NORTH CHICAGO, Ill.,
Jan. 14, 2022 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug
Administration (FDA) has approved RINVOQ® (upadacitinib)
for the treatment of moderate to severe atopic dermatitis in adults
and children 12 years of age and older whose disease did not
respond to previous treatment and is not well controlled with other
pills or injections, including biologic medicines, or when use of
other pills or injections is not recommended.1 RINVOQ 15
mg once daily can be initiated in adults and children 12 years of
age and older weighing at least 40 kg.1 In these
children and adults less than 65 years of age who do not achieve an
adequate response, the dose may be increased to 30 mg once
daily.1
"Early in my career as an allergist, I saw how relentless the
itch and rash could be for my patients with moderate to severe
atopic dermatitis yet had limited options to offer those whose
disease could not be adequately controlled with systemic therapy,"
said Thomas Hudson, M.D., senior
vice president, research and development, chief scientific officer,
AbbVie. "This additional approval for RINVOQ provides a once-daily
oral option that can significantly improve the debilitating itch
and skin symptoms of atopic dermatitis. It's also a proud moment
for AbbVie as we continue our efforts to improve care in this
disease state and other chronic, immune-mediated
conditions."
The FDA approval is supported by efficacy and safety data from
one of the largest registrational Phase 3 programs for atopic
dermatitis with more than 2,500 patients evaluated across three
studies. Approximately 52 percent of the patients had prior
exposure to systemic atopic dermatitis treatment. These studies
evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up
1 and 2) and with topical corticosteroids (AD Up), compared to
placebo, in adults and children 12 years of age and older with
moderate to severe atopic dermatitis.2-3
"Despite available therapies, many people with moderate to
severe atopic dermatitis are caught in an endless cycle of itching
and scratching," said Emma
Guttman-Yassky, M.D., Ph.D., Waldman Professor and System
Chair of Dermatology at the Icahn School of Medicine at
Mount Sinai in New York City.* "In clinical trials,
upadacitinib showed a robust response across skin and itch symptoms
that may help evolve treatment goals for those who have not
achieved adequate control of their disease. And as an oral pill
with two dose strengths, upadacitinib is a welcome addition to the
toolbox of clinicians who are striving to make a significant
difference for their patients with moderate to severe atopic
dermatitis."
Clinical Response at Week
161-3
- Across the three atopic dermatitis pivotal studies, RINVOQ (15
mg and 30 mg, once daily) monotherapy and with topical
corticosteroids met all primary and secondary endpoints at week 16,
with some patients achieving higher levels of skin clearance (EASI
90 and 100).
Week 16
Data
|
|
Measure Up 1
(MU1)
|
Measure Up 2
(MU2)
|
AD Up
(AU)
|
|
RINVOQ
15 mg
(n=281)
|
RINVOQ 30
mg
(n=285)
|
Placebo
(n=281)
|
RINVOQ
15 mg
(n=276)
|
RINVOQ
30 mg
(n=282)
|
Placebo
(n=278)
|
RINVOQ
15 mg
plus TCS
(n=300)
|
RINVOQ
30 mg
plus TCS
(n=297)
|
Placebo plus TCS
(n=304)
|
EASI
75*
|
70%
|
80%
|
16%
|
60%
|
73%
|
13%
|
65%
|
77%
|
26%
|
vIGA-AD
0/1*
|
48%
|
62%
|
8%
|
39%
|
52%
|
5%
|
40%
|
59%
|
11%
|
EASI
90
|
53%
|
66%
|
8%
|
42%
|
58%
|
5%
|
43%
|
63%
|
13%
|
EASI
100
|
17%
|
27%
|
2%
|
14%
|
19%
|
1%
|
12%**
|
23%
|
1%
|
Worst Pruritus NRS
≥4
|
52%
|
60%
|
12%
|
42%
|
60%
|
9%
|
52%
|
64%
|
15%
|
*Co-primary endpoints
were EASI 75 and vIGA-AD 0/1 at week 16. Not all secondary
endpoints are shown.
|
**Endpoint not
controlled for multiplicity.
|
EASI 75 is defined as
at least a 75 percent reduction in Eczema Area and Severity Index.
EASI 90 and 100 are defined as at least 90 percent or 100 percent
reduction in Eczema Area and Severity Index.
|
vIGA-AD 0/1 is
defined as a validated Investigator Global Assessment for Atopic
Dermatitis of clear or almost clear (0/1) with at least two grades
of reduction from baseline.
|
Worst Pruritus NRS ≥4
is defined as the proportion of subjects achieving an improvement
in Worst Pruritus Numerical Rating Scale (NRS) ≥4 for subjects with
Worst Pruritus NRS score ≥4 at baseline.
|
Itch Reduction1-3
- In all three studies, a significant improvement in itch (Worst
Pruritus NRS ≥4) was observed as early as week one, compared to
placebo.
Safety1-3
- Overall, the safety profile observed in patients with atopic
dermatitis treated with RINVOQ 15 mg or 30 mg was similar to the
safety profile observed in patients with rheumatoid arthritis.
Other specific adverse reactions reported in atopic dermatitis
patients included eczema herpeticum/Kaposi's varicelliform
eruption.
- 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.
- Increased risk of death in people 50 years and older with at
least 1 heart disease (cardiovascular) risk factor.
- Cancer and immune system problems. RINVOQ may increase
your risk of certain cancers, including lymphoma, skin, and lung
cancer, as these can happen. Current or past smokers are at higher
risk.
- Increased risk of major cardiovascular events such as heart
attack, stroke, or death in people 50 years and older with at least
1 heart disease (cardiovascular) risk factor, especially in current
or past smokers.
- 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. This has happened more often in
people 50 years and older with at least 1 heart disease
(cardiovascular) risk factor.
Do not take RINVOQ if you
are allergic to upadacitinib or any of the ingredients in
RINVOQ.
Other serious side effects include
serious allergic reactions, tears in the stomach or intestines and
changes in certain laboratory test results.
Patient Access and 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 as little as
$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.
More information about this assistance program can be found on
www.AbbVie.com/myAbbVieAssist.
The Impact of Atopic Dermatitis
Atopic dermatitis is a
chronic, relapsing inflammatory condition characterized by a cycle
of intense itching and scratching that leads to cracked, scaly and
oozing skin.4-6 It affects an estimated 7 percent of
adults and 12 percent of adolescents in the U.S., with
approximately 40 percent of adults experiencing moderate to severe
disease.7-8 It manifests differently across individuals,
with symptoms posing significant physical, psychological and
economic burdens.4-5,9
"Every person with atopic dermatitis has a unique experience
with their disease, and in turn, must have multiple options to
choose from in their journey to find a treatment that meets their
individual needs," said Julie Block,
president and chief executive officer, National Eczema Association.
"This approval is a significant milestone for our community,
providing an additional therapy that may bring relief to those
living with the devastating symptoms of moderate to severe atopic
dermatitis."
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.10 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.
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 are
inadvisable.1 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. 11-18
RINVOQ® (upadacitinib) U.S.
Use and Important Safety Information1
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
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 of AbbVie's acquisition of
Allergan plc ("Allergan"), failure to 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 2020 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.
*Emma Guttman-Yassky, M.D.,
Ph.D., is a researcher/consultant for AbbVie.
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