AbbVie Presents New Data at the European E-Congress of Rheumatology (EULAR) 2020 Showcasing Depth of its Rheumatology Portfolio

NORTH CHICAGO, Ill., May 27, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it will present new safety and efficacy results for RINVOQ™ (upadacitinib) in adult patients with moderate to severe active rheumatoid arthritis, primary data of RINVOQ for investigational use in psoriatic arthritis, as well as additional data on HUMIRA^® (adalimumab) in psoriatic arthritis at the European E-Congress of Rheumatology (EULAR) 2020, June 3-6. A total of 25 abstracts will be presented across multiple rheumatic conditions, including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.

"As a leader in immunology for over two decades, AbbVie is dedicated to developing innovative therapies for patients living with debilitating, chronic immune-mediated conditions," said Marek Honczarenko MD, PhD, vice president, global immunology development, AbbVie. "The new research from across our portfolio presented at EULAR underscores our commitment to improving the standard of care and highlights the potential for our therapies to make a meaningful difference in patients living with rheumatic diseases."

AbbVie will for the first time present data from the SELECT-CHOICE clinical trial. It is the sixth study in the SELECT rheumatoid arthritis clinical trial program, evaluating efficacy and safety of RINVOQ compared to abatacept in patients with moderate to severe active rheumatoid arthritis and prior inadequate response or intolerance to biologic DMARDs. In addition, new long-term efficacy and safety data of up to 72 weeks from the SELECT-COMPARE study and up to 84 weeks from the SELECT-MONOTHERAPY study, along with three additional analyses evaluating the safety profile of RINVOQ, will be presented.

In addition to sharing new data from the robust Phase 3 SELECT rheumatoid arthritis clinical trial program, AbbVie will present investigational data evaluating RINVOQ in adult patients with active psoriatic arthritis from the SELECT-PsA 1 study in a late-breaker presentation and primary data from the SELECT-PsA 2 study. In SELECT-PsA 1, RINVOQ was compared to placebo and adalimumab in patients with an inadequate response to non-biologic DMARDs. In SELECT-PsA 2, RINVOQ was compared to placebo in patients with an inadequate response to biologic DMARDs. RINVOQ is being investigated for the treatment of psoriatic arthritis and its efficacy and safety have not been established.

AbbVie Data at EULAR

RINVOQ Abstracts
Rheumatoid Arthritis

• Efficacy and Safety of Upadacitinib Versus Abatacept in Patients with Active Rheumatoid Arthritis and Prior Inadequate Response or Intolerance to Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-CHOICE): A Double-Blind, Randomized Controlled Phase 3 Trial; SAT0151; Poster View Session; Saturday, June 6, 2020; 10:30 a.m. – 12:00 p.m. CEST
• Upadacitinib as Monotherapy in Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate: Results at 84 Weeks from the SELECT-MONOTHERAPY Study; THU0213; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 weeks from the SELECT-COMPARE Study; THU0201; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Upadacitinib Monotherapy in Methotrexate-Naïve Patients with Rheumatoid Arthritis: Results at 72 weeks from SELECT-EARLY; THU0217; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 years from the SELECT-COMPARE and SELECT-EARLY Studies; THU0211; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Characterization of Serious Infections with Upadacitinib in Patients with Rheumatoid Arthritis; FRI0141; Poster View Session; Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naïve Patients with Early Active Rheumatoid Arthritis Receiving Treatment within 3 months of Diagnosis: A Post-Hoc Analysis of the SELECT-EARLY Study; SAT0145; Poster View Session; Saturday, June 6, 2020; 10:30 a.m. – 12:00 p.m. CEST
• Efficacy and Safety of Upadacitinib in Patients from China, Brazil and South Korea with Rheumatoid Arthritis who have had Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs; SAT0160; Poster View Session; Saturday, June 6, 2020; 10:30 a.m. – 12:00 p.m. CEST
• Proteomics Analysis Comparing the Mode of Action of Upadacitinib and Adalimumab Head to Head in Rheumatoid Arthritis Identifies Novel, Discrete Early Immune Pathway Modulation in the SELECT-COMPARE Phase 3 Study; FRI0026; Poster Tour Session; Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Sustainability of Response to Upadacitinib as Monotherapy or in Combination Among Patients with Rheumatoid Arthritis and Prior Inadequate Response to Conventional Synthetic DMARDs; THU0207; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Incidence and Risk Factors for Herpes Zoster in Rheumatoid Arthritis Patients Receiving Upadacitinib; THU0218; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Safety Profile of Upadacitinib Up to 3 Years of Exposure in Patients with Rheumatoid Arthritis; THU0197; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Sustainability of Response Between Upadacitinib and Adalimumab Among Patients with Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate; FRI0131; Poster View Session; Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Incidence and Risk of Venous Thromboembolic Events Among Patients With Rheumatoid Arthritis Enrolled in the Upadacitinib SELECT Clinical Trial Program; THU0195; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Impact of Baseline Demographics and Disease Activity on Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib; FRI0140; Poster View Session; Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Upadacitinib Treatment and the Routine Assessment of Patient Index Data 3 (RAPID3) Among Patients with Rheumatoid Arthritis; THU0192; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• The Impact of Upadacitinib Versus Methotrexate or Adalimumab on Individual and Composite Disease Measures in Patients with Rheumatoid Arthritis; FRI0138; Poster View Session; Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m. CEST

Psoriatic Arthritis and Axial Spondyloarthritis

• Efficacy and Safety of Upadacitinib Versus Placebo and Adalimumab in Patients with Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-PsA-1): a Double-Blind, Randomized Controlled Phase 3 Trial; LB-0001; Oral Abstract Presentation; Wednesday, June 3, 2020; 4:20 p.m. – 4:30 p.m. CEST
• Efficacy and Safety of Upadacitinib in Patients with Active Psoriatic Arthritis and Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-PsA-2): a Double-Blind, Randomized Controlled Phase 3 Trial; OP0223; Oral Abstract Presentation; Friday, June 5, 2020; 10:15 a.m. – 10:25 a.m. CEST
• Improvements in Global Functioning and Health-related Quality of Life and Their Association with Disease Activity and Functional Improvement in Patients with Active Ankylosing Spondylitis Treated with Upadacitinib: Results from the SELECT-AXIS 1 Trial; THU0375; Poster Tour Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST

HUMIRA Abstracts
Rheumatoid Arthritis

• Adalimumab is More Effective than Etanercept at Preventing TNF-enhanced Osteoclast Development Through Downregulation of Pro-Osteoclastogenic Factors ICAM-1 and IGFBP2 and Upregulation of Anti-Osteoclastogenic Factor FABP4; FRI0367; Poster Tour Session; Friday, June 5, 2020; 11:30 a.m. – 1:30 p.m. CEST

Spondyloarthritis

• Adalimumab Introduction Versus Methotrexate Dose Escalation in Patients with Inadequately Controlled Psoriatic Arthritis: Results from Randomized Phase 4 CONTROL Study; OP0050; Oral Abstract Presentation; Wednesday, June 3, 2020; 4:00 p.m. – 4:05 p.m. CEST

Disease State Abstracts
Rheumatoid Arthritis

• Treatment Satisfaction, Expectations, Patient Preferences and Characteristics, Including Digital Health Literacy (DHL), and the Impact of Suboptimal Disease Control in a Large International Cohort Of Patients with Rheumatoid Arthritis: The SENSE Study; SAT0123; Poster View Session; Saturday, June 6, 2020; 10:30 a.m. – 12:00 p.m. CEST
• Healthcare Costs of Not Achieving Remission in Patients with Rheumatoid Arthritis; Poster View Session; Thursday, June 4, 2020; 11:50 a.m. – 1:30 p.m. CEST
• Comparison of Patients with Rheumatoid Arthritis Among Disease Activity Categories After 6 Months of Treatment with a Tumour Necrosis Factor Inhibitor (TNFi): Results from the Corrona^® RA Registry; FRI0100; Poster View Session; Friday, June 5, 2020; 11:50 a.m. – 1:30 p.m. CEST

About RINVOQ^TM (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.^1-8 In August 2019, RINVOQ received US FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients 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. The approved dose for RINVOQ in rheumatoid arthritis is 15mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.^1-10 Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

Important EU Safety Information about RINVOQ (upadacitinib)¹

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.

Use in combination with other potent immunosuppressants is not recommended.

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/oesophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or travelled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients ≥75 years of age, caution should be used when treating this population.

Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.

Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.

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.

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including non-melanoma 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. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Absolute neutrophil count <1000 cells/mm³, absolute lymphocyte count <500 cells/mm³, or haemoglobin levels <8 g/dL were reported in <1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with these haematological abnormalities observed during routine patient management.

RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.

Upadacitinib treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.

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. Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation. If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

The most commonly reported adverse drug reactions are upper respiratory tract infections (13.5%), nausea (3.5%), increased blood creatine phosphokinase (2.5%), and cough (2.2%). The most common serious adverse reactions were serious infections.

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 HUMIRA^® in the European Union¹¹

HUMIRA, in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs, including methotrexate, has been inadequate.

Important EU Safety Information about HUMIRA (adalimumab)¹¹

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.

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, the possibility that the proposed acquisition of Allergan will not be pursued, failure to obtain necessary regulatory approvals or required financing or to satisfy any of the other conditions to the proposed acquisition, failure to realize the expected benefits of the proposed acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the proposed acquisition, challenges to intellectual property, competition from other products, 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 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). 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:

1. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; March 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
2. Pipeline – Our Science | AbbVie. AbbVie. 2020. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on May 22, 2020.
3. 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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed May 22, 2020.
4. 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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on May 22, 2020.
5. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on May 22, 2020.
6. 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. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on May 22, 2020.
7. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on May 22, 2020.
8. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on May 22, 2020.
9. A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 2). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed on May 22, 2020.
10. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on May 22, 2020.
11. 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 May 22, 2020.

SOURCE AbbVie

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