SAN ANTONIO, Texas—An integrated analysis of data from three randomized, placebo-controlled trials showed that Remicade® (infliximab) produced nearly complete skin clearance on the head, trunk, lower and upper extremities, Alan Menter, MD, reported at the 66th annual meeting of the American Academy of Dermatology.¹

"This analysis shows that treatment with Remicade resulted in a consistently high level of clinical response in each quadrant of the body evaluated by PASI [Psoriasis Area Severity Index], and the results were consistent with patients' overall psoriasis improvement. Remicade remains an important advancement and biologic treatment option for a broad spectrum of patients with severe psoriasis," said Dr. Menter, dermatologist at Baylor Research Institute in Dallas, Texas.

The analysis included data from the SPIRIT (Study of Psoriasis with Infliximab [Remicade] Induction Therapy), EXPRESS (European Infliximab for Psoriasis [Remicade] Efficacy and Safety Study), and EXPRESS II (Evaluation of Infliximab for Psoriasis in a [Remicade] Efficacy and Safety Study) clinical trials, which together comprised 1462 patients.

According to the combined datasets, at week 10 of treatment

• 71% of patients receiving infliximab 3 mg/kg achieved 75% improvement in psoriasis (PASI 75), vs 3% of patients receiving placebo (P <.001)
• 79% of patients receiving infliximab 5 mg/kg achieved PASI 75 vs 3% of patients receiving placebo (P <.001)
• 39% of patients receiving 3 mg/kg achieved nearly complete skin clearance (PASI 90) vs 1% with placebo (P <.001)
• 52% of patients receiving 5 mg/kg achieved PASI 90 vs 1% with placebo (P <.001)
• In September 2006, the US FDA approved infliximab 5 mg/kg for the treatment of chronic plaque psoriasis. Following a 3-infusion induction regimen, the drug is given once every 8 weeks.

Head and neck-related psoriasis in patients treated with the 5 mg/kg dose improved by at least 90% in 69% of SPIRIT patients, 73% of EXPRESS patients, and 67% of EXPRESS II patients versus 12%, 8%, 5% of placebo patients, respectively.

Trunk psoriasis in patients treated with infliximab 5 mg/kg improved by at least 90% in 66% of SPIRIT patients, 72% in EXPRESS patients, and 59% of EXPRESS II patients versus 4%, 1%, 4% of placebo patients, respectively.

Psoriasis of the upper extremities in patients treated with infliximab 5 mg/kg improved by at least 90% in 49% of SPIRIT patients, 56% of EXPRESS patients, and 46% of EXPRESS II patients, versus 2%, 1%, 0.5% with placebo.

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