WAIKOLOA, HAWAII — Clobetasol propionate spray 0.05% resulted in dramatic clinical improvement with a low rate of adverse events and excellent acceptance in patients with moderate to severe generalized psoriasis in the largest community-based trial ever conducted in psoriasis.
Results of the 2,488-patient Clobex Spray Community-Based Research Assessment (COBRA) trial advance psoriasis therapy to the threshold of a breakthrough era, said Dr. John Koo at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation. For patients with moderate to severe generalized disease, there is now the prospect of entirely topical short-term and maintenance therapy that's practical and offers absolute systemic safety.
COBRA was an open-label study conducted at 455 U.S. sites. Participants received clobetasol propionate spray 0.05% (Clobex) twice daily for 4 weeks. The efficacy evaluation involved 1,254 patients with moderate to severe plaque psoriasis treated with clobetasol spray as monotherapy and 731 others with more treatment-resistant disease who received it as add-on therapy. Participants had a 14-year mean duration of psoriasis. Dr. Koo drew particular attention to the mean 11% body surface area involvement at baseline.
COBRA included 183 out of the evaluable 1,254 patients who received clobetasol spray as add-on therapy because they weren't responding adequately to a biologic agent. The other common ongoing treatments alone or in various combinations were topical calcipotriene, non-class-1 topical steroids, and oral antipsoriatic agents.
Treatment success on a target plaque severity measure was defined as clearing, near clearing, or at least a 2-point improvement on a 6-point severity scale. This was achieved at week 2 in 60% of the clobetasol monotherapy group and 59% who received the superpotent topical steroid spray as add-on therapy. After 4 weeks, the success rate was 80% in both populations, explained Dr. Koo, professor and vice chairman of the department of dermatology and director of the psoriasis treatment center at the University of California, San Francisco.
On the target plaque severity scale, success rates at week 4 for clobetasol spray as add-on therapy were 76%–84%.
The other outcome measure was physician global assessment of improvement. Success required a rating of clear or almost clear on whole body assessment. This was achieved in 30% of the monotherapy group and 27% of the add-on treatment group at week 2, and in 69% of monotherapy and 62% of add-on therapy patients at week 4.
Seventy-five percent of participants were reported by their physicians as being very satisfied with their treatment at week 4, while another 19% were somewhat satisfied. Ninety-five percent of patients completed the study.
Among the 2,242 patients included in the safety analysis, one-quarter to one-third experienced treatment-related erythema, stinging/burning, dryness, or peeling/scaling, but these side effects were rated severe in less than 1% of cases. Telangiectasias, skin atrophy, and folliculitis occurred in 1% or less of patients at 4 weeks; pruritus was noted in 5.9%.
Dr. Koo is on the scientific advisory board of Galderma, which sponsored the COBRA trial. He is also a consultant to several other drug and device companies.
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