- Submissions are supported by the Phase 3 SELECT-GCA study
demonstrating upadacitinib 15 mg with a 26-week steroid taper
regimen achieved the primary endpoint of sustained remission from
week 12 through week 521
- The safety profile of upadacitinib in patients with GCA was
generally consistent with that in approved
indications1
NORTH
CHICAGO, Ill., July 12,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that it has submitted applications for a new indication
to the U.S. Food and Drug Administration (FDA) and European
Medicines Agency (EMA) for upadacitinib (RINVOQ®; 15 mg,
once daily) for the treatment of adult patients with giant cell
arteritis (GCA).
GCA is an autoimmune disease of medium and large arteries and
can cause headache, jaw pain, and changes in vision, including
sudden and permanent loss of vision.3,4
"Currently, there are few approved treatment options for
patients with GCA. Most patients are managed with glucocorticoids,
and many are unable to discontinue them without the recurrence of
GCA symptoms," stated Roopal
Thakkar, M.D., executive vice president, research and
development, and chief scientific officer, AbbVie. "We recognize
the importance of maintaining remission and limiting the use of
glucocorticoids in GCA."
The regulatory submissions to the FDA and EMA are supported by
previously announced results from the SELECT-GCA Phase 3 study
evaluating the safety and efficacy of upadacitinib in patients with
GCA.
About SELECT-GCA
SELECT-GCA (M16-852) is a Phase 3,
multicenter, randomized, double-blind placebo-controlled study
designed to evaluate the safety and efficacy of upadacitinib in 428
patients with GCA. The study consists of two periods. The first
period evaluated the efficacy of upadacitinib in combination with a
26-week corticosteroid taper regimen compared to placebo in
combination with a 52-week corticosteroid taper regimen. In
addition, the first period assessed the safety and tolerability of
upadacitinib in these patients. The second period is ongoing to
evaluate the safety and efficacy of continuing versus withdrawing
upadacitinib in maintaining remission in participants who achieved
sustained remission in the first period.1 For more
information regarding this study, please visit ClinicalTrials.gov
(Identifier NCT03725202).
About Giant Cell Arteritis
Giant cell arteritis
(GCA), also known as temporal arteritis, is an autoimmune disease
of medium and large arteries, characterized by granulomatous
inflammation of the three-layered vessel wall, which affects
temporal and other cranial arteries as well as the aorta and other
large arteries.2,4 GCA can cause headache, jaw
pain, and changes in or loss of vision, including sudden and
permanent loss of vision. Caucasian women over the age of 50 –
most commonly between the ages of 70 and 80 years – have the
highest risk of developing giant cell arteritis. Although women are
more likely than men to develop GCA, research suggests that men are
more likely to have ocular manifestations with their
disease.5
About Upadacitinib (RINVOQ®)
Discovered and
developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is
being studied in several immune-mediated inflammatory
diseases.6,7 Based on enzymatic and cellular
assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs
JAK-2, JAK-3, and TYK-2.6 The relevance of
inhibition of specific JAK enzymes to therapeutic effectiveness and
safety is not currently known. Upadacitinib (RINVOQ) is being
studied in Phase 3 clinical trials for alopecia areata, giant cell
arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic
lupus erythematosus, and vitiligo.8-12 The use of
upadacitinib in giant cell arteritis is not approved and its safety
and efficacy have not been evaluated by regulatory authorities.
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/PatientAccessSupport 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 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.
REFERENCES
- AbbVie. Data on file ABVRRTI78418.
- Ameer MA, Peterfy RJ, Khazaeni B. Giant cell arteritis.
Updated August 8,
2023. https://www.ncbi.nlm.nih.gov/books/NBK459376/
- Weyand CM, Goronzy JJ. Immunology of Giant Cell Arteritis. Circ
Res. 2023;132(2):238-250. doi:10.1161/CIRCRESAHA.122.322128
- Giant Cell Arteritis. Arthritis Foundation. Available
at: https://www.arthritis.org/diseases/giant-cell-arteritis.
Accessed April 11, 2024.
- RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024.
- Pipeline – Our Science | AbbVie. 2023. Available
at: https://www.abbvie.com/our-science/pipeline.html. Accessed April
17, 2024.
- 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 April 9, 2024
- A Study to Evaluate the Efficacy and Safety
of Upadacitinib in Participants with Takaysu Arteritis (TAK)
(SELECT-TAK). ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/study/NCT04161898.
Accessed April 9, 2024.
- 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 April 9, 2024.
- A Study to Assess Change in Disease Activity and Adverse Events
of Oral Upadacitinib in Adult and Adolescent Participants With
Moderate to Severe Hidradenitis Suppurativa Who Have Failed
Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/study/NCT05889182.
Accessed April 9, 2024.
- A Study To Assess Adverse Events and Effectiveness of
Upadacitinib Oral Tablets in Adult and Adolescent Participants With
Vitiligo (Viti-Up). ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/study/NCT06118411.
Accessed April 9, 2024.
- A Study to Evaluate the Safety and Effectiveness of
Upadacitinib Tablets in Adult and Adolescent Participants With
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Accessed April 9, 2024.
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