New Phase II data demonstrate that patients with moderate to severe chronic plaque psoriasis receiving Humira (adalimumab) achieved statistically significant results after 12 weeks, with more than 50 per cent of patients achieving at least a 75 per cent improvement in measurements of disease extent and severity with 40 mg every other week (eow) dosing, and some patients achieving this level of improvement as early as four weeks.

At 12 weeks, 49 per cent and 76 per cent of patients taking Humira 40 mg eow or 40 mg weekly, respectively, were "clear" or "almost clear" of their disease activity as measured by the Physician's Global Assessment (PGA).

The data, presented this week at the American Academy of Dermatology annual meeting, were from a study designed to evaluate two dosing regimens of Humira. The data also show that Humira was well tolerated.

"In treating psoriasis, decreasing or clearing the physical manifestations of the disease are key to improving the quality of life of our patients," said Kenneth Gordon, lead study investigator. "These data are encouraging and give us an understanding of the potential in treating psoriasis."

Psoriasis is a non-contagious, chronic skin disease where the turnover of skin cells is rapid and the affected skin is thick, red and scaly. Psoriasis affects more than 4.5 million people in the US and currently has no cure.

Trial participants (n=148) with a diagnosis of moderate to severe chronic plaque psoriasis for at least one year and an affected body surface area of > 5 per cent were randomized to receive Humira or placebo administered by subcutaneous injection (under the skin). Patients received 80 mg of Humira at week 0 followed by 40 mg eow beginning at week 1 (placebo was administered on alternate weeks) (40 mg eow regimen), 80 mg of Humira at week 0 and 1, followed by 40 mg weekly at week 2 (40 mg weekly regimen), or placebo administered weekly beginning at week 0.

The primary efficacy endpoint was the percentage of patients achieving at least a 75 per cent reduction in disease activity at week 12 as measured by the Psoriasis Area and Severity Index Score (>PASI 75), which is a score ranging from 0-72 and measures the extent and severity of psoriasis. Results at 12 weeks show that response rates for both doses of Humira were statistically significantly greater than placebo. Fifty-three per cent of patients achieved at least a PASI 75 with 40 mg of Humira compared to four per cent of placebo patients and 80 per cent of patients achieved >PASI 75 with 40 mg of Humira weekly.

The percentages of patients on Humira therapy with a PASI 75 response were statistically significantly greater than those for patients on placebo as early as four weeks (eow =18 per cent (p=0.003), weekly =28 per cent (p<0.001) vs. placebo = 0 per cent). Additionally, patients taking Humira experienced a statistically significantly greater mean percentage change in PASI score relative to baseline compared to placebo (p<0.001) as early as one week after the initial dose (eow = -14 per cent, weekly = -15 per cent vs. placebo = -1 per cent).

"It is encouraging to see patients in this trial responded to treatment with Humira," said Jim Lefkowith, divisional vice president, Immunosciences Development, Abbott. "These preliminary results give us confidence as we continue to move forward with our clinical development programme in psoriasis."