– First indications of RINVOQ
(upadacitinib) for pediatric patients two years of age and
older1
– RINVOQ is now approved
for eight indications across immune-mediated inflammatory
diseases1
NORTH
CHICAGO, Ill., June 4, 2024
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that
RINVOQ® (upadacitinib) is indicated in the U.S. for the
treatment of pediatric patients two years of age and older with
active polyarticular juvenile idiopathic arthritis (pJIA) as well
as psoriatic arthritis (PsA), provided they have had an inadequate
response or intolerance to one or more tumor necrosis factor (TNF)
blockers. Additionally, a new weight-based oral solution,
RINVOQ® LQ (upadacitinib), is now available as an option
for these pediatric populations.1
Experience the interactive Multimedia News Release
here: https://www.multivu.com/players/English/9254951-rinvoq-upadacitinib-available-pediatric-polyarticular-juvenile-idiopathic-and-psoriatic-arthritis/
"RINVOQ has been an important addition to the treatment
landscape for various rheumatic diseases, helping adult patients
achieve meaningful disease control," said Roopal Thakkar, M.D., senior vice president,
chief medical officer, global therapeutics, AbbVie. "AbbVie is
proud to now offer RINVOQ as a tablet and oral solution to some of
our youngest patients."
Nearly 300,000 children and adolescents in the U.S. have a form
of juvenile idiopathic arthritis, which includes pJIA and
PsA.2-3 The polyarticular form of juvenile idiopathic
arthritis is characterized by inflammation in five or more joints
that persists for at least six weeks in children and adolescents
before 16 years of age.2 The psoriatic arthritis form of
juvenile idiopathic arthritis is characterized by both joint
inflammation and skin lesions associated with
psoriasis.4 These chronic diseases can be painful and
debilitating and, if left untreated, may lead to joint
damage.5-6 Despite treatment advancements, achieving
long-term remission remains elusive for many patients living with a
form of juvenile idiopathic arthritis, with approximately half
requiring ongoing treatment into adulthood.7-8
"Pediatric patients with pJIA and PsA can be severely limited in
their ability to complete daily physical tasks and participate in
everyday activities. Understanding their needs today and knowing
the likelihood of disease in adulthood underscores the need for
additional treatment options," said Aarat Patel, M.D., adult and
pediatric rheumatology, Bon Secours Rheumatology Center of St.
Mary's Hospital. "Having a treatment option available for patients
who do not respond well to a TNFi addresses a need for the
healthcare community, patients, and their families."
Data Supporting the Approvals1
The
approvals of RINVOQ and RINVOQ LQ oral solution are supported by
evidence from well-controlled studies of RINVOQ in adult patients
with rheumatoid arthritis (RA) and PsA, pharmacokinetic data from
adult patients with RA and PsA, as well as 51 pediatric patients
with juvenile idiopathic arthritis with active polyarthritis, in
addition to safety data from 83 pediatric patients two to less than
18 years of age with juvenile idiopathic arthritis with active
polyarthritis. Upadacitinib plasma exposures in pediatric patients
with pJIA and PsA at the recommended dosage are predicted to be
comparable to those observed in adults with RA and PsA based on
population pharmacokinetic modeling and simulation.
RINVOQ*/RINVOQ LQ Safety Considerations
- Overall, the safety profile observed in pediatric patients with
juvenile idiopathic arthritis with active polyarthritis
treated with RINVOQ/RINVOQ LQ was consistent with the known safety
profile of RINVOQ.
- 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 50 years and older who
have at least 1 heart disease (cardiovascular) 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 (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 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 years and older
who have at least 1 heart disease (CV) 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.
*Unless otherwise stated, "RINVOQ" in the Safety Considerations
refers to RINVOQ and RINVOQ LQ.
For more information about RINVOQ, visit RINVOQ.com.
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 $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 RINVOQ® (upadacitinib)
Discovered and
developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is
being studied in several immune-mediated inflammatory diseases. In
human leukocyte cellular assays, RINVOQ inhibited cytokine-induced
STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently
than JAK2/JAK2 mediated STAT phosphorylation. The relevance of
inhibition of specific JAK enzymes to therapeutic effectiveness and
safety is not currently known.1
Phase 3 trials of RINVOQ in alopecia areata, ankylosing
spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's
disease, giant cell arteritis, hidradenitis suppurativa, psoriatic
arthritis, rheumatoid arthritis, systemic lupus erythematosus
(SLE), Takayasu arteritis, ulcerative colitis and vitiligo are
ongoing.9,10,11,12,13,14,15,16,17,18,19,20,21,22
RINVOQ® (upadacitinib) U.S. Uses and Important
Safety Information
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
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.
It is not known if RINVOQ is safe and effective in children
under 12 years of age with atopic dermatitis.
It is not known if RINVOQ LQ is safe and effective in children
with atopic dermatitis.
RINVOQ/RINVOQ LQ is a prescription medicine used to
treat:
- Children 2 years of age and older with
active polyarticular juvenile idiopathic arthritis (pJIA)
when 1 or more medicines called TNF blockers have been used, and
did not work well or could not be tolerated.
- Children 2 to less than 18 years of age 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.
It is not known if RINVOQ/RINVOQ LQ is safe and effective in
children under 2 years of age with polyarticular juvenile
idiopathic arthritis or psoriatic arthritis.
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. 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 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.
- 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
HCP.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ/RINVOQ LQ?
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.
RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is
available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as
RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets
unless the change has been made by your HCP.
*Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY
INFORMATION refers to RINVOQ and RINVOQ LQ.
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.
About AbbVie in Rheumatology
For more than 20 years,
AbbVie has been dedicated to improving care for people living with
rheumatic diseases. Anchored by a longstanding commitment to
discovering and delivering transformative therapies, we pursue
cutting-edge science that improves our understanding of promising
new pathways and targets, ultimately helping more people living
with rheumatic diseases reach their treatment goals. For more
information, visit AbbVie in rheumatology.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines and solutions 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,
and eye care – and products and services in our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on LinkedIn, Facebook,
Instagram, X (formerly Twitter), and YouTube.
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 2023 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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9 A Study to Evaluate the Safety and Effectiveness of
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https://clinicaltrials.gov/study/NCT06012240. Accessed February 19, 2024.
10 A Study to Evaluate Efficacy and Safety of
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(SELECT AXIS 2). ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed
March 24, 2023.
11 Evaluation of Upadacitinib in Adolescent and Adult
Patients With Moderate to Severe Atopic Dermatitis (Eczema)
(Measure Up 1). ClinicalTrials.gov. Available at:
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12 A Study to Evaluate Upadacitinib in Adolescents and
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ClinicalTrials.gov. Available at:
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13 A Study to Evaluate Upadacitinib in Combination With
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Available at: https://clinicaltrials.gov/study/NCT03568318.
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14 A Multicenter, Randomized, Double-Blind,
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https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed
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17 A Study Comparing Upadacitinib (ABT-494) to Placebo
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Stable Dose of Methotrexate and Who Have an Inadequate Response to
Methotrexate (SELECT-COMPARE). ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/ct2/show/NCT02629159. Accessed
March 24, 2023.
19 Program to Assess Adverse Events and Change in
Disease Activity of Oral Upadacitinib in Adult Participants With
Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE).
ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/study/NCT05843643. Accessed February 19, 2024.
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Upadacitinib in Participants with Takaysu Arteritis (TAK)
(SELECT-TAK). ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/study/NCT04161898. Accessed March 30, 2023.
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Moderately to Severely Active Ulcerative Colitis.
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https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed
March 24, 2023.
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Vitiligo (Viti-Up). ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/study/NCT06118411. Accessed February 19, 2024.
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