J Eur Acad Dermatol Venereol. 2021 Sep 20. doi: 10.1111/jdv.17673. Online ahead of print.
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 in 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 (PRO) in patients with psoriasis vulgaris.
METHODS: Five hundred and twenty-one patients from the Phase 3, randomised, 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 randomised 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 compared with 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.
PMID:34543474 | DOI:10.1111/jdv.17673
