- More than 20 abstracts evaluate HUMIRA in approved indications and non-infectious intermediate, posterior, or panuveitis, an investigational indication for HUMIRA
- Data evaluating four investigational medicines will also be presented which include ABT-122 and ABT-981 that were developed using AbbVie's proprietary DVD-Ig™ technology
NORTH CHICAGO, Illinois, June 4, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced that data from more than 30 abstracts on HUMIRA® (adalimumab), investigational medicines and rheumatologic diseases will be presented at the 16th European League Against Rheumatism Annual Congress (EULAR), June 10 - 13 in Rome. Abstracts to be presented include data from a Phase 3 pivotal trial evaluating the efficacy and safety of HUMIRA as an investigational treatment for patients with non-infectious intermediate, posterior, or panuveitis, insights into the real-world impact of rheumatologic diseases, and new research on AbbVie's investigational medicines for rheumatoid arthritis, knee osteoarthritis and lupus.
"We continue to expand upon AbbVie's deep expertise with HUMIRA and demonstrate our leadership in immunology by pioneering the development of innovative medicines, such as those utilizing our proprietary technology," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "AbbVie's presence at EULAR showcases our ongoing commitment to elevating the quality of care for people living with serious inflammatory diseases around the world."
HUMIRA abstracts include new data on the treatment of polyarticular juvenile idiopathic arthritis, oral presentations on non-radiographic axial spondyloarthritis and psoriatic arthritis, and data demonstrating the long-term controlled production and consistency of HUMIRA manufacturing. Since first gaining approval 12 years ago, HUMIRA has been approved in more than 85 countries. It is currently being used to treat over 850,000 patients worldwide across 12 globally approved indications. In the United States, HUMIRA is approved for eight indications. HUMIRA is not approved for non-radiographic axial spondyloarthritis in the U.S.
AbbVie will also present seven abstracts on investigational medicines with the goal of advancing science and technology in immunologic and inflammatory diseases. AbbVie's research in investigational medicines includes the development of a proprietary, novel dual variable domain immunoglobulin (DVD-Ig™) antibody technology, which allows a single biologic agent to simultaneously target two or more antigens involved in the disease process and has the potential to treat complex diseases in which multiple pathways are involved, like rheumatoid arthritis. Data evaluating ABT-122 and ABT-981, two unique DVD-Igs under investigation to treat certain immunologic and inflammatory disorders by blocking both TNF and IL-17, and IL-1α and IL-1β, respectively, will be presented. Additionally, data on ABT-494, a selective JAK-1 inhibitor being studied for RA, and ABT-199, a selective BCL-2 inhibitor directed toward B-cell pathways contributing to autoimmunity in lupus, will be highlighted at the meeting.
Note the EULAR embargo date (10th June, 00:01 CET) for inclusion of information relating to the abstract (besides the abstract title, date and time).
HUMIRA (AbbVie-sponsored) Abstracts
- Long-term Safety and Effectiveness of Adalimumab in Children with Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis, Abstract OP0065, Thursday, June 11, 11:05 a.m. CEST, Oral Presentation, Room B
- HUMIRA® (adalimumab): Fifteen Years of Controlled Production and Consistency of Quality Attributes, Abstract FRI0115, Friday, June 12, 12:00 p.m. CEST, Poster, Hall 6
- Impact of Patient Support Program Use on Clinical Outcomes Among Patients with Rheumatoid Arthritis, Abstract THU0097, Thursday, June 11, 12:00 p.m. CEST, Poster, Hall 6
- Impact of Disease Management by Rheumatologists and Dermatologists on Patients' Attitude Toward Medication in Psoriatic Arthritis: Results from the Global ALIGN Study, Abstract SAT0566, Saturday, June 13, 10:15 a.m. CEST, Poster, Hall 5
- Adalimumab in Patients with Active, Non-Infectious Intermediate, Posterior, or Panuveitis Requiring High-dose Corticosteroids: the VISUAL-1 Trial, Abstract SAT0523, Saturday, June 13, 10:20 a.m. CEST, Poster Tour and Presentation, Hall 6
Health Economics and Outcomes Research
- Real World Comparative Effectiveness of Adalimumab and Tocilizumab for the Treatment of Rheumatoid Arthritis: Results of an Administrative Claims Analysis, Abstract THU0436, Thursday, June 11, 12:00 p.m. CEST, Poster, Hall 5
- Clinical And Economic Outcomes of Dose Tapering and Withdrawal (DT&W) of Biologics Compared to Their Maintenance Upon Achieving Stable Disease Activity in Rheumatoid Arthritis (RA) Patients, Abstract FRI0108, Friday, June 12, 12:00p.m. CEST, Poster, Hall 5
Investigational Medicines Abstracts
- 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 FRI0164, Friday, June 12, 12:00 p.m. CEST, Poster, Hall 6
- Pharmacokinetics of ABT-122, a Dual TNF- and IL-17A-Targeted DVD-Ig, After Single Dosing in Healthy Volunteers and Multiple Dosing in Subjects with Rheumatoid Arthritis, Abstract FRI0156, Friday, June 12, 12:00 p.m. CEST, Poster, Hall 6
- ABT-122, A Novel Dual Variable Domain (DVD)-Ig Targeting TNF and IL-17, Inhibits Peripheral Blood Mononuclear Cell Production of GM-CSF and Decreases Lymphocyte Expression of CXCR4 in Healthy Subjects, Abstract FRI0176, Friday, June 12, 12:00 p.m. CEST, Poster, Hall 6
- Pharmacokinetics, Safety and Tolerability of the Selective JAK1 Inhibitor, ABT-494, in Healthy Volunteers and Subjects with Rheumatoid Arthritis, Abstract THU0176, Thursday, June 11, 12:05 p.m. CEST, Poster Tour and Presentation, Hall 6
- BCL-2 as a Potential Therapeutic Target in Human Lupus Tubulointerstitial Inflammation, Abstract OP0136, Thursday, June 11, 2:50 p.m. CEST, Oral Presentation, Room 1
- Dual Variable Domain-Immunoglobin (dvd-IG) ABT-981 Simultaneously and Dose Dependently Inhibits Interleukin-1 Alpha and -1 Beta in Subjects with Knee Osteoarthritis, Abstract THU0491, Thursday, June 11, 12:00 p.m. CEST, Poster, Hall 5
- A Preclinical Study in Lupus Prone NZB/W F1 Mouse Model Conducted to Evaluate the Efficacy and Mechanism of the Investigative Medicine Venetoclax (ABT-199), a BCL-2 Inhibitor, Abstract THU0382, Thursday, June 11, 12:00 p.m. CEST, Poster, Hall 5
About HUMIRA in the U.S.1
Important Safety Information1
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.
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 your bones and joints and may help your 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 your bones and joints and may help your 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.
- 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.
Read the Full U.S. Prescribing Information and Medication Guide (http://www.rxabbvie.com/pdf/humira.pdf) for complete information on the benefits and risks of HUMIRA.
About HUMIRA in the E.U.2, 3
HUMIRA EU Therapeutic Indications2, 3
HUMIRA is approved for use in adults with moderate to severe rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn's Disease and moderately to severely active ulcerative colitis. Humira is approved for use in paediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, severe active Crohn's disease, and active polyarticular juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy. See SmPC for full indications.
Important EU Safety Information2, 3
HUMIRA is contraindicated in patients with active tuberculosis or other severe infections and in patients with moderate to severe heart failure. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with a TNF-antagonist. 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. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache, abdominal pain, nausea, rash and musculoskeletal pain.
Globally, prescribing information varies; refer to the individual country product label for complete information.
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.
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.
- HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.
- Humira [summary of product characteristics]. AbbVie Inc.; March 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124. Updated May 12, 2015, Accessed May 27, 2015.
- Pharmaceuticals - Community Register. European Commission website. http://ec.europa.eu/health/documents/community-register/html/h256.htm. Accessed May 27, 2015.