News Releases

NORTH CHICAGO, Ill., Oct. 24, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that data from 38 abstracts of HUMIRA^® (adalimumab) and the company's portfolio of investigational immunology medicines will be presented at the 2017 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting, November 3-8, in San Diego.

"Building on more than two decades of clinical trial experience with HUMIRA, AbbVie's body of research reinforces our commitment to developing treatment options for people living with immune-mediated inflammatory diseases," said Shao-Lee Lin, M.D., Ph.D., vice president, therapeutic areas and international development, AbbVie. "We look forward to sharing new developments that illustrate our patient-centered approach to treating rheumatic conditions, and the depth and breadth of AbbVie's portfolio."

AbbVie will present results from two Phase 3 trials of upadacitinib, an investigational oral JAK1-selective inhibitor, evaluating safety and efficacy in patients with moderate to severe rheumatoid arthritis. This includes late-breaking data from the Phase 3 SELECT-BEYOND study of upadacitinib in patients who did not adequately respond or were intolerant to treatment with biologic DMARDs (bDMARDs).

Additionally, data from SELECT-NEXT, a Phase 3 study of upadacitinib in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with conventional synthetic DMARDs (csDMARDs), will be featured as an oral presentation. Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established.

HUMIRA data to be presented at the meeting will include an analysis of long-term safety in nearly 30,000 patients across multiple immune-mediated conditions, highlighting the breadth of continued research in this population. HUMIRA is one of the most comprehensively-studied biologics available for immune-mediated inflammatory diseases, and is supported by more than 20 years of clinical trial experience in immunology.¹

Abstracts of Interest

Upadacitinib Abstracts

• Long-Term Safety and Efficacy of Upadacitinib (ABT-494), an Oral JAK-1 Inhibitor in Patients with Rheumatoid Arthritis in an Open Label Extension Study; Abstract #509; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster I: Comorbidities and Adverse Events; Efficacy and Safety of Small Molecules; Sunday, November 5; 9:00-11:00 a.m. PT
• A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Upadacitinib (ABT-494), a Selective JAK-1 Inhibitor, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Conventional Synthetic DMARDs; Abstract #1904; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy II: Trials Therapy; Monday, November 6; 4:30-6:00 p.m. PT
• Upadacitinib (ABT-494) in Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological DMARDs: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of a Selective JAK-1 Inhibitor; Abstract #10L; ACR Late-Breaking Abstract Poster; Tuesday, November 7; 9:00-11:00 a.m. PT

Risankizumab Abstracts

• Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis; Abstract #2L; ACR Late-Breaking Abstract Session; Tuesday, November 7; 4:45-5:00 p.m. PT

HUMIRA Abstracts

Cross-Indication

• Long-Term Safety of Adalimumab (HUMIRA) in Adult Patients from Global Clinical Trials across Multiple Indications: An Updated Analysis in 29,987 Patients Representing 56,951 Patient Years; Abstract #2481; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III: Efficacy and Safety of Originator Biologics and Biosimilars; Tuesday, November 7; 9:00-11:00 a.m. PT

Rheumatoid Arthritis

• The Value of Adalimumab Trough Levels and Clinical Assessments in Predicting Clinical Response in Patients with Established Rheumatoid Arthritis and an Inadequate Response to Methotrexate; Abstract #1418; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports; Monday, November 6; 9:00-11:00 a.m. PT
• Impact of Patient Support Program Utilization on Patient Activation Measure Scores Among Patients with Rheumatoid Arthritis; Abstract #1038; Health Services Research Poster II: Osteoarthritis and Rheumatoid Arthritis; Monday, November 6; 9:00-11:00 a.m. PT
• The Ability of Patients with Early Rheumatoid Arthritis to Taper Low-Dose Glucocorticoids on Methotrexate Monotherapy and in Combination with Adalimumab; Abstract #1420; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports; Monday, November 6; 9:00-11:00 a.m. PT

Juvenile Idiopathic Arthritis

• Safety of Adalimumab±Methotrexate for the Treatment of Polyarticular Juvenile Idiopathic Arthritis (pJIA); Abstract #2271; Pediatric Rheumatology – Clinical and Therapeutic Aspects Poster III: Juvenile Arthritis; Tuesday, November 7, 2017; 9:00-11:00 a.m. PT

Spondyloarthritis (SpA)

• Impact of Time Since Diagnosis, Age and Number of Prior Non-Steroidal Anti-Inflammatory Drugs on 52-Week Clinical Response to Adalimumab in Patients with Ankylosing Spondylitis; Abstract #1521; Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster II; Monday, November 6; 9:00-11:00 a.m. PT
• Inhibition of Radiographic Progression in Psoriatic Arthritis By Adalimumab Independent of the Control of Clinical Disease Activity; Abstract #2970; Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment V; Wednesday, November 8; 11:00-12:30 p.m. PT

Uveitis

• Impact of Adalimumab on Immunosuppressant Use in Patients with Active and Inactive Non-Infectious Intermediate, Posterior, or Pan-Uveitis in the Ongoing Open Label Study: Visual-III; Abstract #1155; Miscellaneous Rheumatic and Inflammatory Diseases Poster I; Monday, November 6; 9:00-11:00 a.m. PT

Abstracts are available at http://acrabstracts.org/.  

About Risankizumab
Risankizumab is an investigational compound that selectively blocks IL-23 by binding to its p19 subunit.² IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.³ Phase 3 trials of risankizumab in psoriasis are ongoing, and it is also being investigated to treat Crohn's disease and psoriatic arthritis.^4,5,6 Future trials are planned to investigate risankizumab in ulcerative colitis.

Risankizumab is part of a collaboration with Boehringer Ingelheim, with AbbVie leading future development and commercialization of risankizumab globally. Risankizumab is not approved by regulatory authorities. Safety and efficacy have not been established.

About Upadacitinib
Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of rheumatoid arthritis and other immune-mediated inflammatory disorders.^7,8 Phase 3 trials of upadacitinib in psoriatic arthritis are ongoing and it is also being investigated to treat Crohn's disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.^{9,10,11,12,13,14}

Upadacitinib is an investigational oral agent and is not approved by regulatory authorities. Safety and efficacy have not been established.

About HUMIRA in the U.S.
Uses¹⁵
HUMIRA is a prescription medicine used:

• To reduce the signs and symptoms of:
• Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
• Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
• Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
• Ankylosing spondylitis (AS) in adults.
• Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
• Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
• Moderate to severe hidradenitis suppurativa (HS) in adults.
• In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.

Important Safety Information¹⁵
HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy, even if their TB test was negative. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

Please click here for the Full Prescribing Information and Medication Guide.

About AbbVie
AbbVie is a global, research-driven 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 70 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 or LinkedIn.

Forward-Looking Statements 
Some statements in this news release may be 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, 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," in AbbVie's 2016 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.

¹ Burmester G.R., et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases Ann Rheum Dis. 2009;68:1863–1869.
² Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. NEJM. 2017.
³ Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
⁴ AbbVie. Data on File, [ultIMMa-1 #].
⁵ A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease. Clinicaltrials.gov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128?cond=RISANKIZUMAB&draw=3&rank=15. Accessed October 9, 2017.
⁶ BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Clinicaltrials.gov. 2017.
Available at: https://clinicaltrials.gov/ct2/show/NCT02719171?cond=RISANKIZUMAB&draw=3&rank=17. Accessed October 9, 2017.
⁷ 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
⁸ Pipeline – Our Science | AbbVie. AbbVie. 2017. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed September 7, 2017.
⁹ A Study Comparing ABT-494 to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) - Full Text View - ClinicalTrials.gov. Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426?term=select+next&rank=1. Accessed on July 11, 2017.
¹⁰ A Study Comparing 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). Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400?term=ABT-494&phase=2&rank=10. Accessed on July 11, 2017.
¹¹ 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 - Full Text View - ClinicalTrials.gov. Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on July 11, 2017.
¹² 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. Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on July 11, 2017.
¹³ A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). 2017. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487?term=ABT-494&cond=ankylosing+spondylitis&rank=1. Accessed on July 19, 2017.
¹⁴ A Study to Evaluate ABT-494 in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02925117. Accessed on July 11, 2017.
¹⁵ HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

SOURCE AbbVie