- AbbVie will present 15
abstracts, including three oral presentations, in Crohn's disease
and ulcerative colitis reinforcing AbbVie's commitment to advancing
the standards of care in inflammatory bowel diseases
(IBD)
- Data to be presented from the
SEQUENCE head-to-head trial comparing risankizumab
(SKYRIZI®) versus ustekinumab (STELARA®) in
Crohn's disease include an economic analysis and oral presentation
that assessed inflammation biomarkers
- Additional presentations include efficacy
and safety data evaluating clinical, endoscopic, and histologic
outcomes from both the INSPIRE Phase 3 induction study and the
COMMAND Phase 3 maintenance study of risankizumab as a therapy for
adults with moderately to severely active ulcerative
colitis
NORTH
CHICAGO, Ill., May 17, 2024
/PRNewswire/ -- AbbVie (NYSE: ABBV) announced it is presenting 15
abstracts at the 2024 Digestive Disease Week (DDW) Annual Meeting,
being held May 18-21 in Washington, D.C., and virtually.
"AbbVie is presenting research at DDW that evaluated rapid
symptom relief and visible improvement in the GI tract across our
portfolio," said Andrew Anisfeld,
Ph.D., vice president, global medical affairs, Immunology, AbbVie.
"Advancing the standard of care for IBD patients helps doctors
address acute needs, as well as long-term care goals, in a way that
can be felt by the patient and measured by their health care
team."
As a leader in gastroenterology, AbbVie is identifying
opportunities, driving discoveries, and advancing science to
enhance the understanding of IBD. Recognizing that every patient is
different, AbbVie has taken bold steps to help shape the IBD
landscape, building a diverse portfolio of marketed and
investigational products, sharing new evidence that further builds
upon our strong scientific foundation and helping elevate the
standards of care for people living with IBD.
The research presented at DDW will encompass risankizumab
(SKYRIZI®) and upadacitinib (RINVOQ®) across
IBD. Notable data presentations will include:
- Risankizumab vs. Ustekinumab in Crohn's Disease (SEQUENCE
Trial): Compared the efficacy of risankizumab and ustekinumab
in achieving STRIDE-II* recommended short- and long-term treatment
goals of symptomatic, endoscopic, and biomarker improvements in
patients with moderate-to-severe Crohn's disease.
- Risankizumab in Ulcerative Colitis (COMMAND
Study): Evaluated achievement of corticosteroid-free
clinical, endoscopic, and histologic outcomes in patients with
moderately to severely active ulcerative colitis treated with
risankizumab.
- Risankizumab Maintenance Therapy in Ulcerative Colitis
(COMMAND Study): Investigated the efficacy and safety of
risankizumab maintenance therapy in patients with moderately to
severely active ulcerative colitis.
- Upadacitinib Therapy in Ulcerative
Colitis: Explored corticosteroid-free remission over two
years of upadacitinib therapy in patients with moderately to
severely active ulcerative colitis.
- Effect of Upadacitinib on Lipid Profiles in
Inflammatory Bowel Disease: Analyzed the impact of
upadacitinib on lipid profiles in patients with inflammatory bowel
disease, pooling data from Phase 3 induction and maintenance
studies in patients with moderately to severely active Crohn's
disease or ulcerative colitis.
Select AbbVie abstracts at 2024 DDW are outlined below. The 2024
DDW Annual Meeting program is available here.
Abstract
Title
|
Presentation
Details
All times
ET
|
Risankizumab
|
Efficacy and Safety Up
to Three Years of
Risankizumab Treatment in Patients with
Moderate to Severe Crohn's Disease: Results
from the FORTIFY Open-Label Long-Term
Extension
|
Poster
#Su1761
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
Risankizumab Versus
Ustekinumab for the
Achievement of Clinical Remission and Reduction
in Inflammatory Biomarkers in Patients with
Moderate-to-Severe Crohn's Disease: Results
from the Phase 3b SEQUENCE Trial
|
Oral Presentation
#763
Immunology,
Microbiology & Inflammatory Bowel
Diseases (IMIBD) Section Distinguished Abstract Plenary
May 20, 2024
2:00-3:30 PM
|
Risankizumab is
Associated with Lower Cost Per
Responder and Cost Per Remitter Versus
Ustekinumab in Patients with Moderate-to-Severe
Crohn's Disease: Economic Analyses from the
SEQUENCE Trial
|
Poster
#Tu1095
Health Economics (Cost
of Illness, Cost-
Effectiveness, and Health Economic Models)
May 21, 2024
12:30-1:30
PM
|
Achievement of Clinical
and Endoscopic
Outcomes by Baseline Corticosteroid Use in
Patients with Moderately to Severely Active
Ulcerative Colitis Who Received Risankizumab
Induction Treatment: A Post Hoc Analysis of the
INSPIRE Study
|
Poster
#Su1773
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
Efficacy Outcomes of
Placebo Maintenance
Treatment in Patients with Moderately to Severely
Active Ulcerative Colitis Who Responded to
Placebo Induction Therapy: Results from the
Phase 3 COMMAND Study
|
Poster
#Su1792
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
Achievement of
Corticosteroid-Free Clinical,
Endoscopic, and Histologic Outcomes in Patients
with Moderately to Severely Active Ulcerative
Colitis Treated with Risankizumab: Results from
the COMMAND Study
|
Poster
#Su1751
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
Effect of Risankizumab
on Early Symptoms in
Patients with Moderately to Severely Active
Ulcerative Colitis: A Post Hoc Analysis of the
INSPIRE Induction Study
|
Poster
#Su1770
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
Additional Risankizumab
Therapy is Effective in
Patients with Moderately to Severely Active
Ulcerative Colitis Who Did Not Achieve Clinical
Response to Initial 12-Week Induction Therapy:
An Analysis of Phase 3 INSPIRE and COMMAND
Studies
|
Oral Presentation
#904
IBD Controlled Trials
I
May 20, 2024
4:00-5:30 PM
|
Economic Impact of
Risankizumab Induction
Therapy on UC-Related Hospitalizations and
Work Productivity: An Analysis of Data from the
Phase 3 Induction Study
|
Poster
#Tu1102
Health Economics (Cost
of Illness, Cost-
Effectiveness, and Health Economic Models)
May 21, 2024
12:30-1:30
PM
|
Risankizumab
Maintenance Therapy in Patients
with Moderately to Severely Active Ulcerative
Colitis: Efficacy and Safety in the Randomized
Phase 3 COMMAND Study
|
Oral Presentation
#984
IBD Controlled Trials
II
May 21, 2024
8:00-9:30 AM
|
Upadacitinib
|
Upadacitinib Improves
Clinical and Endoscopic
Outcomes in Ulcerative Colitis and Crohn's
Disease Regardless of Baseline Body Mass Index
|
Poster
#Su1792
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
Improvements in
Inflammatory Bowel Disease
Questionnaire Items Fatigue, Depression, Anxiety,
and Bowel Urgency in Patients with Crohn's
Disease Treated with Upadacitinib in Phase 3
Trials
|
Poster
#Su1863
IBD: Quality of Life
and Psychosocial Care
May 19, 2024
12:30-1:30
PM
|
Upadacitinib Treatment
is Associated with
Improved Clinical and Quality of Life Outcomes in
Patients with Crohn's Disease: Results From the
U- ENDURE Long-term Extension
|
Poster #1798
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
Effect of Upadacitinib
on Lipid Profiles in Patients
with Inflammatory Bowel Disease: Pooled
Analysis of Phase 3 Induction and Maintenance
Studies in Patients with Moderately to Severely
Active Crohn's Disease or Ulcerative Colitis
|
Poster
#Sa1757
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
Corticosteroid-Free
Remission Through 2 Years
of Upadacitinib Therapy in Patients with
Moderately to Severely Active Ulcerative Colitis
|
Poster
#Su1786
IBD: Controlled
Clinical Trials in Humans
May 19, 2024
12:30-1:30
PM
|
About SKYRIZI®
(risankizumab-rzaa)
SKYRIZI is an
interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by
binding to its p19 subunit.2 IL-23, a cytokine involved
in inflammatory processes, is thought to be linked to a number of
chronic immune-mediated diseases.3 SKYRIZI is approved
by the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency for the treatment of plaque psoriasis, psoriatic
arthritis and Crohn's disease.4,5
Risankizumab is not approved for the treatment of ulcerative
colitis.
Risankizumab (SKYRIZI) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
SKYRIZI (risankizumab-rzaa) U.S. Uses and Important Safety
Information6
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.
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 at least 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 (risankizumab-rzaa) 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 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 RINVOQ® (upadacitinib)
Discovered and developed
by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is
being studied in several immune-mediated inflammatory diseases. In
human leukocyte cellular assays, RINVOQ inhibited cytokine-induced
STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently
than JAK2/JAK2 mediated STAT phosphorylation. The relevance of
inhibition of specific JAK enzymes to therapeutic effectiveness and
safety is not currently known.7
Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic
dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's
disease, ulcerative colitis, giant cell arteritis, Takayasu
arteritis, and systemic juvenile idiopathic arthritis are
ongoing.
RINVOQ® (upadacitinib) U.S. Uses and
Important Safety Information7
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
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.
It is not known if RINVOQ is safe and effective in children
under 12 years of age with atopic dermatitis.
It is not known if RINVOQ LQ is safe and effective in children
with atopic dermatitis.
RINVOQ/RINVOQ LQ is a prescription medicine used to
treat:
- Children 2 years of age and older with
active polyarticular juvenile idiopathic arthritis
(pJIA) when 1 or more medicines called TNF blockers have
been used, and did not work well or could not be tolerated.
- Children 2 to less than 18 years of age 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.
It is not known if RINVOQ/RINVOQ LQ is safe and effective in
children under 2 years of age with polyarticular juvenile
idiopathic arthritis or psoriatic arthritis.
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 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.
- 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
HCP.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ/RINVOQ LQ?
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.
RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is
available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as
RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets
unless the change has been made by your HCP.
*Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY
INFORMATION refers to RINVOQ and RINVOQ LQ.
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/PatientAccessSupport 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 Inflammatory Bowel Disease (IBD)
Inflammatory
bowel disease (IBD) is a group of diseases characterized by chronic
inflammation of the gastrointestinal (GI) tract. Crohn's disease
(CD) and ulcerative colitis (UC) are the most common forms of IBD.
In both CD and UC, the immune system causes inflammation and damage
to the mucosa – or lining – of the
gut.8,9,10 Specifically, CD manifests as
inflammation within the GI tract, most commonly in the area between
the small intestine (ileum) and the colon, causing persistent
diarrhea and abdominal pain.8,11 UC is a
chronic, idiopathic, immune-mediated IBD of the large intestine
that causes continuous mucosal inflammation extending, to a
variable extent, from the rectum to the more proximal
colon.10,12 The hallmark signs and
symptoms of UC include rectal bleeding, abdominal pain, bloody
diarrhea, tenesmus (a sense of pressure), urgency and fecal
incontinence.10,12 CD and UC are progressive
diseases, meaning they get worse over time and may lead to
life-threatening complications or
surgery.13,14 Because the signs and
symptoms of CD and UC are unpredictable, they cause a significant
burden on people living with the disease—not only physically, but
also emotionally and economically.15
About Digestive Disease Week®
Digestive
Disease Week® (DDW) is the largest international
gathering of physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW is an in-person and online meeting
from May 18-21, 2024. The meeting
showcases more than 3,100 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
About AbbVie in Gastroenterology
With a robust
clinical trial program, AbbVie is committed to cutting-edge
research to drive exciting developments in inflammatory bowel
diseases (IBD), like ulcerative colitis and Crohn's disease. By
innovating, learning and adapting, AbbVie aspires to eliminate the
burden of IBD and make a positive long-term impact on the lives of
people with IBD. For more information on AbbVie in
gastroenterology,
visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
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 – and products
and services in 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.
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.
US-IMMG-240075
*The Selecting Therapeutic Targets in Inflammatory Bowel Disease
(STRIDE)-II recommendations were published in 2021 by the
International Organization for the Study of IBD, to assist
clinicians with helping their patients attain short- and
longer-term treatment goals. Short-term goals include reducing or
eliminating symptoms, while longer-term goals include absence of
inflammation or lesions in the colon (mucosal healing), a normal
quality of life, and absence of disability.1
- STRIDE-II: An Update on the Selecting Therapeutic Targets in
Inflammatory Bowel Disease (STRIDE) Initiative of the International
Organization for the Study of IBD (IOIBD): Determining Therapeutic
Goals for Treat-to-Target strategies in IBD. Accessed May 1, 2024:
https://pubmed.ncbi.nlm.nih.gov/33359090/
- Duvallet E, Sererano L, Assier E, Falgarone G, Boissier MC.
Interleukin-23: a key cytokine in inflammatory diseases. Ann Med.
2011;43(7):503-11. doi:10.3109/07853890.2011.577093
- Pipeline. AbbVie. 2021. Accessed March
20,
2024. https://www.abbvie.com/our-science/pipeline.html
- A study comparing risankizumab to placebo in participants with
active psoriatic arthritis including those who have a history of
inadequate response or intolerance to biologic therapy(ies)
(KEEPsAKE2). ClinicalTrials.gov. Updated February 28, 2023. Accessed March 20,
2024. https://clinicaltrials.gov/ct2/show/NCT03671148
- A multicenter, randomized, double-blind, placebo-controlled
induction study to evaluate the efficacy and safety of risankizumab
in participants with moderately to severely active ulcerative
colitis. ClinicalTrials.gov. Updated March
10, 2023. Accessed March 20,
2024. https://clinicaltrials.gov/ct2/show/record/NCT03398148
- SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- RINVOQ [Package Insert]. North
Chicago, IL: AbbVie Inc.
- Crohn's & Colitis Foundation. The facts about inflammatory
bowel diseases. Crohn's & Colitis Foundation. Published
November 2014. Accessed March 29,
2024. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
- Crohn's & Colitis Foundation. Overview of Crohn's disease.
Crohn's & Colitis Foundation. Accessed March 29,
2024. https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview
- National Institute of Diabetes and Digestive and Kidney
Diseases. Ulcerative colitis. National Institute of Diabetes and
Digestive and Kidney Diseases. Accessed March 29,
2024. https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis
- Mayo Clinic. Crohn's disease - Symptoms and causes. Mayo
Clinic. Accessed March 29,
2024. https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304
- Monstad, I., et al. Clinical course and prognosis in ulcerative
colitis: results from population-based and observational studies.
Ann Gastroenterol. 2014; 27(2): 95–104.
- Mehta F. Report: economic implications of inflammatory bowel
disease and its management. Am J Manag Care. 2016 Mar;22(3
Suppl):s51-60.
- Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev
Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi:
10.1038/nrgastro.2015.150.
- Gajendran M., et al. A comprehensive review and update on
ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi:
10.1016/j.disamonth.2019.02.004. Epub 2019 Mar 2.
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SOURCE AbbVie