To view a video of Dr. Alberto Esquenazi discussing these data, please follow the link below: https://vimeo.com/300659002/a702fbb848 Individualized OnabotulinumtoxinA Treatment for Lower Limb Spasticity Resulted in High Patient and Clinician Satisfaction in the ASPIRE Study Alberto Esquenazi, 1 Ganesh Bavikatte, 2 Wolfgang H. Jost, 3 Daniel S. Bandari, 4 Michael C. Munin, 5 Simon Fuk Tan Tang, 6 Joan Largent, 7 Aleksej Zuzek, 8 Anand Patel, 9 Gerard E. Francisco 10 1 MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA; 2 The Walton Centre, Liverpool, UK; 3 University of Freiburg, Department of Neurology, Freiburg im Breisgau, Germany; 4 Multiple Sclerosis Center of California, Newport Beach, CA, USA; 5 University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; 6 Chang Gung Memorial Hospital, Taoyuan, Taiwan; 7 IQVIA, Cambridge, MA, USA; 8 Allergan plc, Marlow, UK; 9 Allergan plc, Irvine, CA, USA; 10 University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, TX, USA
Transcript
To view a video of Dr. Alberto Esquenazi discussing these data, please follow the link below:
https://vimeo.com/300659002/a702fbb848
Individualized OnabotulinumtoxinA Treatment for Lower Limb Spasticity Resulted in High Patient and Clinician Satisfaction in the ASPIRE StudyAlberto Esquenazi,1 Ganesh Bavikatte,2 Wolfgang H. Jost,3 Daniel S. Bandari,4 Michael C. Munin,5 Simon Fuk Tan Tang,6 Joan Largent,7 Aleksej Zuzek,8 Anand Patel,9 Gerard E. Francisco101MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA; 2The Walton Centre, Liverpool, UK; 3University of Freiburg, Department of Neurology, Freiburg im Breisgau, Germany; 4Multiple Sclerosis Center of California, Newport Beach, CA, USA; 5University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; 6Chang Gung Memorial Hospital, Taoyuan, Taiwan; 7IQVIA, Cambridge, MA, USA; 8Allergan plc, Marlow, UK; 9Allergan plc, Irvine, CA, USA; 10University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, TX, USA
This study was sponsored by Allergan plc, Dublin, Ireland. We would like to thank the participants and investigators who took part in this study. Writing and editorial assistance was provided by Karen Pemberton, PhD, of Evidence Scientifi c Solutions, Inc, and funded by Allergan plc. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. AE consulted for Allergan, Ipsen, and Merz, and received research grants from Allergan and Ipsen; GB has served on a steering committee as a consultant for Allergan; WHJ is a speaker and consultant for Allergan, Ipsen, and Merz; DSB is a consultant and/or speaker for Accorda, Biogen, EMD-Serono, Genentech, Genzyme, Mallinckrodt, and Teva, and has received research support from Allergan, Biogen, Genentech, Genzyme, and Med-day; MCM received research support from Allergan and Ipsen, and has consulted with Merz; SFTT none reported; JL is a full-time employee of IQVIA (formerly QuintilesIMS), the contract research organization responsible for the management of this study, and a former full-time employee of Allergan; AZ and AP are full-time employees of Allergan; GEF has consulted for, and received research grants from, Allergan, Ipsen, and Merz.
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INDIVIDUALIZED ONABOTULINUMTOXINA TREATMENT FOR LOWER LIMB SPASTICITY RESULTED IN HIGH PATIENT AND CLINICIAN SATISFACTION IN THE ASPIRE STUDYAlberto Esquenazi,1 Ganesh Bavikatte,2 Wolfgang H. Jost,3 Daniel S. Bandari,4 Michael C. Munin,5
Simon Fuk Tan Tang,6 Joan Largent,7 Aleksej Zuzek,8 Anand Patel,9 Gerard E. Francisco10
1MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA; 2The Walton Centre, Liverpool, UK; 3University of Freiburg, Department of Neurology, Freiburg im Breisgau, Germany; 4Multiple Sclerosis Center of California, Newport Beach, CA, USA; 5University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; 6Chang Gung Memorial Hospital, Taoyuan, Taiwan; 7IQVIA, Cambridge, MA, USA; 8Allergan plc, Marlow, UK; 9Allergan plc, Irvine, CA, USA; 10University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, TX, USA
Patient Demographics and Clinical Characteristics• Patients were, on average, 53.6 years of age (range=18.5–93.2 years)• Sex was nearly evenly distributed (female: n=380, 52%; male:
n=350, 48%)• Majority of patients were white (n=562, 77%)• 461 patients (63%) were continuing botulinum toxin treatment for
spasticity• Stroke was the most frequently reported etiology (56%) (Figure 2)
Background• OnabotulinumtoxinA treatment for spasticity
is variable, as treatment is individualized and dependent on numerous factors
Objective• To explore real-world patterns of
onabotulinumtoxinA utilization in patients with lower limb spasticity from the ASPIRE study, over 2 years
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ASPIRE provides valuable, real-world data on dosing, injection
guidance, and muscle targeting over 2 years, that may help guide
clinical strategies
This study captured the individualized nature of onabotulinumtoxinA utilization
for spasticity, while demonstrating consistently high satisfaction
These results add to the body of evidence on the
safety and effectiveness of onabotulinumtoxinA
for spasticity
SUM
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Study Disposition• The ASPIRE study was conducted at 54 sites, by 74 clinicians, across
7 countries and 3 continents (Figure 1)• Primary specialty of clinicians: 59.5% Physiatry, 40.5% Neurology
Average 15.7 years treating spasticity 62% had >10 years of experience using onabotulinumtoxinA to treat
spasticity• 730 patients received ≥1 onabotulinumtoxinA treatment for spasticity
during the 2-year study• 397 patients (54%) completed the 2-year study
OnabotulinumtoxinA Treatment Utilization• The most commonly treated lower limb spasticity presentation was
equinovarus foot (Figure 3) Data on onabotulinumtoxinA dosing, localization method, and muscle
targeting for each lower limb spasticity presentation are shown below
RES
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Figure 2. Distribution of patient etiology of spasticity
Figure 3. Lower limb spasticity presentations treated with onabotulinumtoxinA
SUM
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Figure 1. Study disposition
NOTE: Percentages were calculated using naive, non-naive, and total populations as the denominator, in the respective stratifi cations, where more than 1 response was allowed.aIncludes ischemic, hemorrhagic, or embolic stroke.bOther includes hereditary spastic paraparesis, stroke during aneurysm clipping, Chiari malformation, and hydrocephalus.CP = cerebral palsy; MS = multiple sclerosis; SCI = spinal cord injury; TBI = traumatic brain injury.
HCPs = healthcare professionals
NOTE: N refers to number of patients; T refers to number of treatment sessions.Tx = treatment.
21 AEs in 18 patients (3.4%) were considered treatment-related The most common treatment-related AE was muscular weakness
(n=6, 1.1%)• A total of 67/530 patients (12.6%) reported 138 serious AEs• 3 serious AEs in 2 patients (0.4%) were considered treatment-related
Muscular weakness, dysphagia, slow speech• No new safety signals were identifi ed
OnabotulinumtoxinA Treatment Satisfaction• Majority of patients and clinicians were satisfi ed that
onabotulinumtoxinA helped manage spasticity and had sustained benefi t of treatment (Figure 5) The majority of patients and clinicians also indicated that they would
continue onabotulinumtoxinA treatment to manage spasticity
OnabotulinumtoxinA Treatment Information • Treatment strategies often changed between treatment sessions
(Figure 4)
Figure 5. Patient and clinician satisfaction
Figure 4. Lower limb spasticity treatment information
OnabotulinumtoxinA has sustained benefit of treatment
60
40
20
0
80
100
Patientsatisfaction
(T=908)
Cliniciansatisfaction(T=1626)
Trea
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)
Continue onabotulinumtoxinA treatment to manage spasticity
Extremely dissatisfied/definitely not
Dissatisfied/probably not
Neither satisfied nordissatisfied/undecided
Satisfied/probably yes
Extremely satisfied/yes, definitely
• ASPIRE is a prospective, observational registry conducted at select sites in North America, Europe, and Asia (NCT01930786)
• Adult patients across multiple etiologies were treated with onabotulinumtoxinA for focal spasticity, including patients non-naive to botulinum toxins
• Treatments were determined by the participating, treating clinician
• Financial support was not provided to the patients for any treatment/treatment-related costs
• Utilization was assessed at each treatment visit, clinician satisfaction at each following visit, patient satisfaction at 5 ± 1 week post-treatment, and follow-up visit approximately 12 weeks after the fi nal visit
real-world data on dosing, injection nature of onabotulinumtoxinA utilization
NOTE: Localization methods were not mutually exclusive and may have been infl uenced by availability of equipment at the site. EMG = electromyography; E-stim = electrical stimulation; SD = standard deviation.
• Primary study objectives included: Evaluation of onabotulinumtoxinA
treatment utilization in adult patients with spasticity Assessment of patient and clinician
satisfaction with onabotulinumtoxinA treatment for spasticity
• Data were summarized using descriptive statistics
P3.17
To view a video of Dr. Alberto Esquenazi discussing these data or obtain a PDF of this poster:• Scan the QR code
OR • Visit www.allergancongressposters.com/545064Charges may apply. No personal information is stored.
Presented at TOXINS 2019, the 4th International Congress of the International Neurotoxin Association (INA); January 16–19, 2019; Copenhagen, Denmark
