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New Analyses Support Infliximab Use for Severe Psoriasis, Show Significant Drug Effect on Nail Psoriasis: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 5, 2007 -- A retrospective analysis of data from 3 major clinical trials shows that more than three quarters of patients with severe psoriasis receiving Remicade (infliximab) achieved a 75% improvement in their disease at week 10 after initial treatment.

Investigators presented these findings here on February 2^nd at the 65^th Annual Meeting of the American Academy of Dermatology (AAD).

"We looked at integrated data from major Remicade trials, and we saw substantial efficacy for patients with severe psoriasis," said lead investigator Alan Menter, MD, chairman, division of dermatology, Baylor University Medical Center, Dallas, Texas. "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."

In another retrospective analysis of data from a phase 3 clinical study presented at AAD shows that Remicade achieved significant and progressive improvements in psoriasis affecting the nails, which is seen in approximately 50% psoriasis patients.

The integrated analysis included 1,462 patients randomized from 3 Remicade trials (3 mg/kg or 5 mg/kg doses). A total of 991 patients (68%) were diagnosed with severe psoriasis, as defined as psoriasis covering at least 20% of the body surface area. Of these, 73% had received prior phototherapy and 69% had received prior systemic drug therapy.

Treatment efficacy after 10 weeks of treatment was evaluated using the Psoriasis Area Severity Index 75 (PASI 75), which determined 75% or greater improvement in symptoms. The PASI score is the standard measure of improvement in psoriasis treatment. A patient's response is rated as poor (0-24%), fair (25%-49%), good (50%-74%), excellent (75%-99%), or cleared (100%).

Among patients with severe psoriasis who were treated with Remicade, data at week 10 showed 79% of those who had undergone phototherapy prior to study entry and 76% of those who had been treated previously with systemic drugs achieved a PASI 75 compared with 3% and 1%, respectively, of placebo patients.

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

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

"Psoriasis affecting nails is very difficult to treat, and a high proportion of psoriasis patients have it," said investigator Phoebe Rich, MD, associate professor of dermatology, Oregon Health Sciences University, Portland, Oregon.

"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 with chronic severe plaque psoriasis. The drug is administered by IV infusion. After the initial dosing, patients receive additional infusions at weeks 2 and 6. Then patients receive an infusion every 8 weeks.

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

The new analyses were supported by Centocor, Inc.


[Presentation titles: Efficacy of Infliximab in Patients With Severe Psoriasis: Subgroup Analysis From Clinical Trials. Poster 2702. Nail Psoriasis Improvement Is Maintained in Patients With Moderate to Severe Psoriasis Treated With Infliximab. Poster 2716]

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