WASHINGTON, Feb. 7 /PRNewswire/ -- Oral tazarotene, a highly-selective retinoid, offers a unique combination of safety, efficacy and convenience according to year-long trial data presented today at the American Academy of Dermatology (AAD) annual meeting in Washington, D.C.
This new data demonstrates that oral tazarotene provides a new systemic treatment option for people with psoriasis that is conveniently taken as a 4.5 mg gel capsule once daily and specifically targets the skin receptors involved with skin disorders.
“In trials, clinical improvement was evident as early as four weeks after starting oral tazarotene treatment and continued through week 24,” said Alan Menter, M.D., P.A., chairman of the Division of Dermatology at Baylor University Medical Center at Dallas. “The effectiveness of this new therapy, coupled with its favorable safety profile, offers a new systemic retinoid treatment to people with psoriasis.”
Psoriasis is a life-long, genetic skin disorder in which the skin becomes inflamed, producing red, thickened areas with silvery scales, most often on the scalp, elbows, knees and lower back. Current treatments can be inconvenient, ineffective, and have significant tolerability and long-term safety concerns. According to the National Psoriasis Foundation (NPF), approximately 4.5 million people in the United States have the disease.
“All oral tazarotene studies have shown that a majority of patients achieved moderate to complete clearing by week 12 of treatment,” said Kim Papp, M.D., Probity Medical Research, Waterloo, Canada. “And of particular significance, a majority of patients maintained their improvements for at least 12 weeks after treatment was discontinued.”
Oral tazarotene is not affected by body weight, food intake, or alcohol consumption, and there are no known drug-drug interactions with oral tazarotene.
Long-term data
The long-term trial involved 263 patients who were treated with 4.5 mg oral tazarotene once daily for up to 52 weeks then followed for an additional 12 weeks post-treatment. Clinical improvements were evident within four weeks, with the majority of patients achieving moderate to complete clearing of symptoms by week 12. By week 24, about 68 percent had moderate to complete clearing. The majority of patients maintained these clinical improvements throughout the treatment period and for at least 12 weeks post-treatment. About 22 percent of patients who received oral tazarotene achieved no or minimal psoriasis by week 24 and maintained this level of improvement over the remaining 28 weeks of treatment.
Long-term use of oral tazarotene did not significantly increase the risk of side effects, most of which were mild in severity, and included dry lips, dry skin, headache, muscle ache, joint pain, infection, back pain and itch. About 14 percent of patients discontinued treatment because of side effects.
Expansion study
In the second abstract presented, 312 patients who previously completed 12 weeks of treatment but did not exhibit any improvement were enrolled in a 12- week extension trial. Participants included those previously treated with either oral tazarotene or placebo. Both groups showed considerable improvements in their psoriasis symptoms.
Overall, the majority of patients who had not responded to previous treatment experienced moderate to complete clearing by week 12, with many patients maintaining these benefits for at least 12 weeks post-treatment. Only 3 percent of patients discontinued therapy because of side effects, the majority of which were of mild severity.
Baylor University Medical Center, a Dallas-based not-for-profit medical center, cares for more than 300,000 patients each year. Opened in 1903, Baylor University Medical Center, flagship of Baylor Health Care System, is a major patient care, teaching and research center for the Southwest. Through the Baylor Research Institute more than 500 research protocols currently are under way in a range of medical specialties, including multiple psoriasis clinical studies. For more information about Baylor University Medical Center, visit http://www.baylorhealth.com/.
Baylor Health Care System
CONTACT: Wendy Walker of Baylor Health Care System, +1-214-820-4581, orpager, +1-214-920-6483, wendyw@baylorhealth.edu
Web Site: http://www.baylorhealth.com/
