Post on 14-Aug-2020
To view a video of Dr. Gerard Francisco discussing these data, please follow the link below:
https://vimeo.com/295664517/c270120eb0
OnabotulinumtoxinA Treatment Utilization Varies by Etiology of Spasticity, Whilst Maintaining High Patient and Clinician Satisfaction: Results from the ASPIRE StudyGerard E. Francisco,1 Daniel S. Bandari,2 Ganesh Bavikatte,3 Wolfgang H. Jost,4 Joan Largent,5 Aleksej Zuzek,6 Alberto Esquenazi71University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, TX, USA; 2Multiple Sclerosis Center of California, Newport Beach, CA, USA; 3The Walton Centre, Liverpool, UK; 4University of Freiburg, Department of Neurology, Freiburg im Breisgau, Germany; 5IQVIA, Cambridge, MA, USA; 6Allergan plc, Marlow, UK; 7MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, 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 to the authors by Helen Jones, 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. GEF has consulted for, and received research grants from, 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; GB has served on a steering committee as a consultant for Allergan; WHJ is a speaker and consultant for Allergan, Ipsen, and Merz; 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 is a full-time employee of Allergan; AE consulted for Allergan, Ipsen, and Merz, and received research grants from Allergan and Ipsen.
Individualized onabotulinumtoxinA treatment, as demonstrated by dose variation across etiologies of spasticity and within the most frequently treated presentation, is likely a key factor in the observed high levels of
patient/clinician satisfaction
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ONABOTULINUMTOXINA TREATMENT UTILIZATION VARIES BY ETIOLOGY OF SPASTICITY, WHILST MAINTAINING HIGH PATIENT AND CLINICIAN SATISFACTION: RESULTS FROM THE ASPIRE STUDY
To view a video of Dr. Gerard Francisco discussing these data or obtain a PDF of this poster: • Scan the QR code
OR • Visit www.allergancongressposters.com/308846Charges may apply. No personal information is stored.
• ASPIRE is an international, multicenter, prospective, observational registry conducted at select sites in North America, Europe, and Asia (NCT01930786)
• Patients across multiple etiologies treated with onabotulinumtoxinA for spasticity, regardless of past botulinum toxin treatment, were included
• Treatments were determined by the participating, treating clinician
• OnabotulinumtoxinA utilization was recorded at each visit; clinician satisfaction was determined at each subsequent visit, while patient satisfaction was determined at 5 ± 1 week post-treatment
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Gerard E. Francisco,1 Daniel S. Bandari,2 Ganesh Bavikatte,3 Wolfgang H. Jost,4 Joan Largent,5
Aleksej Zuzek,6 Alberto Esquenazi71University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, TX, USA; 2Multiple Sclerosis Center of California, Newport Beach, CA, USA; 3The Walton Centre, Liverpool, UK; 4University of Freiburg, Department of Neurology, Freiburg im Breisgau, Germany; 5IQVIA, Cambridge, MA, USA; 6Allergan plc, Marlow, UK; 7MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA SU
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S Patient Demographics and Clinical Characteristics• In total, 731 patients received ≥1 onabotulinumtoxinA treatment at the 1-year
interim analysis• In the total population, 37% of patients were naive to botulinum toxins for the
treatment of spasticity• The most common etiologies of spasticity observed were stroke, multiple
sclerosis (MS), cerebral palsy (CP), traumatic brain injury (TBI), and spinal cord injury (SCI) (Figure 1)
• Baseline patient demographics are provided in Table 1
Background• Etiology-specifi c differences in
onabotulinumtoxinA treatment utilization and effectiveness are largely unknown
• ASPIRE fi ndings may help optimize onabotulinumtoxinA treatment in patients with spasticity
Objective• Evaluate real-world onabotulinumtoxinA
treatment utilization and effectiveness across etiologies of spasticity from the ASPIRE study
Interim results continue to support the safety and effectiveness of
onabotulinumtoxinA for treatment of spasticity in clinical practice
Figure 1. Distribution of patient etiology of spasticity
60%
100
90
80
70
60
50
40
30
20
10
0
Patie
nts
(%)
Strokeb
(N=411)MS
(N=119)CP
(N=77)TBI
(N=45)SCI
(N=42)
54% 56%
14%18% 16%
9%12% 11%
7% 6% 6% 7% 5% 6%
Naive (N=270)Non-naive (N=461)Total (N=731)a
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. aAdditional etiologies of spasticity that did not align with the 5 diagnoses above were grouped into “Other” (N=72; data not shown); other included hereditary spastic paraparesis, stroke during aneurysm clipping, Chiari malformation, and hydrocephalus. bIncludes ischemic, hemorrhagic, or embolic stroke.CP = cerebral palsy; MS = multiple sclerosis; SCI = spinal cord injury; TBI = traumatic brain injury.
Stroke (N=411)
MS (N=119)
CP (N=77)
TBI (N=45)
SCI (N=42)
Totala
(N=731)Age, y, n
Mean (SD)Min, Max
41158.7 (14.1)19.2, 93.2
11953.1 (10.3)24.7, 77.7
7737.6 (13.4)18.5, 68.1
4542.8 (12.9)20.2, 73.5
4250.9 (16.0)22.8, 93.2
73053.6 (15.4)18.5, 93.2
BMI , kg/m2, nMean (SD)Min, Max
35127.2 (5.2)17.3, 44.5
9625.6 (5.4)14.9, 42.2
6127.4 (8.1)15.5, 56.8
3824.6 (4.8)18.0, 37.1
3626.0 (5.1)17.2, 41.5
60826.7 (5.6)14.9, 56.8
Sex, nFemale, n (%)
411203 (49.4)
119 83 (69.7)
7745 (58.4)
4516 (35.6)
4217 (40.5)
730380 (52.1)
Race, nWhite, n (%)
411309 (75.2)
11999 (83.2)
7765 (84.4)
4532 (71.1)
4226 (61.9)
730562 (77.0)
aData from 1 patient were not provided; data for the total are shown as N=730. BMI = body mass index; CP = cerebral palsy; MS = multiple sclerosis; SCI = spinal cord injury; SD = standard deviation; TBI = traumatic brain injury.
Table 1. Baseline patient demographics and clinical characteristics
OnabotulinumtoxinA Treatment Utilization• The dose of onabotulinumtoxinA administered varied by etiology (Table 2)
In the total population, total doses ranged between 45U and 1038U◦ The median dose of onabotulinumtoxinA ranged between 300U and 365U
Across etiologies, there was slight variation in dosing, with higher mean and median doses of onabotulinumtoxinA administered to patients with TBI compared with patients with stroke, MS, CP, and SCI
• The most frequently treated presentation, as well as the dose of onabotulinumtoxinA administered, varied by etiology (Table 3) Clenched fi st was most common in patients with stroke; equinovarus foot was most common for all other
etiologies For equinovarus foot, the total median dose of onabotulinumtoxinA administered ranged between
100U and 240U across etiologies
• Primary study objectives included: Evaluation of onabotulinumtoxinA treatment
utilization in adult patients with spasticity in actual clinical practice
Assessment of patient and clinician satisfaction with onabotulinumtoxinA treatment for spasticity
• Interim analysis includes all data up to 1-year follow-up
• Data were summarized using descriptive statistics
CP = cerebral palsy; MS = multiple sclerosis; SCI = spinal cord injury; SD = standard deviation; TBI = traumatic brain injury.
Stroke (N=411)
MS (N=119)
CP (N=77)
TBI (N=45)
SCI (N=42)
Most common presentation Clenched fi st Equinovarus foot Equinovarus foot Equinovarus foot Equinovarus foot
Patients, n 290 72 38 28 20Dose, U
Mean (SD)MedianModeMin, Max
99.6 (60.0)100.0100.0
10.0, 500.0
206.0 (124.0)200.0300.0
20.0, 875.0
162.0 (116.0)115.0100.0
20.0, 480.0
223.0 (109.0)200.0150.0
50.0, 450.0
277.0 (168.0)240.0200.0
60.0, 900.0
Table 3. Most frequently treated presentation and corresponding dose of onabotulinumtoxin A by etiology of spasticity
Effectiveness: Disability Assessment Scale • The Disability Assessment Scale (DAS) revealed that patients with stroke, MS, or CP showed signifi cant improvement over the course of
onabotulinumtoxinA treatment, as indicated by reduced DAS scores compared with treatment 1, in the areas of pain, dressing, limb posture, and/or mobility Patients with TBI and SCI did not show consistent improvements on the DAS, which is likely owing to lower sample sizes in these etiologies
Cha
nge
from
Tre
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ent 1
-2.5
-2
-1.5
-1
-0.5
0
-2.5
-2
-1.5
-1
-0.5
0
-2.5
-2
-1.5
-1
-0.5
0
-2.5
-2
-1.5
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-0.5
0
0.5
1
1.5
-2.5
-2
-1.5
-1
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1
1.5* * * * * * * * * * * * * * * * * * * *
Hyg
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Pain
Dre
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Lim
b po
stur
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Mob
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Hyg
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Pain
Dre
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g
Lim
b po
stur
e
Mob
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Hyg
iene
Pain
Dre
ssin
g
Lim
b po
stur
e
Mob
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Hyg
iene
Pain
Dre
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g
Lim
b po
stur
e
Mob
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Hyg
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Pain
Dre
ssin
g
Lim
b po
stur
e
Mob
ility
* *
Tx2 (N=339)Tx3 (N=263)Tx4 (N=153)
Tx2 (N=104)Tx3 (N=77)Tx4 (N=56)
Tx2 (N=69)Tx3 (N=58)Tx4 (N=31)
Tx2 (N=37)Tx3 (N=24)Tx4 (N=14)
Tx2 (N=36)Tx3 (N=28)Tx4 (N=15)
STROKE MULTIPLE SCLEROSIS CEREBRAL PALSY TRAUMATIC BRAIN INJURY SPINAL CORD INJURY
Figure 2. Change in DASa across treatment sessions by etiology of spasticity
aThe Disability Assessment Scale (DAS; modifi ed LL [lower limb], UL [upper limb]) objectively evaluates functional impairment resulting from spasticity. Areas assessed include: hygiene, pain, dressing, limb posture abnormality, and mobility. Patients were scored on a 4-point rating scale (range: 0–3), where a “0” represents no disability and a “3” represents severe disability (normal activities limited). *Indicates statisti cally signifi cant difference from Treatment (Tx) 1 at P<.05; Tx5 data not shown owing to low sample size at 1-year interim analysis.
Effectiveness: Treatment Satisfaction• In the overall population (N=731), the majority of patients and clinicians expressed satisfaction that the most
recent onabotulinumtoxinA treatment helped manage spasticity (Figure 3) The majority of patients and clinicians also indicated that they would continue to use onabotulinumtoxinA to
manage spasticity (Figure 4)
Safety• In total, 559 adverse events (AEs) were reported by 211 patients (28.9%)• 23 AEs in 17 patients (2.3%) were considered treatment-related
Most common treatment-related AE was muscular weakness (n=6, 0.8%)• In total, 136 serious AEs were reported by 75 patients (10.3%)• 5 serious AEs in 2 patients (0.3%) were considered treatment-related
Muscular weakness (2 events in 1 patient) Adverse drug reaction, posture abnormality, slow speech (1 event each)
• No new safety signals were identifi ed
Table 2. Dose of onabotulinumtoxin A by etiology of spasticity
aData from 1 patient were not provided; data for the total are shown as N=730.CP = cerebral palsy; MS = multiple sclerosis; SCI = spinal cord injury; SD = standard deviation; TBI = traumatic brain injury.
Stroke(N=411)
MS (N=119)
CP (N=77)
TBI (N=45)
SCI (N=42)
Totala
(N=731)
Patients, n 411 119 77 45 42 730Dose (U)
Mean (SD)MedianModeMin, Max
371.0 (185.8)350.0200.0
53.3, 1037.5
344.0 (176.6)300.0300.0
58.8, 850.0
295.5 (144.6)300.0400.0
60.0, 620.0
406.2 (152.4)365.0300.0
175.0, 926.7
343.1 (186.3)300.0300.0
100.0, 900.0
356.5 (180.4)328.8200.0
45.0, 1037.5
IN
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Figure 3. Satisfaction with most recent onabotulinumtoxinA treatment in managing spasticity
100
90
80
70
60
50
40
30
20
10
0
Clin
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ns (%
)
Stroke(N=755)
MS(N=237)
CP(N=157)
TBI(N=75)
SCI(N=79)
100
90
80
70
60
50
40
30
20
10
0
Patie
nts
(%)
Stroke(N=337)
MS(N=137)
CP(N=64)
TBI(N=34)
SCI(N=29)
Extremely dissatisfiedDissatisfied
SatisfiedExtremely satisfied
Neither satisfied nor dissatisfied
CP = cerebral palsy; MS = multiple sclerosis; SCI = spinal cord injury; TBI = traumatic brain injury.
Figure 4. Likelihood of continuing onabotulinumtoxinA treatment for spasticity
Definitely notProbably not
Probably yesYes, definitely
Undecided
100
90
80
70
60
50
40
30
20
10
0
Clin
icia
ns (%
)
Stroke(N=755)
MS(N=237)
CP(N=157)
TBI(N=75)
SCI(N=79)
100
90
80
70
60
50
40
30
20
10
0
Patie
nts
(%)
Stroke(N=337)
MS(N=137)
CP(N=64)
TBI(N=34)
SCI(N=29)
CP = cerebral palsy; MS = multiple sclerosis; SCI = spinal cord injury; TBI = traumatic brain injury.
P3.24
Presented at TOXINS 2019, the 4th International Congress of the International Neurotoxin Association (INA); January 16–19, 2019; Copenhagen, Denmark