NORTH CHICAGO, Ill.,
Feb. 24, 2022 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced positive top-line results from
U-EXCEL, a Phase 3 induction study, showing upadacitinib (45 mg
once daily) achieved both primary endpoints of clinical
remissiona,b and endoscopic responsec at
week 12.1 U-EXCEL is the second of two Phase 3
induction studies to evaluate the safety and efficacy
of upadacitinib in adults with moderate to
severe Crohn's disease who had an inadequate response or
were intolerant to conventional or biologic
therapy.1
"The results from this study reaffirm the data from
U-EXCEED and demonstrate the potential impact that upadacitinib
could have on clinical and endoscopic outcomes in patients with
moderate to severe Crohn's disease," said Michael Severino, M.D., vice chairman and
president, AbbVie. "Our decades of collaboration with the
gastroenterology community demonstrates AbbVie's commitment to the
discovery and development of multiple treatment options for
patients with inflammatory bowel diseases."
U-EXCEL included the same primary and key secondary endpoints as
U-EXCEED, with clinical remission measured by the Crohn's Disease
Activity Index (CDAI) and by the patient-reported symptoms of stool
frequency/abdominal pain (SF/AP).1 A significantly
greater proportion of patients treated with a 12-week induction
regimen of upadacitinib 45 mg daily achieved clinical
remission per CDAI at week 12 compared to placebo (49 percent
versus 29 percent; p<0.0001).1 Similar results were
observed with clinical remission per SF/AP (51 percent in
upadacitinib-treated patients versus 22 percent in placebo-treated
patients; p<0.0001).1 At week 12, a significantly
greater proportion of patients treated with upadacitinib 45 mg
achieved endoscopic response compared to the placebo group (46
percent versus 13 percent; p<0.0001).1
Consistent with results from the U-EXCEED induction study, a
significantly higher proportion of patients receiving upadacitinib
45 mg also achieved steroid-free clinical remissiond per
CDAI and per SF/AP compared to placebo at week 12 among patients
taking corticosteroids at baseline.1 Early symptom
improvement measured by CR-100 (defined as reduction of CDAI ≥100
points from baseline) at week two as well as clinical remission at
week four were also achieved by a significantly higher proportion
of patients receiving upadacitinib 45 mg.1
"It is impressive to see the meaningful response that was
achieved in this study in patients with moderate to severe Crohn's
disease who have had inadequate response to an immunosuppressant or
a biologic," said Edward V. Loftus
Jr., M.D., professor of medicine in the division of
gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota, and U-EXCEL study
investigator. "These results suggest that upadacitinib may help
patients who are unable to control their disease, including
symptoms and intestinal inflammation, despite prior conventional or
biologic treatment options."
Efficacy Results
at Week 121
|
|
Placebo
(n=176)
|
Upadacitinib 45
mg
(n=350)
|
Clinical Remission
(per CDAI)a
|
29%
|
49%*
|
Clinical Remission
(per SF/AP)b
|
22%
|
51%*
|
Endoscopic
Responsec
|
13%
|
46%*
|
* Co-primary
endpoints were clinical remission (per CDAI for the U.S. FDA and
per SF/AP for the EU EMA) and endoscopic response at week
12. Both primary endpoints achieved statistical
significance with p-values of <0.0001 versus
placebo.
|
a Clinical remission (per CDAI) is
defined as CDAI <150.
|
b Clinical remission per SF (stool
frequency)/AP (abdominal pain) (also referred to as PRO-2) is
defined as average daily very soft or liquid stool frequency ≤2.8
AND average daily abdominal pain score ≤1.0, and both not greater
than baseline.
|
c Endoscopic response is defined as a
decrease in simple endoscopic score for Crohn's disease (SES-CD)
of >50 percent from baseline (or at least a 2-point
reduction from baseline for subjects with a baseline SES-CD of 4),
as scored by central reviewer.
|
During the 12-week, double-blind, placebo-controlled period, the
safety profile of upadacitinib 45 mg was consistent with the safety
profile observed in previous studies across indications, with no
new safety risks observed.1 The most common adverse
events were acne and anemia in the upadacitinib 45 mg
group.1 Serious adverse events occurred in 6.9 percent
of patients in the upadacitinib 45 mg group compared to 6.8 percent
of patients in the placebo group.1 Rates of serious
infections were 1.1 percent in patients treated with upadacitinib
45 mg and 1.7 percent in those who received placebo.1
Herpes zoster was reported in 2.9 percent of patients treated
with upadacitinib 45 mg, all cases were
nonserious.1 There were no cases of adjudicated
gastrointestinal perforation or death during the placebo-controlled
period.1 One case of adjudicated major cardiovascular
event (MACE) was reported in the placebo group.1
Patients who were on upadacitinib 45 mg and did not achieve
clinical response at week 12 were included in an
additional 12-week treatment cohort with upadacitinib 30
mg.1 In this cohort, one patient died of
COVID-19.1 Patients who were on placebo and did not
achieve clinical response at week 12 were included in a 12-week
treatment cohort with upadacitinib 45 mg.1 Among these
patients, there was one case of adjudicated gastrointestinal
perforation.1
In U-EXCEL, no treatment-emergent cases of adjudicated MACE,
malignancy or adjudicated venous thromboembolic event were reported
in patients on upadacitinib treatment.1
Full results from the U-EXCEL study will be presented at
upcoming medical conferences and published in a peer-reviewed
medical journal. Top-line results from the Phase 3 portion of the
first induction study, U-EXCEED, were announced in December 2021 and the maintenance study for
both is ongoing. Use of upadacitinib in Crohn's disease is not
approved and its safety and efficacy have not been evaluated by
regulatory authorities.
dSteroid-free clinical remission is defined as
clinical remission (per CDAI <150, or per SF/AP with average
daily SF ≤2.8 and not worse than baseline and average daily AP
score ≤1 and not worse than baseline) and discontinuation of
corticosteroid use among patients taking corticosteroids at
baseline.
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 and abdominal pain.15-17 It
is a progressive disease, meaning it gets worse over time in a
substantial proportion of patients.16,17 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.18
About U-EXCEL1,14
The U-EXCEL study is the second of two Phase 3, multicenter,
randomized, double-blind, placebo-controlled induction studies
designed to evaluate the efficacy and safety of upadacitinib 45 mg
induction treatment in adults with moderate to severe Crohn's
disease. U-EXCEL enrolled patients who had inadequately responded
to or are intolerant to one or more conventional and/or biologic
therapies.
The study included slightly different sets of primary and
secondary endpoints for the U.S. Food and Drug Administration
(FDA) and the EU European Medicines Agency (EMA). The primary
endpoints were achievement of clinical remission (per CDAI for the
U.S. FDA, and per SF/AP for the EU EMA, which was measured by
average daily stool frequency and abdominal pain score) and
endoscopic response (per SES-CD) at week 12. More
information can be found
on www.clinicaltrials.gov (NCT03345849).
About the Upadacitinib Phase 3 Crohn's Disease
Program14,19,20
The global upadacitinib Phase 3 program evaluates more than
1,000 patients with moderate to severe Crohn's disease across
two induction studies and a maintenance study. These studies
include assessments of efficacy, safety and tolerability of
upadacitinib. More information on these trials can be found at
www.clinicaltrials.gov (NCT03345836, NCT03345849,
NCT03345823).
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being studied in
several immune-mediated inflammatory diseases.6-14,21
Based on enzymatic and cellular assays, RINVOQ demonstrated greater
inhibitory potency for JAK-1 vs JAK-2, JAK-3, and
TYK-2.21 The relevance of inhibition of specific
JAK enzymes to therapeutic effectiveness is not currently
known.
In the U.S., RINVOQ 15 mg and 30 mg is approved for use in
adults and pediatric patients 12 years of age and older with
refractory, moderate to severe atopic dermatitis whose disease is
not adequately controlled with other systemic drug products,
including biologics, or when use of those therapies is inadvisable.
RINVOQ 15 mg is also approved in the U.S. for adults with
moderately to severely active rheumatoid arthritis who have had an
inadequate response or intolerance to one or more TNF blockers as
well as adults with active psoriatic arthritis who have had an
inadequate response or intolerance to one or more TNF blockers. In
the EU, RINVOQ 15 mg is approved for the treatment of adults with
moderate to severe active rheumatoid arthritis, adults with active
psoriatic arthritis and adults with active ankylosing spondylitis.
RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and
adolescents (15 mg) with moderate to severe atopic dermatitis.
Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic
dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's
disease, ulcerative colitis, giant cell arteritis and Takayasu
arteritis are ongoing.7-14 The use of upadacitinib in
Crohn's disease is not approved and its safety and efficacy have
not been evaluated by regulatory authorities.
RINVOQ® (upadacitinib) U.S. Use and
Important Safety Information21
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid
arthritis when 1 or more 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 tumor necrosis factor (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
under 18 years of age with juvenile idiopathic arthritis or
psoriatic arthritis.
- Adults and children 12 years of age and older with moderate
to severe eczema (atopic dermatitis) who did not respond
to previous treatment and whose 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
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 the common side effects of RINVOQ?
These 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, low white blood
cell count (neutropenia), muscle pain, and flu-like illness.
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,
break, crush, or chew the tablet. Take RINVOQ exactly as your HCP
tells you to use it. RINVOQ is available in 15 mg and 30
mg extended-release tablets.
This is the most important information to know about RINVOQ.
For more information, talk to your HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help.
Visit AbbVie.com/myAbbVieAssist to
learn more.
Please click here for the Full Prescribing
Information and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About 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.
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North Chicago, Ill.: AbbVie
Inc.
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