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An examination of real-world onabotulinumtoxina utilization for the treatment of lower limb spasticity: The Adult Spasticity International Registry (ASPIRE) study
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Oral abstracts / Annals of Physical and Rehabilitation Medicine 61S (2018) e1–e102
Table 1 Beseline demographics and patient characteristics.
contractures. It is increasingly identified by clinicians and patients as a primary treatment goal. Keywords Botulinum toxin A; Spasticity-related pain; Real life practice Disclosure of interest Lynne Turner-Stokes and Jorge Jacinto have received consulting fees from Ipsen. Stephen Ashford has received consulting fees from Ipsen, Allergan and Merz. Klemens Fheodoroff has received consulting fees from Ipsen and Merz. Pascal Maisonobe and Jovita Balcaitiene are employees of Ipsen. https://doi.org/10.1016/j.rehab.2018.05.147 ISPR8-1287
An examination of real-world onabotulinumtoxina utilization for the treatment of lower limb spasticity: The Adult Spasticity International Registry (ASPIRE) study A. Esquenazi 1,∗ , W. Jost 2 , G. Bavikatte 3 , D. Bandari 4 , M. Munin 5 , A. Zuzek 6 , A. Patel 7 , J. Largent 8 , G. Francisco 9 1 MossRehab Gait and Motion Analysis Laboratory, Physical Medicine and Rehabiltiation, Elkins Park, USA 2 University of Freiburg, Neurology, Freiburg im Breisgau, Germany 3 The Walton Centre, Neurology, Liverpool, United Kingdom 4 Hoag Neurosciences Institute, Multiple Sclerosis Center of California, Newport Beach, USA 5 University of Pittsburgh, School of Medicine, Pittsburgh, USA 6 Allerga plc, Medical Affairs, Irvine, USA 7 Allergan plc, Medical Affairs, Marlow, United Kingdom 8 IQVIA, Epidemiology, Cambridge, USA 9 University of Texas McGovern Medical School and TIRR Memorial Hermann, Physical Medicine and Rehabilitation, Houston, USA ∗ Corresponding author. E-mail address: kuang [email protected], [email protected] (A. Esquenazi) Introduction/Background OnabotulinumtoxinA treatment for spasticity is variable as treatment is individualized and dependent on numerous factors. Here, we explore real-world patterns of onabotulinumtoxinA utilization in patients with lower limb spasticity over 2 years. Material and method Multicenter, international, prospective, observational study (NCT01930786), examining adult patients with focal spasticity across multiple etiologies treated with onabotulinumtoxinA at their physician’s discretion. Assessments include utilization (each treatment visit) and patient/physician satisfaction (5 ± 1 weeks post-treatment).
Results Patients (n = 731) were on average 53.6 years of age (18.5–93.2 years), 52% female, and predominantly Caucasian (77%). Stroke was the most frequently reported etiology (56%). The most commonly treated lower limb spasticity presentation was equinovarus foot (59%). Across all equinovarus foot treatment sessions (n = 1609), percentage injected and dose (mode) injected into each muscle are as follows: gastrocnemius (79%, 100 U), soleus (70%, 100 U), tibialis posterior (48%, 50 U), flexor digitorum longus (21%, 50 U), flexor hallucis longus (8%, 50 U) and other muscle (13%, 50 U). EMG was frequently used to localize the muscles to treat equinovarus foot (>40%). Across all treatment sessions, 95% of physicians and 85% of patients reported being satisfied/extremely satisfied that treatment helped manage spasticity, 89% of physicians and 76% of patients reported treatment benefit was sustained, and 98% of physicians and 92% of patients would definitely/probably continue treatment with onabotulinumtoxin A. 261 patients (36%) reported 831 adverse events (AEs); 23 AEs in 20 patients (3%) were considered treatment-related. 94 patients (13%) reported 195 serious AEs; 3 serious AEs in 2 patients (0.3%) were considered treatmentrelated. No new safety signals were identified. Conclusion ASPIRE provides valuable, real-world data on dosing, injection guidance, and muscle targeting over 2 years, that may help guide clinical strategies. The study captured the individualized nature of onabotulinumtoxin A utilization for spasticity, while demonstrating consistently high satisfaction. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxin A for spasticity. Keywords Onabotulinumtoxin A; Spasticity; Observational 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, 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. A. Patel: Full-time employee of Allergan. 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. M. Munin: Participated in an advisory board for Allergan and an advisory board meeting for Merz. https://doi.org/10.1016/j.rehab.2018.05.148
Oral abstracts / Annals of Physical and Rehabilitation Medicine 61S (2018) e1–e102
Table 1 Beseline demographics and patient characteristics.
contractures. It is increasingly identified by clinicians and patients as a primary treatment goal. Keywords Botulinum toxin A; Spasticity-related pain; Real life practice Disclosure of interest Lynne Turner-Stokes and Jorge Jacinto have received consulting fees from Ipsen. Stephen Ashford has received consulting fees from Ipsen, Allergan and Merz. Klemens Fheodoroff has received consulting fees from Ipsen and Merz. Pascal Maisonobe and Jovita Balcaitiene are employees of Ipsen. https://doi.org/10.1016/j.rehab.2018.05.147 ISPR8-1287
An examination of real-world onabotulinumtoxina utilization for the treatment of lower limb spasticity: The Adult Spasticity International Registry (ASPIRE) study A. Esquenazi 1,∗ , W. Jost 2 , G. Bavikatte 3 , D. Bandari 4 , M. Munin 5 , A. Zuzek 6 , A. Patel 7 , J. Largent 8 , G. Francisco 9 1 MossRehab Gait and Motion Analysis Laboratory, Physical Medicine and Rehabiltiation, Elkins Park, USA 2 University of Freiburg, Neurology, Freiburg im Breisgau, Germany 3 The Walton Centre, Neurology, Liverpool, United Kingdom 4 Hoag Neurosciences Institute, Multiple Sclerosis Center of California, Newport Beach, USA 5 University of Pittsburgh, School of Medicine, Pittsburgh, USA 6 Allerga plc, Medical Affairs, Irvine, USA 7 Allergan plc, Medical Affairs, Marlow, United Kingdom 8 IQVIA, Epidemiology, Cambridge, USA 9 University of Texas McGovern Medical School and TIRR Memorial Hermann, Physical Medicine and Rehabilitation, Houston, USA ∗ Corresponding author. E-mail address: kuang [email protected], [email protected] (A. Esquenazi) Introduction/Background OnabotulinumtoxinA treatment for spasticity is variable as treatment is individualized and dependent on numerous factors. Here, we explore real-world patterns of onabotulinumtoxinA utilization in patients with lower limb spasticity over 2 years. Material and method Multicenter, international, prospective, observational study (NCT01930786), examining adult patients with focal spasticity across multiple etiologies treated with onabotulinumtoxinA at their physician’s discretion. Assessments include utilization (each treatment visit) and patient/physician satisfaction (5 ± 1 weeks post-treatment).
Results Patients (n = 731) were on average 53.6 years of age (18.5–93.2 years), 52% female, and predominantly Caucasian (77%). Stroke was the most frequently reported etiology (56%). The most commonly treated lower limb spasticity presentation was equinovarus foot (59%). Across all equinovarus foot treatment sessions (n = 1609), percentage injected and dose (mode) injected into each muscle are as follows: gastrocnemius (79%, 100 U), soleus (70%, 100 U), tibialis posterior (48%, 50 U), flexor digitorum longus (21%, 50 U), flexor hallucis longus (8%, 50 U) and other muscle (13%, 50 U). EMG was frequently used to localize the muscles to treat equinovarus foot (>40%). Across all treatment sessions, 95% of physicians and 85% of patients reported being satisfied/extremely satisfied that treatment helped manage spasticity, 89% of physicians and 76% of patients reported treatment benefit was sustained, and 98% of physicians and 92% of patients would definitely/probably continue treatment with onabotulinumtoxin A. 261 patients (36%) reported 831 adverse events (AEs); 23 AEs in 20 patients (3%) were considered treatment-related. 94 patients (13%) reported 195 serious AEs; 3 serious AEs in 2 patients (0.3%) were considered treatmentrelated. No new safety signals were identified. Conclusion ASPIRE provides valuable, real-world data on dosing, injection guidance, and muscle targeting over 2 years, that may help guide clinical strategies. The study captured the individualized nature of onabotulinumtoxin A utilization for spasticity, while demonstrating consistently high satisfaction. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxin A for spasticity. Keywords Onabotulinumtoxin A; Spasticity; Observational 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, 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. A. Patel: Full-time employee of Allergan. 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. M. Munin: Participated in an advisory board for Allergan and an advisory board meeting for Merz. https://doi.org/10.1016/j.rehab.2018.05.148