Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis (NCT NCT03151551)

Last Updated: 2020-11-03

Results Overview

ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)\& swollen joint count (SJC)\& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \& BSA=0 at week 24.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

566 participants

Primary outcome timeframe

Week 24

Results posted on

2020-11-03

Participant Flow

Per protocol and statistical analysis plan (SAP), the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

Open-Label Treatment Period from Week 0 to Week 52 inclusive followed by Post-Treatment Follow-Up Period of up to a minimum of 12 weeks.

Participant milestones

Participant milestones
Measure	Ixekizumab 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps. Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.	Adalimumab 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps. Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.
Open-Label Treatment Period STARTED	283	283
Open-Label Treatment Period Received at Least One Dose of Study Drug	283	283
Open-Label Treatment Period IXE 160 mg at Baseline, 80 mg Q2W/Q4W	49	0
Open-Label Treatment Period IXE 160 mg at Baseline, 80 mg Q4W	218	0
Open-Label Treatment Period ADA 80 mg at Baseline, 40 mg Q2W	0	51
Open-Label Treatment Period ADA 40 mg at Baseline, 40 mg Q2W	0	219
Open-Label Treatment Period COMPLETED	265	259
Open-Label Treatment Period NOT COMPLETED	18	24
Post-Treatment Follow-Up Period STARTED	265	258
Post-Treatment Follow-Up Period COMPLETED	240	230
Post-Treatment Follow-Up Period NOT COMPLETED	25	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Ixekizumab 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps. Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.	Adalimumab 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps. Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.
Open-Label Treatment Period Adverse Event	0	2
Open-Label Treatment Period Lost to Follow-up	1	1
Open-Label Treatment Period Withdrawal by Subject	12	18
Open-Label Treatment Period Lack of Efficacy	1	1
Open-Label Treatment Period Physician Decision	3	0
Open-Label Treatment Period Protocol Deviation	1	2
Post-Treatment Follow-Up Period Adverse Event	1	3
Post-Treatment Follow-Up Period Lost to Follow-up	4	2
Post-Treatment Follow-Up Period Withdrawal by Subject	20	22
Post-Treatment Follow-Up Period Physician Decision	0	1

Baseline Characteristics

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.	Total n=566 Participants Total of all reporting groups
Age, Continuous	47.5 years STANDARD_DEVIATION 12.02 • n=5 Participants	48.3 years STANDARD_DEVIATION 12.30 • n=7 Participants	47.9 years STANDARD_DEVIATION 12.15 • n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants	133 Participants n=7 Participants	254 Participants n=5 Participants
Sex: Female, Male Male	162 Participants n=5 Participants	150 Participants n=7 Participants	312 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	63 Participants n=5 Participants	65 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	198 Participants n=5 Participants	194 Participants n=7 Participants	392 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) Asian	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	222 Participants n=5 Participants	211 Participants n=7 Participants	433 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Argentina	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment Hungary	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment Ukraine	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United Kingdom	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Switzerland	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment India	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment Spain	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment Canada	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Sweden	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Austria	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Netherlands	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Belgium	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Finland	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Poland	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment Denmark	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Mexico	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment South Africa	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Italy	14 Participants n=5 Participants	25 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment Israel	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Australia	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment France	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Germany	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: All randomized participants. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

Outcome measures

Outcome measures
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)	36 percentage of participants Interval 30.4 to 41.6	27.9 percentage of participants Interval 22.7 to 33.1

SECONDARY outcome

Timeframe: Week 24

ACR50 response is defined as a ≥50% 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), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP).

Outcome measures

Outcome measures
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Percentage of Participants Achieving ACR50	50.5 percentage of participants Interval 44.7 to 56.4	46.6 percentage of participants Interval 40.8 to 52.5

SECONDARY outcome

Timeframe: Week 24

PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if \& only if they had achieved PASI=0 \& BSA=0 at week 24.

Outcome measures

Outcome measures
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Percentage of Participants Achieving PASI100	60.1 percentage of participants Interval 54.4 to 65.8	46.6 percentage of participants Interval 40.8 to 52.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline TJC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=242 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=239 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Tender Joint Count (TJC)	-15.91 score on a scale Standard Error 0.566	-14.88 score on a scale Standard Error 0.569

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline SJC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=242 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=239 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Swollen Joint Count (SJC)	-9.58 score on a scale Standard Error 0.196	-9.53 score on a scale Standard Error 0.198

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline VAS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=242 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS)	-37.21 millimeters (mm) Standard Error 1.623	-36.54 millimeters (mm) Standard Error 1.621

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

The patient's overall assessment of his or her PsA activity was recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=242 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Participant's Global Assessment of Disease Activity	-40.61 Millimeter (mm) Standard Error 1.594	-37.82 Millimeter (mm) Standard Error 1.596

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=223 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=230 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Physician's Global Assessment of Disease Activity	-48.15 Millimeter (mm) Standard Error 1.113	-46.79 Millimeter (mm) Standard Error 1.097

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline CRP value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

CRP is the ACR Core Set laboratory measure of acute-phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on the participant's PsA. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=234 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=238 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in C-Reactive Protein (CRP)	-5.68 Milligram per Liter (mg/L) Standard Error 0.462	-6.01 Milligram per Liter (mg/L) Standard Error 0.461

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline HAQ-DI value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=242 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in HAQ-DI	-0.68 score on a scale Standard Error 0.035	-0.62 score on a scale Standard Error 0.035

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: All randomized participants who had a baseline and at least one post-baseline ACR50 and PASI100 value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

ACR50 response is a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of VAS, Pts Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, participant assessment of physical function using the HAQ-DI, or High Sensitivity(assay) C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participant achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \& BSA=0 at week 52.

Outcome measures

Outcome measures
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Percentage of Participants Simultaneously Achieving ACR50 and PASI100	39.2 percentage of participants Interval 33.5 to 44.9	26.1 percentage of participants Interval 21.0 to 31.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline DAS28-CRP value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in milligrams per liter), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=226 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=228 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)	-2.45 score on a scale Standard Error 0.071	-2.36 score on a scale Standard Error 0.071

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: All randomized participants who had a baseline and at least one post-baseline MDA value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

MDA is a composite of 7 key outcome measures: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures.

Outcome measures

Outcome measures
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Percentage of Participants Achieving Minimal Disease Activity (MDA) MDA-6 Entheseal Points	48.1 percentage of participants Interval 42.2 to 53.9	42.8 percentage of participants Interval 37.0 to 48.5
Percentage of Participants Achieving Minimal Disease Activity (MDA) MDA-18 Entheseal Points	47.3 percentage of participants Interval 41.5 to 53.2	41.0 percentage of participants Interval 35.3 to 46.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: All randomized participants who had a baseline and at least one post-baseline PsARC value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA.

Outcome measures

Outcome measures
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)	66.8 percentage of participants Interval 61.3 to 72.3	65.7 percentage of participants Interval 60.2 to 71.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline CPDAI value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The CPDAI is a validated instrument intended to assess composite psoriatic disease activity and response to therapy. Domains include peripheral arthritis as assessed by the number of tender and swollen joints and the HAQ-DI, skin as assessed by the PASI and the Dermatology Life Quality Index (DLQI), enthesitis as assessed by the number of sites with enthesitis and the HAQ-DI, and dactylitis as assessed by the number of digits affected. Each domain with the exception of spinal disease is scored from 0-3. Individual domain scores are summed to give an overall composite score (range 0-12) with a higher score indicating higher disease activity. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=237 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=234 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score	-4.35 score on a scale Standard Error 0.136	-3.85 score on a scale Standard Error 0.136

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline SPARCC score \> 0. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The SPARCC enthesitis index evaluates tenderness in a total of 16 entheseal sites: the greater trochanter (right/left \[R/L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles of humerus (R/L),Lateral epicondyle humerus (R/L) and the supraspinatus insertion (R/L). Tenderness at each site is quantified on a dichotomous basis: 0 = nontender and 1 = tender. The results from each site are then added to produce a total score (range 0 to 16) with the Higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=163 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=139 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline	-3.93 score on a scale Standard Error 0.234	-4.06 score on a scale Standard Error 0.241

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline enthesitis (LEI \>0). Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle,(R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=141 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=121 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline	-1.93 score on a scale Standard Error 0.113	-2.02 score on a scale Standard Error 0.116

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline dactylitis (LDI-B \>0). Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The LDI-B measures the severity of dactylitis.In each digit,the ratio of the circumference(cf) of the affected digit to the cf of the digit on the opposite hand or foot measured in mm. Each dactylitic digit is defined by a minimum increase of 10% in cf over the contra-lateral digit.If the same digits on each hand or foot were thought to be involved,the clinician referred to a table of normative values for a value which was used to provide the comparison.If the ratio is \>1.1,then subtract 1 from the calculated ratio and multiply it by 100 and the tenderness score of 0(not tender) or 1(tender).Otherwise,if the ratio of the cf of the digit is ≤1.1,then the LDI-B score is set to 0.LDI-B score can be \>=0 with higher numbers indicating worse dactylitis.LS mean was calculated using MMRM model: treatment group,concomitant csDMARD use at baseline,moderate-to-severe Ps involvement,visit as fixed factors,baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=35 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=47 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline	-52.28 score on a scale Standard Error 11.495	-48.89 score on a scale Standard Error 9.855

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline BSA value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=246 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Psoriasis Body Surface Area (BSA)	-12.33 units on a scale Standard Error 0.623	-10.79 units on a scale Standard Error 0.613

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had baseline fingernail involvement (NAPSI \>0). Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided 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 of the 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 sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=169 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=154 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline	-17.78 score on a scale Standard Error 0.731	-15.08 score on a scale Standard Error 0.742

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline NRS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis is indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=242 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in the Itch NRS	-3.83 score on a scale Standard Error 0.159	-3.54 score on a scale Standard Error 0.159

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline Fatigue NRS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rate their fatigue (weariness, tiredness) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=241 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score	-3.03 score on a scale Standard Error 0.161	-2.95 score on a scale Standard Error 0.161

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline PCS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=240 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)	10.07 score on a scale Standard Error 0.526	9.55 score on a scale Standard Error 0.524

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline MCS value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

Outcome measures

Outcome measures
Measure	Ixekizumab n=240 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in SF-36: Mental Component Summary (MCS)	5.23 score on a scale Standard Error 0.660	4.77 score on a scale Standard Error 0.656

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline EQ-5D 5L value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The descriptive part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension.This produced participant-level index scores between -0.594 and 1.0 (worse to better health). LS mean was calculated using MMRM model that included treatment group,concomitant csDMARD use at baseline,moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=240 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=245 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score	0.21 score on a scale Standard Deviation 0.013	0.21 score on a scale Standard Deviation 0.013

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health you can imagine) to 100mm VAS (best health you can imagine). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=240 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=245 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score	22.26 millimeters (mm) Standard Deviation 1.37	17.48 millimeters (mm) Standard Deviation 1.36

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who had a baseline and at least one post-baseline DLQI value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.

Outcome measures

Outcome measures
Measure	Ixekizumab n=241 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=246 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	-8.03 score on a scale Standard Error 0.273	-6.91 score on a scale Standard Error 0.272

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

Population: All randomized participants who had a baseline and at least one post-baseline TSQ value. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.

The TSQ is a clinician-administered questionnaire that provides an assessment of the patient's opinion of the effectiveness, safety, and overall satisfaction of the study medication. Participants were asked to respond to questionnaire items using a 4-point Likert scale (from "mostly satisfied" to "mostly dissatisfied").

Outcome measures

Outcome measures
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ) Effectiveness of Medication	64.3 percentage of participants Interval 58.7 to 69.9	58.7 percentage of participants Interval 52.9 to 64.4
Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ) Effectiveness over Time of Medication	62.9 percentage of participants Interval 57.3 to 68.5	56.2 percentage of participants Interval 50.4 to 62.0
Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ) Long Term Safety of Medication	63.3 percentage of participants Interval 57.6 to 68.9	58.7 percentage of participants Interval 52.9 to 64.4
Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ) Overall Satisfaction with Medication	64.0 percentage of participants Interval 58.4 to 69.6	59.0 percentage of participants Interval 53.3 to 64.7
Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ) Mostly Satisfied to any Questions	70.0 percentage of participants Interval 64.6 to 75.3	67.8 percentage of participants Interval 62.4 to 73.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 52

The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period. 1. Wish to be dead 2. Non-specific active suicidal thoughts 3. Active suicidal ideation with any methods (not plan) without intent to act 4. Active suicidal ideation with some intent to act, without specific plan 5. Active suicidal ideation with specific plan and intent 6. Preparatory acts or behavior 7. Aborted attempt 8. Interrupted attempt 9. Non-fatal suicide attempt 10. Completed suicide

Outcome measures

Outcome measures
Measure	Ixekizumab n=283 Participants 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 Participants 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
Number of Participants Who Answered "Yes" to Any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)	9 Participants	7 Participants

Adverse Events

Ixekizumab

Serious events: 12 serious events

Other events: 65 other events

Deaths: 0 deaths

Adalimumab

Serious events: 35 serious events

Other events: 44 other events

Deaths: 0 deaths

Ixekizumab Follow-up

Serious events: 7 serious events

Other events: 8 other events

Deaths: 0 deaths

Adalimumab Follow-up

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ixekizumab n=283 participants at risk 160 milligrams (mg) ixekizumab (IXE) given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.	Adalimumab n=283 participants at risk 80 mg adalimumab (ADA) given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.	Ixekizumab Follow-up n=265 participants at risk Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.	Adalimumab Follow-up n=260 participants at risk Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.
General disorders Injection site reaction	5.7% 16/283 • Number of events 30 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	1.4% 4/283 • Number of events 9 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	0.00% 0/265 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	0.00% 0/260 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
Infections and infestations Nasopharyngitis	13.4% 38/283 • Number of events 46 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	8.1% 23/283 • Number of events 26 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	1.9% 5/265 • Number of events 5 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	1.2% 3/260 • Number of events 3 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly
Infections and infestations Upper respiratory tract infection	6.4% 18/283 • Number of events 21 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	6.4% 18/283 • Number of events 23 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	1.1% 3/265 • Number of events 3 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly	0.77% 2/260 • Number of events 2 • Up To Week 52 All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60