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
- 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
- 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
- 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
- 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
- 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
- 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.
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
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.
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.
- SKYRIZI [Summary of Product Characteristics]. AbbVie 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: https://clinicaltrials.gov/ct2/show/NCT03086343. Accessed on August 23, 2019.
- Voss, J, et al; Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. doi: 10.1002/art.2013.65.issue-s10.
- Pipeline – Our Science | AbbVie. AbbVie. 2018. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on August 23, 2019.
- 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. 2019. 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 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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on August 23, 2019.
- Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on August 23, 2019.
- 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. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on August 23, 2019.
- A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on August 23, 2019.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on August 23, 2019.
- 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 August 23, 2019.