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news.Abbott has simultaneously submitted an application requesting approval of Humira in chronic plaque psoriasis to both the FDA and the European Medicines Agency.
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Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself and create raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed.
The global submissions are based on the results of two trials of Humira. In both trials, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) score, which measures the extent and severity of psoriasis.
In a 52-week trial, the short-term and sustained clinical efficacy and safety of Humira were evaluated. Patients experienced a significant reduction in the signs of their disease at 16 weeks when treated with Humira; specifically 71% achieved PASI 75 or better, compared to only 6.5% of patients receiving placebo.
Humira is also approved to treat psoriatic arthritis, a form of arthritis that affects up to 30% of people with psoriasis.