Source: DGNews  |  Posted 4 years ago

By Pam Harrison

TORONTO, CANADA -- July 3, 2007 -- Disease control is both more effective and more rapid with a new two-compound gel containing calcipotriene and betamethasone (Daivobet?/Dovobet?) compared with either active ingredient alone in patients with scalp psoriasis, according to findings presented here at the Canadian Dermatology Association 82nd Annual Conference(CDA).

The new two-compound gel combines calcipotriene 50 mcg/g as hydrate and high-potency betamethasone dipropionate 0.5 mg/g in a gel, used once-daily for the treatment of scalp psoriasis for up to 8 weeks.

In one phase 2 study presented by lead author Peter van de Kerkhof, MD, department head, department of dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands, 568 patients were randomised to the two-compound gel, 563 were randomised to betamethasone 0.5 mg/g in the same vehicle, and another 286 patients were assigned to calcipotriene 50 mcg/g, again in the same vehicle. Patients used the formulation once a day for up to 8 weeks.

The primary endpoint of the study was the percent of patients whose disease was judged to be controlled at 8 weeks. Disease control was defined as absence of disease or very mild disease, and control was assessed by the global assessment of disease severity score (IGA). At 8 weeks, disease was controlled in significantly more patients assigned to the two-compound-gel group (68.4%) compared with 61% of those in the betamethasone group and 43.4% in the calcipotriene group.

Patients using the two-compound gel achieved faster control of their psoriasis compared with the controls. At week 2, significantly more patients in the two-compound-gel group had very mild or no disease compared with patients in the other two groups.

Patients' overall assessment of "treatment success" was also significantly higher in the two-compound group (~70%) versus 60% in the calcipotriene group and approximately 45% in the betamethasone group. "The side effect profile was favorable in all groups, but there was more irritation in the calcipotriene group," investigators add.

In a 52-week evaluation of the safety of the two-compound gel, Thomas Luger, MD, professor and chairman, University Clinics, Munster, Germany, and colleagues explored the safety profile of the new gel out to 1 year. Of the patients who were treated with the two-compound gel, 419 patients were available for the safety analysis as were 431 patients in the calcipotriene (calcipotriol in Europe) gel group.

At the end of 52 weeks, 2.6% of patients in the two-compound gel group experienced one or more adverse drug reactions associated with long-term corticosteroid use as did 3% of the calcipotriol group. Two percent of those using the two-compound gel had withdrawn from treatment by the end of the year due to unacceptable toxicity versus 10.2% of those using the calcipotriol gel. Unacceptable efficacy was cited as the reason for withdrawal by 3.3% of patients in the two-compound-gel group versus 11.8% of those using the calcipotriol gel.

"The potential adverse events of concern associated with long-term use of potent topical corticosteroids include skin atrophy, skin striae, and suppression of the hypothalamic-pituitary-adrenal axis, as well as pustular psoriasis and skin infection," investigators observe. "But [in this study], there was no indication of the two-compound gel causing adverse events of concern associated with long-term corticosteroid use."

[[]Presentation title: Disease Control More Effective, Rapid With Two-Compound Gel for Scalp Psoriasis[]]