AbbVie Presents New Data Supporting Leading Gastroenterology Portfolio at 2024 Digestive Disease Week®
- 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
Poster #Su1761
Risankizumab Treatment in Patients with
Moderate to Severe Crohn's Disease: Results IBD: Controlled Clinical Trials in Humans
from the FORTIFY Open-Label Long-Term
Extension
May 19, 2024
12:30-1:30 PM
Risankizumab Versus Ustekinumab for the
Oral Presentation #763
Achievement of Clinical Remission and Reduction
in Inflammatory Biomarkers in Patients with Immunology, Microbiology & Inflammatory Bowel
Moderate-to-Severe Crohn's Disease: Results Diseases (IMIBD) Section Distinguished
Abstract Plenary
from the Phase 3b SEQUENCE Trial
May 20, 2024
2:00-3:30 PM
Risankizumab is Associated with Lower Cost Per
Poster #Tu1095
Responder and Cost Per Remitter Versus
Ustekinumab in Patients with Moderate-to-Severe Health Economics (Cost of Illness, Cost-
Crohn's Disease: Economic Analyses from the Effectiveness, and Health Economic Models)
SEQUENCE Trial
May 21, 2024
12:30-1:30 PM
Achievement of Clinical and Endoscopic
Poster #Su1773
Outcomes by Baseline Corticosteroid Use in
Patients with Moderately to Severely Active IBD: Controlled Clinical Trials in Humans
Ulcerative Colitis Who Received Risankizumab
Induction Treatment: A Post Hoc Analysis of the
May 19, 2024
INSPIRE Study
12:30-1:30 PM
Efficacy Outcomes of Placebo Maintenance
Poster #Su1792
Treatment in Patients with Moderately to Severely
Active Ulcerative Colitis Who Responded to IBD: Controlled Clinical Trials in Humans
Placebo Induction Therapy: Results from the
Phase 3 COMMAND Study
May 19, 2024
12:30-1:30 PM
Achievement of Corticosteroid-Free Clinical,
Poster #Su1751
Endoscopic, and Histologic Outcomes in Patients
with Moderately to Severely Active Ulcerative IBD: Controlled Clinical Trials in Humans
Colitis Treated with Risankizumab: Results from
the COMMAND Study
May 19, 2024
12:30-1:30 PM
Effect of Risankizumab on Early Symptoms in
Poster #Su1770
Patients with Moderately to Severely Active
Ulcerative Colitis: A Post Hoc Analysis of the IBD: Controlled Clinical Trials in Humans
INSPIRE Induction Study
May 19, 2024
12:30-1:30 PM
Additional Risankizumab Therapy is Effective in
Oral Presentation #904
Patients with Moderately to Severely Active
Ulcerative Colitis Who Did Not Achieve Clinical
IBD Controlled Trials I
Response to Initial 12-Week Induction Therapy:
An Analysis of Phase 3 INSPIRE and COMMAND
May 20, 2024
Studies
4:00-5:30 PM
Economic Impact of Risankizumab Induction
Poster #Tu1102
Therapy on UC-Related Hospitalizations and
Work Productivity: An Analysis of Data from the Health Economics (Cost of Illness, Cost-
Phase 3 Induction Study Effectiveness, and Health Economic Models)
May 21, 2024
12:30-1:30 PM
Risankizumab Maintenance Therapy in Patients
Oral Presentation #984
with Moderately to Severely Active Ulcerative
Colitis: Efficacy and Safety in the Randomized
IBD Controlled Trials II
Phase 3 COMMAND Study
May 21, 2024
8:00-9:30 AM
Upadacitinib
Upadacitinib Improves Clinical and Endoscopic
Poster #Su1792
Outcomes in Ulcerative Colitis and Crohn's
Disease Regardless of Baseline Body Mass Index IBD: Controlled Clinical Trials in Humans
May 19, 2024
12:30-1:30 PM
Improvements in Inflammatory Bowel Disease
Poster #Su1863
Questionnaire Items Fatigue, Depression, Anxiety,
and Bowel Urgency in Patients with Crohn's IBD: Quality of Life and Psychosocial Care
Disease Treated with Upadacitinib in Phase 3
Trials
May 19, 2024
12:30-1:30 PM
Upadacitinib Treatment is Associated with
Poster #1798
Improved Clinical and Quality of Life Outcomes in
Patients with Crohn's Disease: Results From the IBD: Controlled Clinical Trials in Humans
U- ENDURE Long-term Extension
May 19, 2024
12:30-1:30 PM
Effect of Upadacitinib on Lipid Profiles in Patients
Poster #Sa1757
with Inflammatory Bowel Disease: Pooled
Analysis of Phase 3 Induction and Maintenance IBD: Controlled Clinical Trials in Humans
Studies in Patients with Moderately to Severely
Active Crohn's Disease or Ulcerative Colitis
May 19, 2024
12:30-1:30 PM
Corticosteroid-Free Remission Through 2 Years
Poster #Su1786
of Upadacitinib Therapy in Patients with
Moderately to Severely Active Ulcerative Colitis 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 Information(6)
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 Information(7)
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)
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/
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