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.
-- Almost 3 out of 4 patients (71%) receiving HUMIRA achieved PASI
75 compared to 7 percent of patients receiving placebo at week 16.
-- At week 16, 62 percent of HUMIRA-treated patients achieved a PGA score
of clear or minimal (0 or 1) compared to 4 percent of placebo-treated
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.
-- Nearly 80 percent (78%) of patients treated with HUMIRA (n=99)
achieved a PASI 75 response, compared to 19 percent of patients
treated with placebo (n=48).
-- More than 70 percent (71%) of patients treated with HUMIRA achieved a
PGA score of clear or minimal at 16 weeks of treatment, compared with
only 10 percent of placebo-treated patients.
The safety profile of HUMIRA in the plaque psoriasis clinical trials
was similar to that seen in HUMIRA clinical trials for rheumatoid arthritis
(RA). The most commonly reported adverse events in HUMIRA psoriasis trials
were upper respiratory tract infection, nasopharyngitis (inflammation of
the nose and pharynx), headache, sinusi
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