Greater improvement in quality of life outcomes in patients using fixed-combination calcipotriol plus betamethasone dipropionate aerosol foam versus gel: results from the PSO-ABLE study.
European journal of dermatology : EJD
BACKGROUND: 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.
OBJECTIVE: To compare HRQoL in mild-severe psoriasis vulgaris patients (involving 2-30% body surface area) over 12 weeks of treatment with Cal/BD foam or gel.
METHODS: HRQoL was assessed using: Dermatology Life Quality Index (DLQI), EuroQoL-5D-5L-PSO (EQ-5D), and Psoriasis QoL (PQoL-12) questionnaires (baseline, Weeks 4, 8 and 12); DLQI score of 0/1 (range: 0-30) and weighted EQ-5D utility index score of 1 (range: 0-1) indicates there is no impact on a patient's QoL and perfect health, respectively. Itch, itch-related sleep loss, and work impairment were also assessed.
RESULTS: In total, 463 patients were randomized to the study (Cal/BD foam, n = 185; Cal/BD gel, n = 188; foam vehicle, n = 47; 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
CONCLUSION: Cal/BD foam demonstrated greater HRQoL improvement in patients with psoriasis than Cal/BD gel over 12 weeks of treatment.
Medical Subject Headings
Absenteeism; Aerosols; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Gels; Humans; Medication Adherence; Middle Aged; Pruritus; Psoriasis; Quality of Life; Single-Blind Method; Surveys and Questionnaires; Treatment Outcome