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Remicade (Infliximab) Effective In Treating Moderate To Severe Psoriasis: Presented at AAD

NEW BRUNSWICK, NJ -- February 22, 2002 -- The monoclonal antibody infliximab has been shown to provide a rapid, durable response and a high level of sustained efficacy for at least six months in patients with moderate-to-severe psoriasis, according to new long-term data presented today at the 60^th Annual Meeting of the American Academy of Dermatology (AAD).

Approximately one quarter of the seven million Americans with psoriasis suffer from moderate-to-severe disease, which can be both physically and emotionally debilitating.

"Our findings to date suggest that infliximab may be a safe and effective therapy for the long-term treatment of this devastating, life-impacting disorder," said Alice Gottlieb, M.D., Ph.D., principal investigator and professor of medicine at the University of Medicine & Dentistry of New Jersey-Robert Wood Johnson Medical School. "With these promising results in psoriasis, we can now begin thinking about the possibility of a disease-modifying drug like infliximab that can achieve long-lived remission without the side effects of existing treatment options."

Infliximab (also known as Remicade®) is a monoclonal antibody that specifically targets and irreversibly binds to a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha), which is believed to play a pivotal role in psoriasis. Histology results have shown a high correlation between the clinical efficacy of infliximab and the cellular improvement in psoriasis plaques. These findings suggest that infliximab may treat underlying disease, as well as external symptoms of the skin.

The purpose of this open-label extension trial was to determine whether or not those who had a favorable response to infliximab in the initial randomized 10-week study (The Lancet, June 9, 2001) could maintain the clinically-relevant benefits of a Psoriasis Area Severity Index (PASI) improvement of >/= 50 percent. In the original trial, 82 and 73 percent of patients (5 mg/kg and 10 mg/kg treatment groups, respectively) experienced a 75 percent improvement in their PASI rating at week 10, following three doses of infliximab (at weeks 0, 2, and 6).

A total of 29 patients (15 at 5 mg/kg, 14 at 10 mg/kg) who received the three doses of infliximab were observed in the open-label extension study through 26 weeks. The data showed that more than half (55 percent, 16 of 29 patients) of the two combined treatment groups sustained their response for six months without re-treatment and maintained a >/= 50 percent improvement in their PASI rating. In addition, 48 percent of patients maintained a 75 percent improvement in PASI over the same study period.

Infliximab was generally well tolerated, with no serious adverse events reported. Overall, the safety profile was consistent with rheumatoid arthritis (RA) and Crohn's disease (CD) trials using infliximab.

Psoriasis is a chronic skin disease that generally appears as patches of raised red skin covered by a flaky white buildup. The flaring and remittance of these plaques can be physically and psychologically debilitating. Although the exact cause is unknown, psoriasis is believed to be related to signals sent by the body's immune system, accelerating the growth cycle of skin cells, causing them to pile up on the surface when the body can't shed them fast enough.

Moderate-to-severe psoriasis is defined as involving five percent or more of the body surface. Although these patients are typically treated with systemic immunosuppressants, such as cyclosporine, long-term exposure can cause toxic side effects such as hypertension and irreversible renal insufficiency.


SOURCE: University of Medicine & Dentistry of New Jersey

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