− Results from the Phase 3 SELECT-GCA
study showed 46 percent of patients with giant cell arteritis (GCA)
who were treated with upadacitinib (RINVOQ®; 15 mg) with
a 26-week steroid taper regimen achieved sustained remission from
week 12 through week 52 compared to 29 percent of patients
receiving placebo with a 52-week steroid taper
regimen1
− The safety
profile in GCA was generally consistent with that in approved
indications, and no new safety signals were
identified1
−
The clinical program reflects AbbVie's history of developing new
treatment options for patients with immune-mediated diseases, where
there remains significant unmet medical need
NORTH
CHICAGO, Ill., April 18,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced positive top-line results from SELECT-GCA, a Phase 3,
multicenter, randomized, double-blind, placebo-controlled study,
showing upadacitinib (RINVOQ®; 15 mg, once daily) in
combination with a 26-week steroid taper regimen achieved its
primary endpoint of sustained remissiona from week
12 through week 52 in adults with giant cell arteritis (GCA).
In this study, 46 percent of patients receiving upadacitinib 15 mg
in combination with a 26-week steroid taper regimen achieved
sustained remission compared to 29 percent of patients
receiving placebo in combination with a 52-week steroid taper
regimen (p=0.0019).1
"Many people living with GCA continue to suffer from the
potentially debilitating symptoms of this disease, with limited
treatment options available to them," said Kori Wallace, M.D., Ph.D., vice president,
global head of immunology clinical development, AbbVie. "These
results demonstrate our relentless commitment to improving the
lives of people living with immune-mediated diseases by developing
new treatments where significant medical needs still exist."
GCA is an autoimmune disease that causes inflammation of
the temporal and other cranial arteries, the aorta, and other large
and medium arteries. GCA generally impacts elderly patients older
than 50 years, most commonly between the ages of 70 and 80 years.
Women have the highest risk of developing this disease, which can
cause headache, jaw pain and changes in or loss of vision,
including sudden and permanent loss of vision.2
Key secondary endpoints were also met, including a higher
percentage of patients receiving upadacitinib 15 mg in combination
with a 26-week steroid taper regimen achieved sustained complete
remissionb from week 12 through week 52 compared to
patients receiving placebo in combination with a 52-week steroid
taper regimen (37 percent versus 16 percent;
p<0.0001).1 A lower percentage of patients
experienced at least one disease flare through week 52 in the
upadacitinib 15 mg group versus the placebo group (34 percent
versus 56 percent; p=0.0014).1 The study results also
showed that upadacitinib 7.5 mg did not meet the primary or any of
the secondary endpoints.1
"I am encouraged by these results, which add to the body of
evidence supporting the efficacy and safety profile of upadacitinib
for the treatment of rheumatic diseases," said Daniel Blockmans,
M.D., Ph.D., Department of General Internal Medicine, University
Hospitals Gasthuisberg, Belgium,
professor of medicine, KU Leuven, Belgium, and lead investigator of the
SELECT-GCA trial. "Based on these results, upadacitinib has the
potential to be the first oral treatment option for patients with
GCA, a disease with inflammation of the large arteries that
primarily impacts older people and has only one approved treatment
to date3 commonly used with steroids."
During the 52-week, placebo-controlled period, the safety
profile of upadacitinib 15 mg was generally consistent with that
observed in approved indications.1 Upadacitinib 15 mg
was generally well tolerated, with no new safety signals identified
in this GCA population.1 Discontinuations due to
adverse events occurred in 15 percent of patients in the
upadacitinib 15 mg group and 21 percent of patients in the placebo
group.1 In this study, the proportion of patients
who experienced a serious adverse event was similar (23 percent in
the upadacitinib 15 mg group and 21 percent in the placebo
group).1 Serious infections occurred in 6 percent
of the upadacitinib 15 mg group and 11 percent of the placebo
group.1 Overall, the proportions of patients with
incidence of malignancy excluding non-melanoma skin cancer and
adjudicated venous thromboembolic events (VTEs) were balanced
across both the upadacitinib 15 mg (2 percent and 3 percent,
respectively) and placebo (2 percent and 4 percent, respectively)
treatment groups.1 There were no adjudicated major
adverse cardiac events (MACE) in the upadacitinib 15 mg group
compared to two events in the placebo group.1 Four
treatment-emergent deaths were reported, two in the placebo group
and two in the upadacitinib 15 mg group.1 Of the two
treatment-emergent deaths in the upadacitinib 15 mg group, one was
attributed to COVID-19, and the other was adjudicated as an
unexplained cause.1
Full results across all treatment groups from the SELECT-GCA
study will be presented at a future medical meeting. Use of
upadacitinib in GCA is not approved and its safety and efficacy
have not been evaluated by regulatory authorities.
a Sustained remission is defined as having an
absence of GCA signs and symptoms from week 12 through week 52 and
adherence to the protocol-defined steroid taper over the course of
the study term.
b Sustained complete remission is defined as
having an absence of GCA signs and symptoms from week 12 through
week 52, adherence to the protocol-defined steroid taper, and
normalization of both erythrocyte sedimentation rate (ESR) and high
sensitivity C-reactive protein (hsCRP) from week 12 through week
52.
About SELECT-GCA
SELECT-GCA (M16-852) was 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, which is reported
in this release, 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 study assessed the safety and tolerability of
upadacitinib in these patients. The second period will 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.2 It is the most
common vasculitis affecting adults in western
countries.2 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.8-13
RINVOQ (upadacitinib) U.S. Uses and Important
Safety Information6
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.
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
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.
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.
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.
- 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/
- RoActemra 20 mg/mL concentrate for solution for infusion. SmPC
Mar 2023
- 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.; 2023.
- 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
Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/study/NCT06012240. Accessed April 9, 2024.
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