"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D3 (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D3.
Clinical studies with radiolabelled calcipotriene ointment indicate that approximately 6% (± 3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques or 5% (± 2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application.
Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D3 (calcitriol), is known to be recycled via the liver and excreted in the bile. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone. The primary metabolites are much less potent than the parent compound.
There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin.
Adequate and well-controlled trials of patients treated with Dovonex® (calcipotriene ointment) ointment have demonstrated improvement usually beginning after two weeks of therapy. This improvement continued in patients using Dovonex® (calcipotriene ointment) once daily and twice daily. After 8 weeks of once daily Dovonex® (calcipotriene ointment) , 56.7% of patients showed at least marked improvements (6.4% showed complete clearing). After 8 weeks of twice daily Dovonex® (calcipotriene ointment) , 70.0% of patients showed at least marked improvement (11.3% showed complete clearing).
Subtracting percentages of patients using placebo (vehicle only) from percentages of patients using Dovonex® (calcipotriene ointment) who had at least marked improvements after 8 weeks yields 39.9% for once daily and 49.6% for twice daily. This adjustment for placebo effect indicates that what might appear to be differences between once daily and twice daily use may reflect differences in the studies independent from the frequency of dosing. Although there was a numerical difference in comparison across studies, twice daily dosing has not been shown to be superior in efficacy to once daily dosing.
Over 400 patients have been treated in open label clinical studies of Dovonex® (calcipotriene ointment) for periods of up to one year. In half of these studies, patients who previously had not responded well to Dovonex® (calcipotriene ointment) were excluded. The adverse events in these extended studies included skin irritation in approximately 25% of patients and worsening of psoriasis in approximately 10% of patients. In one of these open label studies, half of the patients no longer required Dovonex® (calcipotriene ointment) by 16 weeks of treatment, because of satisfactory therapeutic results.
Last reviewed on RxList: 5/6/2008
This monograph has been modified to include the generic and brand name in many instances.
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