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Introduction: Psoriasis is a chronic, inflammatory disease, which ranges in severity from mild to severe. Although topical therapies are frequently used to treat mild disease, they are not routinely used to treat patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥ 5% BSA). Based on well-controlled trials in adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg/g + betamethasone dipropionate 0.5 mg/g (Cal/BD) cutaneous foam has been approved (Enstilar®, LEO Pharma) in the USA and EU for the treatment of psoriasis vulgaris for up to 4 weeks in adults. In this post-hoc subgroup analysis, we used pooled data from phase II/III trials to investigate the efficacy and safety of Cal/BD cutaneous foam in patients with moderate-to-severe psoriasis. Methods: Patients included in this analysis had psoriasis affecting 5–15% BSA and a physician's global assessment (PGA) ≥ 3. Endpoints included: treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety. Results: A total of 340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam. Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam. Sixty-six adverse events (AEs) occurred in 47 (18.5%) patients receiving Cal/BD foam and 11 AEs occurred in 11 (12.8%) patients receiving vehicle foam. Three severe AEs and 15 non-serious treatment-related AEs occurred in patients receiving Cal/BD foam. Conclusion: The results from three clinical trials analyzed together show that topical Cal/BD foam is well tolerated and efficacious for treating patients with moderate-to-severe disease. Data support Cal/BD foam as a potential topical therapy for moderate-to-severe psoriasis. Trial registrations: ClinicalTrials.gov registration numbers: NCT01866163, NCT02132936, NCT01536886. [ABSTRACT FROM AUTHOR]

Introduction: Topicals are a mainstay in psoriasis vulgaris treatment and are used concomitantly even in patients receiving systemic therapy. Patient acceptance of topical treatment can impact adherence and, consequently, real-life effectiveness. This study aimed to identify patient preferences for topical treatment attributes and to evaluate patient acceptability of topical treatments. Methods: This 5-day study evaluated three inactive presentations: fixed combination calcipotriol/betamethasone dipropionate (Cal/BD) ointment vehicle in a tube, Cal/BD gel vehicle in a bottle and Cal/BD gel vehicle in a new Applicator delivery system. Participants with psoriasis on ≥2 locations were recruited, aiming for equal proportions in the categories: male/female; <40/≥40 years old; working/not working. Participants ranked a predefined 'wish list' of 13 topical treatment attributes, applied each product and evaluated them in a user survey, indicating how well the products delivered on 16 statements matching the 13 attributes. Afterward, participants indicated preference by psoriasis plaque location. Results: Patient preferences differed to the extent that the proportion rating an attribute of high importance was similar to the proportion rating the same attribute of low importance. All attributes received similar mean ranking scores. Analysis by demographic characteristics revealed preferences are not associated with gender, age or employment status. Participants did not perceive much difference between the gel and ointment, but expressed preferences for different presentations to treat different plaque locations. The gel Applicator was preferred for 8/14 locations and both gel presentations were strongly preferred for hairy scalp. Conclusions: Patients with psoriasis have diverse preferences, which cannot be predicted by demographics. Individual patient choice should be considered to increase the acceptability and a range of topical formulations should be available to support treatment adherence and improve clinical outcomes. Funding: LEO Pharma A/S, Ballerup, Denmark. [ABSTRACT FROM AUTHOR]