PMID- 33151636
OWN - NLM
STAT- MEDLINE
DCOM- 20211027
LR  - 20220531
IS  - 1934-1563 (Electronic)
IS  - 1934-1482 (Print)
IS  - 1934-1482 (Linking)
VI  - 13
IP  - 10
DP  - 2021 Oct
TI  - Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA 
      Treatment for Adult Lower Limb Spasticity.
PG  - 1079-1093
LID - 10.1002/pmrj.12517 [doi]
AB  - INTRODUCTION: OnabotulinumtoxinA treatment for spasticity varies according to 
      numerous factors and is individualized to meet treatment goals. OBJECTIVE: To 
      explore real-world onabotulinumtoxinA utilization and effectiveness in patients 
      with lower limb spasticity from the Adult Spasticity International Registry 
      (ASPIRE) study. DESIGN: Two-year, multicenter, prospective, observational 
      registry (NCT01930786). SETTING: Fifty-four international clinical sites. 
      PATIENTS: Adults (naive or non-naive to botulinum toxin[s] treatment for 
      spasticity, across multiple etiologies) with lower limb spasticity related to 
      upper motor neuron syndrome. INTERVENTIONS: OnabotulinumtoxinA administered at 
      the clinician's discretion. MAIN OUTCOME MEASURES: OnabotulinumtoxinA treatment 
      utilization, clinician- and patient-reported satisfaction. RESULTS: In ASPIRE, 
      530 patients received >/=1 onabotulinumtoxinA treatment for lower limb spasticity 
      (mean age, 52 years; stroke, 49.4%; multiple sclerosis, 20.4%). Equinovarus foot 
      was treated most often (80.9% of patients), followed by flexed knee (26.0%), 
      stiff extended knee (22.5%), and flexed toes (22.3%). OnabotulinumtoxinA doses 
      ranged between 10 and 1100 U across all presentations. Electromyography (EMG) was 
      most commonly used for injection localization (>/=41.1% of treatment sessions). 
      Despite low patient response on the satisfaction questionnaire, clinicians (94.6% 
      of treatment sessions) and patients (84.5%) reported satisfaction/extreme 
      satisfaction that treatment helped manage spasticity, and clinicians (98.3%) and 
      patients (91.6%) would probably/definitely continue onabotulinumtoxinA treatment. 
      These data should be interpreted with care. Twenty-one adverse events (AEs) in 18 
      patients (3.4%) were considered treatment-related. Sixty-seven patients (12.6%) 
      reported 138 serious AEs; 3 serious AEs in two patients (0.4%) were considered 
      treatment-related. No new safety signals were identified. CONCLUSIONS: ASPIRE 
      provides long-term observational data on the treatment of lower limb spasticity 
      with onabotulinumtoxinA. Real-world data from this primary analysis can help to 
      guide the clinical use of onabotulinumtoxinA to improve spasticity management.
CI  - (c) 2020 The Authors. PM&R published by Wiley Periodicals LLC on behalf of American 
      Academy of Physical Medicine and Rehabilitation.
FAU - Esquenazi, Alberto
AU  - Esquenazi A
AUID- ORCID: 0000-0003-0698-6424
AD  - MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA.
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, Laguna Hills, CA, USA.
FAU - Jost, Wolfgang H
AU  - Jost WH
AD  - Department of Neurology, University of Freiburg, Freiburg im Breisgau, Germany.
AD  - Parkinson-Klinik Ortenau, Wolfach, Germany.
FAU - Munin, Michael C
AU  - Munin MC
AD  - Department of Physical Medicine and Rehabilitation, University of Pittsburgh 
      School of Medicine, Pittsburgh, PA, USA.
FAU - Tang, Simon Fuk Tan
AU  - Tang SFT
AD  - Department of Physical Medicine and Rehabilitation, Lotung Poh-Ai Hospital, 
      Yilan, Taiwan.
FAU - Largent, Joan
AU  - Largent J
AD  - IQVIA Real-World Evidence Solutions, Cambridge, MA, USA.
FAU - Adams, Aubrey Manack
AU  - Adams AM
AD  - Allergan, An AbbVie company, Irvine, CA, USA.
FAU - Zuzek, Aleksej
AU  - Zuzek A
AD  - Allergan, An AbbVie company, Irvine, CA, USA.
FAU - Francisco, Gerard E
AU  - Francisco GE
AUID- ORCID: 0000-0002-5681-1916
AD  - University of Texas Health Science Center McGovern Medical School and TIRR 
      Memorial Hermann, Houston, TX, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01930786
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210111
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/therapeutic use
MH  - Humans
MH  - Lower Extremity
MH  - Middle Aged
MH  - *Muscle Spasticity/drug therapy/etiology
MH  - *Neuromuscular Agents/therapeutic use
MH  - Prospective Studies
MH  - Registries
MH  - *Stroke
MH  - Treatment Outcome
PMC - PMC8519010
EDAT- 2020/11/06 06:00
MHDA- 2021/10/28 06:00
PMCR- 2021/10/15
CRDT- 2020/11/05 12:16
PHST- 2020/09/24 00:00 [revised]
PHST- 2019/11/04 00:00 [received]
PHST- 2020/10/23 00:00 [accepted]
PHST- 2020/11/06 06:00 [pubmed]
PHST- 2021/10/28 06:00 [medline]
PHST- 2020/11/05 12:16 [entrez]
PHST- 2021/10/15 00:00 [pmc-release]
AID - PMRJ12517 [pii]
AID - 10.1002/pmrj.12517 [doi]
PST - ppublish
SO  - PM R. 2021 Oct;13(10):1079-1093. doi: 10.1002/pmrj.12517. Epub 2021 Jan 11.