A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen

The sPGA scale (0 [clear] to 4 [severe]) will be completed by the investigator or qualified designee and is designed to evaluate the assessor's global assessment of the participant's psoriasis. 0 (clear) = No signs of psoriasis; postinflammatory hyperpigmentation may be present, 1 (almost clear) = No thickening; normal to pink coloration; no to minimal focal scaling, 2 (mild) = Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling, 3 (moderate) = Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling, 4 (severe) = Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.

The area of body surface affected by psoriasis will be estimated by the investigator as a percentage of the participant's total BSA wherein the area of the participant's palm will be considered as 1% of total BSA. sPGA of disease severity is measured by the investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease).

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 responders were defined as participants achieving ≥75% improvement at specified timepoints. PASI 90 responders were defined as participants achieving ≥90% improvement at specified timepoints.

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 100 responders were defined as participants achieving 100% improvement at specified timepoints.

The PSI is a psoriasis-specific patient-reported outcome that measures the severity of psoriasis signs and symptoms based on an 8-item scale. The severity of itch, redness, scaling, burning, stinging, cracking, flaking, and pain over the last 24 hours is assessed on a scale of 0 to 4 (not at all, mild, moderate, severe, or very severe) for a total score of 32, with higher scores indicating more severe disease.

The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult participants with skin conditions. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item has four response categories, ranging from 0 (not at all or not relevant) to 3 (very much) assessing the impact of the disease over the last week. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30 and higher scores indicate greater health-related quality-of-life impairment.

The HADS is a self-reported questionnaire that assesses anxiety and depression. The scale includes two subscales, specifically depression and anxiety. Each subscale has 7 items, for a total of 14 items with a total score ranging from 0 to 21 for each scale. Participants report the relative frequency of symptoms over the past week using a 4-point Likert scale ranging from 0 to 3. Higher scores indicate a greater likelihood of depression or anxiety.

The EQ-PSO is a psoriasis-specific adaptation of the EQ-5D, a standardized measure of health status that can be used to provide a simple, generic measure of health outcome. The EQ-5D comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which is assessed by the respondent according to 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems.). The EQ-PSO includes two additional, psoriasis-specific dimensions: skin irritation and self-confidence.

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 responders were defined as participants achieving ≥75% improvement at specified timepoints. PASI 90 responders were defined as participants achieving ≥90% improvement at specified timepoints. PASI 100 responders were defined as participants achieving 100% improvement at specified timepoints.