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| |  Tazarotene Is First New Generation Retinoid For Treating Plaque Psoriasis SYDNEY, Australia, June 19, 1997 -- Research presented here yesterday at the World Congress of Dermatology shows that tazarotene, a novel, once-daily topical retinoid aqueous gel indicated for the treatment of stable plaque psoriasis, provides an important new treatment option for patients suffering from plaque psoriasis on up to 20 percent body surface area. Tazarotene, the first of a new generation of topical, receptor-selective retinoids for the treatment of plaque psoriasis, recently became available in Germany and Argentina under the trade name Zorac(R), and in the United States and Canada under the trade name Tazorac(TM). While oral retinoids have long been used in the treatment of psoriasis, their use has often been limited to patients with severe psoriasis, due to the potential adverse side effects associated with their use. Patients with mild-to-moderate psoriasis have had to rely on topical therapies such as topical steroids, vitamin D3 analogues, coal tar and anthralin. "Tazarotene answers a significant need when it comes to treating people with psoriasis," said Madeleine Duvic, MD, Department of Dermatology, University of Texas, Medical School, Houston, Texas. "Historically, our treatment options for treating mild-to-moderate psoriasis have been limited, at best. Because tazarotene is highly effective and has relatively few side effects, it provides a much-needed solution for the up to three percent of the world's population suffering from this debilitating disease." Tazarotene's Efficacy is Backed by Extensive Clinical Research The key to the efficacy of tazarotene in treating plaque psoriasis lies in its ability to modulate three key pathogenic factors of psoriasis -- abnormal differentiation, hyperproliferation and inflammation. Tazarotene is thought to achieve rapid, sustained efficacy by normalizing epidermal differentiation, reducing hyperproliferation and reducing the influx of inflammatory cells into the skin. In addition, its topical application directly targets the skin, the site of potential psoriatic defects. Results from large-scale clinical studies of 1,400 patients showed treatment success (defined as good, excellent or complete clearing) up to 70 percent on trunk/limb lesions and 60 percent on knee/elbow lesions with tazarotene. The onset of action was seen as early as one week, and therapeutic benefit was sustained in many patients up to 12 weeks after treatment. Tazarotene Fares Well in Comparison Studies In a comparison trial, tazarotene 0.05 percent and 0.1 percent once daily were as effective as fluocinonide (a potent topical corticosteroid) twice daily in decreasing plaque elevation of target lesions, including thick knee and elbow plaques. It also showed a significantly less likelihood of relapse by week 12 after therapy was discontinued than the fluocinonide group (tazarotene 0.1%: 18 percent versus fluocinonide: 55 percent). However, as expected with a potent topical steroid, fluocinonide showed less topical irritation. Unique Mechanism of Action Another reason researchers believe tazarotene is so well tolerated may be because of a unique mechanism of action. Once applied, tazarotene is rapidly metabolized, has a short residence time in the body and thus, has a minimal potential for storage in fatty tissue. "From a theoretical standpoint, there is a good chance that, unlike other retinoids, tazarotene may selectively, rather than indiscriminately, activate selective retinoid pathways," said Roshantha Chandraratna, PhD, Director of Retinoid Research, Allergan. "The topical delivery of tazarotene, together with its suspected intrinsic pharmacological selectivity, suggest that tazarotene can be used safely on a chronic, intermittent basis to maintain a psoriasis-free state." Tazarotene Used in Combination with Other Therapies Tazarotene is also highly effective in reducing the severity of psoriasis when used in combination with other existing therapies. For example, a multicenter, parallel-group, investigator-masked study found that tazarotene plus mid- or high-potency corticosteroids provided excellent results in reducing scaling and overall lesional severity. "What we found was that more than 90 percent of patients achieved treatment success (defined as a moderate, marked, almost clear or complete clearing response) when given a high-potency corticosteroid in combination with tazarotene," said Mark Lebwohl, MD, Department of Dermatology, Mount Sinai Hospital, New York, NY, who presented the phase III data. "These findings suggest that combining mid- or high-potency topical corticosteroids with tazarotene optimizes therapy." Extensive Research Proves Tazarotene's Safety Phase II and phase III clinical trials of more than 2,000 patients have shown that topically applied tazarotene aqueous gel showed significant efficacy with no consistent, clinically significant systemic adverse events. The most common side effects observed were mild-to-moderate local irritation, including pruritus, burning and erythema. "The extensive research we have conducted with tazarotene demonstrates that physicians can feel confident that the therapy will not only improve signs and symptoms of psoriasis -- it will do so with few negative side effects," said Ronald Marks, FRCPath, FRCP, Department of Dermatology, University of Wales College of Medicine, who presented the research. "Although tazarotene is a relatively new therapy, we have extensive data that shows that it is an effective and safe treatment." Tazarotene is contraindicated in women who are or may become pregnant. Women of childbearing potential should be warned of the potential risk and use adequate birth control measures when tazarotene is used. Tazarotene was developed by Allergan, Inc., headquartered in Irvine, California. The company is a technology-driven, global health care company focused on specialty pharmaceutical products for specific disease areas that deliver value to customers, satisfy unmet needs and improve patients' lives.
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