- First registered, randomized Phase 3 trial in
hidradenitis suppurativa (HS) evaluating the efficacy and safety of
upadacitinib (RINVOQ®) in adults and
adolescents with moderate to severe HS1
- HS is a difficult-to-treat chronic,
inflammatory disease with few therapeutic options
available2,3
- AbbVie applies proven expertise in immunology and HS
in continued efforts to bring new treatment options to patients
living with this underserved
condition4
NORTH
CHICAGO, Ill., July 24,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that the first patient has been dosed in the Phase 3
Step-Up HS study evaluating upadacitinib (RINVOQ®) in
adults and adolescents with moderate to severe hidradenitis
suppurativa (HS) who have failed anti-tumor necrosis factor (TNF)
therapy and/or one approved non-anti-TNF inhibitor therapy for
HS.1
"Hidradenitis suppurativa is a chronic, inflammatory disease
that often leads to irreversible skin damage and extreme pain for
patients," said Roopal Thakkar,
M.D., senior vice president, development and regulatory affairs and
chief medical officer, AbbVie. "Leveraging our proven expertise in
immunology and experience in HS, we continue to drive innovation
and pursue advancement of care in patient populations with
difficult-to-treat immune-mediated diseases that have limited
therapeutic options."
HS can appear on the skin as painful bumps, nodules or abscesses
that leak fluid, lead to scarring and even connect under the skin
as tunnels.5 Nodules generally develop in areas of the
body where hair grows or skin rubs against skin, such as the
underarms, groin or back of the neck.5
While HS is estimated to affect up to one percent of the global
population, patients can experience increasing disease severity and
symptoms for as long as seven to 10 years before receiving an
accurate diagnosis.6,7 There is no cure for HS, and
there are limited treatment options, making further study of this
disease critical to better understand its impact and help meet
patients' unmet needs.3,8
About Step-Up HS1
Step-Up HS is the first
Phase 3, randomized, placebo-controlled, double-blind, multicenter
study to evaluate the efficacy and safety of upadacitinib compared
to placebo in adults and adolescents (12 to less than 18 years old)
with moderate to severe HS who have failed anti-TNF therapy and/or
one approved non-anti-TNF inhibitor therapy for HS. Aiming to
enroll approximately 1,300 participants across 275 sites worldwide,
the study consists of three periods. In Period 1 (0 to 16 weeks),
the safety and efficacy of upadacitinib 30 mg will be evaluated
versus placebo, which is the primary analysis of the study. In
Period 2 (16 to 20 weeks), based on clinical response, patients
will be re-randomized to upadacitinib 30 mg, upadacitinib 15 mg or
placebo, followed by a long-term extension Period 3 (20 to 68
weeks).
The study's primary endpoint will measure the percentage of
participants achieving HS clinical response (HiSCR) 50, defined as
at least a 50 percent reduction in the total abscess and
inflammatory nodule (AN) count with no increase in abscess count
and no increase in draining fistula count relative to baseline at
week 16.
The Phase 2 study was completed and study results were presented
at the American Academy of Dermatology (AAD) Annual Meeting in
March 2023 and are planned for
publication in a scientific journal. Additional results from the
Phase 2 study will be presented at a future medical congress.
Additional information about the study can be found
at https://clinicaltrials.gov/ under the identifier
NCT05889182.
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.4 Based on
enzymatic and cellular assays, RINVOQ demonstrated greater
inhibitory potency for JAK-1 vs JAK-2, JAK-3, and
TYK-2.9 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, Takayasu
arteritis, and systemic juvenile idiopathic arthritis are
ongoing.10-18 Use of upadacitinib in HS is not approved
and its safety and efficacy have not been evaluated by regulatory
authorities.
RINVOQ (upadacitinib) U.S. Uses and Important
Safety Information9
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 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, 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 and uses of future or conditional verbs,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those expressed or implied in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
challenges to intellectual property, competition from other
products, difficulties inherent in the research and development
process, adverse litigation or government action, and changes to
laws and regulations applicable to our industry. Additional
information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie's operations
is set forth in Item 1A, "Risk Factors," of AbbVie's 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, and specifically
declines, to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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Adalimumab in Participants With Psoriatic Arthritis Who Have an
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