The objective of this study was to document the disease burden associated with moderate to severe plaque psoriasis, and assess the
impact of efalizumab psoriasis treatment in improving patient-reported outcomes. This included analysis of patient-reported dermatology-
related quality of life (DRQL) and psoriasis symptom scores among patients with moderate to severe psoriasis participating
in three phase III, randomized, double-blinded, parallel-group, placebo-controlled, multi-center clinical trials conducted to evaluate
the efficacy and safety of efalizumab.
A total of 1,242 patients with moderate to severe psoriasis treated either with efalizumab
1.0 mg/kg /wk or placebo were followed for
12 weeks. DRQL and psoriasis symptom severity were assessed at baseline (pre-treatment) and at the end of the first treatment
phase (12 weeks). DRQL was measured using the Dermatology Life Quality Index (DLQI). Symptoms were measured using the
Psoriasis Symptom Assessment (PSA) and an Itch scale. Disease burden was assessed at baseline by examining responses to individual
questions of the DLQI, PSA, and Itch patient-reported outcome measures. The impact of treatment on disease burden was
assessed over a 12-week double-blind study period by comparing changes in DLQI, PSA, and Itch scale scores between the active
treatment and placebo groups. Patient-reported outcomes were also assessed during a 12-week extended treatment phase.
Prior to treatment, the responses to DLQI and PSA items revealed significant disease burden. Greater than 90% of patients reported
being embarrassed or self conscious because of their skin, 53% reported that their skin prevented them from working or studying,
and 98% reported that scaling and itching was bothersome. Compared to placebo-treated patients, efalizumab-treated patients
showed significant improvement in patient-reported outcomes, reducing the limitations and burden associated with moderate to
severe psoriasis within each of the three studies, as measured by DLQI (p<0.001), PSA-Severity (p<0.001), PSA-Frequency (p<0.001),
and Itch (p<0.001) scores. Across all measures, the proportion of patients that improved on both statistical and clinical criteria for
meaningful improvement was at least twofold greater among efalizumab-
treated patients than in placebo-treated patients. The benefit
of efalizumab was maintained over the course of an additional 12
weeks during an extended treatment phase.
In conclusion, patients with moderate to severe plaque psoriasis
reported significant DRQL burden and symptom severity at baseline,
but efalizumab significantly improved patient-reported DRQL
and reduced the frequency and severity of psoriasis symptoms during
12-week double-blind and 12-week extended treatment periods.
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