NORTH CHICAGO, Ill.,
May 25, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that it will present
new data from a total of 41 abstracts covering its portfolio of
immunology assets, including RINVOQ®,
SKYRIZI®, HUMIRA® and its pipeline across
multiple rheumatic diseases at the EULAR 2021 Virtual Congress of
Rheumatology, to be held virtually June
2-5. Among the data presented will be new three-year and
one-year efficacy and safety data for RINVOQ (upadacitinib) for the
treatment of patients with rheumatoid arthritis (RA) and psoriatic
arthritis (PsA), respectively. Additionally, AbbVie will present
new integrated safety data for RINVOQ from the Phase 3 SELECT
clinical trials in patients with RA up to 4.5 years of
exposure.
"As a continuation of our robust scientific expertise and
longstanding leadership in rheumatology, AbbVie remains committed
to developing a portfolio of innovations that advance standards of
care for people living with rheumatic diseases and help them reach
their treatment goals," said Chiedzo Mpofu, Vice President,
Global Medical Affairs, Immunology. "The data being presented at
EULAR 2021 underscore this commitment."
Key data to be presented include:
- Three-year efficacy and safety data for RINVOQ versus HUMIRA in
RA patients with inadequate response to methotrexate.
- 56-week efficacy and safety data for RINVOQ in patients with
PsA and inadequate response to bDMARDs.
- Integrated safety data for RINVOQ in patients with RA with up
to 4.5 years of exposure.
- Primary data on risankizumab (from KEEPsAKE 2 in patients with
PsA and inadequate response to biologics).
- Investigational data on ABBV-3373, a novel Anti-TNF
Glucocorticoid Receptor Modulator Antibody Drug Conjugate, versus
HUMIRA in patients with RA.
- Data from a real-world population-based assessment of COVID-19
outcomes among RA patients using DMARDs.
- Characteristics and outcomes in a real-world cohort of RA
patients with COVID-19.
AbbVie oral or poster presentation data at EULAR 2021
RINVOQ Abstracts
Rheumatoid Arthritis (RA)
- Impact of Concomitant Glucocorticoids on the Clinical Efficacy
and Safety of Upadacitinib in Patients with Rheumatoid Arthritis:
An Ad Hoc Analysis of Data from Three Phase 3 Studies; POS0654;
poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Characteristics and Six-Month Outcomes Among Real-world
Rheumatoid Arthritis Patients Initiating Upadacitinib: CorEvitas'
Rheumatoid Arthritis Registry; POS0435; poster presentation;
on-demand from Wednesday, June 2;
8:00 a.m. CEST
- Patient Characteristics and Outcomes in Patients with
Rheumatoid Arthritis Treated with Upadacitinib: The OM1 RA
Registry; POS0436; poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in
Patients With Rheumatoid Arthritis: Results at 3 Years From the
SELECT-COMPARE Study; POS0087; poster presentation; Thursday, June 3; 11:56
a.m.-12:02 p.m. CEST
- Long-term Safety and Efficacy of Upadacitinib in Patients With
Rheumatoid Arthritis: 3-year Results From the SELECT-EARLY Study;
POS0655; poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Evaluation of Response to Pneumococcal Vaccination in Patients
with Rheumatoid Arthritis Receiving Upadacitinib: Results from a
Phase 2 Open-Label Extension Study; POS0508; poster presentation;
on-demand from Wednesday, June 2;
8:00 a.m. CEST
- Routine Assessment of Patient Index Data 3 (RAPID3) in Patients
With Rheumatoid Arthritis Treated With Long-term Upadacitinib
Therapy; POS0670; poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Integrated Safety Profile of Upadacitinib With Up to 4.5 Years
of Exposure in Patients With Rheumatoid Arthritis; POS0220; poster
presentation; Friday, June 4;
11:50-11:56 a.m. CEST
- Integrated Laboratory Abnormality Profiles of Upadacitinib With
up to 4.5 Years of Exposure in Patients With Rheumatoid Arthritis
Treated in the SELECT Phase 3 Program; OP0128; oral presentation;
Thursday, June 3; 11:15-11:22 a.m. CEST
- Treatment Effectiveness of Upadacitinib at 3 Months in US
Patients With Rheumatoid Arthritis From the United Rheumatology
Normalized Integrated Community Evidence; POS0666; poster
presentation; on-demand from Wednesday, June
2; 8:00 a.m. CEST
- Clinical Responses to Upadacitinib or Abatacept in Patients
With Rheumatoid Arthritis by Type of Prior Biologic
Disease-Modifying Antirheumatic Drug: Data From the Phase 3
SELECT-CHOICE Study; POS0671; poster presentation; on-demand from
Wednesday, June 2; 8:00 a.m. CEST
- Predictors of Response: Baseline Characteristics and Early
Treatment Responses Associated With Achievement of Remission and
Low Disease Activity Among Upadacitinib-Treated Patients With
Rheumatoid Arthritis; POS0222; poster presentation; Friday, June 4; 12:02-12:08 p.m. CEST
- Relationship Between Changes in Lipid Levels and Improvement in
Disease Activity Outcomes in Patients With Rheumatoid Arthritis
Receiving Upadacitinib Treatment: Pooled Analysis of Data From Two
Phase 3 Studies; POS0656; poster presentation; on-demand from
Wednesday, June 2; 8:00 a.m. CEST
- Impact of Upadacitinib or Adalimumab as Initial Therapy on the
Achievement of 48-week Treatment Goals in Patients With Rheumatoid
Arthritis and Inadequate Response to Methotrexate: Post Hoc
Analysis of a Phase 3 Study; POS0653; poster presentation;
on-demand from Wednesday, June 2;
8:00 a.m. CEST
Spondyloarthritis (SpA)
- Upadacitinib Pharmacokinetics and Exposure-Response
Relationships for Efficacy and Safety in Psoriatic Arthritis –
Analyses of the Phase 3 SELECT-PsA Studies; POS1054; poster
presentation; on-demand from Wednesday, June
2; 8:00 a.m. CEST
- Comparison of Axial and Peripheral Manifestations in Patients
With Psoriatic Arthritis and Ankylosing Spondylitis Patients in
Upadacitinib Clinical Trials; POS0235; poster presentation;
Friday, June 4; 12:44-12:50 p.m. CEST
- Efficacy and Safety of Upadacitinib in Patients With Psoriatic
Arthritis and Axial Involvement; OP0233; oral presentation;
Friday, June 4; 11:25-11:32 a.m. CEST
- Impact of Upadacitinib on Reducing Pain in Patients With Active
Psoriatic Arthritis: Results From Two Phase 3 Trials in Patients
With Inadequate Response to Non-Biologic or Biologic DMARDs;
POS1047; poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Upadacitinib in Patients With Psoriatic Arthritis Refractory to
Biologic Disease-Modifying Antirheumatic Drugs: 56-week Data From
the Phase 3 SELECT-PsA 2 Study; POS0196; poster presentation;
Friday, June 4; 12:14-12:20 p.m. CEST
- Efficacy of Upadacitinib in Patients With Psoriatic Arthritis
Stratified by Number of Prior Biologic Disease-Modifying
Anti-Rheumatic Drugs; POS1032; poster presentation; on-demand from
Wednesday, June 2; 8:00 a.m. CEST
- Efficacy and Safety of Upadacitinib in Patients With Active
Ankylosing Spondylitis: 1-Year Results From a Randomized,
Double-Blind, Placebo-Controlled Study With Open-Label Extension;
OP0144; oral presentation; Thursday, June
3; 11:25-11:32 a.m. CEST
- Upadacitinib as Monotherapy and in Combination With
Non-Biologic DMARDs for the Treatment of Psoriatic Arthritis:
Subgroup Analysis From Two Phase 3 Trials; POS1035; poster
presentation; on-demand from Wednesday, June
2; 8:00 a.m. CEST
- Proteomics Analysis Comparing the Mode of Action of
Upadacitinib Between Non-Biologic-DMARD-IR and Biologic-DMARD-IR
PsA Patients Identifies Distinct Pathogenic Pathways in the
SELECT-PsA 1 and SELECT-PsA 2 Phase 3 Studies; POS0407; poster
presentation; on-demand from Wednesday, June
2; 8:00 a.m. CEST
- Treatment of Non-Biologic-DMARD-IR PsA Patients With
Upadacitinib or Adalimumab Results in the Modulation of Distinct
Functional Pathways: Proteomics Analysis of the SELECT-PsA 1 Phase
3 Study; OP0030; oral presentation; on-demand from Wednesday, June 2; 4:15-4:22 p.m. CEST
- Targeted Serum Proteomic Analysis Following Upadacitinib
Treatment in Ankylosing Spondylitis Shows Robust Suppression of
Innate and Adaptive Immune Pathways With Tissue Repair Modulation;
POS0920; poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Efficacy of Upadacitinib in Patients With Psoriatic Arthritis
Stratified by Baseline Skin Severity: A Subgroup Analysis of Two
Phase III Trials; POS1030; poster presentation; on-demand from
Wednesday, June 2; 8:00 a.m. CEST
- Influence of Baseline Demographics on Improvements in Disease
Activity Measures in Patients With Ankylosing Spondylitis Receiving
Upadacitinib: A Post Hoc Subgroup Analysis of SELECT-AXIS 1;
POS0923; poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Predictors of 1-year Treatment Response Among
Upadacitinib-Treated Patients With Ankylosing Spondylitis: A Post
Hoc Analysis of SELECT-AXIS 1; POS0924; poster presentation;
on-demand from Wednesday, June 2;
8:00 a.m. CEST
- Achievement of Partial Remission and Inactive Disease in
Upadacitinib-Treated Patients With Ankylosing Spondylitis; POS0905;
poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Effect of Upadacitinib on Reducing Pain in Patients With Active
Ankylosing Spondylitis and Inadequate Response to Nonsteroidal
Anti-Inflammatory Drugs; POS0907; poster presentation; on-demand
from Wednesday, June 2; 8:00 a.m. CEST
HUMIRA Abstracts
Spondyloarthritis (SpA)
- Impact of Adalimumab Versus Non-Biologic Therapy on Disease
Activity and Patient-Reported Outcomes in Ankylosing Spondylitis
Over 24 Months - Results of the COMPLETE-AS Canadian Observational
Study; OP0143; oral presentation; June
3; 11:15 a.m. CEST
- Clinical Effectiveness of Adalimumab Versus Non-Biologic
Therapy in the Management of Extra-Articular Manifestations in
Ankylosing Spondylitis Patients Over 24 Months - Results of the
COMPLETE-AS Canadian Observational Study; POS0232; poster
presentation; June 4; 12:26 p.m. CEST
ABBV-3373 (TNF-ADC) Abstracts
Rheumatoid Arthritis
(RA)
- Anti-TNF Glucocorticoid Receptor Modulator Antibody Drug
Conjugate for the Treatment of Autoimmune Diseases; POS0365; poster
presentation; on-demand from Wednesday, June
2; 8:00 a.m. CEST
- Efficacy and Safety of ABBV-3373, A Novel Anti-TNF
Glucocorticoid Receptor Modulator Antibody Drug Conjugate, in
Patients With Moderate to Severe Rheumatoid Arthritis Despite
Methotrexate Therapy: A Phase 2a Proof of Concept Study; OP0115;
oral presentation; Thursday, June 3;
10:25-10:32 a.m. CEST
RISANKIZUMAB Abstracts
Spondyloarthritis
(SpA)
- Efficacy and Safety of Risankizumab for Active Psoriatic
Arthritis, Including Patients With Inadequate Response or
Intolerance to Biologic Therapies: 24-week Results From The Phase
3, Randomized, Double-blind, KEEPsAKE 2 Trial; OP0228; oral
presentation; Friday, June 4;
10:35-10:42 a.m. CEST
Disease State Abstracts
Rheumatoid
Arthritis
- Differences in Treatment Satisfaction, Patient Preferences, and
Treatment Patterns Between European, South American, and Japanese
Patients With Suboptimally Controlled Rheumatoid Arthritis: A
Subgroup Analysis of the SENSE Study; POS0512; poster presentation;
Wednesday, June 2; 8:00 a.m. CEST
- Real World Population-Based Assessment of COVID-19 Outcomes
Among Rheumatoid Arthritis Patients Using Biologic or Synthetic
DMARDs; POS1207; poster presentation; on-demand from Wednesday, June 2; 8:00
a.m. CEST
- Characteristics and Outcomes in a Real-world Cohort of
Rheumatoid Arthritis Patients With COVID-19; POS1163; poster
presentation; on-demand from Wednesday, June
2; 8:00 a.m. CEST
Spondyloarthritis (SpA)
- Real-world Patient Experience and Treatment Preferences in
Patients With Psoriatic Arthritis; POS0062-PARE; poster
presentation; Thursday, June 3;
12:20-12:26 p.m. CEST
- Geographic Variations of Ankylosing Spondylitis (AS) Diagnosis
and Treatment in the United
States: A Real-World Evidence Study; POS0943; poster
presentation; on-demand from Wednesday, June
2; 8:00 a.m. CEST
- Comparison of Baseline Disease Activity and Patient-Reported
Measures Between Patients With Psoriatic Arthritis and Axial
Involvement and Axial Spondyloarthritis From CorEvitas' PsA/SpA
Registry; OP0049; oral presentation; Wednesday, June 2; 4:45-4:52 p.m. CEST
The results of these studies will be presented as oral or poster
presentations between June 2-5 at the
EULAR 2021 e-congress. The full scientific program is available
here: https://congress.eular.org/scientific_programme.cfm.
About RINVOQ™ (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK
inhibitor that is being studied in several immune-mediated
inflammatory diseases.1-12 In human cellular assays,
RINVOQ preferentially inhibits signalling by JAK1 or JAK1/3 with
functional selectivity over cytokine receptors that signal via
pairs of JAK2.13 In August
2019, RINVOQ received U.S. FDA approval for adult patients
with moderately to severely active rheumatoid arthritis who have
had an inadequate response or intolerance to methotrexate. RINVOQ
is approved by the European Commission for the treatment of adult
patients with moderate to severe active rheumatoid arthritis who
have responded inadequately to, or who are intolerant to one or
more disease-modifying anti-rheumatic drugs; for the treatment of
active psoriatic arthritis (PsA) in adult patients who have
responded inadequately to, or who are intolerant to one or more
DMARDs; and for the treatment of active ankylosing spondylitis (AS)
in adult patients who have responded inadequately to conventional
therapy. The approved dose for RINVOQ in rheumatoid arthritis,
psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3
trials of RINVOQ in atopic dermatitis, axial spondyloarthritis,
Crohn's disease, ulcerative colitis, giant cell arteritis and
Takayasu arteritis are ongoing.5
Important EU Safety Information about RINVOQ™
(upadacitinib)13
RINVOQ is contraindicated in patients hypersensitive to the
active substance or to any of the excipients, in patients with
active tuberculosis (TB) or active serious infections, in patients
with severe hepatic impairment, and during pregnancy.
Use in combination with other potent immunosuppressants is not
recommended.
Serious and sometimes fatal infections have been reported in
patients receiving upadacitinib. The most frequent serious
infections reported included pneumonia and cellulitis. Cases of
bacterial meningitis have been reported. Among opportunistic
infections, TB, multidermatomal herpes zoster, oral/oesophageal
candidiasis, and cryptococcosis have been reported with
upadacitinib. Prior to initiating upadacitinib, consider the risks
and benefits of treatment in patients with chronic or recurrent
infection or with a history of a serious or opportunistic
infection, in patients who have been exposed to TB or have resided
or travelled in areas of endemic TB or endemic mycoses, and in
patients with underlying conditions that may predispose them to
infection. Upadacitinib therapy should be interrupted if a patient
develops a serious or opportunistic infection. As there is a higher
incidence of infections in patients ≥65 years of age, caution
should be used when treating this population.
Patients should be screened for TB before starting upadacitinib
therapy. Anti-TB therapy should be considered prior to initiation
of upadacitinib in patients with previously untreated latent TB or
in patients with risk factors for TB infection.
Viral reactivation, including cases of herpes zoster, were
reported in clinical studies. Consider interruption of therapy if a
patient develops herpes zoster until the episode resolves.
Screening for viral hepatitis and monitoring for reactivation
should be performed before starting and during therapy with
upadacitinib.
The use of live, attenuated vaccines during, or immediately
prior to therapy is not recommended. It is recommended that
patients be brought up to date with all immunizations, including
prophylactic zoster vaccinations, prior to initiating upadacitinib,
in agreement with current immunization guidelines.
The risk of malignancies, including lymphoma is increased in
patients with rheumatoid arthritis (RA). Immunomodulatory medicinal
products may increase the risk of malignancies, including lymphoma.
The clinical data are currently limited and long-term studies are
ongoing. Malignancies, including non-melanoma skin cancer (NMSC),
have been reported in patients treated with upadacitinib. Consider
the risks and benefits of upadacitinib treatment prior to
initiating therapy in patients with a known malignancy other than a
successfully treated NMSC or when considering continuing
upadacitinib therapy in patients who develop a
malignancy. Periodic skin examination is recommended for
patients who are at increased risk for skin cancer.
Absolute neutrophil count <1000 cells/mm1,
absolute lymphocyte count <500 cells/mm1, or
haemoglobin levels <8 g/dL were reported in <1% of
patients in clinical trials. Treatment should not be initiated, or
should be temporarily interrupted, in patients with these
haematological abnormalities observed during routine patient
management.
RA patients have an increased risk for cardiovascular disorders.
Patients treated with upadacitinib should have risk factors (e.g.,
hypertension, hyperlipidaemia) managed as part of usual standard of
care.
Upadacitinib treatment was associated with increases in lipid
parameters, including total cholesterol, low-density lipoprotein
cholesterol, and high-density lipoprotein cholesterol. The effect
of these lipid parameter elevations on cardiovascular morbidity and
mortality has not been determined.
Treatment with upadacitinib was associated with an increased
incidence of liver enzyme elevation compared to placebo. If
increases in ALT or AST are observed during routine patient
management and drug-induced liver injury is suspected, upadacitinib
therapy should be interrupted until this diagnosis is excluded.
Events of deep vein thrombosis (DVT) and pulmonary embolism (PE)
have been reported in patients receiving JAK inhibitors, including
upadacitinib. Upadacitinib should be used with caution in patients
at high risk for DVT/PE. Risk factors that should be considered in
determining the patient's risk for DVT/PE include older age,
obesity, a medical history of DVT/PE, patients undergoing major
surgery, and prolonged immobilisation. If clinical features of
DVT/PE occur, upadacitinib treatment should be discontinued and
patients should be evaluated promptly, followed by appropriate
treatment.
The most commonly reported adverse drug reactions (ADRs) were
upper respiratory tract infections, bronchitis, nausea, blood
creatine phosphokinase (CPK) increased and cough. The most common
serious adverse reactions were serious infections.
Psoriatic arthritis: Overall, the safety profile observed in
patients with active psoriatic arthritis treated with upadacitinib
15 mg was consistent with the safety profile observed in patients
with rheumatoid arthritis. A higher incidence of acne and
bronchitis was observed in patients treated with upadacitinib 15 mg
(1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%,
respectively). A higher rate of serious infections (2.6 events per
100 patient–years and 1.3 events per 100 patient–years,
respectively) and hepatic transaminase elevations (ALT elevations
Grade 3 and higher rates 1.4% and 0.4%, respectively) was observed
in patients treated with upadacitinib in combination with MTX
therapy compared to patients treated with monotherapy. There was a
higher rate of serious infections in patients ≥ 65 years of age,
although data are limited.
Ankylosing spondylitis: Overall, the safety profile observed in
patients with active ankylosing spondylitis treated with
upadacitinib 15 mg was consistent with the safety profile observed
in patients with rheumatoid arthritis. No new safety findings were
identified.
Please see the full SmPC for complete prescribing information
at www.EMA.europa.eu.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About HUMIRA® in the European
Union14
HUMIRA, in combination with methotrexate, is indicated for the
treatment of moderate to severe, active rheumatoid arthritis in
adult patients when the response to disease-modifying
anti-rheumatic drugs, including methotrexate, has been inadequate.
Humira is indicated for the treatment of adults with severe active
ankylosing spondylitis who have had an inadequate response to
conventional therapy; and for the treatment of active and
progressive psoriatic arthritis in adults when the response to
previous disease-modifying anti rheumatic drug therapy has been
inadequate.
Important EU Safety Information about HUMIRA®
(adalimumab)14
HUMIRA is contraindicated in patients with active tuberculosis
or other severe infections such as sepsis, and opportunistic
infections and in patients with moderate to severe heart failure
(NYHA class III/IV). It is also contraindicated in patients
hypersensitive to the active substance or to any of the excipients;
serious allergic reactions including anaphylaxis have been
reported. The use of HUMIRA increases the risk of developing
serious infections, including hepatitis B reactivation, which may,
in rare cases, be life-threatening. Rare cases of lymphoma and
leukemia have been reported in patients treated with HUMIRA. On
rare occasions, a severe type of cancer called hepatosplenic T-cell
lymphoma has been observed and often results in death. A risk for
the development of malignancies in patients treated with
TNF-antagonists cannot be excluded. Rare cases of pancytopenia,
aplastic anaemia, demyelinating disease, lupus, lupus-related
conditions and Stevens-Johnson syndrome have been reported in
patients treated with HUMIRA. The most frequently reported adverse
events across all indications included respiratory infections,
injection site reactions, headache and musculoskeletal pain.
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine
involved in inflammatory processes, is thought to be linked to a
number of chronic immune-mediated diseases, including
psoriasis.15,16 In April 2019, SKYRIZI
received U.S. Food and Drug Administration approval for the
treatment of moderate to severe plaque psoriasis in adults who are
candidates for systemic therapy or phototherapy. The approved dose
for SKYRIZI is 150 mg (two 75 mg injections), administered by
subcutaneous injection at week 0 and 4, and every 12 weeks
thereafter. SKYRIZI was also approved by the European Commission
in April 2019. Phase 3 trials of SKYRIZI in psoriatic
arthritis, Crohn's disease and ulcerative colitis are
ongoing.17-19 Use of SKYRIZI in psoriatic arthritis
is not approved and its safety and efficacy have not been
established by regulatory authorities.
About SKYRIZI® (risankizumab) in the European
Union15
SKYRIZI (risankizumab) is indicated for the treatment of
moderate to severe plaque psoriasis in adults who are candidates
for systemic therapy.
Important EU Safety Information about
SKYRIZI® (risankizumab)15
SKYRIZI is contraindicated in patients with hypersensitivity to
the active substance or to any of the excipients. SKYRIZI may
increase the risk of infection. In patients with a chronic
infection, a history of recurrent infection, or known risk factors
for infection, SKYRIZI should be used with caution. Treatment with
SKYRIZI should not be initiated in patients with any clinically
important active infection until the infection resolves or is
adequately treated.
Prior to initiating treatment with SKYRIZI, patients should be
evaluated for tuberculosis (TB) infection. Patients receiving
SKYRIZI should be monitored for signs and symptoms of active TB.
Anti-TB therapy should be considered prior to initiating SKYRIZI in
patients with a past history of latent or active TB in whom an
adequate course of treatment cannot be confirmed.
Prior to initiating therapy with SKYRIZI, completion of all
appropriate immunizations should be considered according to current
immunization guidelines. If a patient has received live vaccination
(viral or bacterial), it is recommended to wait at least 4 weeks
prior to starting treatment with SKYRIZI. Patients treated with
SKYRIZI should not receive live vaccines during treatment and for
at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper
respiratory infections, which occurred in 13 percent of patients.
Commonly (greater than or equal to 1/100 to less than 1/10)
reported adverse reactions included tinea infections, headache,
pruritus, fatigue and injection site reactions.
This is not a complete summary of all safety information. See
SKYRIZI full summary of product characteristics (SmPC) at
www.ema.europa.eu.
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, including the impact of the COVID-19 pandemic on
AbbVie's operations, results and financial results, 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 of
the Allergan acquisition, failure to promptly and effectively
integrate Allergan's businesses, significant transaction costs
and/or unknown or inestimable liabilities, potential litigation
associated with the Allergan acquisition, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission (SEC). 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:
- Cohen S., et al. Safety Profile of Upadacitinib Up to 3 Years
of Exposure in Patients With Rheumatoid Arthritis. ACR Convergence
2020; THU0167.
- 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: December 2020.
- 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: ttps://clinicaltrials.gov/ct2/show/NCT03104374.
Accessed: December 2020.
- 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:
December 2020.
- Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed:
December 2020.
- Burmester GR, 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:
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