Tacalcitol in the treatment of psoriasis vulgaris: the Spanish experience.
BACKGROUND: A group of vitamin D derivatives has revealed to be an efficient treatment for psoriasis. Different types of studies have been designed to confirm the efficacy of its use without relevant side-effects. OBJECTIVE: Evaluation of tolerability and efficacy of tacalcitol ointment in moderate psoriasis. DESIGN: A 2-month multicentre prospective open-label observational study in patients with psoriasis treated with tacalcitol ointment. METHODS: A cohort of patients with psoriasis vulgaris seeking medical advice and being treated with tacalcitol based on the decision of their dermatologists was selected. A 2-month follow-up was performed to assess efficacy and tolerability of tacalcitol in an ointment formulation (4 microg/g) once daily. A psoriatic lesion was selected in each patient in order to assess clinical symptoms (erythema, desquamation and thickness) by means of five-point scale: 0 (none) to 4 (maximal severity). Percentages of involved skin, adverse effects, physicians' global assessments of efficacy and tolerability, and patients' global satisfaction scores were also evaluated after 15-30 days (first visit) and 2 months (second visit) of treatment. RESULTS: A total of 556 patients were included. Mean psoriasis duration was 10.1 years (range, 0-61 years). Follow-up data were available for 493 patients in first follow-up visit and 449 in second (final) visit. Adverse events were uncommon (1.0% and 0.6% of patients in first and second follow-up visits, respectively). At first follow-up visit, mean decrease in selected lesions surface area (from a baseline value of 185.8 cm(2) per lesion) was 11.1 cm(2) (95% CI, 1.6-20.6; P = 0.0213). After 2 months of treatment, mean scores for erythema, desquamation and thickness changed from 2.2 +/- 0.8 to 1.1 +/- 0.8 (19% of patients with no erythema at final visit); from 2.4 +/- 0.8 to 0.6 +/- 0.7 (55% of patients with no desquamation); and from 2.2 +/- 0.9 to 0.8 +/- 0.6 (51% of patients with less thickness), respectively. Mean percentage of total body skin involvement was 14% (7.5% and 6.9% of anterior and posterior body surface, respectively). After 2 months of treatment, a 3.2% (95% CI, 2.7-3.8; P = 0.0001) and 3.0% (95% CI, 2.4-3.6; P = 0.0001) decrease was observed in the percentage of involved anterior and posterior skin surface area, respectively. Efficacy and tolerability evaluation by investigators was very good or good in 94% and 74% of patients, respectively; 78% of patients evaluated study treatment as satisfactory/very satisfactory. More than 80%, 50-80% and less than 50% of prescribed doses were used by 88%, 9.3% and 2.3% of patients, respectively. CONCLUSIONS: Tacalcitol was highly effective in the symptomatic treatment of moderate psoriasis. Compliance was very high, probably due to the easy and convenient application. Physicians' global assessments of tacalcitol were excellent, both for tolerability and efficacy. Excellent tolerability was confirmed by the low rate of adverse events. Our results in an everyday clinical setting show that tacalcitol is a useful therapy in patients with moderate psoriasis.