PMID- 31953896
OWN - NLM
STAT- MEDLINE
DCOM- 20210802
LR  - 20210802
IS  - 1934-1563 (Electronic)
IS  - 1934-1482 (Print)
IS  - 1934-1482 (Linking)
VI  - 12
IP  - 11
DP  - 2020 Nov
TI  - Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in 
      High Clinician- and Patient-Reported Satisfaction: Long-Term Observational 
      Results from the ASPIRE Study.
PG  - 1120-1133
LID - 10.1002/pmrj.12328 [doi]
AB  - INTRODUCTION: OnabotulinumtoxinA treatment for spasticity is dependent on 
      numerous factors and varies according to selected treatment goals. OBJECTIVE: To 
      examine real-world onabotulinumtoxinA treatment utilization and effectiveness in 
      patients with upper limb spasticity over 2 years from the Adult Spasticity 
      International Registry (ASPIRE) study. DESIGN: Multicenter, prospective, 
      observational registry (NCT01930786). SETTING: Fifty-four international clinical 
      sites in North America, Europe, and Asia. PATIENTS: Adults (naive or non-naive to 
      botulinum toxins for spasticity) with upper limb focal spasticity related to 
      upper motor neuron syndrome across multiple etiologies. INTERVENTIONS: 
      OnabotulinumtoxinA administered at clinician's discretion. MAIN OUTCOME MEASURES: 
      OnabotulinumtoxinA utilization, clinician and patient satisfaction. RESULTS: Four 
      hundred eighty-four patients received >/=1 treatment of onabotulinumtoxinA for 
      upper limb spasticity. Patients were on average 55.1 years old, 50.8% male, 
      predominantly Caucasian (72.3%), and 38.6% were naive to botulinum toxins. Stroke 
      was the most frequently reported underlying etiology (74.0%). Most patients 
      (81.2%) had moderate to severe spasticity at baseline. The most commonly treated 
      upper limb clinical presentation was clenched fist (79.1% of patients). Across 
      all presentations, onabotulinumtoxinA doses ranged between 5-600U. 
      Electromyography (EMG) was most often utilized to localize muscles (>/=57.0% of 
      treatment sessions). Clinicians (92.9% of treatment sessions) and patients 
      (85.7%) reported being extremely satisfied/satisfied that treatment helped manage 
      spasticity, and clinicians (98.6%) and patients (92.2%) would definitely/probably 
      continue onabotulinumtoxinA treatment. One hundred seventy-nine patients (37.0%) 
      reported 563 adverse events (AEs); 15 AEs in 14 patients (2.9%) were considered 
      treatment related. Sixty-nine patients (14.3%) reported 137 serious AEs; 3 
      serious AEs in 2 patients (0.4%) were considered treatment related. No new safety 
      signals were identified. CONCLUSIONS: ASPIRE captured the real-world 
      individualized nature of onabotulinumtoxinA utilization for upper limb spasticity 
      over 2 years, with consistently high clinician- and patient-reported 
      satisfaction. Data in this primary analysis will guide clinical use of 
      onabotulinumtoxinA, as well as provide insights to improve educational programs 
      on spasticity management.
CI  - (c) 2020 The Authors. PM&R published by Wiley Periodicals, Inc. on behalf of 
      American Academy of Physical Medicine and Rehabilitation.
FAU - Francisco, Gerard E
AU  - Francisco GE
AUID- ORCID: 0000-0002-5681-1916
AD  - The University of Texas Health Science Center McGovern Medical School and TIRR 
      Memorial Hermann, Houston, TX.
FAU - Jost, Wolfgang H
AU  - Jost WH
AD  - Department of Neurology, University of Freiburg, Freiburg im Breisgau, Germany.
FAU - Bavikatte, Ganesh
AU  - Bavikatte G
AD  - The Walton Centre, Liverpool, UK.
FAU - Bandari, Daniel S
AU  - Bandari DS
AD  - Multiple Sclerosis Center of California & Research Group, Newport Beach, CA.
FAU - Tang, Simon F T
AU  - Tang SFT
AD  - Department of Physical Medicine and Rehabilitation, Lotung Poh-Ai Hospital, 
      Yilan, Taiwan.
FAU - Munin, Michael C
AU  - Munin MC
AD  - Department of Physical Medicine and Rehabilitation, University of Pittsburgh 
      School of Medicine, Pittsburgh, PA.
FAU - Largent, Joan
AU  - Largent J
AD  - IQVIA Real-World Evidence Solutions, Cambridge, MA.
FAU - Adams, Aubrey M
AU  - Adams AM
AD  - Allergan plc, Irvine, CA.
FAU - Zuzek, Aleksej
AU  - Zuzek A
AD  - Allergan plc, Irvine, CA.
FAU - Esquenazi, Alberto
AU  - Esquenazi A
AUID- ORCID: 0000-0003-0698-6424
AD  - MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01930786
GR  - KL2 TR003168/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200227
PL  - United States
TA  - PM R
JT  - PM & R : the journal of injury, function, and rehabilitation
JID - 101491319
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adult
MH  - *Botulinum Toxins, Type A
MH  - Europe
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscle Spasticity/drug therapy/etiology
MH  - *Neuromuscular Agents
MH  - Patient Reported Outcome Measures
MH  - Prospective Studies
MH  - Registries
MH  - *Stroke
MH  - Treatment Outcome
MH  - Upper Extremity
PMC - PMC7687094
EDAT- 2020/01/19 06:00
MHDA- 2021/08/03 06:00
PMCR- 2020/11/25
CRDT- 2020/01/19 06:00
PHST- 2019/07/29 00:00 [received]
PHST- 2019/11/23 00:00 [accepted]
PHST- 2020/01/19 06:00 [pubmed]
PHST- 2021/08/03 06:00 [medline]
PHST- 2020/01/19 06:00 [entrez]
PHST- 2020/11/25 00:00 [pmc-release]
AID - PMRJ12328 [pii]
AID - 10.1002/pmrj.12328 [doi]
PST - ppublish
SO  - PM R. 2020 Nov;12(11):1120-1133. doi: 10.1002/pmrj.12328. Epub 2020 Feb 27.