Effect of Calcipotriene/Betamethasone Dipropionate 0.005%/0.064% Foam on Target Lesions in Plaque Psoriasis: A Post-Hoc Analysis

Objective: Investigate the effect of fixed-combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam on target lesion severity in plaque psoriasis. Design: Post-hoc analysis was conducted on data from a Phase 3, randomized, double-blind, multicenter clinical study of Cal/BD foam in the treatment of psoriasis vulgaris for 4 weeks (PSO-FAST; NCT01866163). Participants: In PSO-FAST, 426 patients (≥18 years) with psoriasis vulgaris (≥mild severity) were randomized 3:1 to Cal/BD foam (n=323) or vehicle foam (n=103), applied once daily. Measurements: Assessments included (1) target lesion severity (redness, scaliness, and thickness) at baseline and weeks 1, 2, and 4; and (2) the proportion of patients with ≥50% reduction in total sign score (TSS-50) from baseline at weeks 1, 2, and 4. Results: A greater proportion of patients achieved considerable improvement (a score of 0 or 1) in the severity of target lesions after 4 weeks of treatment with Cal/BD foam vs vehicle foam at week 4 (redness: 76.2% vs 21.4%; P<.001; scaliness: 91.3% vs 61.2%; P<.001; and thickness: 83.3% vs 35.0%; P<.001, respectively). Rapid onset of efficacy was observed as early as week 1. Significantly more patients also achieved TSS-50 at week 4 with Cal/BD foam vs vehicle foam for their target lesions regardless of treatment area, including the elbows and knees (P<.05 for all). Conclusions: Significant improvements in target lesion severity were achieved with up to 4 weeks of treatment with once-daily Cal/BD foam for adults with plaque psoriasis versus vehicle foam, with rapid onset of efficacy observed at week 1. J Drugs Dermatol. 2020;19(2)121-126. doi:10.36849/JDD.2020.4750

Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily Practice Conditions.

BACKGROUND/AIMS: To assess the efficacy and tolerability of the new aerosol foam of calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g (Cal/BD foam, Enstilar®) in psoriasis vulgaris under daily practice conditions. METHODS: 410 adult psoriasis patients (56% male) from 87 German sites were enrolled in a 4-week, open-label, prospective, non-controlled, observational, non-interventional study. RESULTS: At baseline, patients presented with a psoriasis severity of mild (41.81%), moderate (49.63%), and severe (8.31%) assessed by an investigator global assessment (IGA). After 4 weeks of treatment, 49% of the patients achieved an IGA of clear/almost clear. The mean affected body surface area was reduced from 12.91 to 7.55%, the PASI from 10.4 to 5.2 (p < 0.0001). 43% of the patients with severe IGA achieved treatment success (IGA = 0/1 and ≥2-step improvement). 93% of the patients did not show any adverse events. CONCLUSION: The new Cal/BD foam showed a convincing efficacy and tolerability profile in daily practice, particularly in patients with severer disease manifestations.

Practicability of combined treatment with calcipotriol/betamethasone gel (Daivobet® Gel) and improvement of quality of life in patients with psoriasis.

BACKGROUND: The successful treatment of psoriasis depends not only on the efficacy of the medication but also on patientsí acceptance and adherence to the prescribed regimen. PATIENTS AND METHODS: In this non-interventional, prospective trial 579 patients with psoriasis were treated once daily with the fixed combination of calcipotriol 50 µg/g plus betamethasone 0.5 mg/g (Daivobet® Gel) for 4 weeks. Comparing the new medication to their previous treatment, patients assessed their quality of life by means of the Dermatology Life Quality Index (DLQI), reported their therapy- associated burden in daily life by the Psoriasis Disability Index (PDI) and assessed how easy the new medication was to employ. Disease severity was rated at the start and end of the study by physicians and patients using a Global Assessment (PGA from 0-5 points) and the Body Surface Area (BSA) assessed by the physicians. RESULTS: Quality of life improved from 8.7 to 3.2 points (p < 0.0001) parallel to a significant decrease of PGA by 39.6% (p < 0.0001) and BSA (72.5% of patients with BSA > 4% before vs. 37.3% after therapy). The application of the study medication was 30% less time-consuming and handling associated with significantly higher patient satisfaction. Efficacy and tolerability of Daivobet® Gel versus prior treatment were judged "very good" in 85.7% vs. 27.6% of patients. CONCLUSIONS: The study substantiates a significant improvement of the quality of life during therapy with the fixed combination. Patients benefit from the convenience and time-saving as compared to their prior treatment. Thus, Daivobet® Gel can be recommended as an effective and well-tolerated treatment which may easily be integrated into daily life of patients with psoriasis.

Real-World Experience Using Topical Therapy-Calcipotriol and Betamethasone Dipropionate Foam in Adults with Beyond-Mild Psoriasis.

INTRODUCTION: Determining optimal treatment for moderate plaque psoriasis can be challenging. Recent studies have demonstrated the effectiveness of calcipotriol and betamethasone dipropionate (Cal/BD) foam in patients with moderate-to-severe plaque psoriasis. METHODS: This research explored the use of Cal/BD foam in patients with beyond-mild psoriasis (defined as patients eligible for topical treatment, systemic treatment, or combined topical/systemic treatments) using an online questionnaire, retrospective medical-record review, and by capturing the attitudes and treatment approaches of dermatology specialists. RESULTS: Data from 409 patients with beyond-mild psoriasis treated with Cal/BD foam were provided by 120 dermatology specialists from Germany, Spain, and the UK. Cal/BD foam was prescribed as monotherapy for most (58%) patients and was considered to be effective. Cal/BD foam was infrequently used in combination with biologics (7%) in this segment; 26% of patients received Cal/BD foam in combination with a non-biologic systemic treatment. Cal/BD foam prescribers generally use topical agents to bridge the waiting time to non-biologic/biologic systemic treatment, and as an add-on to systemic treatment for residual lesions. CONCLUSIONS: In patients with beyond-mild psoriasis, the most commonly prescribed topical medication was Cal/BD foam, which was regarded as an effective treatment. Further research is needed to determine optimal use of Cal/BD foam in these patients.