AbbVie Presents New Data Analyses for Growing Dermatology Portfolio at the 30th European Academy of Dermatology and Venereology (EADV) Congress

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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SOURCE AbbVie

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