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Safety and efficacy of fixed-dose combination calcipotriol (50mug/g) and betamethasone dipropionate (0.5mg/g) cutaneous foam in adolescent patients (aged 12 to <17years) with plaque psoriasis: results of a phase II, open-label trial. Journal of the European Academy of Dermatology and Venereology : JEADV Seyger, M., Abramovits, W., Liljedahl, M., Hoejen, M. N., Teng, J. 2020

Abstract

BACKGROUND: Fixed-dose combination of calcipotriol (50mug/g; Cal) and betamethasone dipropionate (0.5mg/g; BD) foam is approved for plaque psoriasis treatment in adults, with a paucity of data supporting use in adolescents.OBJECTIVES: To evaluate safety of 4weeks' treatment with Cal/BD foam in adolescent patients with psoriasis, and additional safety outcomes in patients with more severe disease (HPA-axis cohort). Primary objectives included treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio in the HPA-axis cohort. Secondary objectives included exploratory efficacy endpoints [treatment success: change in Psoriasis Area and Severity Index (PASI)]. Systemic exposure to Cal/BD was also assessed.METHODS: A phase II, open-label, study (NCT02387853) in patients (12 to <17years) with at least mild psoriasis, to evaluate Cal/BD foam applied once daily for =4weeks.RESULTS: In patients assigned to treatment (n=106), 32 TEAEs occurred in 22 patients (20.8%). All but two TEAEs were mild; none led to study withdrawal or death. Changes (0-4weeks) in albumin-corrected serum calcium (overall population) and urinary calcium excretion (HPA-axis cohort) were small, transient and not considered clinically relevant. In the HPA-axis cohort, no change in urinary calcium:creatinine ratio was observed and responses to adrenocorticotropic-hormone (ACTH) challenge did not suggest disruption of the HPA-axis. Prespecified treatment success on the body and scalp was achieved by 71.8% and 75.7% of the overall population, respectively. Mean PASI decreased by 82.0% vs. baseline at Week 4. Systemic exposure to Cal/BD was minimal.CONCLUSIONS: Cal/BD foam was well tolerated in adolescent patients with body/scalp psoriasis. There was no evidence for dysregulation of the HPA-axis nor calcium homoeostasis in patients with more severe disease. Exploratory efficacy data in the overall population were encouraging.

View details for DOI 10.1111/jdv.16233

View details for PubMedID 32074665