– At day 30, approximately 90% of all study
patients were satisfied with treatment resulting in a natural look
and more than 80% of all study patients were satisfied with
natural-looking outcomes throughout the 12-month study period for
the temporary improvement in the appearance of their moderate to
severe upper facial lines1
– At day 30,
more than half of patients experienced a notable difference in
self-perceived appearance and psychosocial
well-being1
IRVINE,
Calif., Aug. 30, 2023 /PRNewswire/ -- Allergan
Aesthetics, an AbbVie company (NYSE: ABBV), today announced the
Journal of Cosmetic Dermatology published results from a
year-long, post-hoc analysis of patient-reported outcomes (PROs)
from two Phase 3 clinical studies evaluating the impact of
onabotulinumtoxinA (BOTOX® Cosmetic) on upper facial lines (UFLs)
in adults new to toxin treatment.1 The
peer-reviewed study found that, 30 days after receiving treatment,
90.5% of all study patients reported being either mostly or very
satisfied with receiving a natural look, as rated on a five-point
scale.1 This satisfaction was sustained by more
than 80% of patients throughout the 12-month study period for the
temporary improvement in the appearance of their moderate to severe
UFLs.1 In addition, 30 days after receiving
treatment, more than half of treated patients reported an
improvement in self-perceived appearance and psychological
well-being, defined as those who achieved a meaningful improvement
in five areas (how much their facial lines made them feel older,
feel unhappy, look angry, look tired, or feel that they negatively
affected self-esteem).1
UFLs, which include forehead, glabellar, and crow's feet lines,
fall within the main areas of concern for individuals considering
aesthetic treatments.1 The study, titled
Self-Perception of Natural Outcome, Appearance and Emotional
Well-Being After OnabotulinumtoxinA Treatment for Upper Facial
Lines: Post-Hoc Analysis Across Age and Gender, analyzed
patient-reported outcomes (PROs) from more than 450
neurotoxin-naïve adults treated who saw a reduction in UFL severity
with onabotulinumtoxinA (BOTOX® Cosmetic).1
The study used the Facial Line Satisfaction Questionnaire, a
validated proprietary questionnaire developed according to FDA
guidelines for PRO measures, which assesses treatment satisfaction,
appearance, and emotional impact as perceived by patients.
1
"Regardless of age or gender, most patients contemplating facial
aesthetic treatments desire refreshed, natural-looking results, and
fear of looking unnatural or a 'frozen' look is a common barrier
for many," said Steven Dayan, MD,
founder of Denova Research and study author. "Self-perceived
patient satisfaction, both in physical appearance and emotional
wellbeing, is paramount in aesthetics medicine and it is vital
physicians understand how patients perceive themselves after
treatment to truly address patient concerns and help fulfill their
expectations."
"Assessing patient-reported outcomes for toxin treatments is an
important advancement in supporting physicians with reliable data
and education to help ensure patients achieve their expected and
desired results," said John Maltman,
vice president, global aesthetics medical affairs, AbbVie. "The
study supports that patient satisfaction and a desired natural look
that helps improve the appearance of upper facial lines can be
achieved with proven facial aesthetic neuromodulator
treatment."
BOTOX® Cosmetic (onabotulinumtoxinA)
Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is
indicated in adult patients for the temporary improvement in the
appearance of:
- Moderate to severe glabellar lines associated with corrugator
and/or procerus muscle activity
- Moderate to severe lateral canthal lines associated with
orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis
activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT
SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of
BOTOX® Cosmetic and all botulinum toxin
products may spread from the area of injection to produce symptoms
consistent with botulinum toxin effects. These may include
asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia,
dysphonia, dysarthria, urinary incontinence, and breathing
difficulties. These symptoms have been reported hours to weeks
after injection. Swallowing and breathing difficulties can be life
threatening and there have been reports of death. The risk of
symptoms is probably greatest in children treated for spasticity,
but symptoms can also occur in adults treated for spasticity and
other conditions, particularly in those patients who have an
underlying condition that would predispose them to these symptoms.
In unapproved uses and approved indications, cases of
spread of effect have been reported at doses comparable to those
used to treat cervical dystonia and spasticity and at lower
doses.
|
CONTRAINDICATIONS
BOTOX® Cosmetic is
contraindicated in the presence of infection at the proposed
injection site(s) and in individuals with known hypersensitivity to
any botulinum toxin preparation or to any of the components in the
formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability
Between Botulinum Toxin Products
The potency units of
BOTOX® Cosmetic are specific to the
preparation and assay method utilized. They are not interchangeable
with other preparations of botulinum toxin products and, therefore,
units of biological activity of BOTOX® Cosmetic
cannot be compared to nor converted into units of any other
botulinum toxin products assessed with any other specific assay
method.
Spread of Toxin Effect
Please refer to Boxed Warning
for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of
toxin effect associated with dermatologic use of BOTOX®
Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24
Units (for lateral canthal lines), 40 Units (for forehead lines
with glabellar lines), 44 Units (for simultaneous treatment of
lateral canthal lines and glabellar lines), and 64 Units (for
simultaneous treatment of lateral canthal lines, glabellar lines,
and forehead lines) have been reported. Patients or caregivers
should be advised to seek immediate medical care if swallowing,
speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious
adverse reactions, including excessive weakness, dysphagia, and
aspiration pneumonia, with some adverse reactions associated with
fatal outcomes, have been reported in patients who received
BOTOX® injections for unapproved uses. In these cases,
the adverse reactions were not necessarily related to distant
spread of toxin, but may have resulted from the administration of
BOTOX® to the site of injection and/or adjacent
structures. In several of the cases, patients had pre-existing
dysphagia or other significant disabilities. There is insufficient
information to identify factors associated with an increased risk
for adverse reactions associated with the unapproved uses of
BOTOX®. The safety and effectiveness of
BOTOX® for unapproved uses have not been
established.
Hypersensitivity Reactions
Serious and/or immediate
hypersensitivity reactions have been reported. These reactions
include anaphylaxis, serum sickness, urticaria, soft-tissue edema,
and dyspnea. If such reactions occur, further injection of
BOTOX® Cosmetic should be discontinued and appropriate
medical therapy immediately instituted. One fatal case of
anaphylaxis has been reported in which lidocaine was used as the
diluent and, consequently, the causal agent cannot be reliably
determined.
Cardiovascular System
There have been reports
following administration of BOTOX® of adverse events
involving the cardiovascular system, including arrhythmia and
myocardial infarction, some with fatal outcomes. Some of these
patients had risk factors including pre-existing cardiovascular
disease. Use caution when administering to patients with
pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects With
Pre-existing Neuromuscular Disorders
Individuals with
peripheral motor neuropathic diseases, amyotrophic lateral
sclerosis, or neuromuscular junction disorders (e.g., myasthenia
gravis or Lambert-Eaton syndrome) should be monitored when given
botulinum toxin. Patients with neuromuscular disorders may be at
increased risk of clinically significant effects including
generalized muscle weakness, diplopia, ptosis, dysphonia,
dysarthria, severe dysphagia, and respiratory compromise from
onabotulinumtoxinA (see Warnings and Precautions).
Dysphagia and Breathing Difficulties
Treatment with
BOTOX® and other botulinum toxin products can result in
swallowing or breathing difficulties. Patients with pre-existing
swallowing or breathing difficulties may be more susceptible to
these complications. In most cases, this is a consequence of
weakening of muscles in the area of injection that are involved in
breathing or oropharyngeal muscles that control swallowing or
breathing (see Boxed Warning).
Pre-existing Conditions at the Injection Site
Caution
should be used when BOTOX® Cosmetic treatment is used in
the presence of inflammation at the proposed injection site(s) or
when excessive weakness or atrophy is present in the target
muscle(s).
Dry Eye in Patients Treated With BOTOX®
Cosmetic
There have been reports of dry eye associated
with BOTOX® Cosmetic injection in or near the
orbicularis oculi muscle. If symptoms of dry eye (e.g., eye
irritation, photophobia, or visual changes) persist, consider
referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This
product contains albumin, a derivative of human blood. Based on
effective donor screening and product manufacturing processes, it
carries an extremely remote risk for transmission of viral diseases
and variant Creutzfeldt-Jakob disease (vCJD). There is a
theoretical risk for transmission of Creutzfeldt-Jakob disease
(CJD), but if that risk actually exists, the risk of transmission
would also be considered extremely remote. No cases of transmission
of viral diseases, CJD or vCJD have ever been identified for
licensed albumin or albumin contained in other licensed
products.
ADVERSE REACTIONS
The most frequently reported adverse
reactions following injection of BOTOX® Cosmetic for
glabellar lines were eyelid ptosis (3%), facial pain (1%), facial
paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following
injection of BOTOX® Cosmetic for lateral canthal lines
was eyelid edema (1%).
The most frequently reported adverse reactions following
injection of BOTOX® Cosmetic for forehead lines with
glabellar lines were headache (9%), brow ptosis (2%), and eyelid
ptosis (2%).
DRUG INTERACTIONS
Co-administration of
BOTOX® Cosmetic and aminoglycosides or other agents
interfering with neuromuscular transmission (e.g., curare-like
compounds) should only be performed with caution as the effect of
the toxin may be potentiated. Use of anticholinergic drugs after
administration of BOTOX® Cosmetic may potentiate
systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin
products at the same time or within several months of each other is
unknown. Excessive neuromuscular weakness may be exacerbated
by administration of another botulinum toxin prior to the
resolution of the effects of a previously administered botulinum
toxin.
Excessive weakness may also be exaggerated by administration of
a muscle relaxant before or after administration of
BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or
adequate data from postmarketing surveillance on the developmental
risk associated with use of BOTOX® Cosmetic in pregnant
women. There are no data on the presence of BOTOX®
Cosmetic in human or animal milk, the effects on the breastfed
child, or the effects on milk production.
Please see BOTOX® Cosmetic full Prescribing
Information including Boxed Warning and Medication
Guide.
About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop,
manufacture, and market a portfolio of leading aesthetics brands
and products. Our aesthetics portfolio includes facial injectables,
body contouring, plastics, skin care, and more. Our goal is to
consistently provide our customers with innovation, education,
exceptional service, and a commitment to excellence, all with a
personal touch. For more information, visit
www.allerganaesthetics.com
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions that solve serious health issues today and address
the medical challenges of tomorrow. We strive to have a remarkable
impact on people's lives across several key therapeutic areas –
immunology, oncology, neuroscience, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
Twitter, Facebook, Instagram, YouTube and LinkedIn.
References
- Dayan, S., Ogilvie, P., et al. Self-Perception of Natural
Outcome, Appearance and Emotional Well-Being After
OnabotulinumtoxinA Treatment for Upper Facial Lines: Post-Hoc
Analysis Across Age and Gender. J Cosmet Dermatol. Published
online August 24, 2023. doi:
10.1111/jocd.15947.
View original
content:https://www.prnewswire.com/news-releases/journal-of-cosmetic-dermatology-publishes-data-demonstrating-patient-satisfaction-with-natural-looking-outcomes-following-treatment-with-onabotulinumtoxina-botox-cosmetic-301913155.html
SOURCE AbbVie