November 13, 2014

AbbVie's Leadership in Immunology Featured at 2014 American College of Rheumatology Annual Meeting with New Data on Investigational Medicines and HUMIRA® (adalimumab)

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- 37 abstracts evaluating HUMIRA and investigational medicines in rheumatologic diseases
- New data presented on ABT-122, an investigational novel protein that targets TNF and IL-17

NORTH CHICAGO, Ill., Nov. 13, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that data from 37 abstracts related to HUMIRA® (adalimumab), rheumatologic diseases and investigational medicines will be presented at the upcoming 2014 American College of Rheumatology (ACR) Annual Meeting, November 14 – 19, in Boston. As a long-standing expert in the field of rheumatology with its experience with HUMIRA, AbbVie continues to build on its leadership with data focused on investigational medicines to create innovative solutions for rheumatologic diseases.

"AbbVie's 37 abstracts at ACR demonstrate the breadth of the company's ongoing commitment to research innovative solutions that address chronic, progressive diseases like rheumatoid arthritis, osteoarthritis and lupus," said Scott Brun, vice president, pharmaceutical development, AbbVie. "We continue to build on our more than 17 years of experience in rheumatologic disease management with HUMIRA by applying our scientific expertise to address unmet needs and impact the standard of care for people living with a range of immune-mediated diseases."

Six abstracts on AbbVie's investigational medicines, including two oral presentations, highlight data supporting innovative approaches to treat lupus, osteoarthritis and rheumatoid arthritis. Data will spotlight ABT-122, a novel dual variable domain immunoglobulin (DVD-Ig™) being studied to treat certain immunologic disorders by blocking both TNF and IL-17, and ABT-199, a selective BCL-2 inhibitor directed toward B-cell pathways contributing to autoimmunity in lupus.

HUMIRA data to be presented focus on long-term safety and effectiveness in juvenile idiopathic arthritis, treatment of early rheumatoid arthritis and a cost per responder analysis of treatments for psoriatic arthritis.

In the United States, HUMIRA was approved in 2002 for the treatment of moderate to severe rheumatoid arthritis and is now approved for eight indications, including psoriatic arthritis, ankylosing spondylitis and moderate to severe polyarticular juvenile idiopathic arthritis.  Outside of the United States, HUMIRA is approved for 10 indications.

Selected Abstracts of Interest
Abstracts are available to registered journalists here.

Investigational Medicines Abstracts of Interest

  • ABT-199, a Selective BCL-2 Inhibitor, Studied in Lupus Nephritis in the Spontaneous NZB/W F1 Mouse Model by Depleting Selective Lymphocyte Populations While Sparing Platelets, Abstract 858, Sunday, November 16, 3:00 p.m., Room 153 B
  • Safety, Tolerability, and Functional Activity of ABT-122, a Dual TNF- and IL-17A-Targeted DVD-Ig™, Following Single-Dose Administration in Healthy Subjects, Abstract 951, Sunday, November 16, 5:45 p.m., Ballroom West
  • ABT-122, a Novel Dual Variable Domain (DVD)-Ig™, Targeting TNF and IL-17, in the Peripheral Blood Mononuclear Cell Production of GM-CSF and Lymphocyte Expression of CXCR4 in Healthy Subjects, Abstract 1030, Monday, November 17, 8:30 a.m.4:00 p.m., Exhibit Hall B
  • Interleukin-1 Dual-Variable Domain Immunoglobulin and Multiple Inflammatory Markers in Knee Osteoarthritis Patients, Abstract 2237, Tuesday, November 18, 8:30 a.m.4:00 p.m., Exhibit Hall B
  • BCL-2 as a Potential Therapeutic Target in Human Lupus Tubulointerstitial Inflammation, Abstract 2839, Tuesday, November 18, 2:30 p.m., Room 156 B

HUMIRA (AbbVie-sponsored) Abstracts of Interest

  • Long-Term Safety and Effectiveness of Adalimumab in Children with Moderately to Severely Active Polyarticular or Polyarticular-Course Juvenile Idiopathic Arthritis, Abstract 273,  Sunday, November 16, 8:30 a.m.4:00 p.m., Exhibit Hall B
  • Patient-Reported Outcomes in Children with Moderately to Severely Active Polyarticular or Polyarticular-Course Juvenile Idiopathic Arthritis Who Are Prescribed and Treated with Adalimumab, Abstract 289, Sunday, November 16, 8:30 a.m.4:00 p.m., Exhibit Hall B 
  • The Use of Week 12 CDAI, RAPID3 and DAS28 (CRP) Responses to Predict Optimal Response to Methotrexate, Abstract 378, Sunday, November 16, 8:30 a.m.4:00 p.m., Exhibit Hall B
  • Discontinuation of Concomitant Medication for Enthesitis-Related Arthritis during 52 Weeks of Treatment with Adalimumab, Abstract 269, Sunday, November 16, 8:30 a.m.4:00 p.m., Exhibit Hall B 
  • Identification of Genetic Variants Associated with Response to Adalimumab Plus Methotrexate in Patients with Early Rheumatoid Arthritis: Results from the Optima Study, Abstract 1131, Monday, November 17, 8:30 a.m.4:00 p.m., Exhibit Hall B
  • An Indirect Comparison and Cost Per Responder Analysis of Adalimumab, Methotrexate (MTX) and Apremilast in the Treatment of MTX-naive Psoriatic Arthritis (PsA) Patients, Abstract 1555, Monday, November 17, 8:30 a.m.4:00 p.m., Exhibit Hall B 
  • Data in Physical Function, Quality of Life and Work Productivity Among Rheumatoid Arthritis Patients Treated with 2 Different Doses of Methotrexate in Combination with Adalimumab, Abstract 2393, Tuesday, November 18, 8:30 a.m.4:00 p.m., Exhibit Hall B
  • Long-Term Clinical, Structural, and Functional Consequences of Not Adopting Treatment in MTX Suboptimal Responders, Abstract 2517, Tuesday, November 18, 8:30 a.m.4:00 p.m., Exhibit Hall B

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 adult 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 achieve clinical remission in these adults who have also 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.
  • 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 Information 
HUMIRA is a TNF blocker medicine that affects the immune system and can lower the 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, 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.

Globally, prescribing information varies; refer to the individual country product label for complete information.

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. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit 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 2013 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.



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