November 3, 2015

AbbVie's Leadership and Innovation in Immunology Showcased at the American College of Rheumatology Annual Meeting with More Than 40 Abstracts on HUMIRA® (adalimumab) and Investigational Medicines Across Multiple Inflammatory Diseases

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- Abstracts evaluate HUMIRA®, the real-world impact of TNF-alpha inhibitors and investigational medicines in patients with rheumatologic diseases
- Late-breaking data on investigational medicine ABT-494, a selective JAK1 inhibitor, to be presented

NORTH CHICAGO, Ill., Nov. 3, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that data on HUMIRA® (adalimumab), investigational medicines and the overall impact of rheumatologic diseases from more than 40 abstracts, including three oral presentations, will be presented at the 2015 American College of Rheumatology (ACR) Annual Meeting, Nov. 7-11, in San Francisco. These data reinforce AbbVie's continued leadership in immunology and commitment to those living with a variety of inflammatory diseases.

"As a leader in delivering medicines to address unmet needs in immune-mediated disorders, we are highlighting scientific insights at ACR from our immunology portfolio, including data showcasing ongoing research with HUMIRA and the significant role anti-TNF therapies have played in the management of rheumatologic diseases1-2," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We also continue to drive innovation within our pipeline, looking at multiple scientific approaches and novel solutions to help improve patient care across a variety of autoimmune diseases with unmet needs." 

HUMIRA abstracts to be presented include results from a Phase 3 trial evaluating the efficacy and safety of HUMIRA as an investigational treatment for non-infectious, intermediate, posterior, or panuveitis; and data on the investigational treatment of adult patients with polyarticular juvenile idiopathic arthritis. Additionally, multiple abstracts being presented include data highlighting the importance and ongoing evaluation of established tumor necrosis factor (TNF)-alpha inhibitors in several rheumatologic diseases, including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.

Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 940,000 patients worldwide across 13 globally approved indications. HUMIRA is one of the most comprehensively studied biologics available and is distinguished by 18 years of clinical trial experience in immunology beginning with rheumatoid arthritis.

AbbVie will also present 10 abstracts on investigational medicines aiming to advance the development of novel molecules to create solutions for patients who need it most. Data will spotlight ABT-122 and ABT-981, two unique dual variable domain immunoglobulins (DVD-Ig™) under investigation to treat certain immunologic and inflammatory disorders by blocking both TNF and IL-17, and IL-1? and IL-1?, respectively. Additionally, late-breaking data on ABT-494, an investigational selective JAK1 inhibitor, will be presented at the meeting. AbbVie announced in September of this year that it will advance ABT-494 to Phase 3 studies in rheumatoid arthritis.

Abstracts of Interest

HUMIRA (AbbVie-sponsored) Abstracts

Rheumatoid Arthritis

  • Outcomes Associated with Non-Medical Switching/Discontinuation of Anti-TNF Inhibitors Among Patients with Rheumatoid Arthritis; D. Wolf, et al.; Abstract 555; Poster Session; Sunday, Nov. 8, 2015; 9:00-11:00 a.m. PST
  • The Effect of Prior Disease Duration and Prior DMARD Use on Treatment Outcomes in Patients with Early or Established Rheumatoid Arthritis; J. Smolen, et al.; Abstract 2726; Poster Session; Tuesday, Nov. 10, 2015; 9:00-11:00 a.m. PST
  • Meta-Analysis of the Time Course of the Response to Adalimumab Plus Methotrexate or Methotrexate Monotherapy in Clinical Trials of Patients with Rheumatoid Arthritis; X. Wang, et al.; Abstract 507; Poster Session; Sunday, Nov. 8, 2015; 9:00-11:00 a.m. PST
  • Economic Burden of Switching to an Anti-Tumor Necrosis Factor (Anti-TNF) versus a Non-Tumor Necrosis Factor (Non-TNF) Biologic Therapy among Patients with Rheumatoid Arthritis; Z. Zhou, et al.; Abstract 145; Poster Session; Sunday, Nov. 8, 2015; 9:00-11:00 a.m. PST
  • The Impact of Biologic Agent Initiation After 1 Versus 2 Prior csDMARDs in Patients with Rheumatoid Arthritis; D. Pappas, et al.; Abstract 427; Poster Session; Sunday, Nov. 8, 2015; 9:00-11:00 a.m. PST

Uveitis

  • Adalimumab in Patients With Active, Non-infectious Uveitis Requiring High-Dose Corticosteroids; A. Brezin, et al.; Abstract 2038; Oral Presentation; Monday, Nov. 9, 2015; 2:30-4:00 p.m. PST
  • Adalimumab in Patients With Inactive, Non-infectious Uveitis Requiring Systemic Treatment; Q. Nguyen, et al.; Abstract 1388; Poster Session; Monday, Nov. 9, 2015; 9:00-11:00 a.m. PST
  • Effect of Adalimumab on Visual Functioning (VFQ-25) in Visual-1 Trial Patients with Non-Anterior Non-Infectious Uveitis; J. Sheppard, et al.; Abstract 2039; Oral Presentation; Monday, Nov. 9, 2015; 2:30-4:30 p.m. PST

Psoriatic Arthritis

  • The Prediction of Long-Term Minimal Disease Activity and Its Benefits in Patients with Psoriatic Arthritis; P. Mease, et al.; Abstract 651; Poster Session; Sunday, Nov. 8, 2015; 9:00-11:00 a.m. PST
  • The Majority of Patients with Moderate to Severe Psoriatic Arthritis Had Existing Structural Damage, Predisposing Them to Further Progression, Which Was Markedly Inhibited by Adalimumab; P. Sheth, et al.; Abstract 2894; Poster Session; Tuesday, Nov. 10, 2015; 9:00-11:00 a.m. PST
  • Relative Efficacy of Adalimumab Versus Secukinumab in Active Psoriatic Arthritis: A Matching Adjusted Indirect Comparison; K. Betts, et al.; Abstract 2868; Poster Session; Tuesday, Nov. 10, 2015; 9:00-11:00 a.m. PST
  • Network Meta-Analysis of Tumor Necrosis Factor, Interleukins, and Phosphodiesterase-4 Inhibitor in the Treatment of Psoriatic Arthritis; V. Strand, et al.; Abstract 2848; Poster Session; Tuesday, Nov. 10, 2015; 9:00-11:00 a.m. PST

Juvenile Idiopathic Arthritis

  • Long-Term Safety of Adalimumab Treatment in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis and Enthesitis-Related Arthritis; D. Lovell, et al.; Abstract 2431; Poster Session; Tuesday, Nov. 10, 2015; 9:00-11:00 a.m. PST
  • Clinical and Functional Outcomes in Patients with Polyarticular Juvenile Idiopathic Arthritis Following Treatment with Adalimumab; D. Kingsbury, et al.; Abstract 2452; Poster Session; Tuesday, Nov. 10, 2015; 9:00-11:00 a.m. PST
  • Efficacy and Safety of Adalimumab in Adult Patients with Polyarticular Juvenile Idiopathic Arthritis; D. Lovell, et al.; Abstract 2428; Poster Session; Tuesday, Nov. 10, 2015; 9:00-11:00 a.m. PST

Ankylosing Spondylitis

  • Real-World Impact of Anti-TNF Medication Use on Patient Reported Outcomes in a Prospective Cohort of Patients with Ankylosing Spondylitis; W. Maksymowych, et al.; Abstract 2880; Poster Session; Tuesday, Nov. 10, 2015; 9:00-11:00 a.m. PST

Investigational Medicines Abstracts

Rheumatoid Arthritis

  • Late Breaking Abstract:  Safety and Efficacy of ABT-494, a Novel Selective JAK1 Inhibitor, in Patients With Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Anti-TNF Biologic Therapy; J. Kremer, et al.; Presentation 14L; Tuesday, Nov. 10, 2015: 9:00-11:00 a.m. PST
  • Safety, Tolerability, and Pharmacodynamics of ABT-122, a Dual TNF- and IL-17-Targeted Dual Variable Domain (DVD)-Ig™ in Subjects With Rheumatoid Arthritis; R. Fleischmann, et al.; Abstract 967; Oral Presentation; Sunday, Nov. 8, 2015; 2:30-4:00 p.m. PST

Systemic Lupus Erythematosus

  • Pharmacokinetics of the Selective B-Cell Lymphoma2 (Bcl-2) Inhibitor, ABT-199, in Female Subjects with Systemic Lupus Erythematosus; M. Minocha, et al.; Abstract 1822; Poster Session; Monday, Nov. 9, 2015; 9:00-11:00 a.m. PST
  • Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the BCL-2 Inhibitor Venetoclax (ABT-199) in a Phase 1 Single and Multiple Ascending Dose Study in Female Patients With Systemic Lupus Erythematosus; P. Lu, et al.; Abstract 738; Poster Session; Sunday, Nov. 8, 2015; 9:00-11:00 a.m. PST

Osteoarthritis

  • Phase 1 Studies Of Anti-Interleukin-1 Dual-Variable Domain Immunoglobulin In Healthy Subjects And Patients With Osteoarthritis; S. Wang, et al.; Abstract 319; Poster Session; Sunday, Nov. 8, 2015; 9:00-11:00 a.m. PST
  • Dual Variable Domain-Immunoglobulin (Dvd-Ig™) Abt-981 Simultaneously And Dose-Dependently Inhibits Interleukin-1 ?lpha And -1 ?eta In Subjects With Knee Osteoarthritis; S. Wang, et al.; Abstract 318; Poster Session; Sunday, Nov. 8, 2015; 9:00-11:00 a.m. PST

About HUMIRA in the U.S.

Uses3

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 conventional treatments. 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.

Important Safety Information3

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. 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, 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.

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-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

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 2014 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

  1. Huseyin TE et al. Clinical efficacy of TNF-? inhibitors: an update. Int J Clin Rheumatol. 2010;5(1):101-115.
  2. Geiler J et al. Anti-TNF treatment in rheumatoid arthritis. Curr Pharm Des. 2011;17(29):3141-54.
  3. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

 

SOURCE AbbVie

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