Dataset Information

Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport^®/Azzalure^®): Primary Results of the APPEAL Noninterventional Study.

ABSTRACT:

Background

Although the short- and long-term effectiveness of abobotulinumtoxinA (Dysport^®/Azzalure^®) for glabellar line (GL) treatment is well established, reporting of subject satisfaction over repeat treatment cycles is limited. The APPEAL study aimed to assess subject satisfaction with long-term GL treatment with abobotulinumtoxinA in a real-life setting.

Methods

APPEAL was a noninterventional, prospective, longitudinal study in subjects administered ≥ 3 abobotulinumtoxinA injection cycles for moderate-to-severe GL, according to routine clinical practice. Subjects completed a satisfaction questionnaire at 3 weeks (± 7 days) after each cycle. Primary endpoint included subjects' overall satisfaction with GL after three injection cycles. Secondary endpoints included satisfaction after Cycles 1 and 2 and factors associated with satisfaction after each cycle. Physician satisfaction was also assessed after Cycles 1 and 3.

Results

Of 150 subjects enrolled, 135 completed the overall subject satisfaction questionnaire after Cycle 3. At 3 weeks after Cycle 3, 99.3% of subjects were 'very satisfied' (74.1%) or 'satisfied' (25.2%) with GL. Levels of subject satisfaction and associated factors after Cycles 1 and 2 were as large and significant as after Cycle 3 (83-100%, depending on question). Physicians' satisfaction with GL appearance, facial expression, and overall satisfaction was almost complete after the first injection (≥ 97.4%) and unanimous after the third (100%).

Conclusions

In the APPEAL study, overall satisfaction was high after three abobotulinumtoxinA injection cycles for GL based on both subjects' (99.3%) and physicians' (100.0%) assessments. High levels of subject satisfaction reported after Cycle 1 were maintained with repeated injections. No new safety signals were observed.

Level of evidence iv

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . Trial registration NCT02353897.

SUBMITTER: Gubanova E

PROVIDER: S-EPMC6280832 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport<sup>®</sup>/Azzalure<sup>®</sup>): Primary Results of the APPEAL Noninterventional Study.

Gubanova Elena E Haddad Tabet May M Bergerova Yvonne Y Moiseieva Olena O Chemeris Andrey A Sanches Elena E Sharova Alisa A Rodriguez Pose Luisa L Raymond Romain R Prygova Inna I Carlisle Ian I

Aesthetic plastic surgery 20180817 6

<h4>Background</h4>Although the short- and long-term effectiveness of abobotulinumtoxinA (Dysport<sup>®</sup>/Azzalure<sup>®</sup>) for glabellar line (GL) treatment is well established, reporting of subject satisfaction over repeat treatment cycles is limited. The APPEAL study aimed to assess subject satisfaction with long-term GL treatment with abobotulinumtoxinA in a real-life setting.<h4>Methods</h4>APPEAL was a noninterventional, prospective, longitudinal study in subjects administered ≥ 3 ...[more]

PMID: 30120518

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Project description:BackgroundBotulinum toxin (BoNT) injections were shown to improve muscle tone of limbs in patients with spasticity. However, limited data are available regarding the effects of repeated BoNT injections on walking ability.ObjectiveTo assess changes in walking velocity (WV), step length, and cadence under different test conditions after repeated treatment with abobotulinumtoxinA (aboBoNT-A; Dysport) in spastic lower limb muscles.DesignSecondary analysis of an open-label, multiple-cycle extension (National Clinical Trials number NCT01251367) to a phase III, double-blind, randomized, placebo-controlled, single-treatment cycle study, in adults with chronic hemiparesis (NCT01249404).SettingFifty-two centers across Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, and the United States.Patients352 Ambulatory adults (18-80 years) with spastic hemiparesis and gait dysfunction caused by stroke or traumatic brain injury, with a comfortable barefoot WV of 0.1 to 0.8 m/s.InterventionsUp to four aboBoNT-A treatment cycles, administered to spastic lower limb muscles.Main outcome measurementsChanges from baseline in comfortable and maximal barefoot and with shoes WV (m/s), step length (m/step), and cadence (steps/minutes).ResultsAt Week 12 after four injections, WV improved by 0.08 to 0.10 m/s, step length by 0.03 to 0.04 m/step, and cadence by 3.9 to 6.2 steps/minutes depending on test condition (all P < .0001 to .0003 vs baseline). More patients (7% to 17%) became unlimited community ambulators (WV ≥0.8 m/s) across test conditions compared with baseline, with 39% of 151 patients classified as unlimited community ambulators in at least one test condition and 17% in all four test conditions.ConclusionsClinically meaningful and statistically significant improvements in WV, step length, and cadence under all four test conditions were observed in patients with spastic hemiparesis after each aboBoNT-A treatment cycle.

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Dataset Information

Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport^®/Azzalure^®): Primary Results of the APPEAL Noninterventional Study.

Background

Methods

Results

Conclusions

Level of evidence iv

Publications

Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport<sup>®</sup>/Azzalure<sup>®</sup>): Primary Results of the APPEAL Noninterventional Study.

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Dataset Information

Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport®/Azzalure®): Primary Results of the APPEAL Noninterventional Study.

Background

Methods

Results

Conclusions

Level of evidence iv

Publications

Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport<sup>®</sup>/Azzalure<sup>®</sup>): Primary Results of the APPEAL Noninterventional Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Assessment of Subject and Physician Satisfaction after Long-Term Treatment of Glabellar Lines with AbobotulinumtoxinA (Dysport^®/Azzalure^®): Primary Results of the APPEAL Noninterventional Study.