Abbott has received US Food and Drug Administration (FDA) approval to market Humira (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis, an autoimmune disease characterized by skin lesions that are sometimes painful and itchy.

Humira has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. Humira has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn's disease in 2007.

"The approval of Humira for psoriasis is welcome news for people living with this challenging, lifelong disease," said Pam Field, acting president and CEO, National Psoriasis Foundation. "We are pleased to let people with plaque psoriasis know they now have a new treatment option available to them."

Psoriasis affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease. Psoriasis is a serious, sometimes painful autoimmune disease resulting in inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. In addition to visible symptoms, people with psoriasis may suffer from poor self-image and social isolation, and even feelings of depression, such as sadness and despair. Recent research also suggests psoriasis may be associated with other serious health risks. Up to 30 percent of psoriasis patients develop psoriatic arthritis, which combines skin symptoms with arthritis symptoms, including joint pain and inflammation.

"The approval of Humira is excellent news for patients suffering from psoriasis, which can have a profound physical and emotional impact on a person's life," said Alan Menter, M.D., chairman, division of dermatology, Baylor University Medical Center, Dallas. "Humira offers dermatologists an important new therapeutic option that has been shown to help alleviate a range of psoriasis signs and symptoms, including redness, scaling and itching, in many psoriasis patients."

The approval of Humira is based on data from more than 1,400 adult patients in two pivotal trials - REVEAL and CHAMPION. Both studies evaluated the efficacy and safety of HUMIRA in clearing skin in moderate to severe adult plaque psoriasis patients versus placebo. In addition, CHAMPION compared a biologic medication to methotrexate, a standard systemic treatment for psoriasis. REVEAL results were published in the Journal of the American Academy of Dermatology in January 2008 and CHAMPION results were published online in the British Journal of Dermatology.

In each trial, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). The PASI score measures the extent and severity of psoriasis. PASI may be calculated before and after a treatment period to determine efficacy; for example, a PASI 75 correlates to a 75 per cent improvement in signs and symptoms of psoriasis. PGA also measures efficacy of therapy. On a six-point scale, a zero score means no signs, one means minimal and a five means signs of very severe psoriasis.

In addition to its approval for chronic plaque psoriasis, Humira is approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of joint structural damage, and improving physical function in adult patients with moderately to severely active RA. HUMIRA is indicated for reducing the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. Humira resembles antibodies normally found in the body. It works by blocking tumour necrosis factor alpha (TNF-?), an inflammatory protein that, when produced in excess, plays a key role in the inflammatory responses of some autoimmune diseases.

According to an Abbott press release, to date, Humira has been approved in 72 countries and more than 250,000 people worldwide are currently being treated with Humira. Clinical trials are currently under way evaluating the potential of Humira in other immune-mediated diseases.

In May 2007, Abbott announced it had also submitted an FDA regulatory application for Humira to treat juvenile rheumatoid arthritis and an EMEA regulatory application for Humira to treat juvenile idiopathic arthritis. Clinical trials are currently underway evaluating the potential of Humira in ulcerative colitis. Humira is also approved for reducing signs and symptoms in patients with active AS. Humira is approved for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.