A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.

The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.

Time frame: 16 weeks

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. The 5 dimensions have 5 response levels scored from 1 (best) to 5 (worst). The first 3 dimensions have the response levels lasting from no problems, slight problems, moderate problems, severe problems to unable; the last 2 dimensions have the 5 response levels lasting from no, slight, moderate, severe to extreme. From these 5 dimensions the Crosswalk-index is calculated by concatenating the responses & choosing the corresponding country specific index value from the EQ-5D-5L\_Crosswalk\_Index\_Value\_Calculator.v2 excel file (https://euroqol.org/eq-5d-instruments/eq-5d-5labout/valuation-standard-value-sets/crosswalk-index-value-calculator/). This calculated participant-level index scores from -0.654 (worst health) to 1.0 (best health).

Time frame: Week 16, Week 52

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled best imaginable health state and worst imaginable health state. This resulted in a numeric value set ranging from 0 (=worst imaginable health state) up to 100 (=best imaginable health state).

Time frame: Week 16, Week 52

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

The HAQ-DI (Health Assessment Questionnaire - Disability Index) assesses a patient's level of functional ability & includes questions on fine movements of the upper extremity, locomotor activities of the lower extremity & activities that involve both upper & lower extremities. There are 20 items in 8 categories of functioning including dressing & grooming, arising, eating, walking, hygiene, reach, grip & usual activities. The stem of each item asks over the past week, Are you able to... perform a particular task. Each item is scored on a 4-point scale from 0 to 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) & unable to do (3). The HAQ-DI also includes questions about the use of 'aids or devices' & aid from other people to supplement the answers given to the 20 items. Total scores were calculated by averaging all scores and ranging from 0 (best) to 3 (worst). Subtracting the baseline value from the week 16 or 52 values results in the change.

Time frame: Week 16 and Week 52

Population: Full Analysis set - subset of patients with psoriatic arthritis at baseline: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

Selfadministered 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching & scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; & Scaling: Overall, how severe was your psoriasis related scaling over the past 24 hours? Patients had to rate their pain, itching, & scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) & the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category.

Time frame: 16 and 52 weeks

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

The questionnaire includes 23 items on patient-relevant therapy needs & benefits. The first part of the instrument, the 'Patient Needs Questionnaire' (PNQ), is filled in by the patient before therapy. A 5-step Likert scale (0='not important at all' to 4='very important') records the individual relevance of the different items to the patients. The second part, the PBQ, is filled in by the patient during or after therapy. It comprises the same items as the PNQ, but in contrast, the patients evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0='treatment did not help at all' to 4='treatment helped a lot'). In addition, the Likert scale contains the option 'does not apply to me' in the PNQ & the option 'did not apply to me' in the PBQ. The needs prior to treatment (PNQ) & the benefits achieved by treatment (PBQ) are converted to a weighted index value, the PBI in the narrower sense. PBI can have a value from 0='no benefit' to 4='maximal benefit'.

Time frame: Week 16 and Week 52

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.

Time frame: 52 weeks

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.

Time frame: 52 weeks

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

PASI is a combined assessment of lesion severity & 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 & scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), & severity is estimated by clinical signs, erythema, induration & 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 50, 75, 90 & 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.

Time frame: Week 16, Week 52

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.

Treatment Satisfaction Questionnaire for Medication (TSQM) is general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.

Time frame: 16 and 52 weeks

Population: Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.