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Volume 2 Published - 14:00 UTC    08:00 EST    06-March-2001      
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Back To Vidyya Study Supports Potential Oral Treatment For Psoriasis Sufferers

ASM 981 (Pimecrolimus) Oral Tablet

Data presented at the 59th Annual American Academy of Dermatology (AAD) meeting support the further study of the efficacy and safety of ASM 981 (pimecrolimus) oral tablet in the treatment of adult patients with moderate to severe chronic plaque psoriasis. An ascomycin macrolactam, ASM 981 is a selective inflammatory cytokine inhibitor that is being developed by Novartis Pharmaceuticals Corporation specifically for the treatment of inflammatory skin diseases.

"The findings for oral ASM 981 are encouraging as there is a need for a safer treatment option for patients with moderate to severe plaque psoriasis," said Ken Washenik, MD, PhD, Director of Dermatopharmacology, New York University School of Medicine. "Patients within this spectrum of disease severity can be more challenging to treat, particularly given the extensive range of side effects for currently available treatments. Knowing that a patient may no longer have to face reactions from nausea to high blood pressure, as seen with current treatments, ASM 981 may offer an exceptional new possibility for long-term sufferers."

The randomized, double-blind, placebo-controlled pharmacokinetic study was conducted to assess the safety, tolerability and efficacy of orally-administered ASM 981 in patients with moderate to severe chronic plaque psoriasis. The study examined 50 patients (80 percent on ASM 981, 20 percent on placebo) across five consecutive increasing-dose groups for a total of four weeks. Each group's dosing remained constant, with the respective dose levels of ASM 981 at 5 mg OD (once daily), 10 mg OD, 20 mg OD, 20 mg BID (twice daily), and 30 mg BID.

A treatment effect was noted with all doses, with a substantial effect at the 20 mg and 30 mg BID dosings. This was measured by reduction of the severity and extent of the signs of the disease. A 60 percent (20 mg BID) and 75 percent (30 mg BID) reduction was seen by week 4, as compared to a 4 percent reduction for placebo. The adverse event profile for ASM 981 was favorable at all dosages and no serious adverse events occurred. The most frequently reported adverse event suspected to be related to ASM 981 was transient mild to moderate feeling of warmth not associated with flushing or any changes in vital signs. The study showed no clinically significant change in any safety parameter including physical examination, blood pressure, ECG, blood chemistries, blood glucose tolerance tests, and three different renal function tests.

Psoriasis is a chronic skin disease from which more than 7 million people in the United States suffer, according to the National Psoriasis Foundation. Chronic plaque psoriasis occurs in 80 percent of patients with psoriasis. It is a condition, which results in patches of thick, red skin covered with flaky white or silvery scales. These patches, sometimes referred to as plaques, may itch and burn. They occur on the elbows, knees, scalp, lower back, face, palms, and may also affect other sites including the fingernails and genitalia.

Approximately 20 to 25 percent of psoriasis sufferers have moderate to severe disease. While varied options for treating moderate to severe psoriasis do currently exist, not all are orally administered, all carry the risk of short- and long-term side effects and many are inconvenient to use. Worrisome side effects of current available therapies to treat moderate to severe psoriasis may include liver damage, kidney damage, birth defects, high blood pressure, and an increased risk of skin cancer.

According to Alice Gottlieb, MD, PhD, WH Conzen Chair in Clinical Pharmacology, Professor of Medicine, Director, Clinical Research Center at UMDNJ-Robert Wood Johnson Medical School, "Having psoriasis can generate feelings of frustration, despair, and low self-esteem. Having a new agent that is performing well in early clinical trials is promising, and the fact that it is an oral formulation is particularly encouraging given the low compliance rates among adult sufferers with topical treatments and the toxicity of currently available oral therapies."

Additional studies of ASM 981 tablets are underway to examine its efficacy in treating other skin diseases including atopic dermatitis.

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Editor: Susan K. Boyer, RN
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