Analysis: Remicade fights severe psoriasis

WASHINGTON, Feb. 2 (UPI) -- A new analysis of data from three major clinical trials shows that, 10 weeks after initial treatment, more than three-quarters of patients with severe psoriasis receiving Centocor's Remicade (infliximab) achieved a 75-percent improvement in their disease.

"We looked at integrated data from major Remicade trials, and we saw substantial efficacy for patients with severe psoriasis," lead investigator Alan Menter, chairman of the division of dermatology at Baylor University Medical Center in Dallas, told United Press International.

"Notably, patients with chronic severe psoriasis who previously failed phototherapy or systemic therapy showed significant improvement. These are patients who might have lost hope and who got it back."

Also, a new analysis of data from another clinical study shows that Remicade patients achieved significant and progressive improvements in psoriasis affecting the nails, suffered by approximately 50 percent psoriasis patients.

Investigators presented these findings Friday at the 65th Annual Meeting of the American Academy of Dermatology.

In the integrated analysis of 1,462 randomized patients from three Remicade trials, 991 patients -- or 68 percent -- were diagnosed with severe disease, as defined as psoriasis covering at least 20 percent of the body surface area. Of these 991 subjects, 73 percent had received prior phototherapy, and 69 percent had received prior systemic drug therapy.

At week 10, of the 991 severe psoriasis patients treated with Remicade at a dose of 3 mg/kg or 5 mg/kg, 79 percent of those who had already undergone phototherapy and 76 percent who had been treated with systemic drugs achieved a PASI (Psoriasis Area Severity Index) score of 75, compared with 3 percent and 1 percent, respectively, of placebo patients.

The PASI score is the standard measure of improvement in psoriasis treatment. A patient's response is rated as worse, poor (0 to 24 percent), fair (25 to 49 percent), good (50 to 74 percent), excellent (75 to 99 percent), or cleared (100 percent).

A separate analysis of data from the European Infliximab for Psoriasis Efficacy and Safety Study (EXPRESS) trial showed that, among subjects with psoriasis affecting the nails, 7 percent of those who were treated with Remicade 5 mg/kg showed disease clearance at week 10; 26 percent showed clearance at week 24; and 45 percent showed clearance at week 50.

In contrast, only 5 percent of patients in the placebo group achieved clearance at week 24.

Also, at weeks 10 and 24 the mean percent improvements in the Nail Psoriasis Severity Index (NAPSI) scores were 27 percent and 57 percent, respectively, among patients in the Remicade 5 mg/kg group. Placebo patients saw their disease worsening at weeks 10 and 24.

"Psoriasis affecting nails is very difficult to treat, and a high proportion of psoriasis patients have it," investigator Phoebe Rich, clinical associate professor of dermatology at the Oregon Health Sciences University in Portland, told UPI. "Psoriasis in nails can lead to holes in the nails and to nail separation from the nail bed. The new data shows the efficacy of Remicade treatment for psoriasis patients whose disease is affecting their nails," she added.

In September 2006 Remicade was approved for the treatment of adult patients with chronic severe plaque psoriasis. The drug is administered by IV (intravenous) infusion. After the initial dosing, patients receive additional infusions at weeks 2 and 6. Thereafter, patients receive an infusion every eight weeks.

Remicade is a biologic agent that targets a specific protein called tumor necrosis factor, or TNF, in the body's immune system to help control the development of inflammation, reducing painful symptoms in other diseases such as ulcerative colitis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis.