S160 S290
Disclosures:
Christina Marciniak: Research Grants - Ipsen, San Bio Inc
Objective:
The objective of this post-hoc analysis was to assess key
efficacy outcomes using pooled data from both studies.
Design:
Post-hoc analysis of pooled data from 2 phase 3 placebo-
controlled studies including both a main period (MP) and open-label
extension (OLEX) period.
Setting:
Multiple international study sites in Europe and North
America.
Participants:
465 adults with ULPSS. During the MP, 283/465 received
incobotulinumtoxinA, and 182/465 received placebo.
Interventions:
Study 3001 included 400U fixed doses of incobotuli-
numtoxinA at 12-week intervals, and study 0410 included 400U doses
of incobotulinumtoxinA at flexible intervals ( 12 weeks).
Main Outcome Measures:
Ashworth Scale (AS) scores and Disability
Assessment Scale (DAS) scores, including proportion of responders
(defined as 1-point improvement from MP baseline (BL) at 4 weeks
post-injection). Individual AS scores for flexed wrist, clenched fist,
flexed elbow, thumb-in-palm and pronated forearm were combined to
calculate the AS arm sumscore.
Results:
The mean (SD) AS arm sumscore improvement was greater for
incobotulinumtoxinA-treated subjects vs placebo during the MP (4
weeks post-injection): 3.23 (2.55) vs 1.49 (2.09). OLEX sumscore im-
provements were 4.38 (2.85), 4.87 (3.05), and 5.03 (3.02) in cycles
1
e
3, respectively. At the end of OLEX cycle 3 (12-weeks post-injec-
tion), the AS arm sumscore improved by 3.01 (2.96) compared with the
MP BL. The DAS response rate for principal target domain increased
from 47.4% during the MP (placebo, 27.2%) to 66.6% during OLEX cycle
3. AS response rates for individual joints during the MP demonstrated
dose dependence; a greater effect was observed for larger vs smaller
muscle groups.
Conclusions:
Results from this pooled analysis support previous
studies and show that continuous treatment with incobotulinumtoxinA
enables sustained improvement in muscle tone and disability.
Level of Evidence:
Level I
Poster 71:
AbobotulinumtoxinA Time to Retreatment Across 3
Phase 3 Spasticity Studies
Mauricio Delgado (Texas Scottish Rite Hospital for Children, Dallas,
TX, USA), Gustavo Suarez, Anne-Sophie AS. Grandoulier, MD,
Philippe Picaut, Pharm D, PhD, Jean-Michel Gracies, MD
Disclosures:
Mauricio Delgado: Research Grants - Ipsen
Objective:
Evaluate time to re-treatment following an injection of
abobotulinumtoxinA (aboBoNT-A, Dysport) in 3 populations with
spasticity: Adult Upper Limb Spasticity (AULS), Adult Lower Limb
Spasticity (ALLS), and Pediatric Lower Limb Spasticity (PLLS).
Design:
Data from 3 Phase-3 trials of aboBoNT-A (per indication)
was collated. The studies implemented a flexible time to re-treat-
ment design whereby investigators decided (based on clinical judg-
ment of safety/efficacy) whether an individual patient required re-
injection at Week 12 (mandatory visit) or at optional visits at Week
16 (all studies), Weeks 20 & 24 (adult studies), or Weeks 22 & 28
(pediatric study) of the treatment cycle. Patients completed the
double-blind and advanced to the open-label extension study when
re-injected.
Setting:
34 Sites/8 countries (AULS), 52 sites/11 countries (ALLS), and
23 sites/6 countries (PLLS).
Participants:
The 2 adult studies recruited post-stroke/TBI patients
with upper limb (n
¼
243) and lower limb (n
¼
381) spasticity, respec-
tively. The pediatric study recruited children (2-17y) with dynamic
equinus foot deformity due to cerebral palsy (n
¼
241).
Interventions:
aboBoNT-A injections.
Main Outcome Measures:
Proportion of aboBoNT-A treated patients
re-injected per visit.
Results:
Data are presented for the patients who received aboBoNT-A
in the double-blind study and were treated in Cycle 1 of the relevant
open-label extension. AULS study: 37% of patients were re-injected at
Week-16 or later (17% Week-16, 10% Week-20, 10% Week-24 or later).
ALLS study: 20% of patients were re-injected at Week-16 or later (10%
Week-16, 5% Week-20, 5% Week-24 or later). PLLS study: 74% of pa-
tients were reinjected at Week-16 or later (34% Week-16, 23% Week-
22, 18% Week-28 or later). Similar results were observed in subsequent
treatment cycles.
Conclusions:
These data indicate that a substantial proportion of
adult and pediatric patients treated for spasticity with aboBoNT-A do
not require re-injection at the time-point of 12-weeks. A longer time
to re-treatment may reduce the socioeconomic burden associated
with repeated injections.
Level of Evidence:
Level I
Poster 73:
Medical Complications Associated with Rehabilitation
Outcomes in Patients with a Brain Tumor
Anton N. Dietzen, DC, MD (Marianjoy Rehabilitation Hospital,
Lombard, Illinois, United States), Carrie M. Gould, MD, Anjum Sayyad,
MD, Rishi S. Shah, MD, Colleen McQuillan, PT, Susan L. Brady, DHEd
Disclosures:
Anton Dietzen: I Have No Relevant Financial Relation-
ships To Disclose
Objective:
More than 17,000 people each year in the United States
are diagnosed with a brain tumor. Preoperative brain imaging and
surgical improvements have reduced mortality rates for patients with
a brain tumor. With these improvements, patients are surviving and
may require rehabilitation in order to maximize their function. The
primary objective of this study was to investigate the influence of
medical complications associated with rehabilitation outcomes in pa-
tients with a brain tumor.
Design:
A retrospective medical chart review study of inpatient
rehabilitation with the diagnosis of a brain tumor from 2011-2015.
Pediatric patients and adult patients with a pre-existing develop-
mental delay were excluded. At random, 50% of the medical charts
were reviewed by a second rater for inter-rater reliability.
Setting:
IP rehab.
Participants:
Adults diagnosed with brain tumor.
Interventions:
IP rehab.
Main Outcome Measures:
FIM.
Results:
The study sample included 23 males and 26 females (mean
age 59.4 years). Most patients (84%) were not receiving concurrent
cancer treatment (e.g., chemotherapy, radiation, and proton
therapy). Thirty-one percent (15/49) of the patients at some point
during their inpatient rehabilitation returned to the acute care
facility related to a medical complication. Patients who returned to
the acute care facility trended lower with overall mean FIM gains
of 19.44 as compared to patients who did not at 11.87 (p
¼
.082),
but it was not statistically significant. The following medical
complication rates were observed: VTE
¼
14%; DVT
¼
2%; other
bleed
¼
2%; and respiratory
¼
14%. Forty-nine percent of the patients
were on some type of anticoagulation medication during inpatient
rehabilitation. Patients who experienced a respiratory complication
during inpatient rehabilitation had statistically significant lower
mean FIM gain per day (0.30) as compared to patients who did not
(0.904; t
¼
4.03, p
¼
.0001). No differences in rehabilitation out-
comes observed with patients who experienced a VTE versus those
who did not.
Conclusions:
Respiratory complication during IP rehabilitation was
associated with lower FIM outcomes.
Level of Evidence:
Level III
S160
Abstracts / PM R 9 (2017) S131-S290