March 2, 2016

AbbVie Announces New Dermatology Research from More Than 35 Presentations on HUMIRA® (Adalimumab), Long-Term and Real-World Data at the American Academy of Dermatology 2016 Annual Meeting

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- New research includes further evaluation of the safety and efficacy of HUMIRA in patients with moderate to severe chronic plaque psoriasis, psoriatic arthritis and moderate to severe hidradenitis suppurativa (HS)

NORTH CHICAGO, Ill., March 2, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that more than 35 abstracts on HUMIRA® (adalimumab) and dermatologic diseases will be presented at the upcoming 74th Annual Meeting of the American Academy of Dermatology (AAD), March 4 – 8, in Washington, D.C., reinforcing the company's strong leadership and commitment to patients living with serious dermatologic conditions.   

Abstracts to be presented during the meeting further evaluate HUMIRA for the treatment of moderate to severe hidradenitis suppurativa (HS), assess the burden of the disease and explore how the severity of HS is measured in clinical practice. Additionally, real-world and clinical research continues to examine the long-term safety and efficacy of HUMIRA for moderate to severe chronic plaque psoriasis, including the results of a comprehensive, retrospective safety analysis of HUMIRA from 16 clinical trials and the six-year interim results from the ongoing ESPRIT 10-year postmarketing surveillance safety registry.

"AbbVie's research presented at AAD demonstrates our ongoing commitment to making a meaningful impact on the lives of patients living with serious inflammatory skin diseases. Our leadership in immunology R&D is grounded in more than 18 years of clinical trial experience, beginning with rheumatoid arthritis," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We continue to explore opportunities in our clinical development programs to serve patients in need, including our research evaluating the real-world impact dermatologic diseases can have on patients."

HUMIRA is one of the most comprehensively studied biologics available and is distinguished by 13 years of physician and patient experience in dermatology. HUMIRA is currently being used to treat more than 955,000 patients worldwide1 across 13 globally approved indications.2-3

Abstracts of Interest

Moderate to Severe Chronic Plaque Psoriasis and Psoriatic Arthritis (AbbVie-Sponsored) Abstracts of Interest  

  • Adalimumab PASI Scores in Head Region Among Patients with Moderate to Severe Psoriasis: Analysis from REVEAL and CHAMPION; W. Abramovits, et al.; Abstract 3444; Poster Session; Sunday, March 6, 2016; 8:25 – 8:30 a.m. EST
  • Six-Year Interim Results from the ESPRIT 10-Year Postmarketing Surveillance Registry of Adalimumab in Moderate to Severe Psoriasis; J. Wu, et al.; Abstract 3556; Poster Session; Monday, March 7, 2016; 9:55 – 10:00 a.m. EST
  • Long-Term Safety of Adalimumab in Clinical Trials for Adult Patients with Moderate to Severe Plaque Psoriasis; C. Leonardi, et al.; Abstract 3822; Poster Session; Sunday, March 6, 2016; 2:35 – 2:40 p.m. EST
  • Adalimumab in an Evaluation of Risk of Joint-Related Signs and Symptoms Compared with Methotrexate in Patients with Moderate to Severe Psoriasis; J. Merola, et al.; Abstract 2572; Poster Session; Sunday, March 6, 2016; 8:25 – 8:30 a.m. EST
  • Predicting PASI90 Response Among Adalimumab-Treated Patients with Moderate to Severe Psoriasis; C. Ryan, et al.; Abstract 2571; Poster Session; Sunday, March 6, 2016; 3:25 – 3:30 p.m. EST
  • Cardiovascular Event Risk Assessment in Psoriasis Patients Treated with Tumor Necrosis Factor-Alpha Inhibitors Versus Phototherapy; J. Wu, et al.; Abstract 2602 (Pearls from the Posters); Monday, March 7, 2016; 9:40 – 9:45 a.m. EST

Moderate to Severe Hidradenitis Suppurativa (AbbVie-Sponsored) Abstracts of Interest

  • Evaluating the Clinical Meaning of the Hidradenitis Suppurativa Clinical Response (HiSCR); A. Kimball, et al.; Abstract 2573; Poster Session; Friday, March 4, 2016; 9:10 – 9:15 a.m. EST
  • How is the Severity of Hidradenitis Suppurativa Measured in Clinical Practice?; M. Sundaram; Abstract 2525; Poster Session; Friday, March 4, 2016; 9:40 – 9:45 a.m. EST
  • Risk and Economic Burden of Antibiotic Failure in Patients with Moderate to Severe Hidradenitis Suppurativa; A. Kimball, et al.; Abstract 2552; Poster Session; Friday, March 4, 2016; 10:30 – 10:35 a.m. EST   
  • Uncovering Burden Disparity: A Comparative Analysis of Moderate to Severe Psoriasis and Hidradenitis Suppurativa Impact on Quality of Life; I. Hamzavi, et al.; Abstract 2473; Poster Session; Friday, March 4, 2016; 10:55 – 11:00 a.m. EST

About HUMIRA in the U.S.
Uses4

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 Information4

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. Data on File ABVRRTI61976.
  2. HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124. Published November 25, 2015. Accessed January 13, 2016.
  3. Pharmaceutical and Medical Devices Agency (PMDA) website. New Drugs Approved in FY 2013. Available at: http://www.pmda.go.jp/files/000153463.pdf#page=1. Accessed January 13, 2016.
  4. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

 

SOURCE AbbVie

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