- Final analyses from the U-ACHIEVE Phase 3 maintenance study
of RINVOQ® (upadacitinib) in moderately to severely
active ulcerative colitis
- Data highlighting symptomatic and endoscopic outcomes,
delayed subcutaneous responders and predictors of response in
patients receiving risankizumab (SKYRIZI®) for use in
moderate to severe Crohn's disease*
- Data from the Phase 3 study U-EXCEL evaluating the efficacy
and safety of upadacitinib (RINVOQ®) as induction
therapy for use in adults with moderately to severely active
Crohn's disease*
- A total of 17 abstracts, including seven oral presentations,
reinforce AbbVie's commitment to research into developments
that could help advance standards of care for patients living with
inflammatory bowel disease (IBD)
NORTH CHICAGO, Ill.,
Sept. 29, 2022 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today revealed the spectrum of new data from studies
of risankizumab (SKYRIZI®) in Crohn's disease and
upadacitinib (RINVOQ®) in ulcerative colitis and Crohn's
disease that will be presented as live presentations and e-Posters
at the United European Gastroenterology (UEG) Week 2022,
October 8-11 in Vienna and online. In total, AbbVie is
presenting 17 abstracts across a broad range of studies in
inflammatory bowel disease (IBD).
"With two decades of world-class science and an unwavering
commitment to patients, we continue to advance research within our
robust gastro portfolio with the goal of positively impacting the
lives of people living with inflammatory bowel disease," said
Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical
Affairs, Immunology, AbbVie. "Our data at UEG Week 2022 reinforce
our dedication to innovation and partnership with the
gastroenterology community to help address a wide range of patient
needs and investigate diverse solutions to help advance standards
of care for IBD patients."
Key data to be presented include:
- Final analyses from the U-ACHIEVE study evaluating the efficacy
and safety of RINVOQ as a maintenance therapy in moderately to
severely active ulcerative colitis
- Analyses on symptomatic improvements and endoscopic outcomes in
patients receiving risankizumab as an induction and maintenance
therapy compared to placebo
- Primary results from the 12-week U-EXCEL induction study on the
efficacy and safety of upadacitinib induction therapy in patients
with moderate to severe Crohn's disease who had inadequate response
or intolerance to conventional or biologic therapy
- Results from the 52-week maintenance study, FORTIFY, on the
efficacy and tolerability of subcutaneous risankizumab in patients
with moderate to severe Crohn's disease who had delayed response to
12 weeks of risankizumab induction therapy
- Quantitative data from the Determinants, Incidence and
Consequences of Corticosteroid Excess (DICE) study, reporting on
the incidence and consequences of corticosteroid use in IBD
patients
* The use of upadacitinib and risankizumab are
investigational in Crohn's disease in the European Union.
AbbVie abstracts in the UEG Week 2022 program include:
Abstract
Title
|
Session Details
(All Times CEST)
|
Risankizumab /
Crohn's Disease
|
|
Induction and
Maintenance Treatment with Risankizumab Leads to
Symptomatic Relief in Patients with Moderate to Severe Crohn's
Disease
|
e-Poster
Presentation
P0437
Sunday, Oct
9
9 a.m.
|
Fatigue Improvement
Correlates with Reductions in Work Productivity
Impairment and Related Indirect Cost in Patients with Crohn's
disease: Post
Hoc Analysis of Two Phase 3 Risankizumab Induction
Trials
|
e-Poster
Presentation P0980
Sunday, Oct
9
9 a.m.
|
Baseline and Early
Predictors of Response to Risankizumab Induction and
Maintenance Treatment in Patients with Moderate to Severe Crohn's
Disease
|
Live Moderated
Poster
MP442
Monday, Oct
10
14:06 – 14:12
p.m.
|
52-Weeks
Risankizumab Subcutaneous Maintenance Dosing is Efficacious and
Well Tolerated in Patients with Moderate to Severe Crohn's Disease
Who Had
Delayed Response to 12-Weeks IV Risankizumab
Induction
|
Live Oral
Presentation
OP126
Monday, Oct
10
14 – 14:12
p.m.
|
Clinical and
Endoscopic Improvements with Risankizumab Induction and
Maintenance Dosing Versus Placebo are Observed Irrespective of
Number of
Prior Failed Biologics
|
Live Oral
Presentation
OP128
Monday, Oct
10
14:24 – 14:36
p.m.
|
Upadacitinib / Ulcerative
Colitis
|
|
Efficacy and safety
of upadacitinib in patients with moderately to severely active
ulcerative colitis receiving 16 weeks' extended induction treatment
followed by
52 weeks' maintenance treatment in the U-ACHIEVE/U-ACCOMPLISH
trials
|
e-Poster
Session
P0440
Sunday, Oct
9
9 a.m.
|
Efficacy and safety
of upadacitinib maintenance therapy in patients with
moderately to severely active ulcerative colitis: Final results
from the Phase 3
U-ACHIEVE Maintenance study
|
Live Oral
Presentation
OP001
Sunday, Oct
9
13:55 – 14:07
p.m.
|
Benefit-risk
assessment of upadacitinib treatment in patients with moderately
to
severely active ulcerative colitis
|
Live Moderated
Poster
MP243
Monday, Oct
10
11:12 – 11:18
a.m.
|
Matching-Adjusted
Indirect Comparison of Upadacitinib Versus Vedolizumab
as Induction Therapy in Patients With Moderately to Severely
Active
Ulcerative Colitis
|
Live Moderated
Poster
MP244
Monday, Oct
10
11:18 – 11:24
a.m.
|
Benefits of high
versus low dose upadacitinib as maintenance treatment in
ulcerative colitis patients who were responders to 8-week induction
with
upadacitinib: Results from the U-ACHIEVE phase 3 maintenance
trial
|
Live Oral
Presentation
OP197
Tuesday, Oct
11
11:24 – 11:36
a.m.
|
Symptoms and
Laboratory Values as Proxies for Endoscopic and Histologic
Clinical Endpoints in Ulcerative Colitis: A Mediation Analysis
Based on
Upadacitinib Phase 3 Induction Trials
|
Live Moderated
Poster
MP409
Tuesday, Oct
11
11:48 – 11:54
a.m.
|
Efficacy of
Upadacitinib Dose Escalation in Phase 3 Long-term Extension
Ulcerative Colitis Study
|
Live Oral
Presentation
OP199
Tuesday, Oct
11
11:48 – 12:00
p.m.
|
Impact of
Inflammatory Burden on Efficacy of Upadacitinib Maintenance
Therapy in Ulcerative Colitis: Results from the Phase 3 U-ACHIEVE
Study
|
Live Moderated
Poster
MP441
Tuesday, Oct
11
14 – 14:06
p.m.
|
Upadacitinib /
Crohn's Disease
|
|
Efficacy and Safety
of Upadacitinib Induction Therapy in Patients with
Moderately to Severely Active Crohn's Disease: Results from a
Randomized
Phase 3 U-EXCEL Study
|
Live Oral
Presentation
OP219
Monday, Oct
10
14:36 – 14:48
p.m.
|
Disease State
Abstracts / Inflammatory Bowel Disease
|
|
Steroid use in a
high proportion of IBD patients – first results from the German
cohort of the IBD-DICE study
|
e-Poster
Presentation
P0436
Sunday, Oct
9
9 a.m.
|
Patient-reported
burden of corticosteroid use in inflammatory bowel disease in
the UK: results from the Determinants, Incidence and Consequences
of
Corticosteroid Excess (DICE) impact questionnaire
|
Live Oral
Presentation
OP107
Monday, Oct
10
11:12 – 11:24
a.m.
|
Patterns of
corticosteroid exposure and excess in inflammatory bowel
disease:
Results from the Determinants, Incidence and Consequences of
Corticosteroid
Excess (DICE) online monitoring tool
|
Live Moderated
Poster
MP110
Sunday, Oct
9
15:54 – 16
p.m.
|
The full scientific program for the UEG Week 2022 is available
here.
Risankizumab (SKYRIZI) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
About Ulcerative Colitis
Ulcerative colitis is a chronic, idiopathic, immune-mediated
inflammatory bowel disease (IBD) of the large intestine that causes
continuous mucosal inflammation extending, to a variable extent,
from the rectum to the more proximal colon.1,2 The
hallmark signs and symptoms of ulcerative colitis include rectal
bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of
pressure), urgency and fecal incontinence.1,3 The
disease course of ulcerative colitis varies between patients and
can range from quiescent disease to chronic refractory disease,
which in some cases can lead to surgery or complications, including
cancer or death.2,4 The severity of symptoms and
unpredictability of disease course can lead to substantial burden
and often disability among those living with the
disease.5
About Crohn's Disease
Crohn's disease is a chronic, systemic disease that manifests as
inflammation within the gastrointestinal (or digestive) tract,
causing persistent diarrhea, abdominal pain and rectal
bleeding.2,6,7 It is a progressive disease, meaning it
gets worse over time.2,7 Because the signs and
symptoms of Crohn's disease are unpredictable, it causes a
significant burden on people living with the disease—not only
physically, but also emotionally and economically.5
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being studied in
several immune-mediated inflammatory diseases.8-15 In
human cellular assays, RINVOQ preferentially inhibits signaling by
JAK1 or JAK1/3 with functional selectivity over cytokine receptors
that signal via pairs of JAK2.8
In the EU, RINVOQ is indicated for the treatment of adult
patients with moderately to severely active ulcerative colitis who
have had an inadequate response, lost response or were intolerant
to either conventional therapy or a biologic
agent.8 The use of upadacitinib in Crohn's disease
is not approved and its safety and efficacy have not been
established by global regulatory authorities. Phase 3 trials of
RINVOQ in atopic dermatitis, axial spondylarthritis, Crohn's
disease, giant cell arteritis, psoriatic arthritis, rheumatoid
arthritis, Takayasu arteritis and ulcerative colitis are
ongoing.9-15
US Indications and Important Safety Information about
RINVOQ® (upadacitinib)8
U.S. USES
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 moderate to severe 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 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.
U.S. 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.
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 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
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 RINVOQ.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine
involved in inflammatory processes, is thought to be linked to a
number of chronic immune-mediated diseases.16,17 The use
of risankizumab in Crohn's disease is not approved in the EU and
its safety and efficacy have not been established by regulatory
authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic
arthritis, Crohn's disease and ulcerative colitis are
ongoing.9,18,19
US Indications and Important Safety Information about
SKYRIZI® (risankizumab)17
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 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
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- 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). 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.
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 people with Crohn's disease: A
person with Crohn's disease who received SKYRIZI by intravenous
infusion developed changes in liver blood tests with a rash that
led to hospitalization. Your doctor 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 doctor 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, injection
site reactions, fever, headache, stomach(abdominal) pain, back
pain, joint pain, and low red blood cells (anemia).
The most common side effects of SKYRIZI in people treated for
plaque psoriasis and psoriatic arthritis 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, a
600mg/10mL intravenous infusion, and a 360mg/2.4mL 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 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, virology, women's health and
gastroenterology, in addition to products and services across its
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.
References:
- 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.
- The Facts about Inflammatory Bowel Diseases. Crohn's &
Colitis Foundation of America. 2014. Available at:
https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf.
Accessed on August 22, 2022.
- Ulcerative colitis. Symptoms and Causes. Mayo Clinic. 2020.
Available at:
https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326.
Accessed on August 22, 2022.
- Monstad, I., et al. Clinical course and prognosis in ulcerative
colitis: results from population-based and observational studies.
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