Nail psoriasis data now part of HUMIRA® label

• 80% of patients with plaque psoriasis may develop nail psoriasis in their lifetime
• Over 50% of moderate to severe psoriasis patients suffer from nail disease
• Psoriasis patients with nail involvement are three times more likely to have or develop psoriatic arthritis

MONTREAL, Oct. 25, 2017 /CNW/ - AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that Health Canada has approved the inclusion of nail psoriasis data in the HUMIRA Product Monograph. HUMIRA is approved for use in adult patients with chronic moderate to severe plaque psoriasis. This label update for HUMIRA stemmed from the results of the Nail Psoriasis Pivotal Trial M13-674; a trial specifically evaluating two primary endpoints of nail psoriasis.

According to the Canadian Guidelines for the Management of Plaque Psoriasis (Source: Canadian Psoriasis Guidelines Committee, June 2009) Canadian nail psoriasis is among the most challenging manifestations of psoriasis, in part due to the nature of drug delivery around and beneath the nail plate.  HUMIRA is the first biologic with data incorporated into its Product Monograph that was obtained from a clinical trial specifically designed with two primary endpoints to evaluate nail psoriasis.

Dr Kim Papp, Dermatologist with Probity Medical Research in Waterloo, Ontario said: "Psoriasis involving the finger nails may cause pain – imagine what your fingers feel like when they are caught in a car door.  And psoriasis involving the finger nails can result in significant impairment: inability to grasp or hold objects, impossible to pick up small items."

Stéphane Lassignardie, General Manager, AbbVie Canada added: "While researching nail psoriasis we learnt that patients experienced professional restrictions and missed more work days. At AbbVie, we are committed to our dermatology portfolio and finding solutions for unmet medical needs."

About HUMIRA

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 14 indications globally (10 in Canada), including more than 100 clinical trials with more than 33,000 patients. HUMIRA is approved in 90 countries and used by more than 1 million patients worldwide.

Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects. ¹ Before initiation of, during and after treatment with HUMIRA, patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph¹ available at www.abbvie.ca.

About AbbVie Care
The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey.  For more information, consult www.abbviecare.ca.

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience.  In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

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 before starting HUMIRA. 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 other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines.

Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph¹ at www.abbvie.ca

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¹ HUMIRA (adalimumab) Product Monograph. AbbVie Corporation. (July 28, 2017).

SOURCE AbbVie