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

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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

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-2.5

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-1

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-1

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-2.5

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-2

-1.5

-1

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1.5* * * * * * * * * * * * * * * * * * * *

Hyg

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Mob

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Hyg

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Lim

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Mob

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Hyg

iene

Pain

Dre

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Mob

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Hyg

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Pain

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Mob

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Hyg

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Pain

Dre

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Lim

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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

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Figure 3. Satisfaction with most recent onabotulinumtoxinA treatment in managing spasticity

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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

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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

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60

50

40

30

20

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Clin

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)

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