NORTH CHICAGO, Ill.,
Nov. 9, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced results from new
post-hoc analyses from the Phase 3 SELECT-PsA 1 and SELECT-PsA 2
trials assessing the efficacy of upadacitinib (RINVOQ®)
on axial symptoms in adult patients with active psoriatic arthritis
(PsA) and axial involvement. The analysis showed that patients with
active PsA demonstrated numerically greater clinical responses
related to their axial involvement with upadacitinib (15 mg, once
daily) compared to placebo at week 24 across both studies and
consistently numerically higher responses compared to
HUMIRA® (adalimumab) at week 24 in SELECT-PsA
1.1
Axial involvement was defined by investigator assessment and
patient-reported-outcome-based criteria (Bath Ankylosing
Spondylitis Disease Activity Index (BASDAI) ≥4 and BASDAI Question
2 ≥4 at baseline).1 These results will be featured at
the American College of Rheumatology (ACR) Convergence 2021, in an
oral presentation on Tuesday, Nov. 9,
from 3:30-3:45 p.m. CT (Abstract
#1945).
"These data further add to the body of evidence that support the
potential of upadacitinib to be an important treatment option that
helps reduce the impact of the many disease manifestations of
psoriatic arthritis," said Thomas
Hudson, M.D., senior vice president, research and
development, chief scientific officer, AbbVie. "We remain committed
to advancing research across our portfolio of therapies to help
improve care for more people living with rheumatic diseases,
including psoriatic arthritis."
At week 24, upadacitinib showed numerically greater responses
than adalimumab across all BASDAI and Ankylosing Spondylitis
Disease Activity Score (ASDAS) endpoints in SELECT-PsA
1.1 The proportion of patients achieving ASDAS
clinically important improvement (CII) at week 24 was greater with
upadacitinib (69.8%) versus adalimumab (54.1%, nominal
P<0.05).1
Clinical Responses in
Patients with Axial Involvement Defined by Investigator
Assessment
and PRO-Based Criteria at Week 24 from SELECT-PsA 1 and SELECT-PsA
21
|
Endpoint
|
SELECT-PsA
1
|
SELECT-PsA
2
|
|
PBO
|
UPA
|
ADA
|
PBO
|
UPA
|
Overall
BASDAI§ (mean
change from baseline)
|
-2.05
(n = 90)
|
-3.47***
(n = 98)
|
-2.98
(n = 78)
|
-0.52
(n = 51)
|
-2.48***
(n = 46)
|
Modified BASDAI
(excl.
Q3)§ (mean change
from baseline)
|
-2.02
(n = 90)
|
-3.38***
(n = 98)
|
-2.90
(n = 78)
|
-0.46
(n = 51)
|
-2.40***
(n = 46)
|
BASDAI50†
(%)
|
29.3
(n = 99)
|
60.4***
(n = 106)
|
47.1
(n = 85)
|
3.1
(n = 64)
|
29.8***
(n = 57)
|
ASDAS§ (mean change
from baseline)
|
-0.81
(n = 89)
|
-1.87***
(n = 98)
|
-1.57
(n = 77)
|
-0.11
(n =50)
|
-1.37***
(n = 46)
|
ASDAS
ID†,‡ (%)
|
10.1
(n = 99)
|
36.8***
(n = 106)
|
29.4
(n = 85)
|
0.0
(n = 64)
|
24.6***
(n = 57)
|
ASDAS
LDA†,‡ (%)
|
25.3
(n = 99)
|
61.3***
(n = 106)
|
50.6
(n = 85)
|
4.7
(n = 64)
|
43.9***
(n = 57)
|
ASDAS
MI†,‡ (%)
|
12.1
(n = 99)
|
47.2***
(n = 106)
|
36.5
(n = 85)
|
0.0
(n = 64)
|
26.3***
(n = 57)
|
ASDAS
CII†,‡ (%)
|
31.3
(n = 99)
|
69.8#***
(n = 106)
|
54.1
(n = 85)
|
6.3
(n = 64)
|
45.6***
(n = 57)
|
|
ADA, adalimumab;
ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath
Ankylosing Spondylitis Disease Activity Index; CII, clinically
important improvement; EOW, every other week; ID, inactive disease;
LDA, low disease activity; MI, major improvement; MMRM,
mixed-effect model repeated measures; NRI, non-responder
imputation; PBO, placebo; UPA, upadacitinib
|
|
***P<0.001, UPA 15
mg vs PBO; #P<0.05, UPA 15 mg vs ADA; nominal
P-values are presented and were not adjusted for multiple
comparisons
|
†NRI
analysis constructed using Cochran-Mantel-Haenszel test adjusting
for the main stratification factor of current DMARD use (yes/no)
was used for binary endpoints
|
‡ ASDAS thresholds: ID <1.3; LDA
<2.1; MI change from baseline ≥2; CII change from baseline
≥1.1
|
§ MMRM analysis with unstructured
variance-covariance matrix, including treatment, visit,
treatment-by-visit interaction, the stratification factor current
DMARD use (yes/no) as fixed factors and the continuous fixed
covariate of baseline measurement was used for continuous
endpoints
|
"People with psoriatic arthritis and axial involvement often
face significant functional challenges," said Iain McInnes, professor of medicine and Versus
Arthritis professor of rheumatology at University of Glasgow, U.K. "These data underscore
the potential for upadacitinib to help more patients take control
of their disease, including those impacted by axial symptoms."
Findings from the post-hoc analysis are consistent with previous
data based on investigator assessment alone.1
Across SELECT-PsA 1 and SELECT-PsA 2 studies, the published
safety profile of RINVOQ was consistent with that observed in
previously reported studies, with no new safety risks
detected.2,3,4
As previously reported, in SELECT-PsA 1, through week 24,
serious infections occurred in 1.2% of patients in the 15 mg RINVOQ
group compared to 0.9% in the placebo group and 0.7% in the
HUMIRA group.2 There were no cases of
adjudicated venous thromboembolic events (VTE) in the RINVOQ 15 mg
group, two cases in the adalimumab group (0.5%) and one case in the
placebo group (0.2%).2 No major adverse
cardiovascular events (MACE) were reported in the RINVOQ 15 mg
group.2 There was one MACE reported in the placebo
group and two MACE reported in the
HUMIRA group.2 Herpes zoster was reported in
four cases in the 15 mg RINVOQ group (0.9%), three cases in the
placebo group (0.7%) and no cases in the HUMIRA group.5
There were no deaths in the RINVOQ 15 mg group, one death in the
placebo group (0.2%) and no deaths in the adalimumab
group.2
As previously reported, for the SELECT-PsA 2 study, through week
24, serious infections occurred in 0.5% of patients in the RINVOQ
15 mg group compared to 0.5% in the placebo
group.4 There was one pulmonary embolism reported
in the 15 mg RINVOQ group and none in the placebo
group.4 There was one non-fatal adjudicated major
adverse cardiovascular event (MACE) in the 15 mg RINVOQ group
(acute myocardial infarction) and no MACE in the placebo
group.4 Herpes zoster was reported in three cases in the
15 mg RINVOQ group (1.4%) and in two cases in the placebo group
(0.9%).6 One death was reported in a patient receiving
placebo (motor vehicle accident).4
Use of upadacitinib in psoriatic arthritis 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).
The ACR Convergence 2021 abstracts can be found here.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a heterogeneous, systemic
inflammatory disease with hallmark manifestations across multiple
domains including joints and skin.7 In PsA, the immune
system causes inflammation that can lead to skin lesions associated
with psoriasis, pain, fatigue and stiffness in the
joints.7,8 PsA affects about 30 percent of people with
psoriasis.9,10
About SELECT-PsA 111,12
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. 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 211,13
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 versus placebo. 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-2.11 The relevance of inhibition of specific JAK
enzymes to therapeutic effectiveness 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. 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.14-21
Important Safety Information about
RINVOQ® (upadacitinib)11
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 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. Baraliakos X, et al. Efficacy of Upadacitinib on Psoriatic
Arthritis with Axial Involvement Defined by Investigator Assessment
and PRO-Based Criteria: Results from Two Phase 3 Studies. 2021
American College of Rheumatology Convergence; 1945.
2. AbbVie Data on File. ABVRRTI69835.
3. Cohen S., et al. Safety profile of upadacitinib in rheumatoid
arthritis: integrated analysis from the SELECT phase III clinical
programme. Ann Rheum Dis. 2020 Oct 28;80(3):304-11.
4. AbbVie Data on File. ABVRRTI69484.
5. McInnes, IB., et al. Trial of Upadacitinib and Adalimumab for
Psoriatic Arthritis. N Engl J Med. 2021 April 1; 384:1227-123. doi:
10.1056/NEJMoa2022516.
6. Mease PJ., et al. Upadacitinib for psoriatic arthritis
refractory to biologics: SELECT-PsA 2. Annals of the Rheumatic
Diseases. 2021;80:312-320.
7. Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin
Rheumatol. 2012 Feb;26(1):147-56. doi:
10.1016/j.berh.2012.01.003.
8. 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: June 2021.
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