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Infliximab (Remicade, Centocor) Gives Stunning Psoriasis Results

RxSentinel Staff (6/8/01): According to research published by the University of Medicine and Dentistry of New Jersey (UMDNJ) in the June 9 issue of The Lancet, infliximab (Remicade) could be the next major therapy for approximately a quarter of the seven million Americans who suffer from moderate- to-severe psoriasis.

"The high degree of efficacy and rapid response seen in patients treated with infliximab far exceeded our expectations," said Alice Gottlieb, M.D., Ph.D., principal investigator and professor of medicine at UMDNJ-Robert Wood Johnson Medical School. "Infliximab is able to clear psoriasis in a high proportion of patients in a manner comparable to cyclosporine."

Psoriasis, a chronic skin disease, appears as raised red skin covered by a flaky white buildup. The exact cause is unknown. Some researcher believe that psoriasis is caused by signals from the immune system that accelerate the growth of skin cells, causing them to build up before the body can shed them.

The findings in this study suggest that a body chemical called tumor necrosis alpha (TNF-alpha), plays a pivotal role in the onset of psoriasis. Infliximab targets TNF-alpha. Researchers believe that blocking TNF-alpha activity reduces inflammation in psoriasis. "Since the realization that the T-cell plays an important role in soriasis, there's been a resurgence in drug research," said Dr. Gottlieb

Moderate- to-severe psoriasis is defined as involving 5 percent or more of the body surface. Although patients are typically treated with medicines such as cyclosporine that suppress the immune system, long-term exposure can cause harmful side effects such as high blood pressure and kidney disease.

The UMDNJ study lasted ten weeks and involved thirty-three patients, ages 18 to 75, with moderate-to-severe psoriasis. They received an infusion of infliximab -- 5 or 10 mg/kg -- or placebo. Subjects took infliximab treatments at the beginning of the trial and at weeks 2 and 6.

The study data shows that 82 and 91 percent of patients taking 5 mg/kg and 10 mg/kg of infliximab respectively, achieved a good to excellent or clear rating at week 10, versus 18 percent of patients on placebo. All responders in the infliximab 5 mg/kg group and 64 percent in the10 mg/kg group were rated either excellent for improvement or became clear of signs of disease.

82 and 73 percent of patients in the infliximab 5 mg/kg and 10 mg/kg treatment groups, respectively,experienced a 75 percent or better improvement, compared to 18 percent of patients receiving placebo. .

"The publication of these data in The Lancet underscores the level of unmet need of psoriasis patients and the importance of educating physicians about the potential benefits of novel therapies in development," said Dr. Gottlieb.

Infliximab is currently FDA-approved for the treatment of Crohn's disease and rheumatoid arthritis.