Abbott to file for psoriasis application for Humira
Abbott Laboratories will file in Europe and the US next year to designate its Humira biotherapeutic for treatment of psoriasis after clinical trial results show patients responded twice as well to Humira as to conventional treatment. The Phase III 16-week clinical trial involved 271 patients from eight European countries and Canada who were candidates for systemic therapy or phototherapy for psoriasis.
At the study’s end, 80 percent of the patients receiving Humira (generic name: adilimubab) achieved at least a 75 percent reduction in disease activity, compared to 35.5 percent receiving Methotrexate, the standard treatment for psoriasis, and 18.9 percent receiving a placebo. Patient response to Humira was more rapid than the response to Methotrexate or placebo.
The study is the first to compare a biologic drug, to a standard systemic treatment in monotherapy, meaning not in combination. Dr. Martin Kaul, Abbott’s Global Pharmaceutical Research & Development project head of Humira in the treatment of psoriasis. He says before the study, the position of biologic therapy versus conventional therapy had not been known. "This study, for the first time, shows the differentiating efficacy and safety between a conventional therapy, in this case Methotrexate, and one of the biologics, in this case Humira," he says. "We consider it a breakthrough. It goes beyond the scope of just testing for adilimubab; it has important implications for psoriasis patients for the future."
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