- Thirty-six abstracts underscore AbbVie's commitment to
advancing research to help more people living with rheumatic
diseases
- Additional analysis of long-term safety data for
RINVOQ® (upadacitinib) and
SKYRIZI® (risankizumab)
NORTH
CHICAGO, Ill., Nov. 8, 2022
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it would
present new data across its rheumatology portfolio, including
RINVOQ® (upadacitinib) for rheumatoid arthritis,
psoriatic arthritis and axial spondyloarthritis, and
SKYRIZI® (risankizumab) for psoriasis and psoriatic
arthritis at the American College of Rheumatology's annual meeting
(ACR Convergence 2022) taking place November
10-14 in Philadelphia, PA,
as well as virtually.
"AbbVie has a rich legacy spanning more than two decades where
we have consistently worked to deliver new insights and innovation
in rheumatology," said Celine
Goldberger, M.D., Ph.D., vice president, head of U.S.
medical affairs, AbbVie. "Data being presented at this year's ACR
meeting further reflect AbbVie's commitment to advancing our
portfolio of medicine to help more people living with chronic and
debilitating conditions achieve meaningful disease control."
Data to be presented includes:
- Data on rates of major adverse cardiovascular events (MACE) and
venous thromboembolic events (VTE) in the RA, PsA and AS clinical
trial programs of upadacitinib.1
- Real-world data evaluating the impact of a second-line
therapeutic product on disease control in patients living with
psoriatic arthritis.2
- Several poster presentations on data from the KEEPsAKE clinical
trials evaluating risankizumab in psoriatic arthritis including
long-term data across specific sub-groups, and SELECT clinical
trials evaluating upadacitinib in psoriatic arthritis, rheumatoid
arthritis and axial spondyloarthritis.3-7
Select AbbVie abstracts presented at ACR 2022 are outlined
below.
Abstract
Title
|
Presentation
Details
All times
ET
|
Rheumatoid
Arthritis
|
Safety and Efficacy of
Upadacitinib in Patients with Rheumatoid Arthritis and
Inadequate Response or Intolerance to Biologic DMARDs: Results
Through 5
Years From the SELECT-BEYOND Study
|
Abstract #0294;
Poster Session A;
Nov. 12, 2022
1:00–3:00 p.m.
|
Safety and Efficacy of
Upadacitinib in Patients with Rheumatoid Arthritis and
Inadequate Response to Conventional Synthetic DMARDs: Results
Through 5
Years From the SELECT-NEXT Study
|
Abstract #0295;
Poster Session A;
Nov. 12, 2022
1:00–3:00 p.m.
|
Healthcare Resource
Utilization and Economic Burden of Patients with Adequate
and Inadequate Responses to Advanced Therapies for Rheumatoid
Arthritis in
Japan
|
Abstract #2006;
Poster Session D;
Nov. 14, 2022
1:00–3:00 p.m.
|
Psoriatic
Arthritis
|
Risankizumab (RZB)
Demonstrates Long-Term Efficacy Across Subgroups in
Patients with Active Psoriatic Arthritis (PsA): A Post Hoc,
Integrated Analysis
From the Phase 3 (KEEPsAKE 1 and KEEPsAKE 2) Studies
|
Abstract #0308;
Poster Session A;
Nov. 12, 2022
1:00–3:00 p.m.
|
Efficacy of
Risankizumab in the Treatment of PsA Patients with Limited and
Extensive Joint Involvement
|
Abstract #1504;
Poster Session C;
Nov. 13, 2022
1:00–3:00 p.m.
|
The Impact of
Second-Line Therapeutic on Disease Control After
Discontinuation
of First Line TNF Inhibitor in Patients with PsA: Analysis from the
CorEvitas
Psoriatic Arthritis/Spondylarthritis Registry
|
Abstract #1600;
Oral Presentation;
Room 201;
Nov. 13, 2022
3:45–3:55 p.m.
|
Axial
Spondyloarthritis
|
Efficacy of
Upadacitinib in Patients with Non-Radiographic Axial
Spondyloarthritis
Stratified by Objective Signs of Inflammation at
Baseline
|
Abstract #0419;
Poster Session A;
Nov. 13, 2022
1:00–3:00 p.m.
|
The Impact of Cycling
Among Tumor Necrosis Factor Inhibitors on Disease
Control in Patients with Axial Spondyloarthritis: A Study from the
CorEvitas
PsA/SpA Registry
|
Abstract #1499;
Poster Session C;
Nov. 13, 2022
1:00–3:00 p.m.;
and Live Ignite
Talk at the Center
City Stage, from
1:20-1:25 p.m.
|
Cross-Rheumatology
|
Malignancy in the
Upadacitinib Clinical Trial Programs for Rheumatoid Arthritis,
Psoriatic Arthritis, and Ankylosing Spondylitis
|
Abstract #0292;
Poster Session A;
Nov. 12, 2022
1:00–3:00 p.m.;
and Live Ignite
Talk at the Center
City Stage on Nov.
14, 2022 1:30-
1:35 p.m.
|
MACE and VTE Across
Upadacitinib Clinical Trial Programs in Rheumatoid
Arthritis, Psoriatic Arthritis, and Ankylosing
Spondylitis
|
Abstract #0510;
Oral Presentation;
Room 119;
Nov. 12, 2022
4:00-4:10 p.m.
|
SKYRIZI (risankizumab) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization of SKYRIZI globally.
The full list of all 36 abstracts and ACR Convergence 2022
scientific program can be found here.
About RINVOQ® (upadacitinib) in the United States
Discovered and developed by AbbVie scientists, RINVOQ is a
selective 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-2.8 The relevance of
inhibition of specific JAK enzymes to therapeutic effectiveness and
safety is not currently known.
In the U.S., RINVOQ 15 mg is approved for adults with moderately
to severely active rheumatoid arthritis who have had an inadequate
response or intolerance to one or more TNF blockers; adults with
active psoriatic arthritis who have had an inadequate response or
intolerance to one or more TNF blockers; adults with active
ankylosing spondylitis (AS) who have had an inadequate response or
intolerance to one or more tumor necrosis factor (TNF) blockers and
adults with active non-radiographic axial spondyloarthritis with
objective signs of inflammation who have had an inadequate response
or intolerance to TNF blocker therapy.8 RINVOQ 45
mg is approved for use in adult patients with moderately to
severely active ulcerative colitis who have had an inadequate
response or intolerance to one or more TNF blockers as an induction
therapy once daily for 8 weeks. The recommended dose of RINVOQ for
maintenance treatment is 15 mg once daily. A dosage of 30 mg once
daily may be considered for patients with refractory, severe or
extensive disease. Discontinue RINVOQ if an adequate response is
not achieved with the 30 mg dose. Use the lowest effective dosage
needed to maintain response. RINVOQ 15 mg once daily can also be
initiated in adults and children 12 years of age and older weighing
at least 40 kg with refractory, moderate to severe atopic
dermatitis whose disease is not adequately controlled with other
systemic drug products, including biologics or when use of those
therapies is inadvisable. In these children and adults less than 65
years of age who do not achieve an adequate response, the dose may
be increased to 30 mg once daily.
Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic
dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's
disease, ulcerative colitis, giant cell arteritis and Takayasu
arteritis are ongoing.9-16
RINVOQ® (upadacitinib) U.S. Use and
Important Safety Information8
USES
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 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 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.
It is not known if RINVOQ is safe and effective in children with
juvenile idiopathic arthritis, psoriatic arthritis, ulcerative
colitis, ankylosing spondylitis, or non-radiographic axial
spondyloarthritis.
- 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.
IMPORTANT SAFETY INFORMATION
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 and 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 or 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
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 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.
- 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), muscle pain, flu-like illness, rash, increased blood
cholesterol levels, and increased liver enzyme levels.
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.
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 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 the Full Prescribing
Information and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About SKYRIZI® (risankizumab-rzaa) in
the United
States17
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).
SKYRIZI U.S. Uses and Important Safety
Information17
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.
This is the most important information to know about SKYRIZI.
For more information, talk to your HCP.
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 AbbVie in Rheumatology
For more than 20 years,
AbbVie has been dedicated to improving care for people living with
rheumatic diseases. Anchored by a longstanding commitment to
discovering and delivering transformative therapies, we pursue
cutting-edge science that improves our understanding of promising
new pathways and targets, ultimately helping more people living
with rheumatic diseases reach their treatment goals. For more
information, visit AbbVie in rheumatology.
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, eye care, virology, and
women's health, 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
Twitter, Facebook, LinkedIn or Instagram.
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, among others, 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
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. 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 2021 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 to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
US-MULT-221303
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