NORTH CHICAGO, Ill.,
Sept. 23, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced it will present 27 abstracts across
its dermatology portfolio, including new analyses evaluating the
safety and efficacy of RINVOQ® (upadacitinib) in
atopic dermatitis and new data on SKYRIZI®
(risankizumab) in psoriasis and psoriatic arthritis, at the 30th
European Academy of Dermatology and Venereology (EADV) Congress, to
be held virtually on September 29-October
2.
"Building on nearly two decades of experience working in
dermatology, we're excited to present additional evidence
supporting our growing portfolio of medicines," said Stefan Florentinus, PhD, PharmD, Head
of Dermatology, Global Medical Affairs, AbbVie. "Our
presence at EADV this year reaffirms our commitment to
understanding the evolving needs of patients suffering from chronic
inflammatory diseases and working to raise the standards of
care."
Several presentations will feature analyses from the global
Phase 3 studies evaluating RINVOQ in moderate to severe atopic
dermatitis, including efficacy analyses across different patient
subgroups. Data will also be presented orally from Heads Up, a
Phase 3b head-to-head study
evaluating safety and efficacy of RINVOQ versus dupilumab,
including an efficacy analysis focused on four body regions—head
and neck, trunk, upper limbs and lower limbs. Additionally, new
data from a real-world, multi-country study will be presented,
helping to illustrate the burden of disease on patients with atopic
dermatitis across the world. Late-breaking data will be
presented from an open-label extension study, showcasing the
efficacy and safety data of switching from dupilumab to RINVOQ in
patients with moderate to severe atopic dermatitis.
Presentations will also highlight long-term data from the
LIMMitless open-label extension study, evaluating SKYRIZI
(risankizumab) in adult patients with moderate to severe plaque
psoriasis. In addition, analyses from the Phase 3 clinical trials,
KEEPsAKE-1 and KEEPsAKE-2, will focus on health-related quality of
life, fatigue and work productivity evaluations in
risankizumab-treated patients with psoriatic arthritis.
Late-breaking data will be presented, highlighting new long-term
efficacy and safety data of up to 52 weeks in risankizumab-treated
patients with active psoriatic arthritis.
The full scientific program for the 30th EADV Congress is
available here.
SKYRIZI (risankizumab) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
AbbVie Data at the 30th EADV Congress
RINVOQ (upadacitinib) Abstracts
Atopic
dermatitis
- Effect of Upadacitinib on Hand Eczema in Patients with
Moderate-to-Severe Atopic Dermatitis: Results from Two Phase 3
Trials (Measure Up 1 and Measure Up 2); ePoster #P0247; Wednesday,
29 September 2021; 6:00 CEST
- Efficacy and Safety of Upadacitinib vs Dupilumab Treatment for
Moderate to Severe Atopic Dermatitis in Four Body Regions -
Analysis from the Heads Up Study; Oral Presentation #FC01.03: Free
Communications in Atopic Dermatitis; Thursday, 30 September 2021; 10:20 – 10:30 CEST
- Efficacy of Upadacitinib for Moderate-to-Severe Atopic
Dermatitis: Stratified Analysis from Three Phase 3 Trials by Key
Baseline Characteristics; ePoster #P0183; Wednesday, 29 September 2021; 6:00
CEST
- Deep and Rapid Response on Skin Clearance and Patient-Reported
Outcome Measures with Upadacitinib with or without Topical
Corticosteroids in Moderate to Severe Atopic Dermatitis: Results
from 3 Phase 3 Studies (Measure Up 1, Measure Up 2, and AD Up);
ePoster #P0263; Wednesday, 29 September
2021; 6:00 CEST
- Improvement in Psychosocial Impact Measures with Upadacitinib
with or without Topical Corticosteroids in Moderate to Severe
Atopic Dermatitis: Results from 3 Phase 3 Studies (Measure Up 1,
Measure Up 2, and AD Up); ePoster #P0245; Wednesday, 29 September 2021; 6:00
CEST
- Rapid Skin Clearance and Itch Improvement with Upadacitinib
versus Dupilumab in Adults with Moderate to Severe Atopic
Dermatitis: Results from a Phase 3b
Head-to-Head Trial (Heads Up); ePoster #P0264; Wednesday,
29 September 2021; 6:00 CEST
- Effects of Upadacitinib in Combination with Topical
Corticosteroids on Patient-Reported Symptoms and Impact of Atopic
Dermatitis: 16-Week Results from a Phase 3 Study (AD Up); ePoster
#P0248; Wednesday, 29 September 2021;
6:00 CEST
- Efficacy and Safety of Switching from Dupilumab to Upadacitinib
in Moderate-to-Severe Atopic Dermatitis: Results from an Open Label
Extension Trial; Late Breaking News, Reviews and Updates #D1T01.3B;
Thursday, 30 September; 14:45-15:00
CEST
SKYRIZI (risankizumab) Abstracts
Psoriasis
- Impact of PASI Response on Work Productivity and Estimated
Effects of Risankizumab on Indirect Costs Using Machine Learning in
Patients with Moderate-to-Severe Psoriasis; ePoster #P1297;
Wednesday, 29 September 2021;
6:00 CEST
- Efficacy of Risankizumab for Moderate-to-Severe Plaque
Psoriasis: Subgroup Analysis from a Phase 3 Trial; ePoster #P1319;
Wednesday, 29 September 2021;
6:00 CEST
- Efficacy of Risankizumab for Moderate-to-Severe Plaque
Psoriasis: Subgroup Analysis of Prior Treatment History from a
Phase 3 Trial; ePoster #P1328; Wednesday, 29
September 2021; 6:00 CEST
- Maintenance of Health-Related Quality of Life Improvements for
More than 4 Years Among Psoriasis Patients Treated with
Risankizumab: Analysis of Dermatology Life Quality Index (DLQI)
Scores from the LIMMitless Trial; ePoster #P1332; Wednesday,
29 September 2021; 6:00 CEST
- Response to Risankizumab Treatment Among Patients with
Psoriasis and with or without Metabolic Syndrome: Integrated
Analysis from UltIMMa-1/-2 and IMMerge; ePoster #P1408; Wednesday,
29 September 2021; 6:00 CEST
- Efficacy of Risankizumab in Biologic-Naive and
Biologic-Experienced Patients with Moderate to Severe Psoriasis:
Integrated Analysis of 3 Clinical Trials; ePoster #P1366;
Wednesday, 29 September 2021;
6:00 CEST
- Long-Term Efficacy of Continuous Risankizumab in Psoriasis by
Body Region: An Integrated Analysis from the LIMMitless Open-Label
Extension Study; ePoster #P1452; Wednesday, 29 September 2021; 6:00
CEST
- Efficacy and Safety of Long-Term Risankizumab Treatment for
Nail Psoriasis: An Interim Analysis from the Open-Label Extension
LIMMitless Trial; ePoster #P1353; Wednesday, 29 September 2021; 6:00
CEST
- Long-Term Safety of Risankizumab in Patients with
Moderate-to-Severe Plaque Psoriasis: Integrated Analysis of
Clinical Study Data; ePoster #P1389; Wednesday, 29 September 2021; 6:00
CEST
- Long-Term Efficacy and Safety of Risankizumab for the Treatment
of Moderate-to-Severe Plaque Psoriasis: Interim Analysis of the
LIMMitless Open-Label Extension Trial Beyond 3.5 Years of
Follow-Up; ePoster #P1354; Wednesday, 29
September 2021; 6:00 CEST
- Risankizumab Compared with Ustekinumab in Patients with
Moderate Plaque Psoriasis: Integrated Analysis of Randomized
UltIMMa-1 and UltIMMa-2 Studies; ePoster #P1442; Wednesday,
29 September 2021; 6:00 CEST
Psoriatic arthritis
- Improvements in Health-Related Quality of Life, Fatigue, and
Work Productivity Among Patients with Psoriatic Arthritis Retreated
with Risankizumab Including Those with Inadequate Response or
Intolerance to Biologic Therapies: Analysis of the Phase 3 Clinical
Trial KEEPsAKE 2; ePoster #P0378; Wednesday, 29 September 2021; 6:00
CEST
- Improvements in Health-Related Quality of Life, Fatigue, Pain
and Work Productivity Among Patients with Active Psoriatic
Arthritis and Inadequate Response to Conventional Synthetic
Disease-Modifying Antirheumatic Drugs Treated with Risankizumab:
Analysis of the Phase 3 Clinical Trial KEEPsAKE 1; ePoster #P1496;
Wednesday, 29 September 2021;
6:00 CEST
- Effects of Risankizumab on Nail Psoriasis in Patients with
Active Psoriatic Arthritis at Week 24: Results from KEEPsAKE 1;
Oral Presentation #FC03.04: Free Communications in
Psychodermatology; Thursday, 30 September
2021; 15:00-15:10 CEST
- Efficacy and Safety of Risankizumab for Active Psoriatic
Arthritis: 24-Week Results from the Phase 3, Randomized,
Double-Blind KEEPsAKE 2 Trial for csDMARD-IR and Bio-IR Patients;
ePoster #P1349; Wednesday, 29 September
2021; 6:00 CEST
- Efficacy and Safety of Risankizumab for Active Psoriatic
Arthritis: 24-Week Integrated Results from the Phase 3, Randomized,
Double-Blind KEEPsAKE 1 and 2 Trials for csDMARD and Bio-IR
Patients; ePoster #P1335; Wednesday, 29
September 2021; 6:00 CEST
- Efficacy and Safety of Risankizumab for Active Psoriatic
Arthritis: 52-Week Results From the KEEPsAKE 1 and KEEPsAKE 2
Trials; Late Breaking News, Reviews and Updates #D1T01.4A;
Thursday, 30 September; 15:45-16:00
CEST
HUMIRA (adalimumab) Abstracts
Psoriasis
- Long-Term Real-World Safety and Effectiveness of Adalimumab for
Moderate to Severe Psoriasis: Year-12 Report of Interim Results
from the ESPRIT Registry; ePoster #P1348; Wednesday, 29 September 2021; 6:00
CEST
Disease State Abstracts
Atopic
dermatitis
- The Burden of Flare in Atopic Dermatitis: Results from a
Multi-Country Study; ePoster #P0229; Wednesday, 29 September 2021; 6:00
CEST
- Healthcare Resource Utilization of Active-Severe Atopic
Dermatitis Patients in England: A
Population-Based Linked Cohort Study Using Clinical Practice
Research Datalink and Hospital Episode Statistics; ePoster #P0179;
Wednesday, 29 September 2021;
6:00 CEST
Psoriasis
- Real-World Incidence of Oral and Non-Oral Candidiasis Among
Patients Treated for Psoriasis: A Retrospective Claims Data Study;
ePoster #P1327; Wednesday, 29 September
2021; 6:00 CEST
About RINVOQ® (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.1-12 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 RINVOQ is approved by
the European Commission for adults (15 mg and 30 mg) and
adolescents (15 mg) with moderate to severe atopic dermatitis.
RINVOQ 15 mg is 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.
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.4-12
EU Indications and Important Safety Information about
RINVOQ® (upadacitinib)1
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.
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.
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.
Please see the RINVOQ full SmPC for complete prescribing
information at http://www.EMA.europa.eu.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively
blocks IL-23 by binding to its p19 subunit.13,14 IL-23,
a cytokine involved in inflammatory processes, is thought to be
linked to a number of chronic immune-mediated diseases, including
Crohn's disease.13 In April
2019 SKYRIZI was approved by the European Commission for the
treatment of moderate to severe plaque psoriasis in adults who are
candidates for systemic therapy. The approved dose for SKYRIZI
is 150 mg, administered by subcutaneous injection prefilled pen or
prefilled syringe at week 0 and 4, and every 12 weeks thereafter.
Phase 3 trials of SKYRIZI in psoriatic arthritis, Crohn's disease
and ulcerative colitis are ongoing.15-17 Use of
SKYRIZI in psoriatic arthritis is not approved and its safety and
efficacy have not been established by regulatory
authorities.
Important EU Safety Information
about SKYRIZI® (risankizumab)14
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 HUMIRA® (adalimumab) in the European
Union18
HUMIRA is indicated for the treatment of moderate to severe
chronic plaque psoriasis in adult patients who are candidates for
systemic therapy. HUMIRA is also indicated for the treatment of
active moderate to severe hidradenitis suppurativa (HS; acne
inversa) in adults and adolescents from 12 years of age with an
inadequate response to conventional systemic HS therapy.
Important EU Safety Information about
HUMIRA® (adalimumab)18
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.
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 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, LinkedIn or Instagram.
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.
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