NORTH CHICAGO, Ill.,
Oct. 9, 2019 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced that it will present new results evaluating the
safety and efficacy of SKYRIZI™ (risankizumab) at 2.5 years in
adult patients with moderate to severe plaque psoriasis, as well as
additional data on HUMIRA® (adalimumab) and the
investigational JAK inhibitor upadacitinib, at the 28th
European Academy of Dermatology and Venereology (EADV) Congress,
October 9-13, in Madrid.
"Leveraging more than two decades of clinical experience with
HUMIRA, AbbVie recently expanded its dermatology portfolio with the
approval of SKYRIZI for patients living with moderate to severe
plaque psoriasis," said Marek
Honczarenko, MD, PhD, vice president, global immunology
development, AbbVie. "The new data presented at EADV will advance
the knowledge around new and existing treatments for serious skin
diseases, like psoriasis, as well as diseases with high levels of
unmet need, such as atopic dermatitis and hidradenitis
suppurativa."
In addition to sharing new long-term data from the LIMMitless
open-label extension study in moderate to severe plaque psoriasis,
AbbVie will share results from its ongoing investigational Phase 2
program evaluating risankizumab for the treatment of psoriatic
arthritis. Risankizumab is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
In addition, Phase 2b results
evaluating time to treatment response with upadacitinib, an oral
JAK inhibitor, under investigation for patients with moderate to
severe atopic dermatitis will be shared as an oral presentation.
Upadacitinib is not approved for atopic dermatitis by any
regulatory authority, and its safety and efficacy have not been
established in this indication.
Additional presentations include efficacy and safety results
further evaluating HUMIRA in hidradenitis suppurativa.
"Chronic skin diseases can have a significant physical and
psychosocial impact on patients," said Jean-Marie Meurant, board president of the
International Alliance of Dermatology Patient Organizations. "While
progress has been made to improve the lives of patients, many still
do not have access to the treatment and care they need and deserve.
It's critical that the scientific community build upon current
research to better understand these diseases and continue to keep
the patient experience at the forefront of their efforts."
AbbVie Data at EADV
Risankizumab Abstracts
Psoriasis
- Long-term Efficacy and Safety of Continuous Q12W Risankizumab:
Results from the Open-Label Extension LIMMitless; Oral Presentation
#FC01.01: Free Communications in Psoriasis; Thursday, 10 October 2019; 08:30 – 8:40 a.m. CEST
- Direct Comparison of Risankizumab and Fumaric Acid Esters
(FAEs) in Patients with Moderate to Severe Plaque Psoriasis Who
Were Naive to Systemic Therapy; Oral ePoster #OP02.01: Inflammatory
Skin Diseases; Friday, 11 October
2019; 10:15 – 10:25 a.m.
CEST
- Long-term Efficacy and Safety of Switching from Adalimumab to
Risankizumab: Results from the Open-Label Extension LIMMitless;
ePoster #P1713; Wednesday, 9 October
2019
- Long-term Efficacy and Safety of Switching from Ustekinumab to
Risankizumab: Results from the Open-Label Extension LIMMitless;
ePoster #P1714; Wednesday, 9 October
2019
- Impact of Body-Weight on the Efficacy and Exposure-Response of
Risankizumab in Patients with Moderate to Severe Plaque Psoriasis:
An Integrated Analysis of Two Phase 3 Clinical Trials; Oral
Presentation #FC02.03: Free Communications in Psoriasis; Friday,
11 October 2019; 10:35 – 10:45 a.m. CEST
- Safety of Risankizumab in Patients with Moderate to Severe
Psoriasis: Analysis of Pooled Clinical Trial Data; ePoster #P1764;
Wednesday, 9 October 2019
- Comparison of Dermatology Quality of Life Index for Novel
Treatments of Moderate to Severe Plaque Psoriasis: A Network
Meta-Analysis; ePoster #P1716; Wednesday, 9
October 2019
- Dose Escalation of Targeted Immunomodulator Treatment in
Patients with Moderate to Severe Psoriasis; ePoster #P1791;
Wednesday, 9 October 2019
- Reasons for Drug Discontinuation Among Psoriasis Patients in
the Corrona Psoriasis Registry; ePoster #P1796; Wednesday,
9 October 2019
Psoriatic arthritis
- Efficacy and Safety of Risankizumab in Patients with Active
Psoriatic Arthritis Over 24 Weeks: Clinical and Biomarker Results
from a Phase 2 Trial; Oral Presentation #FC03.01: Free
Communications in Therapy; Thursday, 10
October 2019; 1:15 – 1:25 p.m.
CEST
Upadacitinib Abstracts
Atopic dermatitis
- Time to Upadacitinib Treatment Response Over 16 Weeks for
Patients with Atopic Dermatitis from a Phase 2b, Randomized, Placebo-Controlled Trial; Oral
Presentation #FC07.06: Free Communications in Atopic Dermatitis;
Saturday, 12 October 2019; 2:05 –
2:15 p.m. CEST
- Eosinophil Count, Serum CCL17/18/26 and Immunoglobulin E Levels
in Atopic Dermatitis: Upadacitinib Phase 2 Study Analysis; ePoster
#P0272; Wednesday, 9 October
2019
- Effects of Upadacitinib on Patient-Reported Symptoms and
Impacts Due to Atopic Dermatitis: Post-Hoc Results from the Phase
2b Randomized, Placebo-Controlled
Trial in Moderate-to-Severe Atopic Dermatitis; ePoster #P0255;
Wednesday, 9 October 2019
HUMIRA Abstracts
Psoriasis
- Long-term Real-World Safety and Effectiveness of Adalimumab for
Moderate to Severe Psoriasis: 10-Year Interim Results from the
ESPRIT Registry; Oral Presentation #FC01.02: Free Communications in
Psoriasis; Thursday, 10 October 2019;
8:40 – 8:50 a.m. CEST
- Real-World Treatment Effect of Adalimumab on Patient Reported
Outcomes in Moderate-to-Severe Psoriasis – Results from the EQUIPE
Study; ePoster #P1741; Wednesday, 9 October
2019
Hidradenitis suppurativa
- Post Marketing Observational Study to Assess Quality of Life
Changes in Swedish Patients with Moderate or Severe Hidradenitis
Suppurativa after 6 Months on Adalimumab Treatment (HOPE study);
ePoster #P0020; Wednesday, 9 October
2019
- A Longitudinal Assessment of the Impact of Adalimumab on Work
Productivity, Skin Pain, and Quality of Life Measures Among
Patients with Hidradenitis Suppurativa; ePoster #P0005; Wednesday,
9 October 2019
Disease State Abstracts
Hidradenitis
suppurativa
- An Assessment of the Natural History of Hidradenitis
Suppurativa: Results from the 2-Year Interim Analysis of an
International, Prospective, Disease-based Registry (UNITE); Oral
Presentation #FC08.05: Free Communications in Acne and Related
Disorders; Saturday, 12 October 2019;
3:40 – 3:50 p.m. CEST
- Correlation of Patient Demographic and Clinical Characteristics
with Hidradenitis Suppurativa (HS) Symptom Assessment (HSSA) and
Hidradenitis Suppurativa Impact Assessment (HSIA): Results from the
UNITE Hidradenitis Suppurativa Disease Registry; Oral Presentation
#FC08.03: Free Communications in Acne and Related Disorders;
Saturday, 12 October 2019; 3:20 –
3:30 p.m. CEST
- Baseline clinical characteristics from observational,
multinational UNITE registry by disease severity using the
International Hidradenitis Suppurativa Severity Score System
(IHS4); Oral Presentation #FC08.02: Free Communications in Acne and
Related Disorders; Friday, 11 October
2019; 10:35–10:45 a.m. CEST
About SKYRIZI™ (risankizumab) in the EU1
SKYRIZI (risankizumab) is indicated for the treatment of
moderate to severe plaque psoriasis in adults who are candidates
for systemic therapy.
Important EU Safety Information1
SKYRIZI is contraindicated in patients with hypersensitivity to
the active substance or to any of the excipients and in clinically
important active infections. 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.
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
the 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 Upadacitinib
Discovered and developed by AbbVie, upadacitinib is an
investigational, oral, small molecule JAK inhibitor being studied
for moderately to severely active rheumatoid arthritis and other
immune-mediated inflammatory diseases.2-15 Phase 3
trials of upadacitinib in psoriatic arthritis, Crohn's disease,
atopic dermatitis and ulcerative colitis are ongoing and it is also
being investigated to treat ankylosing spondylitis and giant cell
arteritis.10-15
About HUMIRA in the EU16
HUMIRA is indicated for the treatment of moderate to severe
chronic plaque psoriasis in adult patients who are candidates for
systemic therapy.
HUMIRA is indicated for the treatment of active moderate to
severe hidradenitis suppurativa (acne inversa) in adults and
adolescents from 12 years of age with an inadequate response to
conventional systemic HS therapy.
Important EU Safety Information16
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.
This is not a complete summary of all safety information.
Globally, prescribing information varies; refer to the individual
country product label for complete information.
Full summary of product characteristics is available at:
www.ema.europa.eu
About AbbVie
AbbVie is a global, research and development-based
biopharmaceutical company committed to developing innovative
advanced therapies for some of the world's most complex and
critical conditions. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to markedly
improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than 75
countries, AbbVie employees are working every day to advance health
solutions for people around the world. 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, competition from
other products, challenges to intellectual property, 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 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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:
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Deutschland GmbH & Co KG. Available at:
https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf.
Accessed August 23, 2019.
- 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:
10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
- Genovese MC, et al. Safety and efficacy of upadacitinib in
patients with active rheumatoid arthritis refractory to biologic
disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a
double-blind, randomised controlled phase 3. Lancet. 2018 Jun
23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub
2018 Jun 18.
- Smolen, J. et al. Upadacitinib as monotherapy in patients with
active rheumatoid arthritis and inadequate response to methotrexate
(SELECT-MONOTHERAPY): a randomised, placebo-controlled,
double-blind phase 3 study. Lancet. 2019 May 23. pii:
S0140-6736(19)30419-2. doi: 10.1016/S0140-6736(19)30419-2. [Epub
ahead of print].
- van Vollenhoven, et al. A Phase 3, Randomized, Controlled Trial
Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve
Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual
Meeting; 891.
- Fleischmann R, et al. A Phase 3, Randomized, Double-Blind Study
Comparing Upadacitinib to Placebo and to Adalimumab, in Patients
with Active Rheumatoid Arthritis with Inadequate Response to
Methotrexate. 2018 ACR/ARHP Annual Meeting; 890.
- A Phase 3 Study to Compare ABT-494 to Abatacept in Subjects
With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic
Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an
Inadequate Response or Intolerance to Biologic DMARDs
(SELECT-CHOICE). Clinicaltrials.gov. 2018. Available at:
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10.1002/art.2013.65.issue-s10.
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Inadequate Response to at Least One Non-Biologic Disease Modifying
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Available at: https://clinicaltrials.gov/ct2/show/NCT03104400.
Accessed on August 23, 2019.
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study of ABT-494 for the Induction of Symptomatic and Endoscopic
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- Evaluation of Upadacitinib in Adolescent and Adult Patients
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- A Study to Evaluate the Safety and Efficacy of ABT-494 for
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