- Email: [email protected]
68. Botulinum toxin therapy of cervical dystonia: comparing onabotulinumtoxinA (Botox) and incobotulinumtoxinA (Xeomin)
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Abstracts / Toxicon 93 (2015) S2eS67
*Corresponding author: Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany. E-mail address: [email protected]
Introduction and Objectives: To explore whether more differentiated package sizes allow for more economic use of abobotulinumtoxinA (Dysport) in a large neurologic botulinum toxin (BoNT) outpatient clinic (>9000 standard vials/a). Methods: The study followed a retrospective chart review design based on our digital BoNT therapy data bank. All patients receiving abobotulinumtoxinA exclusively in a constant dose during the observation period (introduction±7 months) were included. Economic calculations are based on abobotulinumtoxinA prices as officially advertised in Germany. Sharing of vials between patients was not allowed. Results: Altogether 83 patients (51 with dystonia, 25 with spasticity, 3 with hemifacial spasm, 4 with other diagnoses) were included in this study. The total amount of MU used before and after introduction was 102,525 MU, the amount prescribed 138,000 MU and 116,300 MU (21,700 MU, 15.7%), the costs V146,103 and V125,250 (V 20,853, 14.3%). The price of D500 before and after introduction was V529.36, for D300, V339.71. The D500 price for 1 MU before and after introduction is V1.0587, the D300 price for 1 MU is V1.1324 (+ V0.073, +7.0% against D500). Conclusions: More flexible packaging reduces drug costs for BoNT therapy considerably. Introduction of smaller packaging sizes is technically possible and should be encouraged. Extra costs for registration and logistics are moderate. Further cost reductions may be possible by introduction of even smaller packaging sizes. They can be calculated based on our model. Keywords: AbobotulinumtoxinA; Botulinum neurotoxin; Dysport; Economics; Therapy
68. BOTULINUM TOXIN THERAPY OF CERVICAL DYSTONIA: COMPARING ONABOTULINUMTOXINA (BOTOX) AND INCOBOTULINUMTOXINA (XEOMIN) Dirk Dressler*, Pawel Tacik, Fereshte Adib Saberi Movement Disorders Section, Department of Neurology, Hannover Medical School, Hannover, Germany *Corresponding author: Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625 Hannover, Germany. E-mail address: [email protected]
Introduction and Objectives: To compare the efficacy and the potency labeling of incobotulinumtoxinA (Xeomin) and onabotulinumtoxinA (Botox) by analyzing the duration of their therapeutic effect in a crossover study. Methods: We studied 40 cervical dystonia patients (26 females, 14 males; age at therapy onset, 52.6±12.0 years; duration of dystonia at therapy onset, 10.0±9.2 years; Tsui score, 9.1±3.9) who first received onabotulinumtoxinA and then incobotulinumtoxinA for at least 4 injection series each. Botulinum neurotoxin doses were exchanged based on a 1:1 conversion ratio. Results: Altogether 1101 treatment cycles were evaluated. For each patient, 27.5±13.1 treatment cycles were recorded. Patients received 18.4±12.4 treatment cycles with onabotulinumtoxinA and 9.2±4.5 with incobotulinumtoxinA. The treatment duration (TD) throughout the treatment course was 11.3±1.0 weeks (onabotulinumtoxinA, 11.2±1.1 weeks; incobotulinumtoxinA, 11.4±1.3 weeks). The interinjection interval (II) throughout the treatment course was 14.8±1.9 weeks (onabotulinumtoxinA, 14.7±1.6 weeks; incobotulinumtoxinA, 15.0±2.2 weeks). The mean difference between onabotulinumtoxinA and incobotulinumtoxinA was 0.3 weeks for TD (2-sided 95% confidence interval; 0.3, 0.9) and 0.5 weeks for II (0.4, 1.4). The confidence intervals of both parameters were within the predefined therapeutic equivalence range set to ±1.5 weeks, thus indicating similar efficacy of both BoNT drugs. Conclusions: Having based the exchange of onabotulinumtoxinA and incobotulinumtoxinA on a conversion factor of 1:1, our data confirm previous findings of an identical potency labeling of both products, thus allowing comparisons of efficacy, adverse effects, and costs.
Keywords: Botulinum toxin; Cervical dystonia; IncobotulinumtoxinA (Xeomin); Interinjection intervals; OnabotulinumtoxinA (Botox); Therapeutic use; Treatment duration 69. ASSESSING ANTIBODIES TO BOTULINUM TOXIN Dirk Dressler Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany. E-mail address: [email protected]
70. PAINFUL LEG AND MOVING TOES SYNDROME TREATED WITH BOTULINUM NEUROTOXIN TYPE A: A VIDEO CASE REPORT Beatriz Echeveste-Gonz alez*, Laura Fernandez, Sandre Iturralde, Tania Iriarte, Milagros Casado, Manuel Murie-Fernandez n, Clínica Universidad de Navarra, Pamplona, Servicio Neurorrehabilitacio Navarra, Spain n, Clínica Universidad de *Corresponding author: Servicio Neurorrehabilitacio Navarra, Pio XII 36, Pamplona, Navarra 31008, Spain. E-mail address: becheveste@ unav.es
Introduction: Painful leg and moving toes syndrome is a rare disease that is characterized by arrhythmic movements of the toes accompanied by pain in the affected limb. Botulinum neurotoxin type A is demonstrating good results with both pain and involuntary movements. Objective: We describe a case of moving toes and painful leg that was successfully treated with this toxin. Video Case Report: The patient was a 70-year-old woman, just after a right hip surgery. She began with a rare feeling of cold in the right leg and a dropped foot due to a compression of the superficial peroneal nerve. This symptomatology got better within the next months. Twelve months after the surgery, she began to feel pain in the distal part of the right leg and to have arrhythmic movement of the toes when she lying down. A lumbar magnetic resonance image (MRI) scan showed L5 radiculopathy. Electromyography showed contraction of the flexor digitorum longus during involuntary movements of the toes. Botulinum neurotoxin type A (abobotulinumtoxinA 200 U) was infiltrated. Ten days after the treatment, the patient was asymptomatic. Conclusion: Since the 1970s, botulinum neurotoxin type A has been widely used to treat various movement disorders. Now it is being used for this syndrome with positive benefits. It is important to do larger prospective studies in order to understand the therapeutic response and to include it as a possible standard medical treatment for this syndrome.
71. AVERAGE DOSE OF BOTULINUM NEUROTOXIN A (BONT/A) INJECTED INTO PATIENTS IN REAL LIFE (PHYSICIAN’S PRACTICE) Youcef Benchikh El-Fegoun a, *, Jovita Balcaitiene a, Charles Rink b a Ipsen Pharma, Paris, France; b IMS Consulting Group, London, UK *Corresponding author: Ipsen Pharma, 65 quai Georges Gorse, Boulogne-Billancourt, Paris 92100, France. E-mail address: [email protected]
Introduction and Objectives: In 2012, a physician survey was initiated to better understand the administration of botulinum neurotoxin A (BoNT/A) in real-life clinical practice; one aim was to determine the average dose of BoNT/A administrated to patients. Methods: Neurologists and physical medicine and rehabilitation specialists from Europe and Brazil (N¼414) were required to complete patient records for patients with the following conditions: adult spasticity, focal dystonia (cervical dystonia [CD], blepharospasm [BFS], hemifacial spasm [HFS] only), and pediatric spasticity due to cerebral palsy (CPS). Small sample size in some groups limited statistical comparisons. Mean abobotulinumtoxinA (Dysport) doses administered are presented here. Results: Overall, 2252 patient records were completed, of which 477 received abobotulinumtoxinA (Brazil, 84; France, 76; Germany, 93; Italy, 67; Spain, 62; UK, 95). For all indications and across countries, mean abobotulinumtoxinA dose injected was lower than the maximum dose
Abstracts / Toxicon 93 (2015) S2eS67
*Corresponding author: Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany. E-mail address: [email protected]
Introduction and Objectives: To explore whether more differentiated package sizes allow for more economic use of abobotulinumtoxinA (Dysport) in a large neurologic botulinum toxin (BoNT) outpatient clinic (>9000 standard vials/a). Methods: The study followed a retrospective chart review design based on our digital BoNT therapy data bank. All patients receiving abobotulinumtoxinA exclusively in a constant dose during the observation period (introduction±7 months) were included. Economic calculations are based on abobotulinumtoxinA prices as officially advertised in Germany. Sharing of vials between patients was not allowed. Results: Altogether 83 patients (51 with dystonia, 25 with spasticity, 3 with hemifacial spasm, 4 with other diagnoses) were included in this study. The total amount of MU used before and after introduction was 102,525 MU, the amount prescribed 138,000 MU and 116,300 MU (21,700 MU, 15.7%), the costs V146,103 and V125,250 (V 20,853, 14.3%). The price of D500 before and after introduction was V529.36, for D300, V339.71. The D500 price for 1 MU before and after introduction is V1.0587, the D300 price for 1 MU is V1.1324 (+ V0.073, +7.0% against D500). Conclusions: More flexible packaging reduces drug costs for BoNT therapy considerably. Introduction of smaller packaging sizes is technically possible and should be encouraged. Extra costs for registration and logistics are moderate. Further cost reductions may be possible by introduction of even smaller packaging sizes. They can be calculated based on our model. Keywords: AbobotulinumtoxinA; Botulinum neurotoxin; Dysport; Economics; Therapy
68. BOTULINUM TOXIN THERAPY OF CERVICAL DYSTONIA: COMPARING ONABOTULINUMTOXINA (BOTOX) AND INCOBOTULINUMTOXINA (XEOMIN) Dirk Dressler*, Pawel Tacik, Fereshte Adib Saberi Movement Disorders Section, Department of Neurology, Hannover Medical School, Hannover, Germany *Corresponding author: Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625 Hannover, Germany. E-mail address: [email protected]
Introduction and Objectives: To compare the efficacy and the potency labeling of incobotulinumtoxinA (Xeomin) and onabotulinumtoxinA (Botox) by analyzing the duration of their therapeutic effect in a crossover study. Methods: We studied 40 cervical dystonia patients (26 females, 14 males; age at therapy onset, 52.6±12.0 years; duration of dystonia at therapy onset, 10.0±9.2 years; Tsui score, 9.1±3.9) who first received onabotulinumtoxinA and then incobotulinumtoxinA for at least 4 injection series each. Botulinum neurotoxin doses were exchanged based on a 1:1 conversion ratio. Results: Altogether 1101 treatment cycles were evaluated. For each patient, 27.5±13.1 treatment cycles were recorded. Patients received 18.4±12.4 treatment cycles with onabotulinumtoxinA and 9.2±4.5 with incobotulinumtoxinA. The treatment duration (TD) throughout the treatment course was 11.3±1.0 weeks (onabotulinumtoxinA, 11.2±1.1 weeks; incobotulinumtoxinA, 11.4±1.3 weeks). The interinjection interval (II) throughout the treatment course was 14.8±1.9 weeks (onabotulinumtoxinA, 14.7±1.6 weeks; incobotulinumtoxinA, 15.0±2.2 weeks). The mean difference between onabotulinumtoxinA and incobotulinumtoxinA was 0.3 weeks for TD (2-sided 95% confidence interval; 0.3, 0.9) and 0.5 weeks for II (0.4, 1.4). The confidence intervals of both parameters were within the predefined therapeutic equivalence range set to ±1.5 weeks, thus indicating similar efficacy of both BoNT drugs. Conclusions: Having based the exchange of onabotulinumtoxinA and incobotulinumtoxinA on a conversion factor of 1:1, our data confirm previous findings of an identical potency labeling of both products, thus allowing comparisons of efficacy, adverse effects, and costs.
Keywords: Botulinum toxin; Cervical dystonia; IncobotulinumtoxinA (Xeomin); Interinjection intervals; OnabotulinumtoxinA (Botox); Therapeutic use; Treatment duration 69. ASSESSING ANTIBODIES TO BOTULINUM TOXIN Dirk Dressler Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, D-30625, Hannover, Germany. E-mail address: [email protected]
70. PAINFUL LEG AND MOVING TOES SYNDROME TREATED WITH BOTULINUM NEUROTOXIN TYPE A: A VIDEO CASE REPORT Beatriz Echeveste-Gonz alez*, Laura Fernandez, Sandre Iturralde, Tania Iriarte, Milagros Casado, Manuel Murie-Fernandez n, Clínica Universidad de Navarra, Pamplona, Servicio Neurorrehabilitacio Navarra, Spain n, Clínica Universidad de *Corresponding author: Servicio Neurorrehabilitacio Navarra, Pio XII 36, Pamplona, Navarra 31008, Spain. E-mail address: becheveste@ unav.es
Introduction: Painful leg and moving toes syndrome is a rare disease that is characterized by arrhythmic movements of the toes accompanied by pain in the affected limb. Botulinum neurotoxin type A is demonstrating good results with both pain and involuntary movements. Objective: We describe a case of moving toes and painful leg that was successfully treated with this toxin. Video Case Report: The patient was a 70-year-old woman, just after a right hip surgery. She began with a rare feeling of cold in the right leg and a dropped foot due to a compression of the superficial peroneal nerve. This symptomatology got better within the next months. Twelve months after the surgery, she began to feel pain in the distal part of the right leg and to have arrhythmic movement of the toes when she lying down. A lumbar magnetic resonance image (MRI) scan showed L5 radiculopathy. Electromyography showed contraction of the flexor digitorum longus during involuntary movements of the toes. Botulinum neurotoxin type A (abobotulinumtoxinA 200 U) was infiltrated. Ten days after the treatment, the patient was asymptomatic. Conclusion: Since the 1970s, botulinum neurotoxin type A has been widely used to treat various movement disorders. Now it is being used for this syndrome with positive benefits. It is important to do larger prospective studies in order to understand the therapeutic response and to include it as a possible standard medical treatment for this syndrome.
71. AVERAGE DOSE OF BOTULINUM NEUROTOXIN A (BONT/A) INJECTED INTO PATIENTS IN REAL LIFE (PHYSICIAN’S PRACTICE) Youcef Benchikh El-Fegoun a, *, Jovita Balcaitiene a, Charles Rink b a Ipsen Pharma, Paris, France; b IMS Consulting Group, London, UK *Corresponding author: Ipsen Pharma, 65 quai Georges Gorse, Boulogne-Billancourt, Paris 92100, France. E-mail address: [email protected]
Introduction and Objectives: In 2012, a physician survey was initiated to better understand the administration of botulinum neurotoxin A (BoNT/A) in real-life clinical practice; one aim was to determine the average dose of BoNT/A administrated to patients. Methods: Neurologists and physical medicine and rehabilitation specialists from Europe and Brazil (N¼414) were required to complete patient records for patients with the following conditions: adult spasticity, focal dystonia (cervical dystonia [CD], blepharospasm [BFS], hemifacial spasm [HFS] only), and pediatric spasticity due to cerebral palsy (CPS). Small sample size in some groups limited statistical comparisons. Mean abobotulinumtoxinA (Dysport) doses administered are presented here. Results: Overall, 2252 patient records were completed, of which 477 received abobotulinumtoxinA (Brazil, 84; France, 76; Germany, 93; Italy, 67; Spain, 62; UK, 95). For all indications and across countries, mean abobotulinumtoxinA dose injected was lower than the maximum dose