NORTH CHICAGO, Ill.,
May 27, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced that it will present new safety and efficacy
results for RINVOQ™ (upadacitinib) in adult patients with moderate
to severe active rheumatoid arthritis, primary data of RINVOQ for
investigational use in psoriatic arthritis, as well as additional
data on HUMIRA® (adalimumab) in psoriatic arthritis at
the European E-Congress of Rheumatology (EULAR) 2020, June 3-6. A total of 25 abstracts will be
presented across multiple rheumatic conditions, including
rheumatoid arthritis, ankylosing spondylitis and psoriatic
arthritis.
"As a leader in immunology for over two decades, AbbVie is
dedicated to developing innovative therapies for patients living
with debilitating, chronic immune-mediated conditions," said
Marek Honczarenko MD, PhD, vice
president, global immunology development, AbbVie. "The new research
from across our portfolio presented at EULAR underscores our
commitment to improving the standard of care and highlights the
potential for our therapies to make a meaningful difference in
patients living with rheumatic diseases."
AbbVie will for the first time present data from the
SELECT-CHOICE clinical trial. It is the sixth study in the SELECT
rheumatoid arthritis clinical trial program, evaluating efficacy
and safety of RINVOQ compared to abatacept in patients with
moderate to severe active rheumatoid arthritis and prior inadequate
response or intolerance to biologic DMARDs. In addition, new
long-term efficacy and safety data of up to 72 weeks from the
SELECT-COMPARE study and up to 84 weeks from the SELECT-MONOTHERAPY
study, along with three additional analyses evaluating the safety
profile of RINVOQ, will be presented.
In addition to sharing new data from the robust Phase 3 SELECT
rheumatoid arthritis clinical trial program, AbbVie will present
investigational data evaluating RINVOQ in adult patients with
active psoriatic arthritis from the SELECT-PsA 1 study in a
late-breaker presentation and primary data from the
SELECT-PsA 2 study. In SELECT-PsA 1, RINVOQ was compared to placebo
and adalimumab in patients with an inadequate response to
non-biologic DMARDs. In SELECT-PsA 2, RINVOQ was compared to
placebo in patients with an inadequate response to biologic DMARDs.
RINVOQ is being investigated for the treatment of psoriatic
arthritis and its efficacy and safety have not been
established.
AbbVie Data at EULAR
RINVOQ Abstracts
Rheumatoid Arthritis
- Efficacy and Safety of Upadacitinib Versus Abatacept in
Patients with Active Rheumatoid Arthritis and Prior Inadequate
Response or Intolerance to Biologic Disease-Modifying
Anti-Rheumatic Drugs (SELECT-CHOICE): A Double-Blind, Randomized
Controlled Phase 3 Trial; SAT0151; Poster View Session;
Saturday, June 6, 2020; 10:30 a.m. – 12:00 p.m.
CEST
- Upadacitinib as Monotherapy in Patients with Rheumatoid
Arthritis and Prior Inadequate Response to Methotrexate: Results at
84 Weeks from the SELECT-MONOTHERAPY Study; THU0213; Poster View
Session; Thursday, June 4, 2020;
11:50 a.m. – 1:30 p.m. CEST
- Long-Term Safety and Effectiveness of Upadacitinib or
Adalimumab in Patients with Rheumatoid Arthritis: Results at 72
weeks from the SELECT-COMPARE Study; THU0201; Poster View Session;
Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Upadacitinib Monotherapy in Methotrexate-Naïve Patients with
Rheumatoid Arthritis: Results at 72 weeks from SELECT-EARLY;
THU0217; Poster View Session; Thursday, June
4, 2020; 11:50 a.m. –
1:30 p.m. CEST
- Radiographic Outcomes in Patients with Rheumatoid Arthritis
Receiving Upadacitinib as Monotherapy or in Combination with
Methotrexate: Results at 2 years from the SELECT-COMPARE and
SELECT-EARLY Studies; THU0211; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Characterization of Serious Infections with Upadacitinib in
Patients with Rheumatoid Arthritis; FRI0141; Poster View Session;
Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Efficacy and Safety of Upadacitinib Monotherapy in
Methotrexate-Naïve Patients with Early Active Rheumatoid Arthritis
Receiving Treatment within 3 months of Diagnosis: A Post-Hoc
Analysis of the SELECT-EARLY Study; SAT0145; Poster View Session;
Saturday, June 6, 2020; 10:30 a.m. – 12:00 p.m.
CEST
- Efficacy and Safety of Upadacitinib in Patients from
China, Brazil and South
Korea with Rheumatoid Arthritis who have had Inadequate
Response to Conventional Synthetic Disease-Modifying Antirheumatic
Drugs; SAT0160; Poster View Session; Saturday, June 6, 2020; 10:30 a.m. – 12:00 p.m.
CEST
- Proteomics Analysis Comparing the Mode of Action of
Upadacitinib and Adalimumab Head to Head in Rheumatoid Arthritis
Identifies Novel, Discrete Early Immune Pathway Modulation in the
SELECT-COMPARE Phase 3 Study; FRI0026; Poster Tour Session;
Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Sustainability of Response to Upadacitinib as Monotherapy or in
Combination Among Patients with Rheumatoid Arthritis and Prior
Inadequate Response to Conventional Synthetic DMARDs; THU0207;
Poster View Session; Thursday, June 4,
2020; 11:50 a.m. –
1:30 p.m. CEST
- Incidence and Risk Factors for Herpes Zoster in Rheumatoid
Arthritis Patients Receiving Upadacitinib; THU0218; Poster View
Session; Thursday, June 4, 2020;
11:50 a.m. – 1:30 p.m. CEST
- Safety Profile of Upadacitinib Up to 3 Years of Exposure in
Patients with Rheumatoid Arthritis; THU0197; Poster View Session;
Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Sustainability of Response Between Upadacitinib and Adalimumab
Among Patients with Rheumatoid Arthritis and Prior Inadequate
Response to Methotrexate; FRI0131; Poster View Session;
Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Incidence and Risk of Venous Thromboembolic Events Among
Patients With Rheumatoid Arthritis Enrolled in the Upadacitinib
SELECT Clinical Trial Program; THU0195; Poster View Session;
Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Impact of Baseline Demographics and Disease Activity on
Outcomes in Patients with Rheumatoid Arthritis Receiving
Upadacitinib; FRI0140; Poster View Session; Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Upadacitinib Treatment and the Routine Assessment of Patient
Index Data 3 (RAPID3) Among Patients with Rheumatoid Arthritis;
THU0192; Poster View Session; Thursday, June
4, 2020; 11:50 a.m. –
1:30 p.m. CEST
- The Impact of Upadacitinib Versus Methotrexate or Adalimumab on
Individual and Composite Disease Measures in Patients with
Rheumatoid Arthritis; FRI0138; Poster View Session; Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m.
CEST
Psoriatic Arthritis and Axial Spondyloarthritis
- Efficacy and Safety of Upadacitinib Versus Placebo and
Adalimumab in Patients with Active Psoriatic Arthritis and
Inadequate Response to Non-Biologic Disease-Modifying
Anti-Rheumatic Drugs (SELECT-PsA-1): a Double-Blind, Randomized
Controlled Phase 3 Trial; LB-0001; Oral Abstract Presentation;
Wednesday, June 3, 2020; 4:20 p.m. – 4:30 p.m.
CEST
- Efficacy and Safety of Upadacitinib in Patients with Active
Psoriatic Arthritis and Inadequate Response to Biologic
Disease-Modifying Anti-Rheumatic Drugs (SELECT-PsA-2): a
Double-Blind, Randomized Controlled Phase 3 Trial; OP0223; Oral
Abstract Presentation; Friday, June 5,
2020; 10:15 a.m. –
10:25 a.m. CEST
- Improvements in Global Functioning and Health-related Quality
of Life and Their Association with Disease Activity and Functional
Improvement in Patients with Active Ankylosing Spondylitis Treated
with Upadacitinib: Results from the SELECT-AXIS 1 Trial; THU0375;
Poster Tour Session; Thursday, June 4,
2020; 11:50 a.m. –
1:30 p.m. CEST
HUMIRA Abstracts
Rheumatoid Arthritis
- Adalimumab is More Effective than Etanercept at Preventing
TNF-enhanced Osteoclast Development Through Downregulation of
Pro-Osteoclastogenic Factors ICAM-1 and IGFBP2 and Upregulation of
Anti-Osteoclastogenic Factor FABP4; FRI0367; Poster Tour Session;
Friday, June 5, 2020; 11:30 a.m. – 1:30 p.m.
CEST
Spondyloarthritis
- Adalimumab Introduction Versus Methotrexate Dose Escalation in
Patients with Inadequately Controlled Psoriatic Arthritis: Results
from Randomized Phase 4 CONTROL Study; OP0050; Oral Abstract
Presentation; Wednesday, June 3,
2020; 4:00 p.m. – 4:05 p.m. CEST
Disease State Abstracts
Rheumatoid
Arthritis
- Treatment Satisfaction, Expectations, Patient Preferences and
Characteristics, Including Digital Health Literacy (DHL), and the
Impact of Suboptimal Disease Control in a Large International
Cohort Of Patients with Rheumatoid Arthritis: The SENSE Study;
SAT0123; Poster View Session; Saturday, June
6, 2020; 10:30 a.m. –
12:00 p.m. CEST
- Healthcare Costs of Not Achieving Remission in Patients with
Rheumatoid Arthritis; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m.
CEST
- Comparison of Patients with Rheumatoid Arthritis Among Disease
Activity Categories After 6 Months of Treatment with a Tumour
Necrosis Factor Inhibitor (TNFi): Results from the
Corrona® RA Registry; FRI0100; Poster View Session;
Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m.
CEST
About RINVOQTM (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being studied
in several immune-mediated inflammatory
diseases.1-8 In August 2019, RINVOQ received
US FDA approval for adult patients with moderately to severely
active rheumatoid arthritis who have had an inadequate response or
intolerance to methotrexate. In December 2019, RINVOQ was
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. The approved dose for
RINVOQ in rheumatoid arthritis is 15mg. Phase 3 trials of
RINVOQ in rheumatoid arthritis, psoriatic arthritis, axial
spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative
colitis and giant cell arteritis are ongoing.1-10 Use of
RINVOQ in psoriatic arthritis is not approved and its safety and
efficacy have not been established by regulatory authorities.
Important EU Safety Information about RINVOQ
(upadacitinib)1
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 ≥75 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/mm3,
absolute lymphocyte count <500 cells/mm3, 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 are upper
respiratory tract infections (13.5%), nausea (3.5%), increased
blood creatine phosphokinase (2.5%), and cough (2.2%). The most
common serious adverse reactions were serious infections.
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
Union11
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.
Important EU Safety Information about HUMIRA
(adalimumab)11
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 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, the possibility
that the proposed acquisition of Allergan will not be pursued,
failure to obtain necessary regulatory approvals or required
financing or to satisfy any of the other conditions to the proposed
acquisition, failure to realize the expected benefits of the
proposed acquisition, failure to promptly and effectively integrate
Allergan's businesses, significant transaction costs and/or unknown
or inestimable liabilities, potential litigation associated with
the proposed 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 2019 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:
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland
GmbH & Co. KG; March 2020.
Available at:
https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
- Pipeline – Our Science | AbbVie. AbbVie. 2020. Available
at: https://www.abbvie.com/our-science/pipeline.html. Accessed
on May 22, 2020.
- 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 May 22, 2020.
- 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 May 22, 2020.
- Evaluation of Upadacitinib in Adolescent and Adult Patients
With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1.
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed
on May 22, 2020.
- 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 on May 22, 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 on May 22, 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
on May 22, 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: https://clinicaltrials.gov/ct2/show/NCT03104374.
Accessed on May 22, 2020.
- 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
on May 22, 2020.
- HUMIRA [Summary of Product Characteristics]. AbbVie Deutschland
GmbH & Co KG. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf.
Accessed May 22, 2020.
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