Calcipotriol plus betamethasone dipropionate aerosol foam versus apremilast, methotrexate, acitretin, or fumaric acid esters

BACKGROUND: Plaque psoriasis has significant impact on patients' quality of life. Topical therapy is considered the treatment mainstay for mild-to-moderate disease according to guidelines. Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam is indicated for psoriasis vulgaris treatment in adults. Cal/BD foam trials demonstrated improved efficacy and similar safety in this population. Psoriasis treatment is complicated by the broad range of disease presentation, variability, and therapeutic options; particularly decisions on transition from topical to non-biologic systemic treatment are difficult. Assessing comparative effectiveness of treatment options provides meaningful value to treatment decisions.

OBJECTIVE: To compare efficacy of Cal/BD foam individual patient data from pooled trials with efficacy of non-biologic systemic treatments based on aggregated patient characteristics and treatment outcomes.

METHODS: Individual data from 4 Cal/BD foam trials in 749 psoriasis patients were pooled to conduct matching-adjusted indirect comparisons. Literature review identified non-biologic systemic treatment trials where methods, populations, and outcomes align with Cal/BD foam trials. Of 3,090 screened publications, 4 studies of apremilast, methotrexate, acitretin, or Fumaric Acid Esters (FAE) were included.

RESULTS: After baseline matching, patients treated with 4 weeks of Cal/BD foam had greater Physician's Global Assessment 0/1 response compared to those treated with 16 weeks of apremilast (52.7% vs. 30.4%; P<0.001). Patients treated with Cal/BD foam had significantly greater Psoriasis Area and Severity Index (PASI) 75 response at Week 4 compared to 16 weeks of apremilast treatment (51.1% vs. 21.6%; P<0.001). Cal/BD foam patients demonstrated significantly greater PASI 75 response improvements at Week 4 versus 12 weeks of methotrexate (50.8% vs. 33.5%; P<0.001) or acitretin (50.9% vs. 31.7%; P=0.009), and comparable response to FAE (42.4% vs. 47.0%; P=0.451).

CONCLUSIONS: Despite recent treatment advances, unmet needs for psoriasis patients remain. Cal/BD foam offers improved efficacy in baseline matched psoriasis patients compared to apremilast, methotrexate, or acitretin, and comparable efficacy to FAE. This article is protected by copyright. All rights reserved.