Trial Outcomes & Findings for A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis. (NCT NCT02752776)

Last Updated: 2019-09-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1660 participants

Primary outcome timeframe

16 weeks

Results posted on

2019-09-25

Participant Flow

A total of 1660 participants were treated and included in the Safety set.

A total of 1858 patients were screened in this study.

Participant milestones

Participant milestones
Measure	Subpopulation A (Naive) Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.
Overall Study STARTED	663	673	324
Overall Study COMPLETED	611	597	276
Overall Study NOT COMPLETED	52	76	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Subpopulation A (Naive) Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.
Overall Study Adverse Event	15	23	11
Overall Study Lack of Efficacy	2	6	14
Overall Study Lost to Follow-up	11	12	4
Overall Study Non-compliance with study treatment	0	0	1
Overall Study Physician Decision	2	6	2
Overall Study Pregnancy	1	6	3
Overall Study Protocol Violation	10	13	6
Overall Study Subject/guardian decision	8	6	4
Overall Study Death	0	0	1
Overall Study Withdrawal by Subject	3	4	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subpopulation A (Naive) n=663 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	Total n=1660 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 14.03 • n=5 Participants	44.4 years STANDARD_DEVIATION 13.67 • n=7 Participants	47.4 years STANDARD_DEVIATION 12.89 • n=5 Participants	44.5 years STANDARD_DEVIATION 13.74 • n=4 Participants
Sex: Female, Male Female	224 Participants n=5 Participants	222 Participants n=7 Participants	107 Participants n=5 Participants	553 Participants n=4 Participants
Sex: Female, Male Male	439 Participants n=5 Participants	451 Participants n=7 Participants	217 Participants n=5 Participants	1107 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	626 Participants n=5 Participants	642 Participants n=7 Participants	307 Participants n=5 Participants	1575 Participants n=4 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	20 Participants n=4 Participants
Race/Ethnicity, Customized Other	22 Participants n=5 Participants	23 Participants n=7 Participants	15 Participants n=5 Participants	60 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16	74.7 Percentage of participants Interval 71.2 to 78.0	71.3 Percentage of participants Interval 67.7 to 74.7	61.7 Percentage of participants Interval 56.1 to 67.0	70.8 Percentage of participants Interval 68.5 to 73.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52	75.3 Percentage of participants Interval 71.7 to 78.5	73.3 Percentage of participants Interval 69.8 to 76.6	62.0 Percentage of participants Interval 56.5 to 67.3	71.9 Percentage of participants Interval 69.6 to 74.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 Wk 16: DLQI cat. score: 2-5	18.3 Percentage of participants Interval 15.5 to 21.6	19.1 Percentage of participants Interval 16.2 to 22.3	21.2 Percentage of participants Interval 16.9 to 26.2	19.2 Percentage of participants Interval 17.3 to 21.2
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 Wk 16: DLQI cat. score: 6-10	5.7 Percentage of participants Interval 4.1 to 7.8	6.3 Percentage of participants Interval 4.6 to 8.5	9.3 Percentage of participants Interval 6.5 to 13.2	6.7 Percentage of participants Interval 5.5 to 8.0
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 Wk 16: DLQI cat. score: 11-20	1.2 Percentage of participants Interval 0.6 to 2.5	2.9 Percentage of participants Interval 1.8 to 4.5	5.3 Percentage of participants Interval 3.2 to 8.5	2.7 Percentage of participants Interval 2.0 to 3.6
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 Wk 16:DLQI cat. score: 21-30	0.0 Percentage of participants Interval 0.0 to 0.7	0.5 Percentage of participants Interval 0.1 to 1.4	2.5 Percentage of participants Interval 1.2 to 5.0	0.7 Percentage of participants Interval 0.4 to 1.2
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 Wk 52: DLQI cat. score: 2-5	17.9 Percentage of participants Interval 15.0 to 21.1	14.0 Percentage of participants Interval 11.5 to 16.9	18.2 Percentage of participants Interval 14.2 to 23.0	16.4 Percentage of participants Interval 14.6 to 18.3
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 Wk 52: DLQI cat. score: 6-10	4.7 Percentage of participants Interval 3.3 to 6.7	7.2 Percentage of participants Interval 5.4 to 9.4	9.6 Percentage of participants Interval 6.7 to 13.4	6.7 Percentage of participants Interval 5.5 to 8.0
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 Wk 52:DLQI cat. score: 11-20	1.8 Percentage of participants Interval 1.0 to 3.3	4.0 Percentage of participants Interval 2.7 to 5.9	8.3 Percentage of participants Interval 5.7 to 12.0	4.0 Percentage of participants Interval 3.1 to 5.1
Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52 Wk 52:DLQI cat. score: 21-30	0.3 Percentage of participants Interval 0.1 to 1.2	1.5 Percentage of participants Interval 0.8 to 2.8	1.9 Percentage of participants Interval 0.8 to 4.2	1.1 Percentage of participants Interval 0.7 to 1.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 16: PASI 50	97.7 Percentage of participants Interval 96.2 to 98.7	97.5 Percentage of participants Interval 95.9 to 98.5	95.0 Percentage of participants Interval 91.9 to 97.2	97.1 Percentage of participants Interval 96.1 to 97.8
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 16: PASI 75	94.4 Percentage of participants Interval 92.3 to 96.0	92.8 Percentage of participants Interval 90.5 to 94.7	85.4 Percentage of participants Interval 81.0 to 89.1	92.0 Percentage of participants Interval 90.6 to 93.3
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 16: PASI 90	82.4 Percentage of participants Interval 79.2 to 85.2	78.8 Percentage of participants Interval 75.5 to 81.8	69.0 Percentage of participants Interval 63.6 to 74.0	78.3 Percentage of participants Interval 76.2 to 80.3
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 16: PASI 100	47.3 Percentage of participants Interval 43.4 to 51.2	38.8 Percentage of participants Interval 35.1 to 42.6	33.4 Percentage of participants Interval 28.4 to 38.9	41.1 Percentage of participants Interval 38.7 to 43.6
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 16: IGA 0/1	87.4 Percentage of participants Interval 84.5 to 89.8	84.9 Percentage of participants Interval 82.0 to 87.5	76.2 Percentage of participants Interval 71.1 to 80.7	84.2 Percentage of participants Interval 82.3 to 85.9
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 52: PASI 50	97.9 Percentage of participants Interval 96.4 to 98.9	96.3 Percentage of participants Interval 94.5 to 97.6	92.9 Percentage of participants Interval 89.4 to 95.5	96.3 Percentage of participants Interval 95.2 to 97.1
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 52: PASI 75	94.4 Percentage of participants Interval 92.3 to 96.0	89.7 Percentage of participants Interval 87.1 to 91.9	83.3 Percentage of participants Interval 78.7 to 87.2	90.4 Percentage of participants Interval 88.8 to 91.7
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 52: PASI 90	80.8 Percentage of participants Interval 77.6 to 83.7	75.5 Percentage of participants Interval 72.0 to 78.7	63.9 Percentage of participants Interval 58.4 to 69.1	75.3 Percentage of participants Interval 73.2 to 77.4
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 52: PASI 100	56.9 Percentage of participants Interval 53.1 to 60.8	45.5 Percentage of participants Interval 41.7 to 49.3	37.0 Percentage of participants Interval 31.8 to 42.6	48.4 Percentage of participants Interval 46.0 to 50.8
Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52 Wk 52: IGA 0/1	86.4 Percentage of participants Interval 83.5 to 88.9	79.9 Percentage of participants Interval 76.7 to 82.9	71.3 Percentage of participants Interval 66.0 to 76.1	80.8 Percentage of participants Interval 78.8 to 82.7

SECONDARY outcome

Timeframe: 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 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).

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 Week 16	0.217 scores on a scale Standard Deviation 0.2294	0.201 scores on a scale Standard Deviation 0.2277	0.235 scores on a scale Standard Deviation 0.2602	0.214 scores on a scale Standard Deviation 0.2352
Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52 Week 52	0.221 scores on a scale Standard Deviation 0.2353	0.193 scores on a scale Standard Deviation 0.2360	0.226 scores on a scale Standard Deviation 0.2596	0.211 scores on a scale Standard Deviation 0.2408

SECONDARY outcome

Timeframe: 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").

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 Week 16	19.7 scores on a scale Standard Deviation 24.36	21.4 scores on a scale Standard Deviation 25.66	18.7 scores on a scale Standard Deviation 26.66	20.2 scores on a scale Standard Deviation 25.36
Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52 Week 52	21.7 scores on a scale Standard Deviation 24.11	22.6 scores on a scale Standard Deviation 25.47	19.5 scores on a scale Standard Deviation 25.14	21.7 scores on a scale Standard Deviation 24.88

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=44 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=117 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=90 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=251 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 Week 16	-0.7 scores on a scale Standard Deviation 0.97	-0.5 scores on a scale Standard Deviation 0.83	-0.3 scores on a scale Standard Deviation 0.85	-0.5 scores on a scale Standard Deviation 0.87
Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52 Week 52	-0.7 scores on a scale Standard Deviation 0.90	-0.5 scores on a scale Standard Deviation 0.90	-0.4 scores on a scale Standard Deviation 0.85	-0.5 scores on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 Pain: Wk 16	-3.0 scores on a scale Standard Deviation 2.87	-3.3 scores on a scale Standard Deviation 3.11	-3.3 scores on a scale Standard Deviation 3.30	-3.2 scores on a scale Standard Deviation 3.06
Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 Pain: Wk 52	-3.1 scores on a scale Standard Deviation 2.95	-3.2 scores on a scale Standard Deviation 3.22	-3.3 scores on a scale Standard Deviation 3.36	-3.2 scores on a scale Standard Deviation 3.14
Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 Itching: Wk 16	-4.9 scores on a scale Standard Deviation 2.96	-4.9 scores on a scale Standard Deviation 3.06	-4.8 scores on a scale Standard Deviation 3.31	-4.9 scores on a scale Standard Deviation 3.07
Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 Itching: Wk 52	-5.0 scores on a scale Standard Deviation 2.92	-5.0 scores on a scale Standard Deviation 3.10	-4.6 scores on a scale Standard Deviation 3.28	-4.9 scores on a scale Standard Deviation 3.07
Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 Scaling: Wk 16	-5.5 scores on a scale Standard Deviation 2.68	-5.5 scores on a scale Standard Deviation 2.71	-5.2 scores on a scale Standard Deviation 3.26	-5.4 scores on a scale Standard Deviation 2.81
Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52 Scaling: Wk 52	-5.4 scores on a scale Standard Deviation 2.72	-5.3 scores on a scale Standard Deviation 2.87	-4.9 scores on a scale Standard Deviation 3.27	-5.3 scores on a scale Standard Deviation 2.90

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 Effectiveness: Wk 16	81.5 scores on a scale Standard Deviation 24.02	80.9 scores on a scale Standard Deviation 25.13	75.0 scores on a scale Standard Deviation 23.43	80.0 scores on a scale Standard Deviation 24.48
Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 Effectiveness: Wk 52	85.1 scores on a scale Standard Deviation 20.64	82.0 scores on a scale Standard Deviation 25.05	74.9 scores on a scale Standard Deviation 24.24	81.9 scores on a scale Standard Deviation 23.50
Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 Convenience: Wk 16	79.2 scores on a scale Standard Deviation 15.50	80.8 scores on a scale Standard Deviation 15.83	75.9 scores on a scale Standard Deviation 15.20	79.2 scores on a scale Standard Deviation 15.67
Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 Convenience: Wk 52	82.8 scores on a scale Standard Deviation 15.67	83.9 scores on a scale Standard Deviation 15.42	78.9 scores on a scale Standard Deviation 15.14	82.5 scores on a scale Standard Deviation 15.57
Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 Global satisfaction: Wk 16	83.8 scores on a scale Standard Deviation 14.71	83.3 scores on a scale Standard Deviation 16.68	75.1 scores on a scale Standard Deviation 20.07	81.9 scores on a scale Standard Deviation 16.99
Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52 Global satisfaction: Wk 52	83.9 scores on a scale Standard Deviation 17.23	81.9 scores on a scale Standard Deviation 20.38	73.5 scores on a scale Standard Deviation 23.10	81.1 scores on a scale Standard Deviation 20.14

SECONDARY outcome

Timeframe: 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 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'.

Outcome measures

Outcome measures
Measure	Subpopulation A (Naive) n=662 Participants Participants who were naïve to any systemic treatment, e.g. participants failing or intolerant to previous topical treatment, including narrow band UVB, but never exposed to any systemic treatment, with or without contraindications to the use of conventional systemic treatment and in a need of a first systemic treatment.	Subpopulation B (Non-biologic) n=673 Participants Participants who have been previously exposed to at least one conventional systemic therapy; either because of failure or intolerance to their previous conventional systemic treatment, they were in a need of a first biologic systemic treatment.	Subpopulation C (Biologic) n=324 Participants Participants who have been previously exposed to at least one biologic systemic therapy; either because of failure or intolerance to their previous biologic systemic treatment, they were in a need of a different biologic systemic treatment.	All Participants n=1659 Participants Participants from all 3 subpopulations: Subpopulation A B \& C combined
Patient Benefit Index (PBI) at Week 16 and Week 52 Week 16	3.5 scores on a scale Standard Deviation 0.61	3.4 scores on a scale Standard Deviation 0.69	3.2 scores on a scale Standard Deviation 0.85	3.4 scores on a scale Standard Deviation 0.70
Patient Benefit Index (PBI) at Week 16 and Week 52 Week 52	3.5 scores on a scale Standard Deviation 0.70	3.4 scores on a scale Standard Deviation 0.80	3.2 scores on a scale Standard Deviation 0.96	3.4 scores on a scale Standard Deviation 0.80

Adverse Events

Subpopulation A (Naive)

Serious events: 43 serious events

Other events: 450 other events

Deaths: 0 deaths

Subpopulation B (Non-biologic)

Serious events: 44 serious events

Other events: 474 other events

Deaths: 0 deaths

Subpopulation C (Biologic)

Serious events: 32 serious events

Other events: 203 other events

Deaths: 1 deaths

All Participants

Serious events: 119 serious events

Other events: 1127 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER