– The co-primary endpoints of endoscopic response
(visible reduction of intestinal lining damage) and clinical
remission were achieved by significantly more patients treated with
RINVOQ (upadacitinib) at week 12 and week 52 versus
placebo1
– Clinical response was
achieved by significantly more patients treated with RINVOQ
(upadacitinib) versus placebo as early as week 2 in induction
studies1
– This indication marks the
seventh FDA approval for RINVOQ across gastroenterology,
rheumatology and dermatology1
NORTH
CHICAGO, Ill., May 18, 2023
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S.
Food and Drug Administration (FDA) has approved RINVOQ®
(upadacitinib) for the treatment of adults with moderately to
severely active Crohn's disease who have had an inadequate response
or intolerance to one or more TNF blockers.1 This is the
seventh FDA approval for RINVOQ across rheumatology, dermatology,
and gastroenterology, where it is now indicated in both ulcerative
colitis and Crohn's disease.1
Access the multimedia news release here:
https://www.multivu.com/players/English/9145751-abbvie-fda-crohns-disease/
"AbbVie recognizes the need for more treatment options for
Crohn's disease that can help address both rapid relief of symptoms
along with the visible reduction of intestinal lining damage," said
Thomas Hudson, M.D., senior vice
president of research and development, chief scientific officer,
AbbVie. "We're pleased that RINVOQ may provide this relief and is
now available to treat Crohn's disease."
Endoscopic Response and Clinical Remission
The
approval is supported by data from two induction studies, U-EXCEED
and U-EXCEL, and the U-ENDURE maintenance
study.1 Statistical significance was achieved for
the co-primary endpoints and key secondary endpoints with RINVOQ 45
mg in the induction studies and RINVOQ 15 mg and 30 mg in the
maintenance study compared to placebo.
- Endoscopic response: In the two induction studies, 34%
and 46% of patients treated with RINVOQ 45 mg achieved endoscopic
response (defined as a decrease of greater than 50% from the
baseline Simplified Endoscopic Score for CD [SES-CD] or for
patients with isolated ileal disease and a baseline SES-CD of 4, at
least a 2-point reduction from baseline) at week 12, respectively,
compared to 3% and 13% of patients receiving placebo.1
In the maintenance study, 28% and 41% of patients treated with
RINVOQ 15 mg and 30 mg achieved endoscopic response at week 52,
respectively, compared to 7% of patients receiving placebo.
- Clinical remission: In the two induction studies, 36%
and 46% of patients treated with RINVOQ 45 mg achieved clinical
remission (defined as a Crohn's Disease Activity Index [CDAI] of
less than 150) at 12 weeks, respectively, compared to 18% and 23%
of patients receiving placebo. Additionally, in the maintenance
trial, 42% and 55% of patients treated with RINVOQ 15 mg and 30 mg
achieved clinical remission at 52 weeks, respectively, compared to
14% of patients receiving placebo.1
"Symptoms of moderately to severely active Crohn's disease can
be disruptive and uncomfortable for patients, so relief as
early as possible is key. Given the progressive nature of the
disease, endoscopic response is just as important," 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.* "Based on the
clinical trial results, treatment with RINVOQ shows both early and
long-term symptom relief along with evidence of a visible reduction
of damage to the intestinal lining caused by excess
inflammation."
"I started feeling better within a couple weeks. My symptoms
lessened – less cramping, firmer stools, and the bleeding stopped.
When I stopped bleeding, I had more energy," said Danielle, who is
living with Crohn's disease and received RINVOQ in an open-label
treatment arm in one of the clinical trials.
Rapid Clinical Response and Corticosteroid-free Clinical
Remission1
- Onset of clinical response based on CDAI was observed as early
as two weeks in U-EXCEED and U-EXCEL, with a greater proportion of
patients achieving clinical response at week 2 in RINVOQ-treated
patients compared with placebo.1
- This is the first clinical program of an approved
moderate-to-severe Crohn's disease treatment to require steroid
taper during the induction period, with a corticosteroid taper
regimen initiated at week 4. Corticosteroid-free clinical remission
(defined as discontinuation of steroid and achievement of clinical
remission per CDAI [CDAI less than 150]) among patients on steroid
at baseline was achieved at week 12 by more patients treated with
RINVOQ in U-EXCEED and U-EXCEL (30% and 40%, respectively) compared
to placebo (11% and 13%, respectively). In U-ENDURE,
corticosteroid-free remission (defined as no corticosteroids for 90
days prior to week 52 and achievement of clinical remission) was
achieved by more patients treated with RINVOQ 15 mg and 30 mg (42%
and 53%, respectively) compared to 14% with placebo.
RINVOQ Safety Considerations1
- Overall, the safety profile observed in patients with Crohn's
disease treated with RINVOQ was consistent with the known safety
profile for RINVOQ in other indications.
- RINVOQ may cause serious side effects, including:
-
- Serious infections. RINVOQ can lower ability to fight
infections. Serious infections, some fatal, occurred, including
tuberculosis (TB) and infections caused by bacteria, fungi, or
viruses.
- Increased risk of death in people age 50+ with at least 1
heart disease risk factor.
- Cancer and immune system problems. Increased risk of
some cancers, including lymphoma and skin. Current or past smokers
have higher risk for lymphoma and lung cancer.
- Increased risk of major cardiovascular events such as heart
attack, stroke, or death in people 50+ with at least 1 heart
disease risk factor, especially in current or past
smokers.
- Blood clots, some fatal, in veins of the legs or lungs
and arteries. This occurred more often in people 50+ with at least
1 heart disease risk factor.
- Serious allergic reactions. Do not take if allergic to
RINVOQ or its ingredients.
- Tears in the stomach or intestines; changes in certain
laboratory test results.
For more information about RINVOQ, visit RINVOQ.com.
Patient Access & Support
AbbVie is committed to helping people access RINVOQ and other
medicines, including offering a patient support program and a
co-pay card that may reduce out-of-pocket costs to $5 per month for eligible, commercially insured
patients. For those with limited or no health insurance, AbbVie
offers myAbbVie Assist, a patient assistance program that provides
RINVOQ at no charge to those who qualify. For more details, please
visit AbbVie.com/myAbbVieAssist.
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.2-4 It is a progressive
disease, meaning it gets worse over time, and in many cases leads
to surgery.3,4 Because the signs and symptoms of Crohn's
disease are unpredictable, it causes a significant burden on people
living with the disease.5
About the U-EXCEED and U-EXCEL Induction and the U-ENDURE
Maintenance Studies1,6-8
The three Phase 3
studies are multicenter, randomized, double-blind,
placebo-controlled studies to evaluate the efficacy and safety of
RINVOQ 45 mg as induction therapy and RINVOQ 15 mg and 30 mg as
maintenance therapy in patients with moderately to severely active
Crohn's disease. Topline results of the U-EXCEED and U-EXCEL
induction studies were announced in December
2021 and February 2022. Topline results of the U-ENDURE
maintenance study were announced in May 2022. More information
can be found
on https://clinicaltrials.gov (U-EXCEED: NCT03345836,
U-EXCEL: NCT03345849, U-ENDURE: NCT03345823).
*Dr. Loftus is a consultant and advisor for AbbVie.
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. Based on enzymatic and cellular assays, RINVOQ
demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3,
and TYK-2.1 The relevance of inhibition of specific JAK
enzymes to therapeutic effectiveness and safety is not currently
known.
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.9-17
RINVOQ (upadacitinib) U.S. Uses and Important
Safety Information1
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
juvenile idiopathic arthritis, psoriatic arthritis, 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.
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. 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 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.
- 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
healthcare provider.
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.
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, Instagram, YouTube and
LinkedIn.
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 2022 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-RNQG-230166
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Available
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Have Inadequately Responded to or Are Intolerant to Biologic
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https://clinicaltrials.gov/ct2/show/NCT03345836?term=NCT03345836&draw=2&rank=1.
Accessed March 30, 2023
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Participants With Moderately to Severely Active Crohn's Disease Who
Have Inadequately Responded to or Are Intolerant to Conventional
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at:
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Accessed March 30, 2023.
- A Maintenance and Long-Term Extension Study of the Efficacy and
Safety of Upadacitinib (ABT-494) in Participants With Crohn's
Disease Who Completed the Studies M14-431 or M14-433.
ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/ct2/show/NCT03345823?term=NCT03345823&draw=2&rank=1.
Accessed March 30, 2023.
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ClinicalTrials.gov. Available
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Dose of Methotrexate and Who Have an Inadequate Response to
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- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study of ABT-494 for the Induction of Symptomatic and Endoscopic
Remission in Subjects With Moderately to Severely Active Crohn's
Disease Who Have Inadequately Responded to or Are Intolerant to
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at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed
March 24, 2023.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants With Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed
March 24, 2023.
- A Study Comparing Upadacitinib (ABT-494) to Placebo and to
Adalimumab in Participants With Psoriatic Arthritis Who Have an
Inadequate Response to at Least One Non-Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed
March 24, 2023.
- A Study to Compare Safety and Efficacy of Upadacitinib to
Dupilumab in Adult Participants With Moderate to Severe Atopic
Dermatitis (Heads Up). ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed
March 24, 2022.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants with Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. Available
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March 30, 2023.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in
Participants with Takaysu Arteritis (TAK) (SELECT-TAK).
ClinicalTrials.gov. Available at:
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Accessed March 30, 2023.
U.S. Media:
Sara Sanders
+1 (973)
307-6145
sara.sanders@abbvie.com
Shannelle
Fowler
+1 (773)
520-2106
shannelle.fowler@abbvie.com
|
Investors:
Liz Shea
+1 (847)
935-2211
liz.shea@abbvie.com
|
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