OBJECTIVE: To assess baseline patient-reported outcomes (PROs) and PRO improvement in patients with psoriasis administeredetanercept 50 mg once weekly (QW). METHODS:Adult patients with moderate-to-severe plaque psoriasis participated in a 12-week, double-blind, controlled trial in which they received etanercept 50 mg QW (n = 96) or placebo QW (n = 46), followed by a 12-week, open-label extension in which they received etanercept 50 mg QW (etanercept-etanercept, n = 90; placebo-etanercept, n = 36). Patients completed the Dermatology Life Quality Index (DLQI), EuroQoL-5D (EQ-5D) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at baseline and subsequent study visits. RESULTS: At baseline, DLQI and EQ-5D scores indicated significant quality of life (QoL) impairment, and FACIT-F scores suggested more fatigue than in the general population. At week 12, etanercept 50 mg QW provided statistically significantly (p < 0.05) and clinically meaningfully greater improvement in DLQI and EQ-5D utility scores than placebo, but not in FACIT-F scores. After 24 weeks of etanercept, the mean DLQI suggested psoriasis had a small effect on QoL, while EQ-5D and FACIT-F scores were comparable to population norms. CONCLUSIONS:Patients with moderate-to-severe psoriasis entered this trial with serious PRO impairment. At week 12, etanercept 50 mg QW provided significant QoL improvements compared with placebo. After 24 weeks of etanercept, the patients' serious PRO impairment had largely abated. (c) 2009 S. Karger AG, Basel.
RCT Entities:
OBJECTIVE: To assess baseline patient-reported outcomes (PROs) and PRO improvement in patients with psoriasis administered etanercept 50 mg once weekly (QW). METHODS: Adult patients with moderate-to-severe plaque psoriasis participated in a 12-week, double-blind, controlled trial in which they received etanercept 50 mg QW (n = 96) or placebo QW (n = 46), followed by a 12-week, open-label extension in which they received etanercept 50 mg QW (etanercept-etanercept, n = 90; placebo-etanercept, n = 36). Patients completed the Dermatology Life Quality Index (DLQI), EuroQoL-5D (EQ-5D) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at baseline and subsequent study visits. RESULTS: At baseline, DLQI and EQ-5D scores indicated significant quality of life (QoL) impairment, and FACIT-F scores suggested more fatigue than in the general population. At week 12, etanercept 50 mg QW provided statistically significantly (p < 0.05) and clinically meaningfully greater improvement in DLQI and EQ-5D utility scores than placebo, but not in FACIT-F scores. After 24 weeks of etanercept, the mean DLQI suggested psoriasis had a small effect on QoL, while EQ-5D and FACIT-F scores were comparable to population norms. CONCLUSIONS:Patients with moderate-to-severe psoriasis entered this trial with serious PRO impairment. At week 12, etanercept 50 mg QW provided significant QoL improvements compared with placebo. After 24 weeks of etanercept, the patients' serious PRO impairment had largely abated. (c) 2009 S. Karger AG, Basel.