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Randomized Controlled Trial
. 2022 Jan;36(1):60-67.
doi: 10.1111/jdv.17673. Epub 2021 Oct 21.

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

A Jalili  1 , P Calzavara-Pinton  2 , L Kircik  3   4   5 , D Lons-Danic  6 , A Pink  7 , S Tyring  8 , P de la Cueva  9 , M Gooderham  10 , S Segaert  11 , N Nyholm  12 , H Thoning  12 , B Petersen  12 , D Thaçi  13
Affiliations
Randomized Controlled Trial

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

A Jalili et al. J Eur Acad Dermatol Venereol. 2022 Jan.

Abstract

Background: Psoriasis has important physical and psychosocial effects that extend beyond the skin. Understanding the impact of treatment on health-related quality of life (HRQoL) and patient-perceived symptom severity in psoriasis is key to clinical decision-making.

Objectives: This post hoc analysis of the PSO-LONG trial data assessed the impact of long-term proactive or reactive management with fixed-dose combination calcipotriene 50 µg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) foam on patient-reported outcomes (PROs) in patients with psoriasis vulgaris.

Methods: Five hundred and twenty-one patients from the Phase 3, randomized, double-blind PSO-LONG trial were included. An initial 4-week, open-label phase of fixed-dose combination Cal/BD foam once daily (QD) was followed by a 52-week maintenance phase, at the start of which patients were randomized to a proactive management arm (Cal/BD foam twice weekly) or reactive management arm (vehicle foam twice weekly). Patient-perceived symptom severity and HRQoL were assessed using the Psoriasis Symptom Inventory (PSI), the Dermatology Life Quality Index (DLQI) and the EuroQol-5D for psoriasis (EQ-5D-5L-PSO).

Results: Statistically and clinically significant improvements were observed across all PRO measures. The mean difference (standard deviation) from baseline to Week 4 was -8.97 (6.18) for PSI, -6.02 (5.46) for DLQI and 0.11 (0.15) for EQ-5D-5L-PSO scores. During maintenance, patients receiving reactive management had significantly higher DLQI (15% [p = 0.007]) and PSI (15% [p = 0.0128]) and a numerically lower EQ-5D-5L-PSO mean area under the curve score than patients receiving proactive management (1% [p = 0.0842]).

Conclusions: Cal/BD foam significantly improved DLQI, EQ-5D-5L-PSO and PSI scores during the open-label and maintenance phases. Patients assigned to proactive management had significantly better DLQI and PSI scores and numerically better EQ-5D-5L-PSO versus reactive management. Additionally, baseline flare was associated with worse PROs than the start of a relapse, and patients starting a relapse also had worse PROs than patients in remission.

Keywords: betamethasone dipropionate; calcipotriol; psoriasis; topical administration.

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Figures

Figure 1
Figure 1
Mean scores in proactive and reactive management arms for (a) PSI, (b) DLQI, and (c) EQ‐5D across study visits (Full Analysis Set; N = 521).
Figure 2
Figure 2
Distribution of AUC scores in proactive and reactive management arms for (a) PSI, (b) DLQI, and (c) EQ‐5D (Full Analysis Set; N = 521).
See this image and copyright information in PMC

References

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