individualized onabotulinumtoxina treatment for upper limb ... · figure 1) • primary specialty...

To view a video of Dr. Gerard Francisco discussing these data, please follow the link below:

https://vimeo.com/300663316/77bd8be38b

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

https://vimeo.com/300663316/77bd8be38b

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.

60

40

20

0

80

100

Patie

nts

who

rece

ived

≥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%

IN

TRO

DU

CTI

ON

M

ETH

OD

S

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

IN

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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

70

60

50

40

30

20

10

0

80

90

100

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%



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%



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%



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%



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%



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)


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

60

40

20

0

80

100

Patientsatisfaction

(T=835)

Cliniciansatisfaction(T=1512)

Trea

tmen

t ses

sion

s (%

)

OnabotulinumtoxinA treatmenthelped manage spasticity

60

40

20

0

80

100

Patientsatisfaction

(T=835)


Trea

tmen

t ses

sion

s (%

)

OnabotulinumtoxinA has sustained benefit of treatment

60

40

20

0

80

100

Patientsatisfaction

(T=835)


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

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/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

CLO

SUR

ES

Presented at TOXINS 2019, the 4th International Congress of the International Neurotoxin Association (INA); January 16–19, 2019; Copenhagen, Denmark

individualized onabotulinumtoxina treatment for upper limb ... · figure 1) • primary specialty...

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