"The skin clearance we have seen in HUMIRA psoriasis clinical trials, combined with ten years of clinical experience across indications and the convenience of self-injection, make HUMIRA a much anticipated treatment option for this condition," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott.
About HUMIRA Psoriasis Clinical Trials
The opinion is primarily based on the results of two randomized, controlled, multi-center clinical trials in adult patients: REVEAL and CHAMPION. 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, the standard systemic treatment for psoriasis.
-- 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 (75 percent or better
improvement in PASI), compared to 6.5 percent of patients receiving
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
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