NORTH CHICAGO, Ill.,
Dec. 14, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that the U.S. Food and
Drug Administration (FDA) has approved RINVOQ®
(upadacitinib; 15 mg, once daily) for the treatment of adults with
active psoriatic arthritis (PsA) who have had an inadequate
response or intolerance to one or more tumor necrosis factor (TNF)
blockers.1
"The efficacy of RINVOQ in relieving the many manifestations of
psoriatic arthritis is well-characterized in two large, long term
clinical studies," said Michael
Severino, M.D., vice chairman and president, AbbVie. "This
new approval underscores our mission to deliver a portfolio of
therapies that can help more people with rheumatic diseases achieve
disease control."
The FDA approval is supported by data from two pivotal Phase 3
trials, SELECT-PsA 1 and SELECT-PsA 2, which assessed the efficacy,
safety and tolerability of RINVOQ in patients with
PsA.2,3 In both studies, the safety profile in patients
with active PsA treated with RINVOQ 15 mg was consistent with the
safety profile observed in patients with rheumatoid arthritis.
"Many adults still struggle to find a treatment option that
helps them lower their disease activity," said Iain McInnes, professor of medicine and Versus
Arthritis professor of rheumatology at University of Glasgow, U.K., and lead investigator
of the SELECT-PsA 1 trial. "With this FDA approval, RINVOQ has the
potential to help more people find meaningful relief from the signs
and symptoms of psoriatic arthritis that they see and feel and to
help reach their treatment goals."
Across SELECT-PsA 1 and SELECT-PsA 2 Phase 3 clinical trials,
RINVOQ met its primary endpoint of ACR20 at week 12 with patients
taking RINVOQ 15 mg achieving significantly higher ACR20 responses
(71% and 57%, respectively) versus placebo (36% and 24%,
respectively).2,3
Joint Efficacy1-3
- Across both SELECT-PsA 1 and SELECT-PsA 2 Phase 3 clinical
trials, patients treated with RINVOQ 15 mg achieved higher ACR50
responses (38% and 32%, respectively) at week 12 compared to
placebo (13% and 5%, respectively).
- Patients treated with RINVOQ 15 mg across the SELECT-PsA 1 and
SELECT-PsA 2 clinical trials achieved higher ACR70 responses (16%
and 9%, respectively) compared to placebo (2% and 1%, respectively)
at week 12.
- Treatment with RINVOQ 15 mg resulted in improvement in
dactylitis and enthesitis in patients with pre-existing dactylitis
or enthesitis.
- In SELECT-PsA 1, treatment with RINVOQ 15 mg significantly
inhibited the progression of structural joint damage (-0.02 change
from baseline) compared to placebo (0.23) as assessed by the change
from baseline in modified Total Sharp Score (mTSS) at week 24.
Physical Function1-3
- Across SELECT-PsA 1 and SELECT-PsA 2 clinical trials, patients
treated with RINVOQ 15 mg showed significant improvement in
physical function from baseline compared to placebo as assessed by
HAQ-DI at week 12.
Fatigue1-3
- In both Phase 3 clinical trials, patients receiving RINVOQ 15
mg experienced significantly greater improvement from baseline in
fatigue, as measured by the Functional Assessment of Chronic
Illness Therapy – Fatigue (FACIT-F) score, at Week 12 compared to
placebo.
Skin Response1-3
- Treatment with RINVOQ 15 mg resulted in improvement in skin
manifestations in patients with PsA. However, RINVOQ has not
been studied in and is not indicated for the treatment of plaque
psoriasis.
Safety1-3
- Overall, the safety profile observed in patients with active
PsA treated with RINVOQ 15 mg was consistent with the safety
profile observed in patients with rheumatoid arthritis. During the
24-week placebo-controlled period, the most common adverse events
reported with RINVOQ 15 mg were upper respiratory tract infection
and blood creatine phosphokinase elevations. The frequencies of
herpes zoster and herpes simplex were 1.1% and 1.4%, respectively,
with RINVOQ 15 mg and 0.8% and 1.3%, respectively, with placebo. A
higher incidence of acne and bronchitis was also observed in
patients treated with RINVOQ 15 mg (1.3% and 3.9%, respectively)
compared to placebo (0.3% and 2.7%, respectively).
- RINVOQ may cause serious side effects, including:
-
- Serious infections. RINVOQ can lower your ability to
fight infections. Serious infections have happened while taking
RINVOQ, including tuberculosis (TB) and infections caused by
bacteria, fungi, or viruses that can spread throughout the body.
Some people have died from these infections.
- Increased risk of death in people 50 years and older with at
least 1 heart disease (cardiovascular) risk factor.
- Cancer and immune system problems. RINVOQ may increase
your risk of certain cancers, including lymphoma, skin, and lung
cancer, as these can happen. Current or past smokers are at higher
risk.
- Increased risk of major cardiovascular events such as heart
attack, stroke, or death in people 50 years and older with at least
1 heart disease (cardiovascular) risk factor, especially in current
or past smokers.
- Blood clots. Blood clots in the veins of the legs or
lungs and arteries can happen with RINVOQ. This may be
life-threatening and cause death. This has happened more often in
people 50 years and older with at least 1 heart disease
(cardiovascular) risk factor.
Other serious side effects include tears in the stomach or
intestines and changes in certain laboratory test results.
Ease of Use and Access
- Designed to help accommodate the physical limitations of people
living with rheumatic diseases, the packaging for RINVOQ includes a
bottle cap with a wide, easy-to-grip texture and an embedded tool
that punctures the foil liner to simplify medication access. This
packaging design was awarded the Arthritis Foundation Ease of Use
Commendation.4
- AbbVie continues to work closely with key stakeholders to
support patient access to RINVOQ, 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 to qualifying patients. For more
details, please visit AbbVie.com/myAbbVieAssist.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a heterogeneous, systemic
inflammatory disease with hallmark manifestations across multiple
domains including joints and skin.5 In PsA, the immune
system causes inflammation that can lead to skin lesions associated
with psoriasis, pain, fatigue and stiffness in the
joints.5,6 PsA affects about 30% of people with
psoriasis.7,8
About SELECT-PsA 11,2
SELECT-PsA 1 is a Phase 3, multicenter, randomized,
double-blind, active comparator- and placebo-controlled study
designed to evaluate the safety and efficacy of RINVOQ compared to
placebo and adalimumab in adult patients with moderately to
severely active psoriatic arthritis who have a history of
intolerance or inadequate response to at least one non-biologic
DMARD. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg,
adalimumab 40 mg every other week, or placebo followed by either
RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The primary endpoint was the percentage of subjects receiving
RINVOQ 15 mg or 30 mg who achieved an ACR20 response after 12 weeks
of treatment versus placebo. Key secondary endpoints included
change from baseline in HAQ-DI at week 12, proportion of patients
achieving, percentage of patients achieving a static Investigator
Global Assessment (sIGA) of psoriasis of 0 or 1 and at least a
2-point improvement from baseline at week 16; percentage of
patients achieving PASI 75 response at week 16; inhibition of
radiographic progression at week 24 per the change from baseline in
mTSS; the percentage of patients achieving MDA at week 24;
percentage of participants with resolution of enthesitis at week
24; change from baseline in FACIT-F questionnaire at week 12; and
percentage of patients with resolution of dactylitis at week 24.
These are not all of the secondary endpoints. The long-term
extension of the trial is ongoing. More information on this trial
can be found at www.clinicaltrials.gov (NCT03104400).
About SELECT-PsA 21,3
SELECT-PsA 2 is a Phase 3, multicenter, randomized,
double-blind, placebo-controlled study designed to evaluate the
safety and efficacy of RINVOQ in adult patients with moderately to
severely active psoriatic arthritis who have a history of
intolerance or inadequate response to at least one biologic DMARD.
Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo
followed by either RINVOQ 15 mg or RINVOQ 30 mg at week 24.
The primary endpoint was the percentage of subjects achieving an
ACR20 response after 12 weeks of treatment vs placebo. Key
secondary endpoints included change from baseline in HAQ-DI at week
12, proportion of patients achieving ACR50 and ACR70 at week 12,
proportion of patients achieving PASI 75 at week 16, as well as
proportion of patients achieving MDA at week 24. These are not all
of the secondary endpoints. The long-term extension of the trial is
ongoing. More information on this trial can be found at
www.clinicaltrials.gov (NCT03104374).
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. RINVOQ 15 mg is approved by the
U.S. Food and Drug Administration (FDA) for adults with moderately
to severely active rheumatoid arthritis who have had an inadequate
response or intolerance to one or more TNF blockers and adults with
active psoriatic arthritis who have had an inadequate response or
intolerance to one or more TNF blockers. RINVOQ 15 mg is also
approved by the European Commission for adults with moderate to
severe active rheumatoid arthritis, adults with active psoriatic
arthritis and adults with active ankylosing
spondylitis. RINVOQ is approved by the European Commission for
adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to
severe atopic dermatitis. Phase 3 trials of RINVOQ in rheumatoid
arthritis, atopic dermatitis, psoriatic arthritis, axial
spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell
arteritis and Takayasu arteritis are ongoing.9-16
RINVOQ U.S. Uses and Important Safety
Information1
RINVOQ is a prescription medicine used to treat adults
with:
- Moderate to severe rheumatoid arthritis when 1 or more
medicines called tumor necrosis factor (TNF) blockers have been
used, and did not work well or could not be tolerated
- Active psoriatic arthritis 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
under 18 years of age.
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. 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.
- 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.
- 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.
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:
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Fever, sweating, or chills
̶
Shortness of breath
̶
Warm, red, or painful skin or sores on your body
|
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Muscle aches
̶
Feeling tired
̶
Blood in phlegm
̶
Diarrhea or stomach pain
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Cough
̶
Weight loss
̶
Burning when urinating or urinating more often than
normal
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- 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 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 while taking RINVOQ and for at least 4 weeks after your
last dose.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into
your breast milk. You should not breastfeed while taking RINVOQ and
for at least 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:
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Swelling
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Pain or tenderness in the leg
|
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Sudden unexplained chest pain
̶
Shortness of breath
|
- Tell your HCP right away if you have a fever or stomach-area
pain that does not go away, and a change in your bowel habits.
What are the common side effects of RINVOQ?
These
include upper respiratory tract infections (common cold, sinus
infections), shingles (herpes zoster), herpes simplex, bronchitis,
nausea, cough, fever, and acne. These are not all the possible side
effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once a day
with or without food. Do not split, break, crush, or chew the
tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ
is available in 15 mg 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.
Please click here for the Full Prescribing
Information and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on
Twitter, Facebook, LinkedIn or Instagram.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, failure to realize
the expected benefits 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 2020 Annual Report on Form 10-K, which
has been filed with the Securities and Exchange Commission, as
updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie
undertakes no obligation to release publicly any revisions to
forward-looking statements as a result of subsequent events or
developments, except as required by law.
References:
- RINVOQ® (upadacitinib) [Package Insert].
North Chicago, Ill.: AbbVie
Inc.
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for psoriatic arthritis. New England Journal of Medicine,
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arthritis refractory to biologics: Select-PSA 2. Annals of the
Rheumatic Diseases, 80(3), 312–320.
https://doi.org/10.1136/annrheumdis-2020-218870.
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https://www.arthritis.org/partnership/ease-of-use-products/rinvoq#:~:text=The%20Arthritis%20Foundation's%20Ease%20of,easy%20to%20use%20for%20everyone.
- Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin
Rheumatol. 2012 Feb;26(1):147-56. doi:
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- Diseases & Conditions: Psoriatic Arthritis. 2019. American
College of Rheumatology. Available at:
https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis.
Accessed on: September 10, 2020.
- Rodrigo Valdes-Rodriguez, M.D.,
Shawn G. Kwatra, M.D., Gil
Yosipovitch, M.D. (2018). Itch in Psoriasis: From Basic Mechanisms
to Practical Treatments. Psoriasis Forum,Volume: 18a issue:
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- Mease, P. J., Gladman, D. D., Papp, K. A., Khraishi, M. M.,
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patients with rheumatoid arthritis and inadequate response to
conventional synthetic disease-modifying anti-rheumatic drugs
(SELECT-NEXT): a randomised, double-blind, placebo-controlled phase
3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi:
10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
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Induction and Maintenance Therapy in Subjects With Moderately to
Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02819635.
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- 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. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02365649.
Accessed on August 17, 2020
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants With Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT03725202.
Accessed: June 2021.
- 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. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT03104400.
Accessed on August 17, 2020.
- A Study to Compare Safety and Efficacy of Upadacitinib to
Dupilumab in Adult Participants With Moderate to Severe Atopic
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at: https://clinicaltrials.gov/ct2/show/NCT03738397.
Accessed: June 2021.
- A Study to Evaluate Efficacy and Safety of Upadacitinib in
Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2).
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT04169373.
Accessed: June 2021.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in
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