March 17, 2015

AbbVie's Dermatology Leadership Showcased with HUMIRA® (adalimumab) Data at American Academy of Dermatology 2015 Annual Meeting

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- 22 abstracts further evaluate the safety, efficacy of HUMIRA in psoriatic arthritis and moderate to severe chronic plaque psoriasis and investigational use of HUMIRA for the treatment of moderate to severe hidradenitis suppurativa (HS)
- Late-breaking data to be presented on investigational use of HUMIRA in patients with moderate to severe HS

NORTH CHICAGO, Ill., March 17, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that data from 22 abstracts on HUMIRA® (adalimumab) and dermatological diseases will be presented at the upcoming 73rd Annual Meeting of the American Academy of Dermatology (AAD), March 20 – 24, in San Francisco. AbbVie's presence at AAD demonstrates the company's commitment to the field of dermatology, which is grounded in HUMIRA. HUMIRA is one of the most comprehensively studied biologics available, and is distinguished by 12 years of physician and patient experience in dermatology.

AbbVie data include abstracts in psoriatic arthritis and moderate to severe chronic plaque psoriasis, as well as investigational research on HUMIRA as a potential treatment for moderate to severe hidradenitis suppurativa (HS). Hidradenitis suppurativa is a painful, chronic inflammatory skin disease for which there currently is no approved medication.1,2,3 HUMIRA is not currently approved by regulatory authorities for the treatment of HS. One abstract on HS will be presented during The Late-Breaking Research in Dermatology Forums on Friday, March 20.

"AbbVie's data presented at AAD underscore our dedication to patients with serious inflammatory diseases and the physicians who care for them, and build upon more than two decades of experience our company has with HUMIRA," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We remain focused on studying innovative solutions that could potentially address unmet medical needs through a variety of clinical development programs, including our investigational studies of HUMIRA for the treatment of moderate to severe hidradenitis suppurativa."

In the United States, HUMIRA is approved for eight indications, including psoriatic arthritis (2005) and moderate to severe chronic plaque psoriasis (2008). Outside of the United States, HUMIRA is approved for 10 indications. There are more than 843,000 patients currently treated with HUMIRA worldwide.

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

Psoriatic Arthritis

HUMIRA and Psoriatic Arthritis:

  • Disconnect Between Radiographic Progression and Skin or Arthritic Outcomes in Psoriatic Arthritis Patients Treated with Adalimumab, Abstract 1703, Sunday, March 22, 9:35-9:40 a.m. PT, ePoster Presentation Center 3

Additional Psoriatic Arthritis Abstracts of Interest Include:

  • Rates and Risk Factors of PsA Disease Progression Amongst Newly Diagnosed PsA Patients, Abstract 1708, Sunday March 22, 2:00-2:05 p.m. PT, ePoster Presentation Center 3
  • Comorbid Psoriatic Arthritis Significantly Impairs Health-Related Quality of Life in Patients with Moderate to Severe Psoriasis, Abstract 1351, Sunday, March 22, 8:55-9:00 a.m. PT, ePoster Presentation Center 3

Moderate to Severe Chronic Plaque Psoriasis

HUMIRA and Moderate to Severe Chronic Plaque Psoriasis:

  • Efficacy of Adalimumab Compared with Methotrexate or Placebo Stratified by Baseline BMI in a Randomized, Placebo-Controlled Trial, Abstract 1350, Sunday, March 22, 10:25-10:30 a.m. PT, ePoster Presentation Center 3
  • Five-Year Interim Results from the ESPRIT 10-Year Post Marketing Surveillance Registry of Adalimumab for Moderate to Severe Psoriasis, Abstract 569, Sunday, March 22, 11:10-11:15 a.m. PT, ePoster Presentation Center 3

Additional Moderate to Severe Chronic Plaque Psoriasis Abstracts of Interest Include:

  • Development of a Patient-Reported Outcomes Instrument for the Measurement of the Sexual Impacts of Psoriasis, Abstract 1041, Sunday, March 22, 9:15-9:20 a.m. PT, ePoster Presentation Center 3

Investigational Studies of HUMIRA for Moderate to Severe Hidradenitis Suppurativa

  • The Late-Breaking Research in Dermatology Forums: Evaluating Optimal Medium-Term Dosing Strategy for Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa Based on Analysis of Integrated Results from the PIONEER I and II Phase 3, Randomized, Placebo-Controlled Trials, Abstract 2545 (Oral Presentation), Friday, March 20, 11:36 a.m. PT, Room 2022 (West Building)
  • Safety and Efficacy of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from First 12 Weeks of PIONEER I, a Phase 3, Randomized, Placebo-Controlled Trial, Abstract 570, Saturday, March 21, 3:30-3:35 p.m. PT, ePoster Presentation Center 2
  • Efficacy and Safety of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from PIONEER II, a Phase 3, Randomized, Placebo-Controlled Trial, Abstract 631, Saturday, March 21, 11:00-11:05 a.m. PT, ePoster Presentation Center 2 
  • Adalimumab for Skin Pain in Patients with Moderate to Severe Hidradenitis Suppurativa (HS): Results from the First 12 Weeks of PIONEER II, Abstract 2052, Saturday, March 21, 9:15-9:20 a.m. PT, ePoster Presentation Center 2
  • Adalimumab in Treatment Satisfaction with Medication (TS-M) in Patients with Moderate to Severe Hidradenitis Suppurativa (HS) in a 12-week Randomized Controlled Trial (PIONEER II), Abstract 2047, Saturday, March 21, 9:10-9:15 a.m. PT, ePoster Presentation Center 2
  • Adalimumab in Health-Related Quality of Life (HRQoL) in Patients with Moderate to Severe Hidradenitis Suppurativa (HS): Results from the First 12 Weeks of PIONEER II, Abstract 669

About HUMIRA in the U.S.

Uses

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 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 U.S. Prescribing Information and Medication Guide.

About HUMIRA in the E.U.

HUMIRA is approved for use in moderate to severe rheumatoid arthritis, active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn's disease and moderate to severely active ulcerative colitis. See SmPC for full indication.

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.

(see SmPC for full details at https://www.medicines.org.uk/emc/medicine/21201)

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 more than 26,000 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. Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
  2. Zouboulis CC, Tsatsou F (2012) Disorders of the Apocrine Sweat Glands. In: Goldsmith LA, Katz SI, Gilchrest BA, Paller AS, Leffell DJ, Wolff K (eds) Fitzpatrick's Dermatology in General Medicine. 8th ed, McGraw Hill, New York Chicago, pp 947-959.
  3. Mayo Health Clinic. Hidradenitis Suppurativa. Available at: http://www.mayoclinic.com/health/hidradenitis-suppurativa/DS00818. Published April 9, 2013. Accessed January 23, 2015.

 

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SOURCE AbbVie

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