COMPARATIVE LONG-TERM SAFETY AND TOLERABILITY OF COMBINATION CALCIPOTRIOL/BETAMETHASONE DIPROPIONATE THERAPY IN SCALP PSORIASIS

Psoriasis of the scalp is widespread, hard to treat, and commonly has poor adherence due to difficulty with topical application and impact of cosmetic acceptability on continued usage. A two-compound scalp formulation containing calcipotriol and betamethasone dipropionate was also designed at a fixed dose to enhance the convenience and tolerability in addition to long-term safety. Methods: This was a long-term randomized comparative safety study, in which 900 adults with a minimum scalp psoriasis of moderate level were randomly assigned to two scalp formulation groups consisting of two compounds and calcipotriol monotherapy (nor 450). Routine clinical practice was followed with regard to the use of treatments once per day, as necessary, and with a 12-month follow-up. The variables of safety were withdrawals, adverse events, adverse drug reactions (ADRs) and events that were potentially linked to long-term exposure to corticosteroids on the scalp. Findings Baseline characteristics did not differ between groups. The percentage of patients who withdrew was less with the two compound formulation compared to calcipotriol (21.3% vs 39.8%) and less patients would have not been withdrawn because of the unacceptable adverse events and inadequate efficacy. The incidence of ADRs in both the two-compound formulation and calcipotriol were lower (17.1% vs 29.6%), as well as pruritus and skin irritation. Such a positive tolerability profile was sustained in exposure (0 to 6 months and 0 to 12 months) in patients who had prolonged exposure to treatment. Judged events which could have been associated with long-term corticosteroid use were rare and had a similar frequency in the groups. Conclusion: Long-term as-needed and once-daily use of the two-compound calcipotriol/betamethasone scalp formulation had a good safety and tolerability profile, decreased withdrawal rates and reduced ADRs than calcipotriol monotherapy without any observed increment in corticosteroid-associated scalp adverse events.