NORTH CHICAGO, Ill.,
Nov. 1, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced the presentation of new
data on RINVOQ® (upadacitinib), SKYRIZI®
(risankizumab) and HUMIRA® (adalimumab) across multiple
rheumatic diseases at the American College of Rheumatology's annual
meeting (ACR Convergence 2021), to be held virtually Nov. 3-9. A total of 38 abstracts, including two
oral presentations and one plenary session presentation, will be
presented from a broad range of studies in rheumatoid arthritis,
psoriatic arthritis and ankylosing spondylitis.
"Many people continue to struggle with the daily, debilitating
challenges of rheumatic diseases," said Brandee Pappalardo, Ph.D., M.P.H., vice
president, U.S. immunology medical affairs, AbbVie. "The data we're
presenting at this year's ACR meeting reflect our commitment to
advancing our portfolio of medicines to help more people achieve
meaningful disease control."
Data evaluating the long-term safety and efficacy of RINVOQ,
will be presented, including:
Rheumatoid Arthritis
- Long-term safety and efficacy data through three years of
upadacitinib and adalimumab for patients with prior inadequate
response to methotrexate (MTX)
- Data on sustainability of response to upadacitinib among
patients with prior inadequate response or intolerance to biologic
disease modifying anti-rheumatic drugs (bDMARDS)
Psoriatic Arthritis
- Efficacy of upadacitinib on axial symptoms in people with
active psoriatic arthritis and axial involvement
Ankylosing Spondylitis
- Long-term efficacy and safety data through two years of
upadacitinib in patients who had an inadequate response to
non-steroidal anti-inflammatory drugs (NSAIDs) and were
bDMARD-naïve
Cross-Rheumatic Diseases
- Long-term safety data of upadacitinib across rheumatoid
arthritis, psoriatic arthritis and ankylosing spondylitis trials
from the SELECT clinical program
A plenary session will highlight data on the efficacy and safety
of risankizumab for active psoriatic arthritis in patients who
either previously had an inadequate response or intolerance to
conventional synthetic DMARDs (csDMARDs) or who previously had an
inadequate response or intolerance to biologics.
Key AbbVie rheumatology abstracts at ACR Convergence 2021
include:
Abstract
Title
|
Presentation
Details
All times
CT
|
Rheumatoid
Arthritis
|
Long-Term Safety and
Efficacy of Upadacitinib or Adalimumab in Patients with Rheumatoid
Arthritis: Results at 3 Years from the SELECT-COMPARE
Study
|
Abstract
#0828
Poster Session
B
Nov. 7,
2021
7:30-9:30
a.m.
|
Consistency in Time
to Response with Upadacitinib as Monotherapy or Combination Therapy
and Across Patient Populations with Rheumatoid Arthritis
|
Abstract
#0832
Poster Session
B
Nov. 7,
2021
7:30-9:30
a.m.
|
Sustainability of
Response Between Upadacitinib and Adalimumab in Patients with
Rheumatoid Arthritis: Results Through 3 Years from the
SELECT-COMPARE Trial
|
Abstract
#0837
Poster Session
B
Nov. 7,
2021
7:30-9:30
a.m.
|
Impact of Serologic
Status on Clinical Responses to Upadacitinib or Abatacept in
Patients with Rheumatoid Arthritis and Prior Inadequate Response to
Biologic DMARDs: Sub-Group Analysis from the Phase 3 SELECT-CHOICE
Study
|
Abstract
#1230
Poster Session
C
Nov. 8,
2021
7:30-9:30
a.m.
|
Routine Assessment of
Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis
Treated with Long-Term Upadacitinib Therapy
|
Abstract
#1234
Poster Session
C
Nov. 8,
2021
7:30-9:30
a.m.
|
Biomarker Driven
Dissection of Inflammation Modulatory Effects of Upadacitinib
versus Abatacept in Patients with Active Rheumatoid Arthritis
Refractory to Biologic DMARDs
|
Abstract
#1240
Poster Session
C
Nov. 8,
2021
7:30-9:30
a.m.
|
Comparison of the
Effects of Upadacitinib Monotherapy with MTX on Protein Biomarkers
in MTX-Naïve and MTX-Inadequate Responders in Patients with Active
Rheumatoid Arthritis: Results from the SELECT-EARLY and
SELECT–MONOTHERAPY Phase 3 Studies
|
Abstract
#1241
Poster Session
C
Nov. 8,
2021
7:30-9:30
a.m.
|
Integrated Laboratory
Abnormality Profiles of Upadacitinib with up to 4.5 Years of
Exposure in Patients with Rheumatoid Arthritis Treated in a Phase 3
Clinical Trial
|
Abstract
#1687
Poster Session
D
Nov. 9,
2021
7:30-9:30
a.m.
|
Long-Term Efficacy
and Safety of Upadacitinib in Patients with Rheumatoid Arthritis:
3-year Results from the SELECT-EARLY Study
|
Abstract
#1692
Poster Session
D
Nov. 9,
2021
7:30-9:30
a.m.
|
Sustainability of
Response to Upadacitinib Among Patients with Active Rheumatoid
Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic
Drugs
|
Abstract
#1694
Poster Session
D
Nov. 9,
2021
7:30-9:30
a.m.
|
Psoriatic
Arthritis
|
Efficacy and Safety
of Risankizumab for Active Psoriatic Arthritis: 24-Week Results
from the Phase 3, Randomized, Double-blind Clinical Trial for
CsDMARD-IR and Bio-IR Patients
|
Abstract
#0183
Poster Session
A
Nov. 6,
2021
7:30-9:30
a.m.
|
An Observational
Study from the Perspective of Rheumatology in the Management of
Patients with Psoriatic Arthritis in Turkey – LOOP Study
|
Abstract
#0205
Poster Session
A
Nov. 6,
2021
7:30-9:30
a.m.
|
Impact of Early Pain
Improvement on Patient-Reported Outcomes in Patients with Psoriatic
Arthritis: Results from a Phase 3 Trial
|
Abstract
#0234
Poster Session
A
Nov. 6,
2021
7:30-9:30
a.m.
|
Efficacy and Safety
of Risankizumab for Active Psoriatic Arthritis: 24-Week Integrated
Results From 2 Phase 3, Randomized, Double-blind Clinical Trials
for CsDMARD-IR and Bio-IR Patients
|
Abstract
#0453
Plenary
Session
Nov. 6,
2021
9:45-10
a.m.
|
Impact of Treatment
Experience on Patient Preferences and Disease Burden in Psoriatic
Arthritis: Results from a Rheumatology Patient Research
Registry
|
Abstract
#1156
Poster Session
C
Nov. 8,
2021
7:30-9:30
a.m.
|
Impact of Achieving
Minimal Disease Activity on Patient-Reported Outcome Measures and
Disease Activity Among Patients with Psoriatic Arthritis Treated
with Biologic and Targeted Synthetic DMARDs
|
Abstract
#1344
Poster Session
C
Nov. 8,
2021
7:30-9:30
a.m.
|
Long-Term Safety and
Effectiveness of Upadacitinib in Patients with Psoriatic Arthritis:
Results at 56 Weeks from the SELECT-PsA 1 Study
|
Abstract
# 1345
Poster Session
C
Nov. 8,
2021
7:30-9:30
a.m.
|
Association Between
Clinically Meaningful Improvements in Patient-Reported Outcomes and
Stringent Measures of Disease Activity in Patients with Psoriatic
Arthritis Treated with Upadacitinib versus Placebo or Adalimumab:
Results from a Phase 3 Trial
|
Abstract
#1910
Abstract
Session
Nov. 9,
2021
1:15-1:30
p.m.
|
Efficacy of
Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined
by Investigator Assessment and PRO-Based Criteria: Results from Two
Phase 3 Studies
|
Abstract
#1945
Abstract
Session
Nov. 9,
2021
3:30-3:45
p.m.
|
Ankylosing
Spondylitis
|
Association Between
Clinically Meaningful Back Pain Improvement and Patient-Reported
Outcomes and Disease Activity in Patients with Ankylosing
Spondylitis: Results from a Phase 2/3 Trial
|
Abstract
#0749
Poster Session
B
Nov. 7,
2021
7:30-9:30
a.m.
|
Influence of Baseline
Demographics on Improvements in Disease Activity Measures in
Patients with Ankylosing Spondylitis Receiving Upadacitinib: A Post
Hoc Subgroup Analysis
|
Abstract
#0920
Poster Session
B
Nov. 7,
2021
7:30-9:30
a.m.
|
Efficacy and Safety
of Upadacitinib in Patients with Active Ankylosing Spondylitis:
2-Year Results from a Randomized, Double-Blind, Placebo-Controlled
Study with Open-Label Extension
|
Abstract
#0924
Poster Session
B
Nov. 7,
2021
7:30-9:30
a.m.
|
Predictors of 1-Year
Treatment Response Among Upadacitinib-Treated Patients with
Ankylosing Spondylitis: A Post Hoc Analysis
|
Abstract
#0926
Poster Session
B
Nov. 7,
2021
7:30-9:30
a.m.
|
Cross-Rheumatology
|
Long-Term Safety
Profile of Upadacitinib in Patients with Rheumatoid Arthritis,
Psoriatic Arthritis, or Ankylosing Spondylitis
|
Abstract
#1691
Poster Session
D
Nov. 9,
2021
7:30-9:30
a.m.
|
Comparison of Axial
and Peripheral Manifestations in Patients with Psoriatic Arthritis
and Ankylosing Spondylitis in Upadacitinib Clinical
Trials
|
Abstract
#1802
Poster Session
D
Nov. 9,
2021
7:30-9:30
a.m.
|
A full list of all 38 AbbVie abstracts accepted for presentation
at ACR Convergence 2021 can be found here.
Use of upadacitinib in psoriatic arthritis and ankylosing
spondylitis is not approved in the U.S. and its safety and efficacy
are currently under review by the U.S. Food and Drug Administration
(FDA). Use of risankizumab in psoriatic arthritis is not approved
and its safety and efficacy are currently under review by the U.S.
FDA.
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 is not currently known. RINVOQ 15 mg is 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.
RINVOQ 15 mg is also approved by the U.S. Food and Drug
Administration (FDA) for adults with moderately to severely active
rheumatoid arthritis. 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.2-11
Important Safety Information about
RINVOQ® (upadacitinib)1
RINVOQ U.S. Use and Important Safety Information
RINVOQ is a prescription medicine used to treat adults with
moderate to severe rheumatoid arthritis in whom methotrexate 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 is a medicine that can lower the ability of your immune
system to fight infections. You should not start taking RINVOQ if
you have any kind of infection unless your healthcare provider
(HCP) tells you it is okay.
- Serious infections have happened in some people 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 HCP
should test you for TB before starting RINVOQ and check you closely
for signs and symptoms of TB during treatment with RINVOQ. You may
be at higher risk of developing shingles (herpes zoster).
- Lymphoma and other cancers, including skin cancers, can
happen in people taking RINVOQ.
- Blood clots in the veins of the legs or lungs and arteries
are possible in some people taking RINVOQ. This may be
life-threatening and cause death.
- Tears in the stomach or intestines and changes in certain
laboratory tests can happen. 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:
-
- 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.
- Have had any type of cancer, hepatitis B or C, shingles (herpes
zoster), or 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 that
increase your risk of getting certain kinds of fungal infections,
such as the Ohio and Mississippi River valleys and the
Southwest. 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
Ask your HCP or pharmacist if you are not sure if you are taking
any of these medicines.
What should I 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.
- Have any signs or symptoms of blood clots during treatment with
RINVOQ, including:
-
- Swelling
- Sudden unexplained chest pain
- Pain or tenderness in the leg
- Shortness of breath
- 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), nausea, cough, and fever. These are not all the
possible side effects of 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.
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 HUMIRA (adalimumab) in the U.S.
Uses
HUMIRA is a prescription medicine used:
- To reduce the signs and symptoms of:
-
- Moderate to severe rheumatoid arthritis (RA) in adults.
HUMIRA can be used alone, with methotrexate, or with certain
other medicines. HUMIRA can be used alone, with methotrexate, or
with certain other medicines. HUMIRA may prevent further damage to
your bones and joints and may help your ability to perform daily
activities.
- Moderate to severe polyarticular juvenile idiopathic
arthritis (JIA) in children 2 years of age and older.
HUMIRA can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be
used alone or with certain other medicines. HUMIRA may prevent
further damage to your bones and joints and may help your ability
to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe hidradenitis suppurativa (HS) in people
12 years and older.
- To treat moderate to severe Crohn's disease (CD) in adults
and children 6 years of age and older.
- To treat moderate to severe ulcerative colitis (UC) in
adults and children 5 years of age and older. It is not
known if HUMIRA is effective in people who stopped responding to or
could not tolerate anti-TNF medicines.
- To treat moderate to severe chronic plaque psoriasis (Ps) in
adults who are ready for systemic therapy or phototherapy,
and are under the care of a doctor who will decide if other
systemic therapies are less appropriate.
- To treat non-infectious intermediate (middle part
of the eye), posterior (back of the eye), and
panuveitis (all parts of the eye) in adults and
children 2 years of age and older.
Important Safety Information About
HUMIRA® (adalimumab)
What is the most important information I should know about
HUMIRA?
You should discuss the potential benefits and risks
of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that
can lower the ability of your immune system to fight infections.
You should not start taking HUMIRA if you have any kind of
infection unless your doctor says it is okay.
- Serious infections have happened in people taking HUMIRA.
These serious infections include tuberculosis (TB) and infections
caused by viruses, fungi, or bacteria that have spread throughout
the body. Some people have died from these
infections. Your doctor should test you for TB before
starting HUMIRA, and check you closely for signs and symptoms of TB
during treatment with HUMIRA, even if your TB test was negative. If
your doctor feels you are at risk, you may be treated with medicine
for TB.
- Cancer. For children and adults taking TNF
blockers, including HUMIRA, the chance of getting lymphoma or other
cancers may increase. There have been cases of unusual cancers in
children, teenagers, and young adults using TNF blockers. Some
people have developed a rare type of cancer called hepatosplenic
T-cell lymphoma. This type of cancer often results in death. If
using TNF blockers including HUMIRA, your chance of getting two
types of skin cancer (basal cell and squamous cell) may increase.
These types are generally not life-threatening if treated; tell
your doctor if you have a bump or open sore that doesn't heal.
What should I tell my doctor BEFORE starting HUMIRA?
Tell your doctor about all of your health conditions, including
if you:
- Have an infection, are being treated for infection, or have
symptoms of an infection
- Get a lot of infections or infections that keep coming
back
- Have diabetes
- Have TB or have been in close contact with someone with TB, or
were born in, lived in, or traveled where there is more risk for
getting TB
- Live or have lived in an area (such as the Ohio and
Mississippi River valleys) where there is an increased risk for
getting certain kinds of fungal infections, such as histoplasmosis,
coccidioidomycosis, or blastomycosis. These infections may happen
or become more severe if you use HUMIRA. Ask your doctor if you are
unsure if you have lived in these areas
- Have or have had hepatitis B
- Are scheduled for major surgery
- Have or have had cancer
- Have numbness or tingling or a nervous system disease such as
multiple sclerosis or Guillain-Barré syndrome
- Have or had heart failure
- Have recently received or are scheduled to receive a vaccine.
HUMIRA patients may receive vaccines, except for live vaccines.
Children should be brought up to date on all vaccines before
starting HUMIRA
- Are allergic to rubber, latex, or any HUMIRA ingredients
- Are pregnant, planning to become pregnant, breastfeeding, or
planning to breastfeed
- Have a baby and you were using HUMIRA during your pregnancy.
Tell your baby's doctor before your baby receives any vaccines
Also tell your doctor about all the medicines you
take. You should not take HUMIRA with
ORENCIA® (abatacept),
KINERET® (anakinra),
REMICADE® (infliximab),
ENBREL® (etanercept),
CIMZIA® (certolizumab pegol), or
SIMPONI® (golimumab). Tell your doctor if you have
ever used RITUXAN® (rituximab),
IMURAN® (azathioprine), or
PURINETHOL® (mercaptopurine,
6-MP)b®
What should I watch for AFTER starting HUMIRA?
HUMIRA can cause serious side effects, including:
- Serious infections. These include TB and
infections caused by viruses, fungi, or bacteria. Symptoms related
to TB include a cough, low-grade fever, weight loss, or loss of
body fat and muscle.
- Hepatitis B infection in carriers of the
virus. Symptoms include muscle aches, feeling very tired,
dark urine, skin or eyes that look yellow, little or no appetite,
vomiting, clay-colored bowel movements, fever, chills, stomach
discomfort, and skin rash.
- Allergic reactions. Symptoms of a serious allergic
reaction include hives, trouble breathing, and swelling of your
face, eyes, lips, or mouth.
- Nervous system problems. Signs and symptoms include
numbness or tingling, problems with your vision, weakness in your
arms or legs, and dizziness.
- Blood problems (decreased blood cells that help
fight infections or stop bleeding). Symptoms include a fever that
does not go away, bruising or bleeding very easily, or looking very
pale.
- Heart failure (new or worsening). Symptoms include
shortness of breath, swelling of your ankles or feet, and sudden
weight gain.
- Immune reactions including a lupus-like
syndrome. Symptoms include chest discomfort or pain that
does not go away, shortness of breath, joint pain, or rash on your
cheeks or arms that gets worse in the sun.
- Liver problems. Symptoms include feeling very
tired, skin or eyes that look yellow, poor appetite or vomiting,
and pain on the right side of your stomach (abdomen). These
problems can lead to liver failure and death.
- Psoriasis (new or worsening). Symptoms include red
scaly patches or raised bumps that are filled with pus.
Call your doctor or get medical care right away if you
develop any of the above symptoms.
Common side effects of HUMIRA include injection site
reactions (pain, redness, rash, swelling, itching, or
bruising), upper respiratory infections (sinus infections),
headaches, rash, and nausea. These are not all of the possible side
effects with HUMIRA. Tell your doctor if you have any side effect
that bothers you or that does not go away.
Remember, tell your doctor right away if you have an
infection or symptoms of an infection, including:
- Fever, sweats or chills
- Muscle aches
- Cough
- Shortness of breath
- Blood in phlegm
- Weight loss
- Warm, red or painful skin sores on your body
- Diarrhea or stomach pain
- Burning when you urinate
- Urinating more often than normal
- Feeling very tired
HUMIRA is given by injection under the skin.
This is the most important information to know about HUMIRA.
For more information, talk to your health care provider.
Please click here for the Full Prescribing Information and
Medication Guide.
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.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About SKYRIZI® (risankizumab-rzaa)
in the United States12
SKYRIZI is a prescription
medicine used to treat adults with moderate to severe plaque
psoriasis who may benefit from taking injections or pills (systemic
therapy) or treatment using ultraviolet or UV light
(phototherapy).
Important Safety Information
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI
may cause serious side effects, including infections. SKYRIZI is a
prescription medicine that may lower the ability of your immune
system to fight infections and may increase your risk of
infections. Your healthcare provider should check you for
infections and tuberculosis (TB) before starting treatment with
SKYRIZI and may treat you for TB before you begin treatment with
SKYRIZI if you have a history of TB or have active TB. Your
healthcare provider should watch you closely for signs and symptoms
of TB during and after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an
infection or have symptoms of an infection, including:
-
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- burning when you urinate or urinating more often than
normal
Before using SKYRIZI, tell your healthcare provider about all
of your medical conditions, including if you:
- have any of the conditions or symptoms listed in the section
"What is the most important information I should know about
SKYRIZI?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). Medications that interact with the immune
system may increase your risk of getting an infection after
receiving live vaccines. You should avoid receiving live vaccines
right before, during, or right after treatment with SKYRIZI. Tell
your healthcare provider that you are taking SKYRIZI before
receiving a vaccine.
- are pregnant or plan to become pregnant. It is not known if
SKYRIZI can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SKYRIZI passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
What are the possible side effects of SKYRIZI?
SKYRIZI
may cause serious side effects. See "What is the most important
information I should know about SKYRIZI?"
The most common side effects of SKYRIZI include upper
respiratory infections, feeling tired, fungal skin infections,
headache, and injection site reactions.
These are not all the possible side effects of SKYRIZI. Call
your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use
it. SKYRIZI is available in a 150 mg/mL prefilled syringe and
pen.
This is not a complete summary of all safety
information.
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.
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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 on AbbVie in rheumatology, visit
https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.html.
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, Instagram, YouTube and LinkedIn.
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:
1. RINVOQ® (upadacitinib)
[Package Insert]. North Chicago,
Ill.: AbbVie Inc.
2. Burmester G.R., et al. Safety and efficacy of upadacitinib in
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.
3. 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: June 2021.
4. 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. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02819635.
Accessed: June 2021.
5. A Study Evaluating the Safety and Efficacy of Upadacitinib in
Subjects With Active Ankylosing Spondylitis (SELECT Axis 1).
ClinicalTrials.gov. 2020. Available at:
https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed:
June 2021.
6. 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.
7. A Study Comparing Upadacitinib (ABT-494) to Placebo in
Participants With Active Psoriatic Arthritis Who Have a History of
Inadequate Response to at Least One Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT-PsA 2). Clinicaltrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT03104374.
Accessed: June 2021.
8. A Study to Compare Safety and Efficacy of Upadacitinib to
Dupilumab in Adult Participants With Moderate to Severe Atopic
Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available at:
https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed:
June 2021.
9. 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.
10. A Study to Evaluate the Efficacy and Safety of Upadacitinib
in Subjects With Takayasu Arteritis (SELECT-TAK).
ClinicalTrials.gov. 2020. Available at
https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed:
June 2021.
11. 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: June 2021.
12. SKYRIZI® (risankizumab)
[Package Insert]. North Chicago,
Ill.: AbbVie Inc.
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SOURCE AbbVie