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Home » ABBOTT ANNOUNCES DATA ON HUMIRA TO TREAT PSORIASIS
ABBOTT ANNOUNCES DATA ON HUMIRA TO TREAT PSORIASIS
October 6, 2006
Positive Phase III data presented at the European Academy of Dermatology and Venereology Congress showed that Abbott's Humira was statistically superior to methotrexate in patients with psoriasis. More than twice the percentage of patients (80 percent) with moderate to severe psoriasis receiving Humira (adalimumab) achieved at least 75 percent improvement in disease extent and severity after 16 weeks compared with patients receiving methotrexate (36 percent), a standard systemic treatment for psoriasis. The study met its primary efficacy endpoint, which was to determine whether Humira would reduce disease activity more than methotrexate or placebo, as measured by a well-known psoriasis assessment tool. This is the first psoriasis study to feature a head-to-head comparison between a biologic agent and a standard systemic treatment, according to Abbott.
The CHAMPION study included 271 patients from eight European countries and Canada who were candidates for systemic therapy or phototherapy. The three-arm, 16-week study evaluated the treatment effect of Humira in comparison to methotrexate (MTX) or placebo, each dosed as monotherapy. The comparison of Humira and MTX was a non-inferiority analysis. Patients were randomized to receive either Humira in its standard dose of 40 mg subcutaneous injection every other week beginning one week following an initial single dose of 80 mg, or MTX or placebo.
The primary efficacy endpoint was the percentage of patients achieving at least a 75 percent reduction in disease activity at week 16 as measured by the Psoriasis Area and Severity Index score (PASI). Results at week 16 showed that nearly 80 percent of patients receiving Humira achieved PASI 75, compared with 35.5 percent receiving MTX and 18.9 percent receiving placebo. Patient response to Humira was rapid, with a mean PASI improvement of 57 percent achieved at week four, compared with baseline.
Abbott expects to submit a regulatory application for a psoriasis indication in Europe and the United States during the first half of 2007.
KEYWORDS Drug Pipeline Alert
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