12797 Safety of long-term proactive management with fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam in patients with psoriasis vulgaris: Results of a phase III, multicenter, randomized, 52-week, vehicle-controlled trial

Abstract

Patients achieving treatment success (physician’s global assessment of disease severity [PGA] score ‘clear’/‘almost clear’ with ≥2-grade improvement from baseline) following once-daily Cal/BD for 4 weeks, were randomized 1:1 to twice-weekly Cal/BD or vehicle for 52 weeks. Eligibility criteria: ≥18 years; truncal and/or limb psoriasis at least ‘mild’ by PGA; involving 2%-30% body surface area (BSA); modified Psoriasis Area and Severity Index score (mPASI) ≥2. Additional criteria for HPA axis subgroup: truncal and/or limb psoriasis at least ‘moderate’ by PGA; involving 10%-30%, BSA; normal HPA axis function. Safety end points: adverse events (AEs); rebounds (mPASI ≥12 and increase from baseline in mPASI ≥125% or development of more inflammatory disease); effect on calcium homeostasis and HPA axis. 545 patients were randomized to Cal/BD (n = 272) or vehicle (n = 273). Characteristics at randomization were similar between groups. Rate of AEs per 100 patient-years was 165.1 and 156.1, Cal/BD and vehicle groups, respectively. Rate of serious AEs per 100 patient-years was low and comparable (8.2 Cal/BD; 7.8 vehicle), as was rate of treatment-related AEs (2.7 Cal/BD; 4.5 vehicle). Two AEs (chorioretinopathy and pain of skin) were adjudicated as related to long-term corticosteroid use. Three patients (2 Cal/BD [0.7%]; 1 vehicle [0.4%]) experienced AEs leading to discontinuation. Rebound within two months of entering the proactive-management phase occurred in six and seven patients, Cal/BD and vehicle, respectively. Rebound was four times as likely with vehicle (n = 17) compared with Cal/BD (n = 4) following relapse. No clinically relevant effect on calcium metabolism or HPA axis by subgroup analysis was observed.