Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand. DermNet Editor in Chief: Adjunct A/Prof Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand. Copy edited by Gus Mitchell. October 2019.
Calcipotriol/betamethasone dipropionate foam (trade name Enstilar®) is a dual-action investigational aerosol foam containing calcipotriol, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.
Enstilar is specifically indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
Enstilar is supplied as a foam for topical administration and is applied to affected areas once daily for up to 4 weeks. Treatment is discontinued when control is achieved.
The FDA approval of Enstilar foam in 2015 was based on two multicentre, randomised, double-blind trials conducted in patients with plaque psoriasis.
The product is also approved for the treatment of psoriasis in Australia, Canada, and the European Union. It has not yet been approved in New Zealand as of October 2019.
Trial 1 patients (n = 302) were randomly assigned to receive :
Trial 2 patients (n = 426) were randomly assigned to receive :
Disease severity was graded using a 5-point Investigator’s Global Assessment (IGA) scale. Treatment success defined as the proportion of patients at week 4 who were ‘Clear’ or ‘Almost Clear’ according to the IGA. Subjects with ‘Mild’ disease at baseline were required to be ‘Clear’ to be considered a treatment success.
The majority of subjects in both trials (76% and 75%, respectively) had a disease of moderate severity at baseline, 14% and 15% had a disease of mild severity at baseline and 10% had a severe disease at baseline in both trials.
The extent of disease involvement assessed by mean body surface area was 7.1% (range 2 to 28%) and 7.5% (range 2 to 30%) in trials 1 and 2, respectively.
In both trials, patients were treated once daily for up to 4 weeks.
The percentage of psoriasis patients achieving treatment success, according to the Investigator’s Global Assessment of Disease Severity, was 45% in the Enstilar foam group, 30.7% for betamethasone dipropionate in the vehicle and 14.9% for calcipotriene in vehicle.
Results for the primary endpoint 'treatment success' (IGA) at week 4 showed Enstilar to be statistically significantly more effective than all the comparators included and responses were observed in all categories of baseline disease severity.
The effect of Enstilar on itch and itch-related sleep loss was investigated in Trial 1 using a visual analogue scale (VAS) ranging from 0 mm (no itch/no sleep loss at all) to 100 mm (worst itch you can imagine/worst possible sleep loss).
A statistically significantly higher number of patients in the Enstilar group compared to vehicle achieved a 70% reduction in itch and itch-related sleep loss from day 3 and throughout the treatment period.
The percentage of psoriasis patients achieving treatment success according to the Investigator’s Global Assessment of Disease Severity was 53.3% in the Enstilar foam group and 4.8% in the vehicle only group.
In trial 2, the effect of Enstilar on scalp psoriasis was investigated as the percentage of patients with 'treatment success' according to the PGA of the scalp at Week 4.
The percentage of subjects with 'treatment success' according to the PGA of the scalp at Week 4 was 53% in the Enstilar foam group, 47.5% in the betamethasone dipropionate in the vehicle group, and 35.6% in the calcipotriene in the vehicle only group.
Enstilar was statistically significantly more effective compared to calcipotriene and also associated with a higher rate of treatment success than betamethasone dipropionate, but this comparison did not reach statistical significance.
The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies.
Adverse effects associated with the use of Enstilar include the following:
Health-related quality of life (HRQoL) measures provide patient-centred evaluations of response to treatment.
In the 12-week, Phase III PSO-ABLE study, fixed-combination calcipotriol 50 μg/g as hydrate (Cal) plus betamethasone 0.5 mg/g as dipropionate (BD) aerosol foam was significantly more effective for the treatment of psoriasis than Cal/BD gel .
HRQoL was assessed using the Dermatology Life Quality Index (DLQI), EuroQoL, and Psoriasis QoL (PQoL-12) questionnaires at baseline and weeks 4, 8, and 12.
Itch, itch-related sleep loss, and work impairment were also assessed.
463 patients were randomised to Cal/BD foam (n = 185), Cal/BD gel, (n = 188) foam vehicle (n = 47), and gel vehicle (n = 43).
Significantly more Cal/BD foam patients achieved DLQI scores of 0/1 at weeks 4 (45.7% vs 32.4%; p = 0.013) and 12 (60.5% vs 44.1%; p = 0.003) than Cal/BD gel patients.
Cal/BD foam significantly improved EQ-5D utility index (0.09 vs 0.03; p < 0.001) and PQoL-12 scores (-2.23 vs -2.07; p = 0.029) from baseline to week 4 versus Cal/BD gel.
Itch, itch-related sleep loss, and work impairment improved more with Cal/BD foam than gel.
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