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Efficacy of incobotulinumtoxin a in treatment of lower-limb spasticity, including pes equinovarus, in adults
Oral abstracts / Annals of Physical and Rehabilitation Medicine 61S (2018) e1–e102
ISPR8-1805
Efficacy of incobotulinumtoxin a in treatment of lower-limb spasticity, including pes equinovarus, in adults D. Bensmail 1,∗ , J. Wissel 2 , I. Laffont 3,4 , O. Simon 5 , A. Scheschonka 6 , B. Flatau-Baqué 6 , D. Dressler 7 , D. Simpson 8 1 Hôpital Raymond-Poincaré, AP–HP, University of Versailles–Saint-Quentin, Garches, France 2 Vivantes Hospital Spandau, Department of Neurorehabilitation and Physical Therapy, Department of Neurology, Berlin, Germany 3 Hôpital Lapeyronie, Physical Medicine and Rehabilitation, Montpellier, France 4 Euromov, Montpellier University, IFRH, Montpellier, France 5 Formerly of Merz Pharmaceuticals GmbH, Medical Affairs, Frankfurt am Main, Germany 6 Merz Pharmaceuticals GmbH, Medical Affairs, Frankfurt am Main, Germany 7 Hannover Medical School, Movement Disorders Section, Department of Neurology, Hannover, Germany 8 Icahn School of Medicine at Mount Sinai, Department of Neurology, New York, USA ∗ Corresponding author. E-mail address: [email protected] (D. Bensmail) Introduction/Background The TOWER study (NCT01603459) previously demonstrated that escalating doses of incobotulinumtoxinA (400–≤800 U) in patients with upper- (UL) and lower-limb (LL) spasticity due to stroke or other cerebral causes increased treatment efficacy without compromising safety or tolerability (Wissel, Neurology 2017). This post-hoc analysis assessed the efficacy of incobotulinumtoxinA for LL spasticity, including pes equinovarus. Material and method Patients received treatment with escalating total incobotulinumtoxinA doses on the same body side during three injection cycles (ICs) (400 U, 600 U and 600–800 U, respectively; maximum 600 U per limb; optional pes equinovarus, planned dose range 100–400 U). Outcomes included change from IC baseline to 4 weeks post-injection in Ashworth Scale (AS) for the ankle joint (in patients treated for pes equinovarus or not) and LL resistance to passive movement scale (REPAS) scores (in patients treated in the LL [with/without UL treatment], or UL only). Results In total, 155 patients were enrolled. In IC1, IC2 and IC3, respectively, 109, 137 and 137 patients received LL treatment with mean (standard deviation [SD]) total limb doses of incobotulinumtoxinA: 191.7 (97.6), 254.0 (111.6) and 320.9 (127.6) U. Pes equinovarus was treated in 88, 117 and 122 of these patients. The mean (SD) improvement in ankle joint AS score at 4 weeks post-injection was –0.66 (0.77), –0.70 (0.82) and –0.82 (0.77) in patients treated for pes equinovarus, and –0.21 (0.64), –0.38 (0.85) and –0.61 (0.70) in patients who were not, with a significant difference between the groups in IC1 (P = 0.0006). For all ICs, the mean improvement in REPAS LL scores 4 weeks post-injection was greater in patients who were treated in the LL than in patients treated in the UL only, with significant differences between groups in IC1 (P < 0.0001) and IC2 (P = 0.0043). Conclusion Results suggest that incobotulinumtoxinA is effective for treating LL spasticity, including pes equinovarus. Keywords Incobotulinumtoxin A; Spasticity; Lower limb Authors contribution D. Bensmail and J. Wissel contributed equally to this work as co-first authors. D. Dressler and D.M. Simpson contributed equally to this work as co-last authors. Disclosure of interest This study was supported by Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany. Editorial support was provided, under the guidance of the authors, by Claire Cairney, PhD, of CMC CONNECT, a division of Complete Medical Communications and was funded by Merz Pharmaceuticals GmbH. D. Bensmail served as a consultant for Allergan, Almirall, Ipsen, Medtronic and Merz. J. Wissel received research grant support from and served as a consultant for Allergan, Ipsen, Medtronic
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and Merz. I. Laffont served as a consultant for Ipsen and received grant support from Merz. O. Simon is a former employee of Merz Pharmaceuticals. A. Scheschonka is an employee of Merz Pharmaceuticals. B. Flatau-Baqué is an employee of Merz Pharmaceuticals. D. Dressler received payments from Abbvie, Allergan, Bayer, IABInterdisciplinary Working Group for Movement Disorders, Ipsen, Medtronic, Merz, Sintetica, Syntaxin and UCB. He holds patents on botulinum toxin and botulinum toxin therapy and is a shareholder of Allergan DM Simpson received research grant support from and served as a consultant for Allergan, Ipsen and Merz. https://doi.org/10.1016/j.rehab.2018.05.146 ISPR8-2530
Relief of spasticity-related pain with botulinum neurotoxin-A (bont-A) in real life practice. Post-hoc analysis from a large international cohort series L. Turner-Stokes 1,∗ , J. Jacinto 2 , K. Fheodoroff 3 , P. Maisonobe 4 , O. Senturk 4 , S. Ashford 1 1 King’s College London School of Medicine- Palliative Care, Policy and Rehabilitation and Regional Rehabilitation Unit, Northwick Park Hospital, Regional Hyperacute Rehabilitation Unit, London, United Kingdom 2 Centro de Medicina de Reabilitac¸ãode, Alcoitão, Servic¸o de Reabilitac¸ão de adultos, Estoril, Portugal 3 Gailtal-Klinik, Neurorehabilitation, Hermagor, Austria 4 Ipsen Pharma, Medical Affairs, Boulogne-Billancourt, France ∗ Corresponding author. E-mail address: [email protected] (L. Turner-Stokes) Introduction/Background Pain is a common treatment goal for upper limb spasticity (ULS). Whilst clinical trials of botulinum toxin A (BoNT-A) show variable results for spasticity-related pain, here we describe treatment in real-life clinical practice. This post-hoc analysis compares patients whose primary treatment goal is pain relief, with primary goals in other areas. Material and method The Upper Limb International Spasticity (ULIS) programme is a series of observational cohort studies across > 30 countries, examining local clinical practice and patientcentred outcomes in ULS treatment with BoNT-A/concomitant therapies. ULIS-II (NCT01020500) examined a single treatment cycle in stroke patients. ULIS-III (NCT02454803) examines repeated cycles in all neurological conditions. Baseline data are recently available. Outcome measures: goal achievement, goal attainment scaling (GAS), Neurological Impairment Scale, Modified Ashworth Scale. Results In ULIS-II (n = 456), pain was the fourth most common primary goal area, expressed by 13% of patients (pain group), whilst 87% had other primary goal areas, (e.g. function, mobility, involuntary movements). At baseline, the pain group showed significant differences in age (61 years vs. 56 years; P = 0.014) and contracture severity (5.9 vs. 4.5; P = 0.008), compared with others (Table 1). Time since stroke, sex, motor impairment and spasticity were comparable between groups. The pain group showed somewhat better primary goal achievement (84% vs. 79%) and mean [standard deviation] GAS-T score (54.3 [9.4] vs. 52.5 [9.5]). Pain group goal attainment was significantly associated with improved pain visual analogue scale (Spearman rho = 0.65; P < 0.001), proximal spasticity (rho = 0.40, P = 0.002) and patient-reported global benefit (rho = 0.41; P = 0.001), but unrelated spasticity duration (rho = 0.15; P = 0.298). ULIS-III baseline data showed pain was the second most common primary goal area, identified by 25% of patients. Conclusion Pain reduction is an important goal in patient-centred spasticity management, irrespective of chronicity or presence of
ISPR8-1805
Efficacy of incobotulinumtoxin a in treatment of lower-limb spasticity, including pes equinovarus, in adults D. Bensmail 1,∗ , J. Wissel 2 , I. Laffont 3,4 , O. Simon 5 , A. Scheschonka 6 , B. Flatau-Baqué 6 , D. Dressler 7 , D. Simpson 8 1 Hôpital Raymond-Poincaré, AP–HP, University of Versailles–Saint-Quentin, Garches, France 2 Vivantes Hospital Spandau, Department of Neurorehabilitation and Physical Therapy, Department of Neurology, Berlin, Germany 3 Hôpital Lapeyronie, Physical Medicine and Rehabilitation, Montpellier, France 4 Euromov, Montpellier University, IFRH, Montpellier, France 5 Formerly of Merz Pharmaceuticals GmbH, Medical Affairs, Frankfurt am Main, Germany 6 Merz Pharmaceuticals GmbH, Medical Affairs, Frankfurt am Main, Germany 7 Hannover Medical School, Movement Disorders Section, Department of Neurology, Hannover, Germany 8 Icahn School of Medicine at Mount Sinai, Department of Neurology, New York, USA ∗ Corresponding author. E-mail address: [email protected] (D. Bensmail) Introduction/Background The TOWER study (NCT01603459) previously demonstrated that escalating doses of incobotulinumtoxinA (400–≤800 U) in patients with upper- (UL) and lower-limb (LL) spasticity due to stroke or other cerebral causes increased treatment efficacy without compromising safety or tolerability (Wissel, Neurology 2017). This post-hoc analysis assessed the efficacy of incobotulinumtoxinA for LL spasticity, including pes equinovarus. Material and method Patients received treatment with escalating total incobotulinumtoxinA doses on the same body side during three injection cycles (ICs) (400 U, 600 U and 600–800 U, respectively; maximum 600 U per limb; optional pes equinovarus, planned dose range 100–400 U). Outcomes included change from IC baseline to 4 weeks post-injection in Ashworth Scale (AS) for the ankle joint (in patients treated for pes equinovarus or not) and LL resistance to passive movement scale (REPAS) scores (in patients treated in the LL [with/without UL treatment], or UL only). Results In total, 155 patients were enrolled. In IC1, IC2 and IC3, respectively, 109, 137 and 137 patients received LL treatment with mean (standard deviation [SD]) total limb doses of incobotulinumtoxinA: 191.7 (97.6), 254.0 (111.6) and 320.9 (127.6) U. Pes equinovarus was treated in 88, 117 and 122 of these patients. The mean (SD) improvement in ankle joint AS score at 4 weeks post-injection was –0.66 (0.77), –0.70 (0.82) and –0.82 (0.77) in patients treated for pes equinovarus, and –0.21 (0.64), –0.38 (0.85) and –0.61 (0.70) in patients who were not, with a significant difference between the groups in IC1 (P = 0.0006). For all ICs, the mean improvement in REPAS LL scores 4 weeks post-injection was greater in patients who were treated in the LL than in patients treated in the UL only, with significant differences between groups in IC1 (P < 0.0001) and IC2 (P = 0.0043). Conclusion Results suggest that incobotulinumtoxinA is effective for treating LL spasticity, including pes equinovarus. Keywords Incobotulinumtoxin A; Spasticity; Lower limb Authors contribution D. Bensmail and J. Wissel contributed equally to this work as co-first authors. D. Dressler and D.M. Simpson contributed equally to this work as co-last authors. Disclosure of interest This study was supported by Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany. Editorial support was provided, under the guidance of the authors, by Claire Cairney, PhD, of CMC CONNECT, a division of Complete Medical Communications and was funded by Merz Pharmaceuticals GmbH. D. Bensmail served as a consultant for Allergan, Almirall, Ipsen, Medtronic and Merz. J. Wissel received research grant support from and served as a consultant for Allergan, Ipsen, Medtronic
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and Merz. I. Laffont served as a consultant for Ipsen and received grant support from Merz. O. Simon is a former employee of Merz Pharmaceuticals. A. Scheschonka is an employee of Merz Pharmaceuticals. B. Flatau-Baqué is an employee of Merz Pharmaceuticals. D. Dressler received payments from Abbvie, Allergan, Bayer, IABInterdisciplinary Working Group for Movement Disorders, Ipsen, Medtronic, Merz, Sintetica, Syntaxin and UCB. He holds patents on botulinum toxin and botulinum toxin therapy and is a shareholder of Allergan DM Simpson received research grant support from and served as a consultant for Allergan, Ipsen and Merz. https://doi.org/10.1016/j.rehab.2018.05.146 ISPR8-2530
Relief of spasticity-related pain with botulinum neurotoxin-A (bont-A) in real life practice. Post-hoc analysis from a large international cohort series L. Turner-Stokes 1,∗ , J. Jacinto 2 , K. Fheodoroff 3 , P. Maisonobe 4 , O. Senturk 4 , S. Ashford 1 1 King’s College London School of Medicine- Palliative Care, Policy and Rehabilitation and Regional Rehabilitation Unit, Northwick Park Hospital, Regional Hyperacute Rehabilitation Unit, London, United Kingdom 2 Centro de Medicina de Reabilitac¸ãode, Alcoitão, Servic¸o de Reabilitac¸ão de adultos, Estoril, Portugal 3 Gailtal-Klinik, Neurorehabilitation, Hermagor, Austria 4 Ipsen Pharma, Medical Affairs, Boulogne-Billancourt, France ∗ Corresponding author. E-mail address: [email protected] (L. Turner-Stokes) Introduction/Background Pain is a common treatment goal for upper limb spasticity (ULS). Whilst clinical trials of botulinum toxin A (BoNT-A) show variable results for spasticity-related pain, here we describe treatment in real-life clinical practice. This post-hoc analysis compares patients whose primary treatment goal is pain relief, with primary goals in other areas. Material and method The Upper Limb International Spasticity (ULIS) programme is a series of observational cohort studies across > 30 countries, examining local clinical practice and patientcentred outcomes in ULS treatment with BoNT-A/concomitant therapies. ULIS-II (NCT01020500) examined a single treatment cycle in stroke patients. ULIS-III (NCT02454803) examines repeated cycles in all neurological conditions. Baseline data are recently available. Outcome measures: goal achievement, goal attainment scaling (GAS), Neurological Impairment Scale, Modified Ashworth Scale. Results In ULIS-II (n = 456), pain was the fourth most common primary goal area, expressed by 13% of patients (pain group), whilst 87% had other primary goal areas, (e.g. function, mobility, involuntary movements). At baseline, the pain group showed significant differences in age (61 years vs. 56 years; P = 0.014) and contracture severity (5.9 vs. 4.5; P = 0.008), compared with others (Table 1). Time since stroke, sex, motor impairment and spasticity were comparable between groups. The pain group showed somewhat better primary goal achievement (84% vs. 79%) and mean [standard deviation] GAS-T score (54.3 [9.4] vs. 52.5 [9.5]). Pain group goal attainment was significantly associated with improved pain visual analogue scale (Spearman rho = 0.65; P < 0.001), proximal spasticity (rho = 0.40, P = 0.002) and patient-reported global benefit (rho = 0.41; P = 0.001), but unrelated spasticity duration (rho = 0.15; P = 0.298). ULIS-III baseline data showed pain was the second most common primary goal area, identified by 25% of patients. Conclusion Pain reduction is an important goal in patient-centred spasticity management, irrespective of chronicity or presence of