A long-term assessment of the safety and tolerability of calcitriol ointment in the treatment of chronic plaque psoriasis

Abstract

Calcitriol (1α,25-dihydroxyvitamin D₃) ointment has been shown to be effective in the treatment of chronic plaque psoriasis. The present open study was designed to assess the safety and tolerability of 3 μg/g calcitriol ointment applied twice daily over treatment periods of up to 78 weeks. In 253 evaluable patients with chronic plaque psoriasis no clinically relevant changes were observed in the baseline/endpoint analyses of any laboratory tests, including measurements of calcium homeostasis such as serum levels of total calcium, albumin-adjusted total calcium and phosphorus and plasma calcitriol levels. The treatment was well tolerated with no serious adverse events occurring during the course of the study. Eight patients withdrew due to adverse events which, though not serious, were thought to be treatment related: seven patients showed skin irritation reactions and in one case a mild, transient, asymptomatic hypercalcaemia was observed. Assessments of global severity, global improvement and Psoriasis Area and Severity Index (PASI) scores confirmed the therapeutic efficacy demonstrated in earlier studies. In conclusion, the twice daily application of 3 μg/g calcitriol ointment was safe, well tolerated and effective in the long-term treatment of chronic plaque psoriasis, and did not affect systemic calcium metabolism during prolonged treatment.

Key Words:

• Vitamin D
• Calcitriol
• Psoriasis