KOLOA, HAWAII — With the plethora of topical clobetasol propionate formulations already on the market, why do physicians and patients need the recently approved Clobex spray that's now reaching pharmacy shelves?
“Compliance, compliance, compliance,” Dr. Chai Sue Lee said at the annual Hawaii Dermatology Seminar sponsored by the Skin Disease Education Foundation.
A 2005 survey from the National Psoriasis Foundation showed that 73% of psoriasis patients, regardless of disease severity, are less than “very satisfied” with their current treatment.
Clobetasol propionate is already the most commonly prescribed topical corticosteroid for moderate to severe psoriasis in the United States and Europe. Some patients will find the new clobetasol propionate 0.05% spray (Clobex spray) more user friendly than other formulations of the drug. And increased patient satisfaction is likely to translate into improved treatment compliance, explained Dr. Lee, director of the psoriasis treatment center at the University of California, Davis.
In two multicenter phase III randomized, double-blind, vehicle-controlled, and Galderma-sponsored clinical trials, twice-daily Clobex spray resulted in a high rate of durable treatment responses. Indeed, 72% of Clobex spray responders in one study and 76% in the other remained clear, almost clear, or with only mild psoriasis, a full 4 weeks after the end of 4 weeks of therapy. Adverse events were similar in the Clobex and control groups.
The prospect of better compliance is also a major selling point for the combination calcipotriene/betamethasone dipropionate approved by the FDA earlier this year. The two drugs aren't ordinarily compatible due to differing pH requirements. However, Warner-Chilcott came up with a water-free vehicle that allows for a stable combined product.
In the United States, the combination is known as Taclonex. In Europe and Canada, where it has been available as Dovobet or Daivobet for several years, it has rapidly grabbed market share. The widespread use is attributed in part to the fact that the combination product is highly effective as once-daily therapy, which confers a significant compliance advantage over other psoriasis topicals. Moreover, once-daily dosing means half the exposure to drug side effects, compared with twice-daily dosing, as well as lower medication volume and cost, Dr. Lee continued.
Taclonex is one of the most extensively studied topical agents in the world. It has been the subject of seven completed international clinical trials totaling more than 7,000 psoriasis patients. A recent metaanalysis involving six of these double-blind randomized trials totaling more than 6,000 psoriasis patients concluded that 4 weeks of therapy with the two-compound product resulted in 65%–74% reductions in the Psoriasis Area and Severity Index, significantly better than with either agent alone. The tolerability profile was similar to betamethasone monotherapy and better than with calcipotriol alone (J. Eur. Acad. Dermatol. Venereol. 2006; 20:39–44).
The studies demonstrated Taclonex was effective not only for acute flares, but also as maintenance therapy in a 52-week trial.
“Also, for those of us who do not feel comfortable prescribing a class-2 steroid like betamethasone for long-term maintenance, another strategy would be to switch to intermittent therapy with weekday calcipotriol and weekend Taclonex, or even just calcipotriol monotherapy once the disease has been gotten under control,” Dr. Lee said.
Yet another intriguing development in topical therapy is an over-the-counter (OTC) hydrogel patch modified by the addition of an impermeable coating on one side. The goal is an inexpensive, user-friendly form of occlusive therapy for psoriasis.
Preliminary results of a 120-patient, open-label right/left comparison study by University of California, San Francisco, dermatologists showed that the patch readily covered hard-to-wrap areas such as the elbow. The patch alone resulted in substantial improvement in mild psoriasis lesions. Moreover, when the patch was applied over OTC 1% hydrocortisone, tacrolimus 1% ointment, or more potent topical agents, the result was in every case superior to the drugs alone, according to Dr. Lee.
Dr. Lee disclosed that she has conducted research sponsored by Warner-Chilcott.
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