Short- and Long-term Safety Assessment of a Two-compound Ointment Containing Calcipotriene/Betamethasone Dipropionate (Taclonex®/Daivobet®/Dovobet® Ointment): Hypothalamic-Pituitary-Adrenal Axis Function in Patients with Psoriasis Vulgaris

The two-compound ointment (Taclonex®/Daivobet®/Dovobet® ointment) combining calcipotriene 50 μg/g and betamethasone 0.5 mg/g (as dipropionate) is very effective in the treatment of psoriasis vulgaris. There is a possibility that hypothalamo-pituitaryaxis (HPA) suppression may occur if the potent corticosteroid component is absorbed to a sufficient extent. The effect of the two-compound ointment on HPA axis function was assessed in two studies. Study 1 was a four-week, double-blind study which compared the effects of the two-compound ointment with betamethasone 0.5 mg/g (as dipropionate; Diprosone®) ointment in 24 patients with extensive psoriasis (involving 15–30% of the body surface area). No patients receiving the two-compound ointment had HPA axis suppression. Study 2 assessed HPA axis function after four and 52 weeks in a subset of patients (n=19) participating in a long-term safety study. Patients were treated with the two-compound ointment for the first four weeks followed by 48 weeks of treatment as needed with either 1) two-compound ointment; 2) two-compound ointment alternating with calcipotriene four-weekly or 3) calcipotriene. No patients using the two-compound ointment for all 52 weeks or alternating four-weekly with calcipotriene had HPA axis suppression.