New formulation: Calcitriol (Vectical), a Vitamin D analogue, was approved on January 23, 2009, for the treatment of mild-to-moderate plaque psoriasis
Calcitriol is a vitamin D analogue that was approved on January 23, 2009, for the topical treatment of mild-to-moderate plaque psoriasis in adults aged ≥18 years. The mechanism of action by which calcitriol exerts its effects on plaque psoriasis has not yet been established.
Efficacy. The efficacy of this agent was assessed in 2 multicenter, double-blind studies. A total of 839 patients were randomized to treatment with either calcitriol ointment 3 mcg/g or vehicle ointment twice daily for 8 weeks. The primary end point was the percentage of patients classified as having "clear" or "minimal" disease with a ≥2-grade change from baseline at 8 weeks. In Study 1, 23.4% of calcitriol-treated patients and 14.4% of vehicle-treated patients achieved this end point; in Study 2, 20.5% of calcitriol-treated patients and 6.6% of vehicle-treated patients achieved this end point.
Safety. In clinical trials, hypercalcemia was observed more frequently in calcitriol-treated patients than in vehicle-treated patients. Patients should avoid excessive exposure of treatment areas to natural or artificial sunlight. The most common adverse events associated with calcitriol treatment include laboratory test abnormalities, urine abnormalities, psoriasis, hypercalciuria, and pruritus.