- A total of 29 abstracts, including three late-breaking
presentations, demonstrate AbbVie and Allergan Aesthetics' shared
commitment to advancing science across a spectrum of
immune-mediated dermatologic conditions and aesthetic
indications
NORTH
CHICAGO, Ill., March 6,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Allergan
Aesthetics, an AbbVie company, today announced they will present 29
abstracts, including three late-breaking presentations, during the
2024 American Academy of Dermatology (AAD) Annual
Meeting, March 8-12, in San Diego, California. The presented data across AbbVie
and Allergan Aesthetics' extensive portfolios reinforce the
companies' ongoing commitment to developing transformative medical
dermatology and aesthetic treatments to advance and redefine the
standard of care for patients.
The oral and poster presentations from AbbVie highlight
efficacy, durability and safety data across the company's
dermatology portfolio. Notable presentations include:
- Efficacy data of RINVOQ® (upadacitinib) on nighttime
itch and sleep disturbance, and minimal disease activity in
patients with moderate-to-severe atopic dermatitis
- Data evaluating the efficacy of SKYRIZI®
(risankizumab-rzaa) on difficult to treat areas including for the
treatment of scalp and nail psoriasis compared to apremilast in
adults with moderate psoriasis, and safety and efficacy of
SKYRIZI® (risankizumab-rzaa) in adults with moderate to
severe plaque psoriasis with palmoplantar (nonpustular)
involvement
- Data evaluating changes in tissue-resident memory T cell (Trm)
populations after high-induction dosing of SKYRIZI®
(risankizumab-rzaa) in patients with moderate-to-severe plaque
psoriasis
AbbVie is also presenting data across a number of underserved
dermatologic diseases across new and existing molecules. Key
research includes:
- Phase 2 efficacy and safety data for lutikizumab (ABT-981),
which has a novel mechanism of action, in the treatment of moderate
to severe hidradenitis suppurativa being presented for the first
time at a medical meeting
- Efficacy and safety results of a Phase 2, 52-week study for
upadacitinib in the treatment of non-segmental vitiligo
- New data on disease and economic burden of alopecia areata in
the United States
"AbbVie's commitment to advancing standards of care in
dermatology is underscored by the breadth of new research presented
at AAD this year," said Andrew
Anisfeld, Ph.D., vice president, global medical affairs,
Immunology, AbbVie. "We are dedicated to improving patient outcomes
and helping to redefine treatment expectations so that all patients
may feel free in their own skin."
With a growing pipeline of more than 60 programs in development,
Allergan Aesthetics has one of the most robust portfolios for
aesthetics innovation in the industry. At AAD the company will
spotlight:
- Detailed results from two Phase 3 studies of onabotulinumtoxinA
(BOTOX® Cosmetic) for the treatment of platysma
prominence, an aesthetically unappealing disruption to the lines
and contour of the lower face and neck that can occur as part of
the natural aging process. Topline results shared in 2023
demonstrated all primary and secondary endpoints were met for both
studies,1 and if approved, onabotulinumtoxinA will be
the first and only neurotoxin for this indication.
- Data on the safety and effectiveness of JUVÉDERM®
VOLUMA® XC for injection in the temple region to improve
moderate to severe temple hollowing in adults over the age of
21.2 JUVÉDERM® VOLUMA® XC is the
first and only hyaluronic acid (HA) dermal filler to receive U.S.
FDA approval for the improvement of moderate to severe temple
hollowing with results lasting up to thirteen months with optimal
treatment.2
- Data on a novel cosmetic regimen for mild to moderate facial
acne.
"Allergan Aesthetics is focused on creating evidence-based
products and technologies that advance aesthetics medicine and
address the evolving needs of patients and providers globally,"
said John Maltman, Ph.D., vice
president, global aesthetics medical affairs, Allergan Aesthetics.
"With patient safety and optimal outcomes as our main priorities,
we are proud to share our learnings and engage with the larger
medical community at AAD."
Select AbbVie and Allergan Aesthetics abstracts at AAD 2024 are
outlined below. The 2024 AAD Annual Meeting e-Posters are available
here and late-breaking sessions are available here.
Abstract
Titles
|
Presentation Details
(All Times PT)
|
ALOPECIA
AREATA
|
Real-World Work
Productivity Losses and
Associated Costs in Patients with Alopecia
Areata in the US
|
March 9, 2024, 10:55 AM
– 11:00 AM
ePoster with Oral
Presentation
Poster Center 1, Upper
Level, Sails Pavilion
|
ATOPIC
DERMATITIS
|
Treatment With
Upadacitinib Increases the
Achievement of Minimal Disease Activity
Among Patients with Moderate-to-Severe
Atopic Dermatitis: Results from Phase 3
Studies (Measure Up 1 and Measure Up 2)
|
March 8, 2024, 9:05 -
9:10 AM
ePoster with Oral
Presentation
Poster Center 2, Upper
Level, Sails Pavilion
|
Upadacitinib Improves
Atopic Dermatitis
Related Nighttime Itch and Reduces Sleep
Disturbance: Analysis of Time Spent in
Response State from the Integrated Phase 3
Measure Up 1 & 2 Clinical Trials
|
March 8, 2024, 9:20 -
9:25 AM
ePoster with Oral
Presentation
Poster Center 2, Upper
Level, Sails Pavilion
|
HIDRADENITIS
SUPPURATIVA
|
A Phase 2 Multicenter,
Randomized,
Double-Blind Placebo-Controlled Study to
Evaluate the Safety and Efficacy of
Lutikizumab (ABT-981) in Adult Patients with
Moderate to Severe Hidradenitis Suppurativa
Who Have Failed Anti-TNF Therapy
|
March 9, 2024, 9:30 –
9:40 AM
Late-Breaking
Presentation
Session 1, Room
20BCD
|
PSORIASIS
|
High Induction Dosing
of Risankizumab in
Patients with Moderate-to-Severe Plaque
Psoriasis: 52 Week Results from the Phase
2 KNOCKOUT Study
|
March 9, 2024, 9:10 -
9:20 AM
Late-Breaking
Presentation
Session 1, Room
20BCD
|
Efficacy of
Risankizumab Versus Apremilast
Among Patients with Scalp or Nail Psoriasis
from the Phase 4 IMMpulse Study
|
March 9, 2024, 3:00 -
3:05 PM
ePoster with Oral
Presentation
Poster Center 2, Upper
Level, Sails Pavilion
|
Long Term Real-World
Achievement of Skin
Clearance Treatment Targets
and Maintenance of Response
with Risankizumab in Patients with Moderate
to Severe Psoriasis: 2-year Results from
the CorEvitas Psoriasis Registry
|
March 9, 2024, 3:10 PM
- 3:15 PM
ePoster with Oral
Presentation
Poster Center 2, Upper
Level, Sails Pavilion
|
Achievement of High NPF
Treatment Targets
After 52 Weeks in Psoriasis Patients
Switching to Risankizumab After Suboptimal
Response to Secukinumab or Ixekizumab
|
March 9, 2024, 3:30 -
3:35 PM
ePoster with Oral
Presentation
Poster Center 2, Upper
Level, Sails Pavilion
|
Long-term Safety and
Efficacy
of Risankizumab for the Treatment
of Moderate to-Severe Plaque
Psoriasis: Interim Analysis of Results from
the LIMMitless Open-label Extension
Trial For up to 6 Years of Follow-up
|
March 10, 2024, 2:30 PM
- 2:35 PM
ePoster with Oral
Presentation
Poster Center 1, Upper
Level, Sails Pavilion
|
Efficacy and Safety
After 52 weeks
in Psoriasis Patients Switching
to Risankizumab After Suboptimal Response
to Secukinumab or Ixekizumab - a Subgroup
Analysis
|
March 10, 2024 , 2:40
PM - 2:45 PM
ePoster with Oral
Presentation
Poster Center 1, Upper
Level, Sails Pavilion
|
Efficacy of
Risankizumab for Moderate-to-
Severe Plaque Psoriasis Through
304 Weeks: Subgroup Analysis by
Baseline Demographics and Disease
Characteristics from the LIMMitless Trial
|
March 10, 2024, 2:45 PM
- 2:50 PM
ePoster with Oral
Presentation
Poster Center 1, Upper
Level, Sails Pavilion
|
Safety and Efficacy of
Risankizumab in Adult
Patients with Moderate to Severe Plaque
Psoriasis with Palmoplantar (nonpustular)
Involvement: Change in PASI and PPASI
from Phase 3b IMMprint Trial
|
ePoster
|
VITILIGO
|
Efficacy and Safety
after 52 weeks of Once-
Daily Upadacitinib in Adults with Extensive
Non-Segmental Vitiligo (NSV): Final Results
from a Phase 2 Multicenter, Randomized,
Double-Blind, Placebo-Controlled, Dose-
Ranging Study
|
March 9, 2024, 11:30 –
11:40 AM
Late-Breaking
Presentation
Session 1, Room
20BCD
|
Impact of Achieving
FVASI 75 or T-VASI 50
on Patient- and Physician-Reported
Outcomes in Patients with Non-Segmental
Vitiligo (NSV) Receiving Upadacitinib During
a Phase 2 Study
|
March 9, 2024, 2:20 PM
– 2:25 PM
ePoster with Oral
Presentation
Poster Center 2, Upper
Level, Sails Pavilion
|
Psychometric Properties
of the Vitiligo
Noticeability Scale (VNS) Using Data from a
Phase 2 Upadacitinib Study in Adults with
Non-Segmental Vitiligo
|
March 9, 2024, 2:25 PM
– 2:30 PM
ePoster with Oral
Presentation
Poster Center 2, Upper
Level, Sails Pavilion
|
AESTHETICS
|
Treating Platysma
Prominence with
OnabotulinumtoxinA: Efficacy and Safety
Results from a Phase 3 Multicenter,
Randomized, Double-blind, Placebo-
Controlled Study
|
March 8, 2:35 -
2:40 PM
ePoster with Oral
Presentation
Poster Center 1, Upper
Level, Sails Pavilion
|
Evaluating the Safety
and Efficacy of
OnabotulinumtoxinA for the Treatment of
Platysma Prominence: Results from a Phase
3 Multicenter, Randomized, Double-Blind,
Placebo-Controlled Study
|
March 8, 9:45 - 9:50
AM
ePoster with Oral
Presentation
Poster Center 1, Upper
Level, Sails Pavilion
|
Improving Temple
Hollowing With a
Hyaluronic Acid Injectable Gel, VYC-20L:
Results From a Multicenter, Randomized,
Evaluator-Blinded, Controlled Pivotal Study
|
ePoster
|
Comparable Efficacy and
Less Dryness With
a Novel Cosmetic Regimen When Compared
to a Topical Drug Combination of Adapalene
0.1% and Benzoyl Peroxide 2.5% in
Subjects With Mild to Moderate Facial Acne
|
ePoster
|
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
of SKYRIZI globally.
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK
inhibitor that is being studied in several immune-mediated
inflammatory diseases. Based on enzymatic and cellular assays,
RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2,
JAK-3, and TYK-2.3 The relevance of inhibition of
specific JAK enzymes to therapeutic effectiveness and safety is not
currently known.
Phase 3 trials of RINVOQ alopecia areata, ankylosing
spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's
disease, giant cell arteritis, hidradenitis suppurativa, psoriatic
arthritis, rheumatoid arthritis, systemic lupus erythematosus
(SLE), Takayasu arteritis, ulcerative colitis and vitiligo are
ongoing.4-17
Use of upadacitinib in vitiligo is not approved and its safety
and efficacy have not been evaluated by regulatory authorities.
RINVOQ (upadacitinib) U.S. Uses and Important
Safety Information3
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis (RA)
when 1 or more medicines called tumor necrosis factor (TNF)
blockers have been used, and did not work well or could not be
tolerated.
- Adults with active psoriatic arthritis (PsA) when 1 or
more medicines called TNF blockers have been used, and did not work
well or could not be tolerated.
- Adults with active ankylosing spondylitis
(AS) when 1 or more medicines called TNF blockers have
been used, and did not work well or could not be tolerated.
- Adults with active non-radiographic axial spondyloarthritis
(nr-axSpA) with objective signs of inflammation when a TNF
blocker medicine has been used, and did not work well or could not
be tolerated.
- Adults with moderate to severe ulcerative colitis (UC)
when 1 or more medicines called TNF blockers have been used, and
did not work well or could not be tolerated.
- Adults with moderate to severe Crohn's disease (CD) when
1 or more medicines called TNF blockers have been used, and did not
work well or could not be tolerated.
It is not known if RINVOQ is safe and effective in children with
juvenile idiopathic arthritis, psoriatic arthritis, ankylosing
spondylitis, non-radiographic axial spondyloarthritis, ulcerative
colitis, or Crohn's disease.
- Adults and children 12 years of age and older with moderate
to severe eczema (atopic dermatitis [AD]) that did not respond
to previous treatment and their eczema is not well controlled with
other pills or injections, including biologic medicines, or the use
of other pills or injections is not recommended.
RINVOQ is safe and effective in children 12 years of age and
older weighing at least 88 pounds (40 kg) with atopic
dermatitis.
It is not known if RINVOQ is safe and effective in children
under 12 years of age with atopic dermatitis.
What is the most important information I should know about
RINVOQ?
RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower your ability to
fight infections. Serious infections have happened while taking
RINVOQ, including tuberculosis (TB) and infections caused by
bacteria, fungi, or viruses that can spread throughout the body.
Some people have died from these infections. Your healthcare
provider (HCP) should test you for TB before starting RINVOQ and
check you closely for signs and symptoms of TB during treatment
with RINVOQ. You should not start taking RINVOQ if you have any
kind of infection unless your HCP tells you it is okay. If you get
a serious infection, your HCP may stop your treatment until your
infection is controlled. You may be at higher risk of developing
shingles (herpes zoster).
- Increased risk of death in people 50 years and older who
have at least 1 heart disease (cardiovascular) risk
factor.
- Cancer and immune system problems. RINVOQ may increase
your risk of certain cancers. Lymphoma and other cancers, including
skin cancers, can happen. Current or past smokers are at higher
risk of certain cancers, including lymphoma and lung cancer. Follow
your HCP's advice about having your skin checked for skin cancer
during treatment with RINVOQ. Limit the amount of time you spend in
sunlight. Wear protective clothing when you are in the sun and use
sunscreen.
- Increased risk of major cardiovascular (CV) events, such as
heart attack, stroke, or death, in people 50 years and older who
have at least 1 heart disease (CV) risk factor, especially if you
are a current or past smoker.
- Blood clots: Blood clots in the veins of the legs or
lungs and arteries can happen with RINVOQ. This may be
life-threatening and cause death. Blood clots in the veins of the
legs and lungs have happened more often in people who are 50 years
and older and with at least 1 heart disease (CV) risk factor.
- Allergic reactions. Symptoms such as rash (hives),
trouble breathing, feeling faint or dizzy, or swelling of your
lips, tongue, or throat, that may mean you are having an allergic
reaction have been seen in people taking RINVOQ. Some of these
reactions were serious. If any of these symptoms occur during
treatment with RINVOQ, stop taking RINVOQ and get emergency medical
help right away.
- Tears in the stomach or intestines. This happens most
often in people who take nonsteroidal anti-inflammatory drugs
(NSAIDs) or corticosteroids. Get medical help right away if you get
stomach-area pain, fever, chills, nausea, or vomiting.
- Changes in certain laboratory tests. Your HCP should do
blood tests before you start taking RINVOQ and while you take it.
Your HCP may stop your RINVOQ treatment for a period of time if
needed because of changes in these blood test results.
Do not take RINVOQ if you are allergic to upadacitinib or any
of the ingredients in RINVOQ. See the Medication Guide or
Consumer Brief Summary for a complete list of ingredients.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
- Are being treated for an infection, have an infection that
won't go away or keeps coming back, or have symptoms of an
infection such as:
- Fever, sweating, or chills
- Shortness of breath
- Warm, red, or painful skin or sores on your body
- Muscle aches
- Feeling tired
- Blood in phlegm
- Diarrhea or stomach pain
- Cough
- Weight loss
- Burning when urinating or urinating more often than normal
- Have TB or have been in close contact with someone with
TB.
- Are a current or past smoker.
- Have had a heart attack, other heart problems, or stroke.
- Have had any type of cancer, hepatitis B or C, shingles (herpes
zoster), blood clots in the veins of your legs or lungs,
diverticulitis (inflammation in parts of the large intestine), or
ulcers in your stomach or intestines.
- Have other medical conditions including liver problems, low red
or white blood cell counts, diabetes, chronic lung disease, HIV, or
a weak immune system.
- Live, have lived, or have traveled to parts of the country,
such as the Ohio and Mississippi
River valleys and the Southwest, that increase your risk of getting
certain kinds of fungal infections. If you are unsure if you've
been to these types of areas, ask your HCP.
- Have recently received or are scheduled to receive a vaccine.
People who take RINVOQ should not receive live vaccines.
- Are pregnant or plan to become pregnant. Based on findings in
animal studies, RINVOQ may harm your unborn baby. Your HCP
will check whether or not you are pregnant before you start RINVOQ.
You should use effective birth control (contraception) to avoid
becoming pregnant during treatment with RINVOQ and for 4 weeks
after your last dose.
- There is a pregnancy surveillance program for RINVOQ. The
purpose of the program is to collect information about the health
of you and your baby. If you become pregnant while taking RINVOQ,
you are encouraged to report the pregnancy by calling
1-800-633-9110.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into
your breast milk. Do not breastfeed during treatment with
RINVOQ and for 6 days after your last dose.
Tell your HCP about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. RINVOQ and other
medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
If you are not sure if you are taking any of these medicines,
ask your HCP or pharmacist.
What should I avoid while taking RINVOQ?
Avoid food or
drink containing grapefruit during treatment with RINVOQ as it may
increase the risk of side effects.
What should I do or tell my HCP AFTER starting
RINVOQ?
- Tell your HCP right away if you have any symptoms of an
infection. RINVOQ can make you more likely to get infections or
make any infections you have worse.
- Get emergency help right away if you have any symptoms of a
heart attack or stroke while taking RINVOQ, including:
- Discomfort in the center of your chest that lasts for more than
a few minutes or that goes away and comes back
- Severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- Pain or discomfort in your arms, back, neck, jaw, or
stomach
- Shortness of breath with or without chest discomfort
- Breaking out in a cold sweat
- Nausea or vomiting
- Feeling lightheaded
- Weakness in one part or on one side of your body
- Slurred speech
- Tell your HCP right away if you have any signs or symptoms of
blood clots during treatment with RINVOQ, including:
- Swelling
- Pain or tenderness in one or both legs
- Sudden unexplained chest or upper back pain
- Shortness of breath or difficulty breathing
- Tell your HCP right away if you have a fever or
stomach-area pain that does not go away, and a change in your bowel
habits.
What are other possible side effects of
RINVOQ?
Common side effects include upper respiratory tract infections
(common cold, sinus infections), shingles (herpes zoster), herpes
simplex virus infections (including cold sores), bronchitis,
nausea, cough, fever, acne, headache, increased blood levels of
creatine phosphokinase, allergic reactions, inflammation of hair
follicles, stomach-area (abdominal) pain, increased weight, flu,
tiredness, lower number of certain types of white blood cells
(neutropenia, lymphopenia, leukopenia), muscle pain, flu-like
illness, rash, increased blood cholesterol levels, increased liver
enzyme levels, pneumonia, low number of red blood cells (anemia),
and infection of the stomach and intestine (gastroenteritis).
A separation or tear to the lining of the back part of the eye
(retinal detachment) has happened in people with atopic dermatitis
treated with RINVOQ. Call your HCP right away if you have any
sudden changes in your vision during treatment with RINVOQ.
Some people taking RINVOQ may see medicine residue (a whole
tablet or tablet pieces) in their stool. If this happens, call your
healthcare provider.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split,
crush, or chew the tablet. Take RINVOQ exactly as your HCP tells
you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg
extended-release tablets.
This is the most important information to know about RINVOQ.
For more information, talk to your HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to
learn more.
Please click here for the Full Prescribing
Information and Medication Guide for RINVOQ.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About
SKYRIZI® (risankizumab-rzaa)
SKYRIZI is an
interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by
binding to its p19 subunit.18 IL-23, a cytokine
involved in inflammatory processes, is thought to be linked to a
number of chronic immune-mediated diseases, including
psoriasis.18 Phase 3 trials of SKYRIZI in
psoriasis, Crohn's disease, ulcerative colitis and psoriatic
arthritis are ongoing.19 - 24
SKYRIZI® (risankizumab-rzaa) U.S. Indications and
Important Safety Information25
SKYRIZI is a prescription medicine used to treat adults
with:
- moderate to severe plaque psoriasis who may benefit from taking
injections or pills (systemic therapy) or treatment using
ultraviolet or UV light (phototherapy).
- active psoriatic arthritis (PsA).
- moderate to severe Crohn's disease.
IMPORTANT SAFETY INFORMATION
What is the most
important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI
is a prescription medicine that may cause serious side effects,
including:
Serious allergic reactions:
- Stop using SKYRIZI and get emergency medical help right away if
you get any of the following symptoms of a serious allergic
reaction:
- fainting, dizziness, feeling lightheaded (low blood
pressure)
- swelling of your face, eyelids, lips, mouth, tongue, or
throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- itching
Infections:
SKYRIZI may lower the ability of your
immune system to fight infections and may increase your risk of
infections. Your healthcare provider should check you for
infections and tuberculosis (TB) before starting treatment with
SKYRIZI and may treat you for TB before you begin treatment with
SKYRIZI if you have a history of TB or have active TB. Your
healthcare provider should watch you closely for signs and symptoms
of TB during and after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an
infection or have symptoms of an infection, including:
- fever, sweats, or chills
- cough
- shortness of breath
- blood in your mucus (phlegm)
- muscle aches
- warm, red, or painful skin or sores on your body different from
your psoriasis
- weight loss
- diarrhea or stomach pain
- burning when you urinate or urinating more often than
normal
Do not use SKYRIZI if you are allergic to
risankizumab-rzaa or any of the ingredients in SKYRIZI. See the
Medication Guide or Consumer Brief Summary for a complete list of
ingredients.
Before using SKYRIZI, tell your healthcare provider about all
of your medical conditions,
including if you:
- have any of the conditions or symptoms listed in the section
"What is the most important information I should know about
SKYRIZI?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). Medicines that interact with the immune
system may increase your risk of getting an infection after
receiving live vaccines. You should avoid receiving live vaccines
right before, during, or right after treatment with SKYRIZI. Tell
your healthcare provider that you are taking SKYRIZI before
receiving a vaccine.
- are pregnant or plan to become pregnant. It is not known if
SKYRIZI can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SKYRIZI passes into your breast milk.
- become pregnant while taking SKYRIZI. You are encouraged to
enroll in the Pregnancy Registry, which is used to collect
information about the health of you and your baby. Talk to your
healthcare provider or call 1-877-302-2161 to enroll in this
registry.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
What are the possible side effects of
SKYRIZI?
SKYRIZI may cause serious side effects. See
"What is the most important information I should know about
SKYRIZI?"
Liver problems in Crohn's disease: A person with
Crohn's disease who received SKYRIZI through a vein in the arm
developed changes in liver blood tests with a rash that led to
hospitalization. Your healthcare provider will do blood tests to
check your liver before, during, and up to 12 weeks of treatment
and may stop treatment with SKYRIZI if you develop liver problems.
Tell your healthcare provider right away if you notice any of the
following symptoms: unexplained rash, nausea, vomiting, stomach
(abdominal) pain, tiredness (fatigue), loss of appetite, yellowing
of the skin and eyes (jaundice), and dark urine.
The most common side effects of SKYRIZI in people treated for
Crohn's disease include: upper respiratory infections,
headache, joint pain, stomach (abdominal) pain, injection site
reactions, low red blood cells (anemia), fever, back pain, and
urinary tract infection.
The most common side effects of SKYRIZI in people treated for
plaque psoriasis and psoriatic arthritis include: upper
respiratory infections, headache, feeling tired, injection site
reactions, and fungal skin infections.
These are not all the possible side effects of SKYRIZI. Call
your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use
it.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a
600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or
360 mg/2.4 mL single-dose prefilled cartridge with on-body
injector.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to
learn more.
Please click here for Full Prescribing
Information and Medication Guide for
SKYRIZI.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About Lutikizumab (ABT-981)
Lutikizumab
(ABT-981) is a dual-variable-domain interleukin (IL) 1α/1β
antagonist being investigated in several immune-mediated diseases,
including hidradenitis suppurativa (HS) and ulcerative colitis.
Studies have shown IL 1α and 1β are elevated in HS
lesions.26 Lutikizumab is an investigational
agent and is not approved by regulatory authorities. Safety and
efficacy have not been established.
BOTOX® Cosmetic (onabotulinumtoxinA)
Important Safety Information
BOTOX® Cosmetic (onabotulinumtoxinA) is a
prescription medicine that is injected into muscles and used to
temporarily improve the look of moderate to severe forehead lines,
crow's feet, and frown lines between the eyebrows in adults.
Talk to your doctor about BOTOX® Cosmetic
and whether it's right for you. There are risks with this
product—the effects of BOTOX® Cosmetic may spread
hours to weeks after injection causing serious symptoms. Alert your
doctor right away as difficulty swallowing, speaking, breathing,
eye problems or muscle weakness can be a sign of a life-threatening
condition. If this happens, do not drive a car, operate machinery,
or do other dangerous activities. Patients with these conditions
before injection are at the highest risk. Swallowing problems may
last for several months. Side effects may include allergic
reactions, neck and injection-site pain, fatigue and headache.
Allergic reactions can include rash, welts, asthma symptoms, and
dizziness. Don't receive BOTOX® Cosmetic if there's
a skin infection. Tell your doctor your medical history, muscle or
nerve conditions (including ALS/Lou
Gehrig's disease, myasthenia gravis, or
Lambert-Eaton syndrome), and
medications, including botulinum toxins, as these may increase the
risk of serious side effects.
Please see BOTOX® Cosmetic Full Product
Information including Boxed Warning and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
JUVÉDERM® VOLUMA® XC Important
Information
INDICATIONS
JUVÉDERM® VOLUMA® XC injectable gel is
indicated for deep (subcutaneous and/or supraperiosteal) injection
for cheek augmentation to correct age-related volume deficit in the
mid-face, for augmentation of the chin region to improve the chin
profile, and for supraperiosteal injection to augment the temple
region to improve temple hollowing in adults over the age of
21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Not for patients with a history of
anaphylaxis, presence of multiple severe allergies, or allergies to
Gram-positive bacterial proteins or lidocaine in these
products.
WARNINGS: Do not inject into blood vessels. Introduction
of this product into the vasculature may lead to embolization,
occlusion of the vessels, ischemia, or infarction. Rare but serious
adverse events associated with the intravascular injection of
dermal fillers in the face have been reported and include temporary
or permanent vision impairment, blindness, cerebral ischemia or
cerebral hemorrhage leading to stroke, skin necrosis, and damage to
underlying facial structures. Treatment should be deferred where
there is active infection or inflammatory process at the injection
site.
PRECAUTIONS: This product should only be used by
healthcare professionals who are knowledgeable about the anatomy
and the product for use in indicated areas, and who have
appropriate training in facial anatomy, vasculature, safe injection
techniques, and identification and management of potential adverse
events, including intravascular complications. The safety for use
during pregnancy, breastfeeding, and in patients with known
susceptibility to keloid formation, hypertrophic scarring, and
pigmentation disorders has not been established. Dermal filler
implantation carries a risk of infection. Use in patients who are
taking products that prolong bleeding may increase
bruising/bleeding at the injection site. Use with caution in
patients on immunosuppressive therapy. Patients may experience
late-onset adverse events with injectable gel implants.
ADVERSE EVENTS: The most common reported side effects
were redness, swelling, pain, tenderness, firmness, lumps/bumps,
bruising, discoloration, and itching. The majority were mild or
moderate in severity.
To report an adverse reaction, please call
Allergan® Product Support at 1-877-345-5372. Please
visit rxabbvie.com for more information.
The products in the JUVÉDERM® Collection are
available only by a licensed physician or properly licensed
practitioner.
SkinMedica®
Most
SkinMedica® products are intended to meet the FDA's
definition of a cosmetic product, an article applied to the human
body to cleanse, beautify, promote attractiveness, and alter
appearances. These SkinMedica® products are not
intended to be drug products that diagnose, treat, cure, or prevent
any disease or condition. These products have not been approved by
the FDA and the statements have not been evaluated by the FDA.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines 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 – in
addition to products and services across our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie
on LinkedIn, Facebook, Instagram, X (formerly
Twitter), and YouTube.
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.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions and uses of future or conditional verbs,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those expressed or implied in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
challenges to intellectual property, competition from other
products, difficulties inherent in the research and development
process, adverse litigation or government action, and changes to
laws and regulations applicable to our industry. Additional
information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie's operations
is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual
Report on Form 10-K, which has been filed with the Securities and
Exchange Commission, as updated by its subsequent Quarterly Reports
on Form 10-Q. AbbVie undertakes no obligation, and specifically
declines, to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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SOURCE AbbVie