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Oral Tazarotene Appears Tolerable, Safe and Effective in Long-term Treatment of Moderate to Severe Plaque Psoriasis: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 10, 2004 -- The investigative oral formulation of tazarotene appears to have significant efficacy and a good safety profile for patients with moderate to very severe plaque psoriasis, researchers reported here February 9^th at the American Academy of Dermatology 62^nd Annual Meeting.

Alan Menter, MD, chairman, division of dermatology, and director, Psoriasis Center, Baylor University Medical Center, Dallas, Texas, and colleagues reported that 56% of the 263 treated subjects achieved moderate to complete clearing (50% or greater global improvement) by week 12 of the initial treatment period in this open-label trial, which lasted a total of 64 weeks.

At the end of the 12-week active-treatment period, 152 subjects entered an extension phase for the remaining 52 weeks. Sixty-eight percent achieved moderate to complete clearing by week 24, and 44% achieved at least a marked (75%) improvement by Week 36.

At baseline, psoriasis was moderate in 66% of subjects, severe in 30% and very severe in 4%. The subjects were 68% male, 83% Caucasian, and had a mean age of 48 years, with a mean duration of psoriasis of 21 years.

The researchers observed that the subjects achieved significant reductions from baseline in the mean scores of plaque elevation, of scaling and erythema from week 2 through at least week 64 for all lesions overall, of elbow and knee lesions and trunk and limb lesions, as well as significant reductions from baseline in the mean scores for pruritus and scalp psoriasis from week 2 through at least week 64. They reported no evidence of tachyphylaxis.

Citing safety and tolerability issues, the authors reported: "Compared to other retinoids, oral tazarotene was associated with only a low incidence of adverse events, such as alopecia, hypertriglyceridaemia, hepatotoxicity, ocular dryness, desquamation and pruritis."

"We have seen notable results from 12-week treatment studies with oral tazarotene," said Dr. Menter. "In this study we've gone out to 1 year using the optimal dose of 4.5 mg daily. We found that the important distinguishing issue for this drug is that of safety and tolerability. All of us in dermatology are concerned about retinoid side effects. The most important thing that we see in this study is in the incidence of side effects; we see a very different and better side-effect profile emerging for this drug than what we have come to expect with retinoids for psoriasis."

On November 25, 2003, Allergan, Inc. submitted a new drug application to the U.S. Food & Drug Administration (FDA) for oral tazarotene for the treatment of moderate to very severe psoriasis.


[Study title: A Long-Term, Open-Label Study of the Safety and Efficacy of Oral Tazarotene in Moderate to Very Severe Plaque Psoriasis. Abstract 6]

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