Real-world evidence (RWE) of fixed-combination calcipotriol (Cal) 50 μg/g plus betamethasone dipropionate (BD) 0.5 mg/g foam use in regular clinical practice is important and necessary to fully understand the benefits of this topical therapy for plaque psoriasis across different healthcare settings. |
Several non-interventional studies (NIS) have corroborated the beneficial efficacy and safety profiles determined in the randomized clinical trials (RCT) of Cal/BD foam; however, heterogenicity in these NIS prevents the use of a data pooling strategy for comparisons of effectiveness outcomes across different patient populations. |
Therefore, a post hoc analysis of effectiveness data consolidated from six prospective NIS was employed to discern any differences in improvement in signs and symptoms of plaque psoriasis attributable to Cal/BD foam treatment across the countries. |
The results provide real-world evidence in 1388 patients showing that 4 weeks of Cal/BD foam is an effective and safe treatment option with quick onset of action for patients with plaque psoriasis. |
Overall, this post hoc analysis shows that regardless of NIS location, Cal/BD foam remains a well-tolerated, efficacious option for patient care that could be used as a first-line topical therapy for mild-to-severe plaque psoriasis. |
Introduction
Methods
Selection of Cal/BD Foam NIS
Country | Completion date | Title and assessment of Cal/BD foam | Reference |
---|---|---|---|
Germany | 03/2017 | Evaluated efficacy and tolerability | [12] |
Greece | 02/2019 | CELSUS study; evaluated effectiveness | [13] |
Austria | 03/2020 | Evaluated effectiveness and tolerability | [14] |
Italy | 11/2020 | LION study, evaluated patient satisfaction and effectiveness | [15] |
France | 11/2020 | Evaluated effectiveness | [16] |
Korea | 07/2021 | Evaluated effectiveness, patient satisfaction, and tolerability | [17] |
Results
Baseline Characteristics
Study | Age (years) | Male patients | Disease (years) | Previously on systemic Treatment | Treatment-naïve | TCS-experienced | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Mean (SD) | n/N | % | N | Mean (SD) | n/N | % | n/N | % | n/N | % | |
Germany | 410 | 52.8 (15.3) | 230/410 | 56 | 410 | 15.3 (14.2) | 64/410 | 16 | 71/410 | 17 | 329/410 | 80 |
Greece | 400 | 53.6 (16.8) | 218/400 | 54 | 400 | 8.9 (11.0) | 37/400 | 9 | 216/400 | 54 | 163/400 | 41 |
Austria | 107 | 50.3 (15.1) | 60/107 | 56 | 101 | 12.4 (13.8) | 12/107 | 11 | 23/107 | 21 | 81/107 | 76 |
Italy | 256 | 55.6 (15.4) | 152/256 | 59 | 256 | 12.9 (14.0) | 66/256 | 26 | 50/256 | 20 | 184/256 | 72 |
France | 40 | 45.6 (13.6) | 15/40 | 38 | 40 | 13.8 (13.5) | 3/40 | 7 | 29/40 | 72 | 8/40 | 20 |
Korea | 175 | 46.7 (15.1) | 103/175 | 59 | 175 | 10.3 (11.6) | 40/175 | 23 | 65/175 | 37 | 98/175 | 56 |