- RINVOQ is now approved as the first and only oral JAK
inhibitor for adults with active non-radiographic axial
spondyloarthritis (nr-axSpA)
- RINVOQ is the first and only JAK inhibitor approved for both
active ankylosing spondylitis (AS) and
nr-axSpA1-3
- In a clinical study, RINVOQ delivered rapid and meaningful
disease control based on patients achieving ASAS40 vs. placebo, as
well as significant improvement in signs and symptoms of
nr-axSpA at week 141,2
NORTH
CHICAGO, Ill., Oct. 21,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announces that the U.S. Food and Drug Administration (FDA) has
approved RINVOQ® (upadacitinib 15 mg, once daily), an
oral therapy, for the treatment of adults with active
non-radiographic axial spondyloarthritis (nr-axSpA) with objective
signs of inflammation who have had an inadequate response or
intolerance to tumor necrosis factor (TNF) blocker therapy.
This additional indication follows the FDA approval of RINVOQ in
April of this year for adults with active ankylosing spondylitis
(AS) who have had an inadequate response or intolerance to one
or more TNF blockers, making it the first and only JAK inhibitor
that is approved for both conditions.1
Experience the full interactive Multichannel News Release
here:
https://www.multivu.com/players/English/9092951-abbvie-fda-active-non-radiographic-axial-spondyloarthritis/
Nr-axSpA is a chronic, progressive inflammatory rheumatic
disease that causes joint inflammation, leading to back pain and
stiffness, and cannot be detected by x-ray.5,6 Nr-axSpA
and AS are two sub-types of a broader condition called axial
spondyloarthritis. Approximately five percent of patients with
nr-axSpA will progress to AS after five years, and 19 percent will
progress after ten years.7
"This latest FDA approval of RINVOQ in active nr-axSpA provides
a new oral, once-daily treatment option for patients who
historically have had limited treatment options for this painful,
chronic disease," said Thomas
Hudson, M.D., senior vice president, research and
development, chief scientific officer, AbbVie. "RINVOQ is now
approved to treat patients across the spectrum of axial
spondyloarthritis. This further underscores AbbVie's commitment to
advancing the standards of care for patients living with these
diseases."
The FDA approval decision is supported by data from the Phase 3
SELECT-AXIS 2 clinical trial, which assessed the efficacy, safety,
and tolerability of RINVOQ in adults with active nr-axSpA.
Among patients who received RINVOQ 15 mg, nearly half achieved an
ASAS40* response, the primary endpoint, at week 14 compared to
placebo (44.9 percent vs. 22.3 percent respectively).1,2
ASAS40 responses were observed as early as two weeks in nr-axSpA
patients treated with RINVOQ. The safety profile in patients
with nr-axSpA treated with RINVOQ 15 mg was consistent with the
safety profile in patients with rheumatoid arthritis, psoriatic
arthritis, and ankylosing spondylitis.1
"Many patients living with nr-axSpA continue to experience
symptoms and are unable to control disease with current treatments.
In the SELECT-AXIS 2 trials, RINVOQ demonstrated efficacy in
both nr-axSpA and AS with safety that was consistent across
indications," said Atul Deodhar,
M.D., professor of medicine and medical director of the
Rheumatology Clinics for the Division of Arthritis and Rheumatic
Diseases at Oregon Health & Science University, and lead
investigator of the SELECT-AXIS 2 nr-axSpA trial. "Today's FDA
approval offers an important new therapeutic option for patients
and their caregivers to help take control of their symptoms and
disease."
"There are limited treatment options for people living with
nr-axSpA, a condition that can pose many challenges for patients
and significantly impact their quality of life as their symptoms
persist despite treatment," said Cassie
Shafer, chief executive officer, Spondylitis Association of
America (SAA). "This approval of RINVOQ is a tremendous step
forward in providing our patient community with another option to
help them reach their treatment goals, and to find
relief."
This FDA approval marks the sixth indication for RINVOQ in
the United States across chronic
immune-mediated diseases, including four in
rheumatology.1
Additional study results include the following:
Improvement in nr-axSpA Signs & Symptoms at Week
141,2
In the SELECT-AXIS 2 nr-axSpA trial, patients receiving RINVOQ
15 mg experienced greater improvements at week 14 compared to
placebo in the individual components of the ASAS composite index,
including total back pain, patient global assessment of disease
activity, morning stiffness, and physical function.
Multiplicity-controlled endpoints included total back pain and Bath
Ankylosing Spondylitis Disease Activity Index (BASFI).
- A significantly greater mean decrease from baseline in Total
Back Pain (-2.91 change from baseline) compared to those receiving
placebo (-2.00).2
- A significantly greater improvement in physical function (-2.61
change from baseline) as assessed by mean change from baseline in
BASFI compared to patients on placebo (-1.47).2
*ASAS40 is a composite index that measures disease
activity.2 To achieve an ASAS40 response, a patient's
disease activity must have improved by at least 40%, as well as
improved by two units (on a 0 to 10 scale) in at least three of
four disease areas assessed, and the remaining area must not have
gotten worse, including back pain, patient global assessment of
disease activity, physical function, and morning
stiffness.2
Other Health-Related Outcomes
Patients treated with RINVOQ 15 mg showed significant
improvements in health-related quality of life as measured by
Ankylosing Spondylitis Quality of Life (ASQoL) compared to placebo
at Week 14.
Safety Considerations
- 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 age 50+ with at least 1
heart disease 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 events such as heart
attack, stroke, or death in people 50+ with at least 1 heart
disease 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+ with at least
1 heart disease 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.
For more information about RINVOQ, visit RINVOQ.com.
Patient Access & 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 SELECT-AXIS 2 trial program4
SELECT-AXIS 2 was conducted as a master study protocol that
contains two standalone studies with randomization, data
collection, analysis and reporting conducted independently. The
Phase 3, randomized, placebo-controlled, double-blind studies are
evaluating the efficacy and safety of RINVOQ compared with placebo
on reduction of signs and symptoms in adult participants with
active axial spondyloarthritis (axSpA), including bDMARD-IR AS
(Study 1) and non-radiographic axial spondyloarthritis
(nr-axSpA) (Study 2). More information on this trial can be found
at https://www.clinicaltrials.gov/ (NCT04169373).
In the clinical trial, the primary endpoint was the percentage
of subjects achieving an ASAS40 response after 14 weeks of
treatment with RINVOQ versus placebo.
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. 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 is approved for adults with moderately
to severely active rheumatoid arthritis who have had an inadequate
response or intolerance to one or more TNF blockers; adults with
active psoriatic arthritis who have had an inadequate response or
intolerance to one or more TNF blockers; adults with active
ankylosing spondylitis (AS) who have had an inadequate response or
intolerance to one or more tumor necrosis factor (TNF) blockers and
adults with active non-radiographic axial spondyloarthritis with
objective signs of inflammation who have had an inadequate response
or intolerance to TNF blocker therapy.1 RINVOQ 45
mg is approved for use in adult patients with moderately to
severely active ulcerative colitis who have had an inadequate
response or intolerance to one or more TNF blockers as an induction
therapy once daily for 8 weeks. The recommended dose of RINVOQ for
maintenance treatment is 15 mg once daily. A dosage of 30 mg once
daily may be considered for patients with refractory, severe or
extensive disease. Discontinue RINVOQ if an adequate response is
not achieved with the 30 mg dose. Use the lowest effective dosage
needed to maintain response. RINVOQ 15 mg once daily can also be
initiated in adults and children 12 years of age and older weighing
at least 40 kg with refractory, moderate to severe atopic
dermatitis whose disease is not adequately controlled with other
system drug products, including biologics or when use of those
therapies is inadvisable. 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.
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.4,8-14
U.S. Uses and Important Safety Information About
RINVOQ® (upadacitinib) 1
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 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 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.
It is not known if RINVOQ is safe and effective in children with
juvenile idiopathic arthritis, psoriatic arthritis, ulcerative
colitis, ankylosing spondylitis, or non-radiographic axial
spondyloarthritis.
- 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 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. 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
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 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), muscle pain, flu-like illness, rash,
increased blood cholesterol levels, and increased liver enzyme
levels.
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.
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 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 in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care
for people living with rheumatic diseases. Our longstanding
commitment to discovering and delivering transformative therapies
is underscored by our pursuit of cutting-edge science that improves
our understanding of promising new pathways and targets in order to
help 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
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 women's health, 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,
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 from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and 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 2021 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.
*Dr. Atul Deodhar, M.D., is a
researcher/consultant for AbbVie.
US-RNQR-221074
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- Deodhar A, Van den Bosch F, Poddubnyy D, et al. U Upadacitinib
for the treatment of active non-radiographic axial
spondyloarthritis (SELECT-AXIS 2): a randomized, double-blind,
placebo-controlled, phase 3 trial. Lancet. 2022;400:369–79.
doi:10.1016/S0140-6736(22)01212-0.
- van der Heijde D, Baraliakos X, Sieper J, et al. Efficacy and
safety of upadacitinib for active ankylosing spondylitis refractory
to biological therapy: a double-blind, randomized,
placebo-controlled phase 3 trial. Ann Rheum Dis. 2022;0:1–9.
doi:10.1136/annrheumdis-2022-222608.
- A Study to Evaluate Efficacy and Safety of Upadacitinib in
Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2).
ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed
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adalimumab in adults with rheumatoid arthritis who are on a stable
dose of methotrexate and who have an inadequate response to
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NCT02629159. Accessed October 21,
2022.
https://www.clinicaltrials.gov/ct2/show/NCT02629159
- A Study to Evaluate the Safety and Efficacy of ABT-494 for
Induction and Maintenance Therapy in Subjects With Moderately to
Severely Active Ulcerative Colitis. ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on
October 21, 2022.
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study of ABT-494 for the Induction of Symptomatic and Endoscopic
Remission in Subjects With Moderately to Severely Active Crohn's
Disease Who Have Inadequately Responded to or Are Intolerant to
Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on
October 21, 2022.
- 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:
October 21, 2022.
- A Study Comparing Upadacitinib (ABT-494) to Placebo and to
Adalimumab in Participants With Psoriatic Arthritis Who Have an
Inadequate Response to at Least One Non-Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov.
Available at: https://clinicaltrials.gov/ct2/show/NCT03104400.
Accessed on October 21, 2022.
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Dupilumab in Adult Participants With Moderate to Severe Atopic
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https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed:
October 21, 2022.
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Subjects With Takayasu Arteritis (SELECT-TAK).
ClinicalTrials.gov. Available at
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October 21, 2022.
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