulation of BTA. Conclusions: Although rare, allergic reactions to commercially available BTA may vary from rash to life-threatening anaphylaxis. We reported a case of facial angioedema following injection of GGP-BTA, with resolution after adequate systemic treatment with anti-allergic medications. References: 1. Ricciardi L, Bove F, Fasano A. Xeomin use in patients with systemic immune reactions to other botulinum toxins type A. Eur J Neurol 2013;20:e45-46. LC, Rodrigues CJ. Allergic reactions to Botulinum Toxin: 2. Tamura BM, Cuce positive intradermal test. Dermatol Surg 2008;34:1117-1119. 3. Brueggemann N, Doegnitz L, Harms L, Moser A, Hagenah JM. Skin reactions after intramuscular injections of Botulinum toxin A: a rare side effect. J. Neurol Neurosurg Psychiatry 2008;79:231-232.