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Title: Abbott's HUMIRA® Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis
URL: http://www.pslgroup.com/dg/219732.htm
Doctor's Guide
December 20, 2007

ABBOTT PARK, IL -- December 20, 2007 -- 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 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.


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.

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).