Trial Outcomes & Findings for A Study in Japanese Participants With Moderate-to-Severe Psoriasis (NCT NCT01624233)

Results Overview

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

91 participants

Primary outcome timeframe

Week (Wk) 12

Results posted on

2019-09-10

Participant Flow

Period 2-Induction Dosing Period (Weeks 0 up to 12), Period 3-Maintenance Dosing Period (Weeks 12 up to 52), Period 4-Drug Free Period (Weeks 52 up to 100), Period 5-Retreatment Period (up to 192 additional weeks) and Period 6-Post-Treatment Follow-Up Period up to 12 weeks after the last visit.

Participant milestones

Participant milestones
Measure	80 mg Ixekizumab (LY2439821) Ixekizumab: Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52). Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks.
Period 2 - Induction STARTED	91
Period 2 - Induction Received at Least 1 Dose of Study Drug	91
Period 2 - Induction Erythrodermic Psoriasis (Ps)	8
Period 2 - Induction Pustular Ps	5
Period 2 - Induction Plaque Ps	78
Period 2 - Induction COMPLETED	90
Period 2 - Induction NOT COMPLETED	1
Period 3 - Maintenance STARTED	90
Period 3 - Maintenance Received at Least 1 Dose of Study Drug	90
Period 3 - Maintenance COMPLETED	83
Period 3 - Maintenance NOT COMPLETED	7
Period 4 - Drug Free Period STARTED	70
Period 4 - Drug Free Period Adverse Event	1
Period 4 - Drug Free Period Physician Decision	1
Period 4 - Drug Free Period COMPLETED	9
Period 4 - Drug Free Period NOT COMPLETED	61
Period 5 - Retreatment Period STARTED	80
Period 5 - Retreatment Period COMPLETED	70
Period 5 - Retreatment Period NOT COMPLETED	10
Period 6: Follow-up STARTED	88
Period 6: Follow-up COMPLETED	79
Period 6: Follow-up NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	80 mg Ixekizumab (LY2439821) Ixekizumab: Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52). Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks.
Period 2 - Induction Adverse Event	1
Period 3 - Maintenance Adverse Event	2
Period 3 - Maintenance Lack of Efficacy	1
Period 3 - Maintenance Physician Decision	2
Period 3 - Maintenance Withdrawal by Subject	2
Period 4 - Drug Free Period Relapsed	61
Period 5 - Retreatment Period Adverse Event	5
Period 5 - Retreatment Period Lack of Efficacy	1
Period 5 - Retreatment Period Physician Decision	1
Period 5 - Retreatment Period Withdrawal by Subject	3
Period 6: Follow-up Adverse Event	3
Period 6: Follow-up Lack of Efficacy	2
Period 6: Follow-up Physician Decision	1
Period 6: Follow-up Withdrawal by Subject	3

Baseline Characteristics

Only participants with non-missing data were included.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	80 mg Ixekizumab (LY2439821) n=91 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Age, Continuous	46.2 years STANDARD_DEVIATION 11.89 • n=91 Participants
Sex: Female, Male Female	21 Participants n=91 Participants
Sex: Female, Male Male	70 Participants n=91 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=91 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=91 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=91 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=91 Participants
Race (NIH/OMB) Asian	91 Participants n=91 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=91 Participants
Race (NIH/OMB) Black or African American	0 Participants n=91 Participants
Race (NIH/OMB) White	0 Participants n=91 Participants
Race (NIH/OMB) More than one race	0 Participants n=91 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=91 Participants
Region of Enrollment Japan	91 participants n=91 Participants
Psoriasis Area and Severity Index (PASI) Total Score	27.24 units on a scale STANDARD_DEVIATION 10.545 • n=91 Participants
Static Physician Global Assessment (sPGA) Score 0: Clear	0 participants n=91 Participants
Static Physician Global Assessment (sPGA) Score 1: Minimal	0 participants n=91 Participants
Static Physician Global Assessment (sPGA) Score 2: Mild	1 participants n=91 Participants
Static Physician Global Assessment (sPGA) Score 3: Moderate	26 participants n=91 Participants
Static Physician Global Assessment (sPGA) Score 4: Severe	53 participants n=91 Participants
Static Physician Global Assessment (sPGA) Score 5: Very Severe	11 participants n=91 Participants
Percentage (%) of Body Surface Area (BSA)	45.5 units on a scale STANDARD_DEVIATION 23.22 • n=91 Participants
Nail Psoriasis Severity Index (NAPSI) Total Score	31.1 units on a scale STANDARD_DEVIATION 22.16 • n=56 Participants • Only participants with non-missing data were included.
Psoriasis Scalp Severity Index (PSSI) Total Score	27.0 units on a scale STANDARD_DEVIATION 15.99 • n=87 Participants • Only participants with non-missing data were included.
Quick Inventory of Depressive Symptomatology-Self Reported 16 Items(QIDS-SR16) Total Score	4.6 units on a scale STANDARD_DEVIATION 4.14 • n=91 Participants
Itch Numeric Rating Scale (NRS) Score	6.1 units on a scale STANDARD_DEVIATION 2.53 • n=91 Participants
Quick Inventory of Depressive Symptomatology-Self Reported (DLQI) Total Score	10.8 units on a scale STANDARD_DEVIATION 6.50 • n=91 Participants
Joint Pain Visual Analog Scale (VAS)	62.4 units on a scale STANDARD_DEVIATION 23.79 • n=11 Participants • Only participants with non-missing data were included.

PRIMARY outcome

Timeframe: Week (Wk) 12

Population: All participants with Plaque Ps who received at least one dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to specified time points were defined as non-responders for Non-Responder Imputation (NRI) analysis.

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=78 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)	98.7 percentage of participants

SECONDARY outcome

Timeframe: Wks 24 and 52

Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to Wk 52 were defined as non-responders for NRI analysis.

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region, the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=78 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Percentage of Participants Achieving ≥75% Improvement in PASI Wk 24	95.9 percentage of participants
Percentage of Participants Achieving ≥75% Improvement in PASI Wk 52	92.3 percentage of participants

SECONDARY outcome

Timeframe: Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168)

Population: All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who had at least 1 dose of study drug and evaluable Ctrough data at the specified time points.

PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=43 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab Wk 12 (80 mg Q2W) Cohort 2	9.63 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 43.6
Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab Wk 24 (80 mg Q4W) Cohort 1	3.48 micrograms/milliliter (µg/mL) Geometric Coefficient of Variation 65.4

SECONDARY outcome

Timeframe: Baseline through Wk 52

Population: All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who received at least 1 dose of study drug.

Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=91 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Number of Participants With Anti-Ixekizumab Antibodies Plaque Ps	10 participants
Number of Participants With Anti-Ixekizumab Antibodies Erythrodermic Ps	0 participants
Number of Participants With Anti-Ixekizumab Antibodies Pustular Ps	0 participants

SECONDARY outcome

Timeframe: Wks 12, 24 and 52

Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 12 and 52.

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=78 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Percent of Participants Achieving PASI 90% and 100% Improvement Wk 12 (80 mg Q2W) PASI 90%	83.3 percentage of participants
Percent of Participants Achieving PASI 90% and 100% Improvement Wk 12 (80 mg Q2W) PASI 100%	32.1 percentage of participants
Percent of Participants Achieving PASI 90% and 100% Improvement Wk 24 (80 mg Q4W) PASI 90%	90.5 percentage of participants
Percent of Participants Achieving PASI 90% and 100% Improvement Wk 24 (80 mg Q4W) PASI 100%	48.6 percentage of participants
Percent of Participants Achieving PASI 90% and 100% Improvement Wk 52 (80 mg Q4W) PASI 90%	80.8 percentage of participants
Percent of Participants Achieving PASI 90% and 100% Improvement Wk 52 (80 mg Q4W) PASI 100%	48.7 percentage of participants

SECONDARY outcome

Timeframe: Wks 12, 24 and 52

Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of sPGA after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI analysis for Wks 12 and 52.

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=78 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) Wk 12 (80 mg Q2W) sPGA (0 or 1)	89.7 percentage of participants
Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) Wk 24 (80 mg Q4W) sPGA (0 or 1)	89.2 percentage of participants
Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) Wk 52 (80 mg Q4W) sPGA (0 or 1)	83.3 percentage of participants
Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) Wk 12 (80 mg Q2W) sPGA (0)	35.9 percentage of participants
Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) Wk 24 (80 mg Q4W) sPGA (0)	51.4 percentage of participants
Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA) Wk 52 (80 mg Q4W) sPGA (0)	52.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52

Population: All participants with Plaque Ps with a baseline and at least 1 post-dose result. Participants with missing BSA at Wks 12 and 52 were imputed by last observation carried forward (LOCF).

BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=78 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Change From Baseline in Percent of Body Surface Area (BSA) Involvement Wk 12 (80 mg Q2W)	-38.3 percentage of BSA Standard Deviation 19.26
Change From Baseline in Percent of Body Surface Area (BSA) Involvement Wk 24 (80 mg Q4W)	-41.2 percentage of BSA Standard Deviation 20.23
Change From Baseline in Percent of Body Surface Area (BSA) Involvement Wk 52 (80 mg Q4W)	-40.8 percentage of BSA Standard Deviation 19.73

SECONDARY outcome

Timeframe: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52

Population: All participants Plaque Ps with NAPSI at baseline and at least 1 post dose result. Participants with missing NAPSI at Wks 12 and 52 were imputed by LOCF.

The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=44 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Wk 12 (80 mg Q2W)	-7.7 units on a scale Standard Deviation 14.65
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Wk 24 (80 mg Q4W)	-20.5 units on a scale Standard Deviation 19.42
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Wk 52 (80 mg Q4W)	-23.4 units on a scale Standard Deviation 23.67

SECONDARY outcome

Timeframe: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52

Population: All participants with Plaque Ps with a PSSI baseline and at least 1 post-dose result. Participants with missing PSSI at Wks 12 and 52 were imputed by LOCF.

The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=76 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Wk 12 (80 mg Q2W)	-24.8 units on a scale Standard Deviation 15.12
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Wk 24 (80 mg Q4W)	-24.9 units on a scale Standard Deviation 15.11
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Wk 52 (80 mg Q4W)	-23.3 units on a scale Standard Deviation 16.48

SECONDARY outcome

Timeframe: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52

Population: Participants with Plaque Ps who had QIDS-SR16 at baseline and at least 1 post-dose result. Participants with missing QIDS-SR16 at Wks 12 and 52 were imputed by LOCF.

QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains \[sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation\] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=78 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] Wk 12 (80 mg Q2W)	-1.1 units on a scale Standard Deviation 3.65
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] Wk 24 (80 mg Q4W)	-1.6 units on a scale Standard Deviation 3.80
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] Wk 52 (80 mg Q4W)	-1.4 units on a scale Standard Deviation 3.57

SECONDARY outcome

Timeframe: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52

Population: Participants with Plaque Ps who had Itch NRS at baseline and at least 1 post-dose result. Participants with missing Itch NRS at Wks 12 and 52 were imputed by LOCF.

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=78 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Change From Baseline in Itch Numeric Rating Scale (NRS) Score Wk 12 (80 mg Q2W)	-4.7 units on a scale Standard Deviation 2.68
Change From Baseline in Itch Numeric Rating Scale (NRS) Score Wk 24 (80 mg Q4W)	-4.8 units on a scale Standard Deviation 2.90
Change From Baseline in Itch Numeric Rating Scale (NRS) Score Wk 52 (80 mg Q4W)	-4.8 units on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52

Population: Participants with Plaques Ps who had DLQI at baseline and at least 1 post-dose result. Participants with missing DLQI at Wks 12 and 52 were imputed by LOCF.

DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant.

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=78 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score Wk 12 (80 mg Q2W)	-9.2 units on a scale Standard Deviation 5.75
Change From Baseline in Dermatology Life Quality Index (DLQI) Score Wk 24 (80 mg Q4W)	-9.2 units on a scale Standard Deviation 6.57
Change From Baseline in Dermatology Life Quality Index (DLQI) Score Wk 52 (80 mg Q4W)	-9.6 units on a scale Standard Deviation 6.24

SECONDARY outcome

Timeframe: Wks 12, 24 and 52

Population: Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.

ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR).

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=5 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20] Wk 12 (80 mg Q2W)	4 participants
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20] Wk 24 (80 mg Q4W)	4 participants
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20] Wk 52 (80 mg Q4W)	5 participants

SECONDARY outcome

Timeframe: Baseline, Wk 12; Baseline, Wk 52

Population: Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.

The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=5 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS) Wk 12 (80 mg Q2W)	-47.3 mm Standard Deviation 22.05
Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS) Wk 52 (80 mg Q4W)	-51.0 mm Standard Deviation 19.05

SECONDARY outcome

Timeframe: Wk 100 and Retreatment Wk 192

Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Outcome measures

Outcome measures
Measure	80 mg Ixekizumab (LY2439821) n=67 Participants Ixekizumab: Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.
Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement Wk 100, PASI 75	7.5 percentage of participants
Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement Wk 100, PASI 90	3.0 percentage of participants
Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement Wk 100, PASI 100	0 percentage of participants
Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement Wk 192, PASI 75	0 percentage of participants
Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement Wk 192, PASI 90	0 percentage of participants
Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement Wk 192, PASI 100	0 percentage of participants

SECONDARY outcome

Timeframe: Wk 100 and Retreatment Wk 192

Population: All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).