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Abbott's HUMIRA® Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis - Abbott has received marketing authorization from the European Commission for the use of HUMIRA® (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. HUMIRA is the first fully human, self-injectable biologic for the treatment of psoriasis
Abbott's HUMIRA® Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis


NewswireToday - /newswire/ - Abbott Park, IL, United States, 2007/12/20 - Abbott has received marketing authorization from the European Commission for the use of HUMIRA® (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. HUMIRA is the first fully human, self-injectable biologic for the treatment of psoriasis.


In Clinical Trials, Patients Taking HUMIRA Saw Significant and Sustained Skin Clearance.

In one clinical trial, more than 80 percent of patients taking HUMIRA achieved skin clearance of 75 percent or better and in another, almost three quarters of patients achieved 75 percent clearance. In both trials, nearly half of the patients taking HUMIRA achieved 90 percent clearance as early as 16 weeks into treatment. Psoriasis is the fifth approved indication for HUMIRA in the European Union. A regulatory application for HUMIRA to treat psoriasis is also under review with the U.S. Food and Drug Administration.
''Psoriasis is not only a skin disease – it is a systemic, autoimmune disorder that, in its more severe forms, may require systemic treatment,'' said Professor Jean-Hilaire Saurat, M.D., chairman, department of dermatology, University of Geneva, Switzerland. ''HUMIRA is the first and only biologic that has been compared to methotrexate, and this approval brings an important new option for dermatologists to treat this disease.''

Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than painful skin lesions; data also suggest an association with other health conditions, including psoriatic arthritis. Patients may also suffer from poor self-image and social isolation.
''Patients taking HUMIRA for psoriasis experienced rapid, significant skin clearance and maintained improvement for up to a year,'' said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. ''This fifth indication for HUMIRA demonstrates its versatility in effectively treating multiple autoimmune disorders from rheumatoid arthritis to Crohn’s disease and now psoriasis.''

About HUMIRA Psoriasis Clinical Trials
The approval is primarily based on the results of two randomized, controlled, multi-center clinical trials in adult patients: CHAMPION and REVEAL. In both trials, the signs and symptoms of psoriasis were measured and evaluated using the Psoriasis Area and Severity Index (PASI) among other measures. CHAMPION was the first head-to-head study comparing a biologic medication to methotrexate, a standard systemic treatment for psoriasis.

In CHAMPION, a pivotal 16-week study evaluating 271 psoriasis patients from eight European countries and Canada, HUMIRA-treated patients experienced a significant reduction in the signs and symptoms of their disease compared with methotrexate or placebo-treated patients. More than twice the percentage (80 percent) of patients treated with HUMIRA achieved a PASI 75 response (75 percent or better improvement in PASI), compared to patients treated with methotrexate (36 percent), a standard systemic treatment for psoriasis, and more than four times the percentage of patients treated with placebo (19 percent). Nearly 17 percent of patients treated with HUMIRA achieved a PASI 100 response at week 16, compared to 7 percent of patients receiving methotrexate and 2 percent of patients receiving placebo. In addition, a mean percentage PASI improvement of 57 percent was achieved at week four in patients receiving HUMIRA, compared to baseline.

In REVEAL, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of HUMIRA were evaluated in more than 1,200 patients from the United States and Canada with moderate-to-severe chronic plaque psoriasis. Patients experienced a significant reduction in the signs and symptoms of their disease at 16 weeks when treated with HUMIRA. Specifically, almost three out of four patients (71 percent) receiving HUMIRA achieved PASI 75 compared to 6.5 percent of patients receiving placebo. One in five patients (20 percent) receiving HUMIRA achieved PASI 100 (complete clearance), compared to 1 percent of patients receiving placebo. For patients who maintained a PASI 75 response after eight months of continuous HUMIRA therapy, patients were either continued on HUMIRA or administered placebo for the remainder of the study. Significantly fewer patients (5 percent) on HUMIRA lost response (<50 percent improvement in PASI response relative to baseline, with a minimum six point increase in PASI score compared to week 33 of the year-long study) compared to patients on placebo (28 percent).

The most commonly reported adverse events in HUMIRA psoriasis trials were nasopharyngitis (inflammation of the nose and pharynx), upper respiratory tract infection and headache.

In the EU, the recommended HUMIRA dosing for adult patients with moderate-to-severe psoriasis is 80 mg at week zero, followed by 40 mg every other week starting at week one. HUMIRA is administered subcutaneously.

HUMIRA has ten years of clinical experience. More than 190,000 patients worldwide are currently being treated with HUMIRA. HUMIRA is also approved to treat psoriatic arthritis, a form of arthritis that affects up to 30 percent of people with psoriasis.

More Information About Psoriasis
Psoriasis is a chronic autoimmune disease that speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis appears as red, raised areas of skin covered with flaky white scales, which may itch or burn. Psoriasis most commonly appears on the scalp, knees, elbows, lower back, hands and feet, though it can develop anywhere on the skin. It may even occur in the fingernails and toenails.

While psoriasis occurs in people of all ages, it typically appears in patients between the ages of 15 and 25. Psoriasis affects an estimated 125 million people worldwide. The severity of the disease varies from person to person with approximately 25 percent of patients experiencing moderate-to-severe disease.

Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information.
Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.

TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA.


Written by / Agency / Source: Edelman Public Relations


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Abbott's HUMIRA® Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis

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