March 17, 2009 (San Francisco, California) — Calcitriol ointment as adjunctive therapy to topical steroids is beneficial in continuing to suppress the re-emergence of plaque psoriasis. The research, based on analysis of the first 150 of 300 patients to complete the regimen, was presented here at the American Academy of Dermatology 67th Annual Meeting.
High levels of topical steroids are the standard of care for plaque psoriasis, but when therapeutic levels of the drug are reduced to a maintenance level, about two thirds of patients relapse within 5 months.
This study patient population consisted of adults with moderate to severe plaque psoriasis over 3% to 20% of their body surface area. They received clobetasol propionate 0.05% sprayed twice daily for up to 4 weeks, as warranted. At the end of that period, they were switched to calcitriol ointment (3 μg/g), an active form of vitamin D, self-applied twice a day for up to 8 weeks.
"Roughly 75% of patients were considered a treatment success — a roughly 1-grade improvement between baseline and week 12," explained Lori Johnson, PhD, who works for Galderma Laboratories, the company that makes both of the products.
"You can tell from the photographs that some patients did continue to improve during the last 8 weeks of the study," after the steroids were stopped and calcitriol was used, she told Medscape Dermatology.
The last patient recently completed the trial and full analysis of the data is underway. The company hopes to submit a paper for review in the third quarter of this year.
Calcitriol ointment has been approved for use in Europe for many years and was approved by the US Food and Drug Administration last month. The ointment has a documented safety profile out to 52 weeks of use.
Jeffrey M. Weinberg, MD, director of dermatology research at St. Luke's–Roosevelt Hospital Center, in New York City, pointed to a published European trial from 6 years ago that showed that calcitriol had "superior safety and tolerability, superior efficacy in the target lesions, and superior patient-reported tolerability." He found the latest findings consistent with the earlier studies.
One theoretical concern about the use of a vitamin D product is that it can affect calcium uptake. Dr. Weinberg noted that although some patients in the trial had calcium levels at the upper level of normal, the effect was not significant.
The study was conducted at 12 academic medical centers with the financial support of Galderma Laboratories, where Dr. Johnson is employed. Dr. Weinberg has disclosed no relevant financial relationships.
American Academy of Dermatology (AAD) 67th Annual Meeting: Poster P3362. Presented March 8, 2009.
Medscape Medical News © 2009 Medscape
Cite this: Bob Roehr. AAD 2009: Calcitriol Maintains Suppression of Psoriasis - Medscape - Mar 17, 2009.
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