- SELECT-AXIS 2 highlights the efficacy and safety data of
upadacitinib (RINVOQ®) in patients with non-radiographic
axial spondyloarthritis, and in patients with radiographic axial
spondyloarthritis (ankylosing spondylitis) with an inadequate
response to biologic disease-modifying antirheumatic drugs
(bDMARDs)
- SELECT-PsA 1 & 2 highlight the efficacy
and safety data of RINVOQ at two years in psoriatic arthritis (PsA)
patients with an inadequate response or intolerance to ≥1
non-biologic DMARD, and in PsA patients with prior inadequate
response or intolerance to ≥1 bDMARD, respectively
-
KEEPsAKE 1 & 2 trials showcase the efficacy and safety data
of SKYRIZI ® (risankizumab) in patients with active
PsA
NORTH
CHICAGO, Ill., May 24, 2022
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced accepted
abstracts and presentations, including three oral
presentations, three poster tours and 25 posters, at the European
Alliance of Associations for Rheumatology (EULAR) 2022 Congress.
The range of data accepted for presentation showcases AbbVie's
commitment to discovering and delivering diverse and innovative
solutions for the management of rheumatic diseases. The hybrid
congress will take place from 1-4 June in Copenhagen, as well as virtually.
"For more than two decades, AbbVie has helped to raise the bar
in the care of patients with rheumatic diseases to help patients
control their disease and inhibit disease progression," said
Chiedzo Mpofu, MBChB, Ph.D., vice president, Global Medical
Affairs, Immunology, AbbVie. "We continue that legacy of our
scientific ambition as evidenced by the research we are presenting
at this year's EULAR Congress, which showcases AbbVie's relentless
pursuit of innovation and our aspiration to help eliminate the
burden of rheumatic disease for patients."
Key data to be presented include:
- SELECT-AXIS 2 trial results that were submitted in regulatory
filings for upadacitinib (RINVOQ®) in the U.S.
and Europe. The trial evaluated
the efficacy and safety of upadacitinib in patients with
non-radiographic axial spondyloarthritis (nr-axSpA) and in patients
with active ankylosing spondylitis (AS) with an inadequate response
to bDMARDs (bDMARD-IR)
- Results from the impact of treatment with RINVOQ vs
HUMIRA® (adalimumab) on RAPID3 in patients in
SELECT-PsA 1
- Two-year data from the SELECT-PsA 1 and SELECT-PsA 2 studies of
RINVOQ in patients with psoriatic arthritis (PsA)
- Results of the one-year data evaluating the efficacy and safety
of SKYRIZI® (risankizumab) in patients with
active PsA in KEEPsAKE 1 and KEEPsAKE 2
- Efficacy and safety results from several rheumatoid arthritis
studies of RINVOQ in different patient populations, including the
Phase 2 long-term BALANCE-EXTEND and Phase 3 SELECT-COMPARE studies
in patients with an inadequate response to methotrexate (MTX-IR),
and the SELECT-BEYOND and SELECT-CHOICE studies in bDMARD-IR
patients
AbbVie abstracts at EULAR include:
Abstract
Title
|
Session Details (All
Times CEST)*
|
Upadacitinib /
Rheumatoid Arthritis
|
Consistency in Time
to Response with Upadacitinib as Monotherapy or Combination Therapy
and Across Patient Populations with Rheumatoid
Arthritis
|
POS0677; poster
session; 1-4 June
|
Clinical Outcomes
Associated with Glucocorticoid Discontinuation Among Patients with
Rheumatoid Arthritis Receiving Upadacitinib or
Adalimumab
|
POS0540; poster
session; 1-4 June
|
Predictors of
Remission in Rheumatoid Arthritis Patients Treated with
Upadacitinib or Adalimumab in the SELECT-COMPARE Phase 3 Study:
Clinical Status at Week 12, but not Standard Laboratory Measures,
Provides the Best Current Predictor of Remission at Week
26
|
POS0541; poster
session; 1-4 June
|
Long-Term Safety and
Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis:
Final Results from the BALANCE-EXTEND Open-Label Extension
Study
|
POS0685; poster
session; 1-4 June
|
Rheumatoid Arthritis
Patients Who Switched Treatment from Adalimumab to Upadacitinib
Demonstrate a Robust Reduction of Inflammation-Related Biomarkers:
Proteomics Analysis from the SELECT-COMPARE Phase 3
Study
|
POS0692; poster
session; 1-4 June
|
Effectiveness of
Upadacitinib in the Treatment of Rheumatoid Arthritis: Analysis of
6-month Real-World Data from the United Rheumatology Normalized
Integrated Community Evidence (UR-NICETM)
Database
|
POS0686; poster
session; 1-4 June
|
Efficacy and Safety
of Upadacitinib in TNFi-IR Patients with Rheumatoid Arthritis from
Three Phase 3 Clinical Trials
|
POS0683; poster
session; 1-4 June
|
Impact of
Upadacitinib versus Abatacept on Individual Disease Outcomes in
Patients with Rheumatoid Arthritis and Inadequate Responses to
Biologic DMARDs
|
POS0693; poster
session; 1-4 June
|
Sustainability of
Response Between Upadacitinib and Adalimumab in Patients with
Rheumatoid Arthritis: Results Through Three Years from the
SELECT-COMPARE Trial
|
POS0643; poster
session; 1-4 June
|
Sustainability of
Response to Upadacitinib Among Patients with Active Rheumatoid
Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic
Drugs
|
AB0333; abstract
supplement
|
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
|
AB0352; abstract
supplement
|
Efficacy and Safety
of Upadacitinib in a Chinese Subgroup of Patients with Rheumatoid
Arthritis and Inadequate Response to Conventional Synthetic
Disease-Modifying Antirheumatic Drugs
|
AB0392; abstract
supplement
|
Is Upadacitinib
Capable of Improving Patient-Reported Outcomes of Rheumatoid
Arthritis in a Real-World Setting? Results from the Post-Marketing
Observational UPwArds Study
|
POS0684; poster
session; 1-4 June
|
Upadacitinib /
Spondyloarthritis
|
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
|
AB0889; abstract
supplement
|
Evaluating Numeric
Rating Scale Versions of the 3 and 4 Visual Analog Scale (3/4-VAS)
Composite Measures in Patients with Active Psoriatic Arthritis from
the SELECT-PsA Program
|
AB0904; abstract
supplement
|
Predictors for
Achievement of Low Disease Activity at Week 56 in Patients with
Psoriatic Arthritis Who Received Upadacitinib 15 mg Once Daily:
Pooled Analysis of Two Phase 3 Studies
|
POS1026; poster
session; 1-4 June
|
Comparison of
Composite Indices for Disease Activity in Patients with Psoriatic
Arthritis Treated with Upadacitinib: A Post-Hoc Analysis from
SELECT-PsA 1
|
POS1025; poster
session; 1-4 June
|
Efficacy and Safety
of Upadacitinib in Patients with Active Ankylosing Spondylitis
Refractory to Biologic Therapy: A Double-Blind, Randomized,
Placebo-Controlled Phase 3 Trial
|
POS0306; poster tour; 4
June; 11:37-11:45am
|
Efficacy and Safety
of Upadacitinib in Patients with Active Non-Radiographic Axial
Spondyloarthritis: A Double-Blind, Randomized, Placebo-Controlled
Phase 3 Trial
|
OP0016; oral
presentation; 1 June; 4:35 – 4:45pm
|
Long-Term Efficacy
and Safety of Upadacitinib in Patients with Psoriatic Arthritis:
Two-Year Results from the Phase 3 SELECT-PsA 1 Study
|
POS0081; poster tour; 2
June; 1:14 – 1:22pm
|
Long-Term Efficacy
and Safety of Upadacitinib in Patients with Psoriatic Arthritis
Refractory to Biologic Therapies: Two-Year Results from the Phase 3
SELECT-PsA 2 Study
|
POS1041; poster
session; 1-4 June
|
Differentiation
Between IL-6 and IL-17 Pathway Inhibition in Relationship with
Clinical Outcomes in Non-Biological DMARD-IR and Biological
DMARD-IR Psoriatic Arthritis Patients Treated with Upadacitinib in
SELECT-PsA 1 and SELECT-PsA 2 Studies
|
OP0024; oral
presentation; 1 June; 4:35 – 4:45pm
|
Efficacy of
Upadacitinib on Psoriatic Arthritis with Axial Involvement Defined
by Investigator Assessment and PRO-Based Criteria: Results from Two
Phase 3 Studies
|
POS0934; poster
session; 1-4 June
|
Upadacitinib Versus
Adalimumab on Routine Assessment of Patient Index Data 3 (RAPID3)
in Patients with Psoriatic Arthritis
|
POS1050; poster
session; 1-4 June
|
Risankizumab /
Psoriatic Arthritis
|
Long-Term Safety of
Risankizumab in Patients with Psoriatic Disease: Findings from
Integrated Analyses of 17 Clinical Trials in Psoriasis and Four in
Psoriatic Arthritis
|
POS1023; poster
session; 1-4 June
|
Impact of
Risankizumab on Enthesitis and Associated Pain: Pooled Results from
the Phase 3, Randomized, Double-Blind KEEPsAKE 1 and 2
Trials
|
POS1057; poster
session; 1-4 June
|
Routine Assessment
of Patient Index Data 3 (RAPID3) in Patients with Active Psoriatic
Arthritis (PsA) After Inadequate Response or Intolerance to DMARDs:
Pooled Results from the Phase 3, Randomized, Double-Blind KEEPsAKE
1 and 2 Trials
|
AB0905; abstract
supplement
|
Effects of Treatment
with Risankizumab on Minimal Disease Activity (MDA) and Disease
Activity in Psoriatic Arthritis (DAPSA): An Analysis of the
KEEPsAKE 1 and 2 Trials
|
POS1029; poster
session; 1-4 June
|
Effects of Treatment
with Risankizumab on Reducing Pain and Inflammation in Patients
with Psoriatic Arthritis: An Analysis of KEEPsAKE 1 and 2
Trials
|
AB0901; abstract
supplement
|
Efficacy and Safety
of Risankizumab (RZB) for Active Psoriatic Arthritis (PsA): 52-Week
Results from KEEPsAKE 2
|
POS1036; poster
session; 1-4 June
|
Efficacy and Safety
of Risankizumab (RZB) for Active Psoriatic Arthritis (PsA): 52-Week
Results from KEEPsAKE 1
|
POS1024; poster
session; 1-4 June
|
Impact of
Risankizumab on Improving Health-Related Quality of Life, Work
Productivity, and Reducing Fatigue Among Patients with Active
Psoriatic Arthritis: A Pooled Analysis of Two Phase 3 Clinical
Trials
|
POS1042; poster
session; 1-4 June
|
Risankizumab for
Active Psoriatic Arthritis: Integrated Subgroup Analysis from Two
Double-Blind, Placebo-Controlled, Phase 3 Studies (KEEPsAKE 1 and
KEEPsAKE 2)
|
POS1032; poster
session; 1-4 June
|
Impact of
Risankizumab on Improving Symptoms and Health-Related Quality of
Life and Reducing Fatigue and Pain Among Psoriatic Arthritis
Patients with Moderate-to-Severe Skin Involvement: Evidence from
Two Phase 3 Trials
|
AB0897; abstract
supplement
|
Disease State
Abstracts: Spondyloarthritis
|
Radiographic
Progression from Non-Radiographic to Radiographic Axial
Spondyloarthritis: Results from a 5-Year Multi-Country Prospective
Observational Study
|
OP0149; oral
presentation; 2 June; 10:45 – 10:55am
|
Disease State
Abstracts: Psoriatic Arthritis
|
Clinical and
Economic Burden of Patients with Psoriatic Arthritis with and
without Axial Involvement
|
POS1064; poster
session; 1-4 June
|
Residual Burden and
Disease Activity of Canadian PsA Patients Treated with Advanced
Therapies: Preliminary Results from a Multiple Registry Analysis
(UNISON-PsA)
|
AB0895; abstract
supplement
|
Disease State
Abstracts: Rheumatoid Arthritis
|
A Canadian
Retrospective Chart Review Evaluating Concomitant Methotrexate
De-Escalation Patterns in RA Patients Treated with Biologic or
Targeted Synthetic DMARDs
|
POS0288; poster tour; 4
June; 10:33 – 10:41am
|
Persisting Pain in
Rheumatoid Arthritis: Do We Need to Reconsider Our Idea of Pain
Alleviation Despite Anti-Inflammatory Treatment?
|
POS0598; poster
session; 1-4 June
|
Improving
Treat-to-Target Implementation in Rheumatoid Arthritis: A
Systematic Literature Review of Barriers, Facilitators, and
Interventions
|
POS0607; poster
session; 1-4 June
|
*Poster sessions will take place onsite 1-4 June and will be
available on the EULAR online platform until 31 July, 2022.
SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading the development and
commercialization of SKYRIZI globally.
The full EULAR scientific program is available here:
https://congress.eular.org/scientific_programme.cfm.
About
RINVOQ® (upadacitinib)1
Discovered and developed by AbbVie scientists, RINVOQ is a
selective JAK inhibitor that is being studied in several
immune-mediated inflammatory diseases.2 In human
cellular assays, RINVOQ preferentially inhibits signaling by JAK1
or JAK1/3 with functional selectivity over cytokine receptors that
signal via pairs of JAK2.1
In the U.S., RINVOQ is approved for the treatment of adults with
moderately to severely active rheumatoid arthritis who have had an
inadequate response or intolerance to one or more TNF blockers,
adults with active psoriatic arthritis who have had an inadequate
response or intolerance to one or more TNF blockers, as well as
adults with active ankylosing spondylitis who have had an
inadequate response or intolerance to one or more TNF
blockers.3 RINVOQ is approved for use in adults and
pediatric patients 12 years of age and older with refractory,
moderate to severe atopic dermatitis whose disease is not
adequately controlled with other systemic drug products, including
biologics, or when use of those therapies are inadvisable. RINVOQ
is approved for the treatment of adults with moderately to severely
active ulcerative colitis who have had an inadequate response or
intolerance to one or more TNF blockers.
In the EU, RINVOQ is approved for the treatment of adults 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; for
the treatment of active ankylosing spondylitis (AS) in adult
patients who have responded inadequately to conventional therapy;
and for adults (15 mg and 30 mg) and adolescents (15 mg) with
moderate to severe atopic dermatitis.1
Phase 3 trials of RINVOQ in atopic dermatitis, axial
spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell
arteritis and Takayasu arteritis are ongoing.4-11 Use of
RINVOQ in nr-axSpA is not approved and remains under review by
regulatory authorities.
EU Indications and Important Safety Information about
RINVOQ® (upadacitinib)1
Indications
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe
active rheumatoid arthritis in adult patients who have responded
inadequately to, or who are intolerant to one or more
disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used
as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic
arthritis in adult patients who have responded inadequately to, or
who are intolerant to one or more DMARDs. RINVOQ may be used as
monotherapy or in combination with methotrexate.
Ankylosing spondylitis
RINVOQ is indicated for the treatment of active ankylosing
spondylitis in adult patients who have responded inadequately to
conventional therapy.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe
atopic dermatitis in adults and adolescents 12 years and older who
are candidates for systemic therapy.
Important Safety Information
Contraindications
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.
Special warnings and precautions for use
Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not
recommended.
Serious infections
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/esophageal
candidiasis, and cryptococcosis have been reported with
upadacitinib. As there is a higher incidence of infections in
patients ≥65 years of age, caution should be used when treating
this population.
Viral reactivation
Viral reactivation, including cases of herpes zoster, was
reported in clinical studies. The risk of herpes zoster appears to
be higher in Japanese patients treated with upadacitinib.
Vaccinations
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.
Malignancy
The risk of malignancies, including lymphoma is increased in
patients with rheumatoid arthritis (RA). Malignancies, including
nonmelanoma 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.
Hematological abnormalities
Treatment should not be initiated, or should be temporarily
interrupted, in patients with hematological abnormalities observed
during routine patient management.
Diverticulitis
Upadacitinib should be used with caution in patients with
diverticular disease and especially in patients chronically treated
with concomitant medications associated with an increased risk of
diverticulitis.
Cardiovascular risk
RA patients have an increased risk for cardiovascular disorders.
Patients treated with upadacitinib should have risk factors (e.g.,
hypertension, hyperlipidemia) managed as part of usual standard of
care.
Lipids
Upadacitinib treatment was associated with dose-dependent
increases in lipid parameters, including total cholesterol,
low-density lipoprotein cholesterol, and high-density lipoprotein
cholesterol.
Hepatic transaminase elevations
Treatment with upadacitinib was associated with an increased
incidence of liver enzyme elevation compared to placebo.
Venous thromboembolisms
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.
Adverse reactions
The most commonly reported adverse reactions in rheumatoid
arthritis, psoriatic arthritis, and ankylosing spondylitis clinical
trials (≥2% of patients in at least one of the indications) with
upadacitinib 15 mg were upper respiratory tract infections, blood
creatine phosphokinase (CPK) increased, alanine transaminase (ALT)
increased, bronchitis, nausea, cough, aspartate transaminase (AST)
increased, and hypercholesterolemia.
The most commonly reported adverse reactions in atopic
dermatitis trials (≥2% of patients) with upadacitinib 15 mg or 30
mg were upper respiratory tract infection, acne, herpes simplex,
headache, CPK increased, cough, folliculitis, abdominal pain,
nausea, neutropenia, pyrexia, and influenza. The most common
serious adverse reactions were serious infections.
The safety profile of upadacitinib with long term treatment was
generally similar to the safety profile during the
placebo-controlled period across indications.
Overall, the safety profile observed in patients with psoriatic
arthritis or active ankylosing spondylitis treated with
upadacitinib 15 mg was consistent with the safety profile observed
in patients with RA. In atopic dermatitis, dose-dependent increased
risks of infection and herpes zoster were observed with
upadacitinib. Based on limited data, there was a higher rate of
overall adverse reactions with the upadacitinib 30 mg dose compared
to the 15 mg dose in patients aged 65 years and older.
The safety profile for upadacitinib 15 mg in adolescents was
similar to that in adults. The safety and efficacy of the 30 mg
dose in adolescents are still being investigated. Dose-dependent
changes in ALT increased and/or AST increased (≥ 3 x ULN), lipid
parameters, CPK values (> 5 x ULN), and neutropenia (ANC < 1
x 109 cells/L) associated with upadacitinib treatment
were similar to what was observed in the rheumatologic disease
clinical studies.
This is not a complete summary of all safety
information.
See RINVOQ full summary of product characteristics (SmPC)
at www.ema.europa.eu/en.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About SKYRIZI® (risankizumab)12
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19
subunit.12 IL-23, a cytokine involved in
inflammatory processes, is thought to be linked to a number of
chronic immune-mediated diseases, including
psoriasis.12 SKYRIZI is approved in the U.S. to
treat moderate to severe plaque psoriasis in adults who are
candidates for systemic therapy or phototherapy, as well as to
treat active psoriatic arthritis in adults. In the EU, SKYRIZI is
indicated for the treatment of moderate to severe plaque psoriasis
in adults who are candidates for systemic therapy; SKYRIZI, alone
or in combination with methotrexate (MTX), is indicated for the
treatment of active psoriatic arthritis in adults who have had an
inadequate response or who have been intolerant to one or more
disease-modifying antirheumatic drugs
(DMARDs).12 The approved dose for SKYRIZI is 150 mg
(one 150 mg pre-filled pen or pre-filled syringe) administered by
subcutaneous injection at week 0 and 4, and every 12 weeks
thereafter. Phase 3 trials of SKYRIZI in psoriasis, Crohn's
disease, ulcerative colitis and psoriatic arthritis are
ongoing.2,12-15
EU Indications and Important Safety Information
about SKYRIZI® (risankizumab)12
SKYRIZI is indicated for the treatment of moderate to severe
plaque psoriasis in adults who are candidates for systemic therapy.
SKYRIZI, alone or in combination with methotrexate (MTX), is
indicated for the treatment of active psoriatic arthritis in adults
who have had an inadequate response or who have been intolerant to
one or more disease-modifying anti-rheumatic drugs (DMARDs).
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 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. 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 HUMIRA® (adalimumab) in the European
Union16
HUMIRA, in combination with methotrexate, is indicated for the
treatment of moderate to severe, active rheumatoid arthritis in
adult patients when the response to DMARDs, 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 DMARD therapy has been inadequate.
Important EU Safety Information about HUMIRA®
(adalimumab)16
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 anemia, 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.
This is not a complete summary of all safety
information.
See HUMIRA full summary of product characteristics (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 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 2021 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.
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