Individualized OnabotulinumtoxinA Treatment for Upper Limb ... · Figure 1) • Primary specialty...
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Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Patient and Clinician Satisfaction in the ASPIRE StudyGerard E. Francisco,1 Ganesh Bavikatte,2 Wolfgang H. Jost,3 Daniel S. Bandari,4 Simon Fuk Tan Tang,5Michael C. Munin,6 Joan Largent,7 Aleksej Zuzek,8 Anand Patel,9 Alberto Esquenazi10
1University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, TX, 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; 5Chang Gung Memorial Hospital, Taoyuan, Taiwan; 6University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; 7IQVIA, Cambridge, MA, USA; 8Allergan plc, Marlow, UK; 9Allergan plc, Irvine, CA, USA; 10MossRehab 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 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; 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; SFTT none reported; MCM has received research support from Allergan and Ipsen, and has consulted for 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 and AP are full-time employees of Allergan; AE consulted for Allergan, Ipsen, and Merz, and received research grants from Allergan and Ipsen.
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80
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Patie
nts
who
rece
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≥1
ona
botu
linum
toxi
nAin
ject
ion
over
the
2 ye
ars
(%)
Clenchedfist
(n=383)
Flexedelbow
(n=367)
Flexedwrist
(n=284)
Pronatedforearm(n=191)
Adducted/internallyrotated
shoulder(n=185)
Thumb-in-palm(n=147)
Intrinsicplus hand(n=119)
52%
39%
26% 26% 25% 20% 16%
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INDIVIDUALIZED ONABOTULINUMTOXINA TREATMENT FOR UPPER LIMB SPASTICITY RESULTED IN HIGH PATIENT AND CLINICIAN SATISFACTION IN THE ASPIRE STUDYGerard E. Francisco,1 Ganesh Bavikatte,2 Wolfgang H. Jost,3 Daniel S. Bandari,4 Simon Fuk Tan Tang,5
Michael C. Munin,6 Joan Largent,7 Aleksej Zuzek,8 Anand Patel,9 Alberto Esquenazi10
1University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, TX, 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; 5Chang Gung Memorial Hospital, Taoyuan, Taiwan; 6University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; 7IQVIA, Cambridge, MA, USA; 8Allergan plc, Marlow, UK; 9Allergan plc, Irvine, CA, USA; 10MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, 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 upper 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
MA
RY
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 upper limb spasticity presentation was
clenched fi st (Figure 3) Data on onabotulinumtoxinA dosing, localization method, and muscle
targeting for each upper limb spasticity presentation are shown below
RES
ULT
S
Figure 2. Distribution of patient etiology of spasticity
Figure 3. Upper limb spasticity presentations treated withonabotulinumtoxinA
SUM
MA
RY
Figure 1. Study disposition
NOTE: N refers to number of patients; T refers to number of treatment sessions.Tx = treatment.
Safety• Overall, 179/484 patients (37.0%) reported 563 adverse events (AEs)
15 AEs in 14 patients (2.9%) were considered treatment-related The most common treatment-related AE was muscular weakness
(n=7, 1.4%)• A total of 69/484 patients (14.3%) reported 137 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• The 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 4. Upper limb spasticity treatment information
• ASPIRE is a prospective, observational registry conducted at select sites in North America, Europe, and Asia (NCT01930786)
• Adult patients across multiple etiologies 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 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
Number of participating patients
6640
23
30
44388
40
Number of participating HCPs
35
76
4
9
5
8
Number of participating sites
26
6
5
4
4 2
7
USA Germany UK France Spain Italy Taiwan
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60
50
40
30
20
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0
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Patie
nts
(%)
Strokea
(N=411)MS
(N=119)CP
(N=77)Otherb
(N=72)TBI
(N=45)SCI
(N=42)
60%54% 56%
14%18%16%
9%12%11% 9%10%10%
7% 6% 6% 7% 5% 6%
Naive (N=269)Non-naive (N=461)Total (N=730)
Dose adjusted from last TxMuscles treated
changed from last Tx
Better controlspasticity
Presentation changed (additional
spastic muscles)
Presentation changed (fewer spastic muscles)
Not enough effect inprevious muscles treated
Increased number ofmuscles treated
Other
Tx2 (N=386) Tx3 (N=327) Tx4 (N=279) Tx5 (N=216) Tx6 (N=162) Tx7 (N=110) Tx8 (N=32) Overall (T=1974)
Top
3 re
ason
s w
hy (%
)(m
ore
than
1 re
spon
se a
llow
ed)
Que
stio
n(%
)
0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100%
55%51%50%50%49%
44%28%
50%
51%42%
37%31%33%
24%31%
39%
49%47%
42%56%
53%60%
56%49%
37%35%
42%34%
42%35%
67%38%
28%32%
27%24%
15%31%33%
27%
41%34%33%
29%22%
36%30%
35%
31%28%
42%39%
26%19%
10%32%
15%23%
14%27%30%
19%40%
20%
Flexed elbow (367 patients, 1352 treatment sessions)
6040200
80100
Bicepsbrachii
Brachialis Brachioradialis OtherTrea
tmen
t ses
sion
s(%
)
87%
61% 56%
3%
Muscles targetedDose, UMean (SD)Mode (Min, Max)
Localization, n (%)AnatomicalE-stimEMGUltrasound
116 (74)100 (15, 600)
432 (32)168 (12)771 (57)303 (22)
Pronated forearm (191 patients, 610 treatment sessions)
6040200
80100
Pronatorquadratus
Pronator teres OtherTrea
tmen
t ses
sion
s(%
)
25%
97%
1%
Muscles targetedDose, UMean (SD)Mode (Min, Max)
Localization, n (%)AnatomicalE-stimEMGUltrasound
46 (29) 50 (10, 250)
129 (21) 90 (15)397 (65)156 (26)
Thumb-in-palm (147 patients, 323 treatment sessions)
6040200
80100
Adductorpollicis
Flexorpollicisbrevis
Flexorpollicislongus
OtherTrea
tmen
t ses
sion
s(%
)
39% 31%
54%
8%
Muscles targetedDose, UMean (SD)Mode (Min, Max)
Localization, n (%)AnatomicalE-stimEMGUltrasound
35 (30) 20 (5, 300)
85 (26) 48 (15)185 (57) 89 (28)
Flexed wrist (284 patients, 1024 treatment sessions)
6040200
80100
Flexor carpiradialis
Flexor carpiulnaris
Palmarislongus
OtherTrea
tmen
t ses
sion
s(%
)
87%75%
19%4%
Muscles targetedDose, UMean (SD)Mode (Min, Max)
Localization, n (%)AnatomicalE-stimEMGUltrasound
80 (59)100 (10, 500)
310 (30)154 (15)595 (58)261 (25)
Adducted/internally rotated shoulder (185 patients, 612 treatment sessions)
6040200
80100
Latissimusdorsi
Pectoraliscomplex
Subscapularis Teresmajor
OtherTrea
tmen
t ses
sion
s(%
)
84%
22%6% 12%9%
Muscles targetedDose, UMean (SD)Mode (Min, Max)
Localization, n (%)AnatomicalE-stimEMGUltrasound
91 (57)100 (12, 450)
203 (33) 49 (8)374 (61)189 (31)
Intrinsic plus hand (119 patients, 350 treatment sessions)
6040200
80100
Lumbricalas/interossei
OtherTrea
tmen
t ses
sion
s(%
)
98%
4%
Muscles targetedDose, UMean (SD)Mode (Min, Max)
Localization, n (%)AnatomicalE-stimEMGUltrasound
44 (22) 50 (5, 125)
115 (33) 36 (10)208 (59) 97 (28)
Clenched fi st (383 patients, 1505 treatment sessions)
Dose, UMean (SD)Mode (Min, Max)
Localization, n (%)AnatomicalE-stimEMGUltrasound
106 (70)100 (10, 525)
531 (35)279 (19)861 (57)395 (26)
6040200
80100
Flexordigitorumprofundus
Flexordigitorum
superficialis
Flexorpollicisbrevis
Flexorpollicislongus
OtherTrea
tmen
t ses
sion
s(%
)
80% 86%
9%25%
6%
Muscles targeted
Figure 5: Patient and clinician satisfaction
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Patientsatisfaction
(T=835)
Cliniciansatisfaction(T=1512)
Trea
tmen
t ses
sion
s (%
)
OnabotulinumtoxinA treatmenthelped manage spasticity
60
40
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80
100
Patientsatisfaction
(T=835)
Cliniciansatisfaction(T=1512)
Trea
tmen
t ses
sion
s (%
)
OnabotulinumtoxinA has sustained benefit of treatment
60
40
20
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80
100
Patientsatisfaction
(T=835)
Cliniciansatisfaction(T=1512)
Trea
tmen
t ses
sion
s (%
)
Continue onabotulinumtoxinA treatment to manage spasticity
Extremely dissatisfied/definitely not
Dissatisfied/probably not
Neither satisfied nordissatisfied/undecided
Satisfied/probably yes
Extremely satisfied/yes, definitely
NOTE: T refers to number of treatment sessions.
P3.23
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OR • Visit www.allergancongressposters.com/647632Charges may apply. No personal information is stored.
• 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
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: 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.
DIS
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ES
Presented at TOXINS 2019, the 4th International Congress of the International Neurotoxin Association (INA); January 16–19, 2019; Copenhagen, Denmark