- A total of 27 abstracts reinforce AbbVie leadership in
advancing research and the standards of care across multiple
gastroenterological conditions, including inflammatory bowel
disease (IBD) and irritable bowel syndrome (IBS)
- Presentations include further analyses of Phase 3 clinical
study programs for RINVOQ® (upadacitinib) in moderately
to severely active ulcerative colitis and investigational use of
risankizumab in moderately to severely active Crohn's
disease
NORTH
CHICAGO, Ill., May 16, 2022
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that 27
abstracts across its gastroenterology portfolio will be presented
at the Digestive Disease Week (DDW) Annual Meeting, May 21-24, 2022, in San
Diego and virtually.
AbbVie's research to be presented at DDW 2022 addresses
digestive and inflammatory bowel diseases, including ulcerative
colitis (UC), Crohn's disease (CD), and irritable bowel syndrome
with constipation (IBS-C) / chronic idiopathic constipation
(CIC).
"Since establishing our commitment to gastroenterology 15 years
ago, our presence at DDW has grown continuously as our portfolio
has expanded," said Celine Goldberger
M.D., Ph.D., vice president, head of US medical affairs,
AbbVie. "We are proud to present data on a range of digestive
conditions across our portfolio and pipeline. AbbVie's commitment
to GI and IBD patients remains strong, and we are looking forward
to connecting again with the gastroenterology community at DDW this
year."
AbbVie will share oral presentations from two assets,
RINVOQ® (upadacitinib) and LINZESS®
(linaclotide). Notably, a late-breaking oral presentation will
focus on the efficacy and safety of upadacitinib in adult patients
with moderately to severely active Crohn's disease who have failed
prior biologics. Additional RINVOQ oral presentations will include
analyses from the pivotal Phase 3 trials (U-ACHIEVE induction and
U-ACCOMPLISH) of RINVOQ in adults with moderately to severely
active UC, including data evaluating changes in ulcerative colitis
symptoms one day after treatment, and data on patients who received
an extended induction phase prior to maintenance treatment. An oral
presentation will also address an evaluation of patients' threshold
for meaningful improvement based on the novel abdominal score
outcome measure in adult patients with IBS-C for LINZESS.
A database with all AbbVie abstracts accepted for presentation
at DDW 2022 can be found here. Notable poster data will be on
display from May 22-24 from
12:30-1:30 PM PT, including efficacy
and safety data from Phase 3 studies of risankizumab in moderately
to severely active Crohn's disease, and Phase 2 investigational
data evaluating linaclotide in children two to five years old with
functional constipation.
The details of AbbVie's oral presentations at DDW 2022 are
outlined below.
Abstract
Title
|
Presentation
Details
All times
PDT
|
Ulcerative Colitis
(UC)
|
|
Efficacy and safety of
extended induction treatment with upadacitinib 45 mg
once daily followed by maintenance upadacitinib 15 or 30 mg once
daily in
patients with moderately to severely active ulcerative
colitis
|
Oral presentation;
Controlled IBD
Trials 2: Small Molecules; May
24; 10:15 AM to 10:30 AM
|
Upadacitinib therapy
reduces ulcerative colitis symptoms within day 1 of
treatment onset
|
Oral presentation;
Controlled IBD
Trials 2: Small Molecules; May
24; 10:30 AM to 10:45 AM
|
Crohn's Disease
(CD)
|
|
Efficacy and safety of
upadacitinib induction therapy in patients with
moderately to severely active Crohn's disease who failed prior
biologics:
results from a randomized phase 3 U-EXCEED study
|
Oral Presentation;
Late-Breaking
Clinical Science Abstract
Plenary; May 24; 9:15 AM to
9:30 AM
|
Irritable Bowel
Syndrome with Constipation (IBS-C)
|
|
Patient-derived
meaningful change thresholds in the novel abdominal score
outcome measure in irritable bowel syndrome with
constipation
|
Oral presentation; New
Concepts
In Diseases of the Colon &
Rectum; May 21; 3:00-3:15 PM
|
SKYRIZI® is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization of SKYRIZI globally. Use of risankizumab in
Crohn's disease is not approved and its safety and efficacy have
not been evaluated by regulatory authorities.
LINZESS is part of a collaboration between AbbVie and Ironwood
Pharmaceuticals to share development and commercialization of
LINZESS in the United States.
RINVOQ (upadacitinib) U.S. Uses and Important Safety
Information1
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis 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 when 1 or more
medicines called TNF blockers have been used, and did not work well
or could not be tolerated.
- Adults with moderately to severely active ulcerative
colitis 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 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, ulcerative
colitis or ankylosing spondylitis.
- Adults and children 12 years of age and older with moderate
to severe eczema (atopic dermatitis) that did not respond to
previous treatment and their eczema is not well controlled with
other pills or injections, including biologic medicines, or when
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 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.
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.
- 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 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.
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 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.
LINZESS (linaclotide) Uses and Important Safety
Information2
USES
LINZESS® (linaclotide) is a prescription medication
used in adults to treat irritable bowel syndrome with constipation
(IBS-C) and chronic idiopathic constipation (CIC). "Idiopathic"
means the cause of the constipation is unknown. It is not known
if LINZESS is safe and effective in children less than 18 years of
age.
IMPORTANT RISK INFORMATION
- Do not give LINZESS to children who are less than 2 years of
age. It may harm them. LINZESS can cause severe diarrhea and
your child could get severe dehydration (loss of a large amount of
body water and salt).
- Do not take LINZESS if a doctor has told you that you have a
bowel blockage (intestinal obstruction).
Before you take LINZESS, tell your doctor about your medical
conditions, including if you are:
- Pregnant or plan to become pregnant. It is not known if LINZESS
will harm your unborn baby.
- Breastfeeding or plan to breastfeed. You and your doctor should
decide if you will take LINZESS and breastfeed.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
Side Effects
LINZESS can cause serious side effects, including diarrhea,
which is the most common side effect and can sometimes be
severe. Diarrhea often begins within the first 2 weeks of
LINZESS treatment. Stop taking LINZESS and call your doctor
right away if you get severe diarrhea during treatment with
LINZESS.
Other common side effects of LINZESS include gas, stomach-area
(abdominal) pain, swelling, or a feeling of fullness or pressure in
your abdomen (distension). Call your doctor or go to the nearest
hospital emergency room right away if you develop unusual or severe
stomach-area (abdominal) pain, especially if you also have bright
red, bloody stools or black stools that look like tar.
These are not all the possible side effects of LINZESS. For more
information, ask your doctor or pharmacist.
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
and Ironwood may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn
more.
Please see full Prescribing Information including Boxed
Warning.
SKYRIZI (risankizumab-rzaa) U.S. Uses and Important Safety
Information3
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).
- with active psoriatic arthritis (PsA).
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medication that may cause serious
side effects, including:
Serious Allergic Reactions:
- Stop using SKYRIZI and get emergency help right away if you get
any of the following symptoms of 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.
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). Medications 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.
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?"
The most common side effects of SKYRIZI include upper
respiratory infections, feeling tired, fungal skin infections,
headache, and injection site reactions.
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.
This is not a complete summary of all safety
information.
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 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 virtual meeting from
May 21-24, 2022. The meeting
showcases more than 5,000 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
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,
women's health and gastroenterology, 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-220661
References:
- RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- LINZESS (linaclotide) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- SKYRIZI (risankizumab) [Package Insert]. North
Chicago, Ill.: AbbVie Inc.
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SOURCE AbbVie