- Email: [email protected]
Botulinum toxin a in upper limb spasticity management: Baseline data from the upper limb international spasticity (ULIS)–III study
Oral abstracts / Annals of Physical and Rehabilitation Medicine 61S (2018) e1–e102
ISPR8-1289
Comparison of onabotulinumtoxina utilization across various etiologies of spasticity from the Adult spasticity international registry study: ASPIRE G.E. Francisco 1,∗ , D.S. Bandari 2 , G. Bavikatte 3 , W.H. Jost 4 , A. Zuzek 5 , E. McCusker 6 , A. Patel 7 , J. Largent 8 , A. Esquenazi 9 1 University of Texas McGovern Medical School and TIRR Memorial Hermann, Physical Medicine & Rehabilitation, Houston, USA 2 Hoag Neurosciences Institute, Multiple Sclerosis Center of California, Newport Beach, USA 3 The Walton Centre, Neurology, Liverpool, United Kingdom 4 University of Freiburg, Department of Neurology, Freiburg im Breisgau, Germany 5 Allergan plc, Medical Affairs, Irvine, USA 6 Allergan plc, Clinical Development, Irvine, USA 7 Allergan plc, Medical Affairs, Marlow, United Kingdom 8 IQVIA Real-World Evidence Solutions, Epidemiology, Cambridge, USA 9 MossRehab Gait and Motion Analysis Laboratory, Physical Medicine and Rehabilitation, Elkins Park, USA ∗ Corresponding author. E-mail address: [email protected] (G.E. Francisco) Introduction/Background Etiology-specific differences in onabotulinumtoxin A utilization to treat spasticity are largely unknown. Real-world clinical practice data from the ASPIRE study may help optimize onabotulinumtoxin A treatment for spasticity. Our objective is to evaluate real-world utilization of onabotulinumtoxin A for spasticity caused by various etiologies. Material and method 1-year interim analysis; international, multicenter, prospective, observational study (NCT01930786) examining adult patients with spasticity across etiologies. Patients were treated with onabotulinumtoxin A at the physician’s discretion; utilization patterns were recorded at each visit. Results A total of 731 patients received ≥ 1 onabotulinumtoxinA treatment; 37% of patients were naïve to botulinum toxins for spasticity. The most common etiology was stroke (n = 411/731, 56%), followed by multiple sclerosis (MS; n = 119/731, 16%), cerebral palsy (CP; n = 77/731, 11%), traumatic brain injury (TBI; n = 45/731, 6%), spinal cord injury (SCI; n = 42/731, 6%), and other (n = 72/731). Across etiologies (n = 731), total onabotulinumtoxin A doses per treatment session ranged from 45–1038 U. The most frequently treated lower limb presentations, with mean doses injected per presentation, varied by etiology. Stroke: equinovarus foot (223 U [SD = 131]), flexed toe (64 U [SD = 51]), and flexed knee (143 U [SD = 86]); MS: equinovarus foot (206 U [SD = 124]), stiff extended knee (155 U [SD = 134]), and adducted thigh (173 U [SD = 112]); CP: equinovarus foot (162 U [SD = 116]), flexed knee (150 U [SD = 89]), and adducted thigh (163 U [SD = 94]); TBI: equinovarus foot (223 U [SD = 109]), flexed toe (89 U [SD = 61]), and flexed knee (154 U [SD = 60]); and SCI: equinovarus foot (277 U [SD = 168]), adducted thigh (140U [SD = 66]), and flexed knee (165 U [SD = 84]). In the overall population (n = 731), adverse events (AEs) were reported by 28.9% of patients, with 2.3% of events considered treatmentrelated. Serious AEs were reported by 10.3% of patients, with 0.3% of events considered treatment-related. No new safety signals were identified. Conclusion Real-world 1-year interim data from ASPIRE captured etiology-specific utilization of onabotulinumtoxin A for spasticity in clinical practice, while further demonstrating safety across etiologies. Keywords Onabotulinumtoxin A; Spasticity; Etiologies Disclosure of interest G. Francisco: Consulted for, and received research grants from, Allergan. D. Bandari: Consultant, speaker, and/or conducted research for Accorda, Allergan, Biogen, Genentech, Genzyme, EMD-Serono,
e69
Questcore, and Teva. Received research support from Biogen, Teva, Genentech, Allergan, and Genzyme. G. Bavikatte: Served on a steering committee as a consultant for Allergan. W. Jost: Speaker and consultant for Allergan, Ipsen, and Merz. A. Zuzek: Full-time employee of Allergan plc. E. McCusker: Full-time employee of Allergan plc. A. Patel: Full-time employee of Allergan plc. J. Largent: Full-time employee of IQVIA (formerly QuintilesIMS), the contract research organization responsible for the management of this study and was formerly a full-time employee of Allergan. A. Esquenazi: Participated in advisory boards and consulted for Allergan. Received research grants from Allergan and Ipsen. https://doi.org/10.1016/j.rehab.2018.05.149 ISPR8-2524
Botulinum toxin a in upper limb spasticity management: Baseline data from the upper limb international spasticity (ULIS)–III study L. Turner-Stokes 1,∗ , S. Ashford 2 , J. Jacinto 2 , K. Fheodoroff 3 , P. Maisonobe 4 , O. Senturk 4 , A. Brashear 5 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, Centro de Medicina de Reabilitac¸ãode Alcoitão, Estoril, Portugal 3 Gailtal-Klinik, Department of Neurorehabilitation, Hermagor, Austria 4 Ipsen Pharma, Medical Affairs, Boulogne-Billancourt, France 5 Wake Forest School of Medicine, Department of Neurology, Winston-Salem, USA ∗ Corresponding author. E-mail address: [email protected] (L. Turner-Stokes) Introduction/Background ULIS-III describes real-life clinical practice in upper limb spasticity (ULS) management using licensed botulinum toxin A (BoNT-A) products and concomitant therapies. ULIS-III assesses long-term impact on patient-centred outcomes and identifies best practice strategies according to patient needs. Baseline data are presented for patients enrolled by June 2017. Material and method This longitudinal, prospective, observational, cohort study of integrated ULS management in adults (NCT02454803) examines impact of repeated BoNT-A injections over 2 years. Person-centred outcomes are assessed using the Upper Limb Spasticity Index, combining individual goal setting with targeted standardised measures, using patient-selected goal areas. Injection practices and physical treatments are recorded, alongside economic and quality-of-life data. Results Baseline data were analysed for 975 patients across 57 sites (14 countries; 5 continents). Table 1 presents baseline characteristics; 82% of patients had spasticity post-stroke; two-thirds had received previous BoNT-A for ULS (< 5 injections, 46%; > 10 injections, 28%). Median time from diagnosis to first injection and enrolment was 1.0 and 3.4 years, respectively. Baseline muscle tone and disability measures are shown in Table 1. Upper arm and forearm muscles were most commonly injected; 34% received concomitant BoNT-A for lower limb spasticity (Table 2). Shoulder injection frequency increased since ULIS-II (e.g. pectoralis major: 34 vs. 19%). Instrumental injection guidance techniques were used in 73% of patients. Most common primary goal areas were passive function (31%) and pain (25%), showing notable changes in goal selection since ULIS-II (Fig. 1). Conclusion ULIS-III contributes to greater understanding of achievable treatment goals and developing practice with improved clinical reasoning, as reflected in ULIS-III baseline data. ULIS-III will
e70
Oral abstracts / Annals of Physical and Rehabilitation Medicine 61S (2018) e1–e102
Table 1 Baseline demographics and patient characteristics for ULIS-III.
consulting fees from Ipsen, Allergan and Merz. Klemens Fheodoroff has received consulting fees from Ipsen and Merz. Allison Brashear has consulted with Ipsen, Allergan, Concert, Revance and WorldMeds. Research is supported by NINDS, Allergan, Ipsen, Merz and Revance. Dr Brashear’s Disclosure of interest is managed by Wake Forest School of Medicine. Pascal Maisonobe and Jovita Balcaitiene are employees of Ipsen. https://doi.org/10.1016/j.rehab.2018.05.150 ISPR8-1719
The effect of neuro-orthopedic surgery on spasticity in patients with Stiff knee gait (SKG)
M. Galletti ∗ , A. Merlo , E. Giannotti , P. Zerbinati , P. Prati , F. Mascioli , D. Mazzoli O.P.A. Sol et Salus, Gait & Motion Analysis Laboratory, Torre Pedrera di Rimini RN, Italy ∗ Corresponding author. E-mail address: [email protected] (M. Galletti)
Table 2 BoNT-A injection practices at baseline.
Introduction/Background Quadriceps femoris (QF) spasticity is frequent in patients with upper motor neuron lesion (UMNL) and SKG. Aim of this work is to study the effect of QF lengthening by functional surgery (FS) on spasticity in adults with UMNL following stroke or traumatic brain injury (TBI). Material and method A sample of 25 chronic patients with UMNL, 53 (13) years, 16/19 L/R, 6 (5) years after lesion, who underwent surgical QF lengthening was included in the study. The same surgeon always performed the surgeries. QF spasticity was assessed through the Modified Tardieu Scale (MTS) before and 1 month after surgery. MTS was used in this study as is not affected by passive muscle characteristics. Paired MTS values were compared using the non-parametric Wilcoxon test. Percentages of patients with worsened, unchanged and improved MTS scores were also computed and reported. Results MTS distribution is presented in Fig. 1. Spasticity significantly decreased at 1 month after surgery (P < 0.001). MTS score, was stable in 9 subjects (36%), improved in 16 subjects (64%) and never worsened. Noteworthy, 12 subjects (48%) were completely relieved from QF spasticity at the 1-month mark, with MTS decreasing from 3 to 0 and from 2 to 0. Conclusion Along with restoring passive muscle length, FS can also be effective in reducing QF spasticity in adult stroke and TBI survivors. This is reasonably due to the reduction in spindle activa-
Fig. 1 Primary goal selection at baseline of ULIS-III compared with ULIS-II. improve understanding of treatment and outcomes for long-term ULS management. Final data are expected in 2019. Keywords Botulinum toxin A; Upper limb spasticity; Baseline data Disclosure of interest Lynne Turner-Stokes and Jorge Jacinto have received consulting fees from Ipsen. Stephen Ashford has received
Fig. 1
ISPR8-1289
Comparison of onabotulinumtoxina utilization across various etiologies of spasticity from the Adult spasticity international registry study: ASPIRE G.E. Francisco 1,∗ , D.S. Bandari 2 , G. Bavikatte 3 , W.H. Jost 4 , A. Zuzek 5 , E. McCusker 6 , A. Patel 7 , J. Largent 8 , A. Esquenazi 9 1 University of Texas McGovern Medical School and TIRR Memorial Hermann, Physical Medicine & Rehabilitation, Houston, USA 2 Hoag Neurosciences Institute, Multiple Sclerosis Center of California, Newport Beach, USA 3 The Walton Centre, Neurology, Liverpool, United Kingdom 4 University of Freiburg, Department of Neurology, Freiburg im Breisgau, Germany 5 Allergan plc, Medical Affairs, Irvine, USA 6 Allergan plc, Clinical Development, Irvine, USA 7 Allergan plc, Medical Affairs, Marlow, United Kingdom 8 IQVIA Real-World Evidence Solutions, Epidemiology, Cambridge, USA 9 MossRehab Gait and Motion Analysis Laboratory, Physical Medicine and Rehabilitation, Elkins Park, USA ∗ Corresponding author. E-mail address: [email protected] (G.E. Francisco) Introduction/Background Etiology-specific differences in onabotulinumtoxin A utilization to treat spasticity are largely unknown. Real-world clinical practice data from the ASPIRE study may help optimize onabotulinumtoxin A treatment for spasticity. Our objective is to evaluate real-world utilization of onabotulinumtoxin A for spasticity caused by various etiologies. Material and method 1-year interim analysis; international, multicenter, prospective, observational study (NCT01930786) examining adult patients with spasticity across etiologies. Patients were treated with onabotulinumtoxin A at the physician’s discretion; utilization patterns were recorded at each visit. Results A total of 731 patients received ≥ 1 onabotulinumtoxinA treatment; 37% of patients were naïve to botulinum toxins for spasticity. The most common etiology was stroke (n = 411/731, 56%), followed by multiple sclerosis (MS; n = 119/731, 16%), cerebral palsy (CP; n = 77/731, 11%), traumatic brain injury (TBI; n = 45/731, 6%), spinal cord injury (SCI; n = 42/731, 6%), and other (n = 72/731). Across etiologies (n = 731), total onabotulinumtoxin A doses per treatment session ranged from 45–1038 U. The most frequently treated lower limb presentations, with mean doses injected per presentation, varied by etiology. Stroke: equinovarus foot (223 U [SD = 131]), flexed toe (64 U [SD = 51]), and flexed knee (143 U [SD = 86]); MS: equinovarus foot (206 U [SD = 124]), stiff extended knee (155 U [SD = 134]), and adducted thigh (173 U [SD = 112]); CP: equinovarus foot (162 U [SD = 116]), flexed knee (150 U [SD = 89]), and adducted thigh (163 U [SD = 94]); TBI: equinovarus foot (223 U [SD = 109]), flexed toe (89 U [SD = 61]), and flexed knee (154 U [SD = 60]); and SCI: equinovarus foot (277 U [SD = 168]), adducted thigh (140U [SD = 66]), and flexed knee (165 U [SD = 84]). In the overall population (n = 731), adverse events (AEs) were reported by 28.9% of patients, with 2.3% of events considered treatmentrelated. Serious AEs were reported by 10.3% of patients, with 0.3% of events considered treatment-related. No new safety signals were identified. Conclusion Real-world 1-year interim data from ASPIRE captured etiology-specific utilization of onabotulinumtoxin A for spasticity in clinical practice, while further demonstrating safety across etiologies. Keywords Onabotulinumtoxin A; Spasticity; Etiologies Disclosure of interest G. Francisco: Consulted for, and received research grants from, Allergan. D. Bandari: Consultant, speaker, and/or conducted research for Accorda, Allergan, Biogen, Genentech, Genzyme, EMD-Serono,
e69
Questcore, and Teva. Received research support from Biogen, Teva, Genentech, Allergan, and Genzyme. G. Bavikatte: Served on a steering committee as a consultant for Allergan. W. Jost: Speaker and consultant for Allergan, Ipsen, and Merz. A. Zuzek: Full-time employee of Allergan plc. E. McCusker: Full-time employee of Allergan plc. A. Patel: Full-time employee of Allergan plc. J. Largent: Full-time employee of IQVIA (formerly QuintilesIMS), the contract research organization responsible for the management of this study and was formerly a full-time employee of Allergan. A. Esquenazi: Participated in advisory boards and consulted for Allergan. Received research grants from Allergan and Ipsen. https://doi.org/10.1016/j.rehab.2018.05.149 ISPR8-2524
Botulinum toxin a in upper limb spasticity management: Baseline data from the upper limb international spasticity (ULIS)–III study L. Turner-Stokes 1,∗ , S. Ashford 2 , J. Jacinto 2 , K. Fheodoroff 3 , P. Maisonobe 4 , O. Senturk 4 , A. Brashear 5 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, Centro de Medicina de Reabilitac¸ãode Alcoitão, Estoril, Portugal 3 Gailtal-Klinik, Department of Neurorehabilitation, Hermagor, Austria 4 Ipsen Pharma, Medical Affairs, Boulogne-Billancourt, France 5 Wake Forest School of Medicine, Department of Neurology, Winston-Salem, USA ∗ Corresponding author. E-mail address: [email protected] (L. Turner-Stokes) Introduction/Background ULIS-III describes real-life clinical practice in upper limb spasticity (ULS) management using licensed botulinum toxin A (BoNT-A) products and concomitant therapies. ULIS-III assesses long-term impact on patient-centred outcomes and identifies best practice strategies according to patient needs. Baseline data are presented for patients enrolled by June 2017. Material and method This longitudinal, prospective, observational, cohort study of integrated ULS management in adults (NCT02454803) examines impact of repeated BoNT-A injections over 2 years. Person-centred outcomes are assessed using the Upper Limb Spasticity Index, combining individual goal setting with targeted standardised measures, using patient-selected goal areas. Injection practices and physical treatments are recorded, alongside economic and quality-of-life data. Results Baseline data were analysed for 975 patients across 57 sites (14 countries; 5 continents). Table 1 presents baseline characteristics; 82% of patients had spasticity post-stroke; two-thirds had received previous BoNT-A for ULS (< 5 injections, 46%; > 10 injections, 28%). Median time from diagnosis to first injection and enrolment was 1.0 and 3.4 years, respectively. Baseline muscle tone and disability measures are shown in Table 1. Upper arm and forearm muscles were most commonly injected; 34% received concomitant BoNT-A for lower limb spasticity (Table 2). Shoulder injection frequency increased since ULIS-II (e.g. pectoralis major: 34 vs. 19%). Instrumental injection guidance techniques were used in 73% of patients. Most common primary goal areas were passive function (31%) and pain (25%), showing notable changes in goal selection since ULIS-II (Fig. 1). Conclusion ULIS-III contributes to greater understanding of achievable treatment goals and developing practice with improved clinical reasoning, as reflected in ULIS-III baseline data. ULIS-III will
e70
Oral abstracts / Annals of Physical and Rehabilitation Medicine 61S (2018) e1–e102
Table 1 Baseline demographics and patient characteristics for ULIS-III.
consulting fees from Ipsen, Allergan and Merz. Klemens Fheodoroff has received consulting fees from Ipsen and Merz. Allison Brashear has consulted with Ipsen, Allergan, Concert, Revance and WorldMeds. Research is supported by NINDS, Allergan, Ipsen, Merz and Revance. Dr Brashear’s Disclosure of interest is managed by Wake Forest School of Medicine. Pascal Maisonobe and Jovita Balcaitiene are employees of Ipsen. https://doi.org/10.1016/j.rehab.2018.05.150 ISPR8-1719
The effect of neuro-orthopedic surgery on spasticity in patients with Stiff knee gait (SKG)
M. Galletti ∗ , A. Merlo , E. Giannotti , P. Zerbinati , P. Prati , F. Mascioli , D. Mazzoli O.P.A. Sol et Salus, Gait & Motion Analysis Laboratory, Torre Pedrera di Rimini RN, Italy ∗ Corresponding author. E-mail address: [email protected] (M. Galletti)
Table 2 BoNT-A injection practices at baseline.
Introduction/Background Quadriceps femoris (QF) spasticity is frequent in patients with upper motor neuron lesion (UMNL) and SKG. Aim of this work is to study the effect of QF lengthening by functional surgery (FS) on spasticity in adults with UMNL following stroke or traumatic brain injury (TBI). Material and method A sample of 25 chronic patients with UMNL, 53 (13) years, 16/19 L/R, 6 (5) years after lesion, who underwent surgical QF lengthening was included in the study. The same surgeon always performed the surgeries. QF spasticity was assessed through the Modified Tardieu Scale (MTS) before and 1 month after surgery. MTS was used in this study as is not affected by passive muscle characteristics. Paired MTS values were compared using the non-parametric Wilcoxon test. Percentages of patients with worsened, unchanged and improved MTS scores were also computed and reported. Results MTS distribution is presented in Fig. 1. Spasticity significantly decreased at 1 month after surgery (P < 0.001). MTS score, was stable in 9 subjects (36%), improved in 16 subjects (64%) and never worsened. Noteworthy, 12 subjects (48%) were completely relieved from QF spasticity at the 1-month mark, with MTS decreasing from 3 to 0 and from 2 to 0. Conclusion Along with restoring passive muscle length, FS can also be effective in reducing QF spasticity in adult stroke and TBI survivors. This is reasonably due to the reduction in spindle activa-
Fig. 1 Primary goal selection at baseline of ULIS-III compared with ULIS-II. improve understanding of treatment and outcomes for long-term ULS management. Final data are expected in 2019. Keywords Botulinum toxin A; Upper limb spasticity; Baseline data Disclosure of interest Lynne Turner-Stokes and Jorge Jacinto have received consulting fees from Ipsen. Stephen Ashford has received
Fig. 1