Initial flare treatment for psoriasis with fixed-dose calcipotriene and betamethasone dipropionate (Cal/BD) foam was associated with statistically and clinically significant improvements in all patient-reported outcomes (PROs), according to study findings published in the Journal of the European Academy of Dermatology and Venereology.

The randomized, double-blind, PSO-LONG trial assessed the long-term safety and efficacy outcomes of calcipotriene 50 µg/g and betamethasone dipropionate 0.5 mg/g foam topical treatment for patients with psoriasis. A 4-week, open-label phase of fixed-dose combination Cal/BD foam once daily was followed by a 52-week maintenance phase in which  the participants were randomly assigned to proactive management (Cal/BD foam twice weekly) or reactive management (vehicle foam twice weekly).

The EuroQoL 5-dimensional questionnaire for psoriasis (EQ-5D-5L-PSO), Dermatology Life Quality Index (DLQI), and the Psoriasis Symptom Inventory (PSI) were used to assess patient-perceived symptom severity and health-related quality of life.


Continue Reading

A total of 521 patients were included in the full analysis set in the post-hoc analysis. The participants had a mean age of 52.3 years, 67.4% were men, 90.2% were White, and 85.2% had a moderate baseline Physician’s Global Assessment of disease severity score.

In the open-label phase, initial flare treatment with Cal/BD foam once daily resulted in statistically and clinically significant improvements in all PRO measures. The mean difference from baseline to week 4 was −8.97 (standard deviation [SD] 6.18; P < .0001) for PSI scores, −6.02 (SD 5.46; P < .0001) for DLQI scores, and 0.11 (SD  .15; P < .0001) for EQ-5D-5L-PSO scores.

The improvements were maintained for 1 year in the proactive and reactive management groups for the 3 PRO measures. The mean PSI area under the curve (AUC) score was 15% higher for those in the reactive management arm (5.74 ) compared with those in the proactive management arm (4.99) during the maintenance phase (difference −0.75; P = .0128). Analysis of the PSI total score was based on the first 28 weeks of the maintenance phase.

The mean DLQI score was 15% higher for reactive management participants (3.40) compared with proactive management participants (2.95) (difference −0.45; P = .007). Patients in the reactive management group had a numerically lower EQ-5D-5L-PSO mean AUC score compared with patients receiving proactive management (1%; P = .0842).

The researchers noted that their analysis has inherent limitations owing to the post-hoc design.

“Overall, the results of this analysis add to the original PSO-LONG findings, suggesting that proactive management with fixed-dose Cal/BD foam could offer not only improved long-term control of psoriasis but also improved health-related quality of life and patient-perceived symptom severity over conventional reactive treatment with Cal/BD foam,” the investigators commented.

Disclosure: This research was sponsored by LEO Pharma. Several of the study authors declared affiliations with pharmaceutical companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Jalili A, Calzavara-Pinton P, Kircik L, et al. Quality of life and patient-perceived symptoms in patients with psoriasis undergoing proactive or reactive management with the fixed-dose combination Cal/BD foam: a post-hoc analysis of PSO-LONG. J Eur Acad Dermatol Venereol. Published online September 20, 2021. doi:10.1111/jdv.17673