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A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis (SPIRIT-H2H)

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ClinicalTrials.gov Identifier: NCT03151551
Recruitment Status : Completed
First Posted : May 12, 2017
Results First Posted : April 2, 2019
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Interventions Drug: Ixekizumab
Drug: Adalimumab
Enrollment 566
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description

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.

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.

Period Title: Open-Label Treatment Period
Started 283 283
Received at Least One Dose of Study Drug 283 283
IXE 160 mg at Baseline, 80 mg Q2W/Q4W 49 0 [1]
IXE 160 mg at Baseline, 80 mg Q4W 218 0 [1]
ADA 80 mg at Baseline, 40 mg Q2W 0 [2] 51
ADA 40 mg at Baseline, 40 mg Q2W 0 [2] 219
Completed 265 259
Not Completed 18 24
Reason Not Completed
Adverse Event             0             2
Lost to Follow-up             1             1
Withdrawal by Subject             12             18
Lack of Efficacy             1             1
Physician Decision             3             0
Protocol Deviation             1             2
[1]
Row represents Ixekizumab data only.
[2]
Row represents adalimumab data only.
Period Title: Post-Treatment Follow-Up Period
Started 265 [1] 258 [1]
Completed 240 230
Not Completed 25 28
Reason Not Completed
Adverse Event             1             3
Lost to Follow-up             4             2
Withdrawal by Subject             20             22
Physician Decision             0             1
[1]
All participants who received at least one dose of study drug could enter the follow-up period.
Arm/Group Title Ixekizumab Adalimumab Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 283 283 566
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants 283 participants 566 participants
47.5  (12.02) 48.3  (12.30) 47.9  (12.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
Female 121 133 254
Male 162 150 312
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
Hispanic or Latino 63 65 128
Not Hispanic or Latino 198 194 392
Unknown or Not Reported 22 24 46
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
American Indian or Alaska Native 27 27 54
Asian 29 33 62
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 1 1
White 222 211 433
More than one race 5 11 16
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 283 participants 566 participants
Argentina 31 27 58
Hungary 15 18 33
Ukraine 15 11 26
United Kingdom 13 7 20
Switzerland 1 3 4
India 20 26 46
Spain 24 18 42
Canada 5 5 10
Sweden 3 3 6
Austria 4 4 8
Netherlands 2 1 3
Belgium 6 5 11
Finland 5 6 11
Poland 24 29 53
Denmark 1 3 4
Mexico 32 33 65
South Africa 15 21 36
Italy 14 25 39
Israel 14 14 28
Australia 12 5 17
France 9 3 12
Germany 18 16 34
1.Primary Outcome
Title Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36
(30.4 to 41.6)
27.9
(22.7 to 33.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 & BSA≥3% were considered PASI100 responders if, and only if, PASI=0 & BSA=0 achieved at week 24.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
0.5 to 15.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving ACR50
Hide Description 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).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.5
(44.7 to 56.4)
46.6
(40.8 to 52.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
-4.3 to 12.1
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving PASI100
Hide Description 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.1
(54.4 to 65.8)
46.6
(40.8 to 52.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 & BSA≥3% were considered PASI100 responders if, and only if, PASI=0 & BSA=0 achieved at week 24.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
5.3 to 21.6
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Change From Baseline in Tender Joint Count (TJC)
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 242 239
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-15.91  (0.566) -14.88  (0.569)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.03
Confidence Interval (2-Sided) 95%
-2.46 to 0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.725
Estimation Comments [Not Specified]
5.Other Pre-specified Outcome
Title Change From Baseline in Swollen Joint Count (SJC)
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 242 239
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-9.58  (0.196) -9.53  (0.198)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.54 to 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.249
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS)
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 242 246
Least Squares Mean (Standard Error)
Unit of Measure: millimeters (mm)
-37.21  (1.623) -36.54  (1.621)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.752
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-4.80 to 3.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.104
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Change From Baseline in Participant's Global Assessment of Disease Activity
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 242 246
Least Squares Mean (Standard Error)
Unit of Measure: Millimeter (mm)
-40.61  (1.594) -37.82  (1.596)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.79
Confidence Interval (2-Sided) 95%
-6.83 to 1.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.060
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 223 230
Least Squares Mean (Standard Error)
Unit of Measure: Millimeter (mm)
-48.15  (1.113) -46.79  (1.097)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.332
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-4.08 to 1.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.391
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Change From Baseline in C-Reactive Protein (CRP)
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 234 238
Least Squares Mean (Standard Error)
Unit of Measure: Milligram per Liter (mg/L)
-5.68  (0.462) -6.01  (0.461)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.592
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
-0.86 to 1.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.599
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Change From Baseline in HAQ-DI
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 242 246
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.68  (0.035) -0.62  (0.035)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.15 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Percentage of Participants Simultaneously Achieving ACR50 and PASI100
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
39.2
(33.5 to 44.9)
26.1
(21.0 to 31.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 & BSA≥3% were considered PASI100 responders if, and only if, PASI=0 & BSA=0 achieved at week 52.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 13.1
Confidence Interval (2-Sided) 95%
5.4 to 20.7
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 226 228
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-2.45  (0.071) -2.36  (0.071)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.26 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.091
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Percentage of Participants Achieving Minimal Disease Activity (MDA)
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
MDA-6 Entheseal Points
48.1
(42.2 to 53.9)
42.8
(37.0 to 48.5)
MDA-18 Entheseal Points
47.3
(41.5 to 53.2)
41.0
(35.3 to 46.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments MDA-18 Entheseal Points
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-1.8 to 14.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments MDA-6 Entheseal Points
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
-2.9 to 13.5
Estimation Comments [Not Specified]
14.Other Pre-specified Outcome
Title Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Hide Description 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.8
(61.3 to 72.3)
65.7
(60.2 to 71.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.846
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-8.9 to 6.7
Estimation Comments [Not Specified]
15.Other Pre-specified Outcome
Title Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 237 234
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.35  (0.136) -3.85  (0.136)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.83 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.170
Estimation Comments [Not Specified]
16.Other Pre-specified Outcome
Title Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 163 139
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-3.93  (0.234) -4.06  (0.241)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.687
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.48 to 0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.305
Estimation Comments [Not Specified]
17.Other Pre-specified Outcome
Title Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 141 121
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.93  (0.113) -2.02  (0.116)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.19 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.144
Estimation Comments [Not Specified]
18.Other Pre-specified Outcome
Title Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 35 47
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-52.28  (11.495) -48.89  (9.855)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.40
Confidence Interval (2-Sided) 95%
-32.78 to 25.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.951
Estimation Comments [Not Specified]
19.Other Pre-specified Outcome
Title Change From Baseline in Psoriasis Body Surface Area (BSA)
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 246 246
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-12.33  (0.623) -10.79  (0.613)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.54
Confidence Interval (2-Sided) 95%
-3.09 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.790
Estimation Comments [Not Specified]
20.Other Pre-specified Outcome
Title Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 169 154
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-17.78  (0.731) -15.08  (0.742)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.70
Confidence Interval (2-Sided) 95%
-4.57 to -0.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.949
Estimation Comments [Not Specified]
21.Other Pre-specified Outcome
Title Change From Baseline in the Itch NRS
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 242 246
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-3.83  (0.159) -3.54  (0.159)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.158
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.68 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.202
Estimation Comments [Not Specified]
22.Other Pre-specified Outcome
Title Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 241 246
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-3.03  (0.161) -2.95  (0.161)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.711
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.49 to 0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments [Not Specified]
23.Other Pre-specified Outcome
Title Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 240 246
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
10.07  (0.526) 9.55  (0.524)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.439
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
-0.80 to 1.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.674
Estimation Comments [Not Specified]
24.Other Pre-specified Outcome
Title Change From Baseline in SF-36: Mental Component Summary (MCS)
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 240 246
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
5.23  (0.660) 4.77  (0.656)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.594
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
-1.23 to 2.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.860
Estimation Comments [Not Specified]
25.Other Pre-specified Outcome
Title Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 240 245
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
0.21  (0.013) 0.21  (0.013)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.03 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.017
Estimation Comments [Not Specified]
26.Other Pre-specified Outcome
Title Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 240 245
Least Squares Mean (Standard Deviation)
Unit of Measure: millimeters (mm)
22.26  (1.37) 17.48  (1.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.78
Confidence Interval (2-Sided) 95%
1.28 to 8.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.782
Estimation Comments [Not Specified]
27.Other Pre-specified Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Hide Description 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.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 241 246
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-8.03  (0.273) -6.91  (0.272)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-1.78 to -0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.335
Estimation Comments [Not Specified]
28.Other Pre-specified Outcome
Title Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)
Hide Description 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").
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 283 283
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Effectiveness of Medication
64.3
(58.7 to 69.9)
58.7
(52.9 to 64.4)
Effectiveness over Time of Medication
62.9
(57.3 to 68.5)
56.2
(50.4 to 62.0)
Long Term Safety of Medication
63.3
(57.6 to 68.9)
58.7
(52.9 to 64.4)
Overall Satisfaction with Medication
64.0
(58.4 to 69.6)
59.0
(53.3 to 64.7)
Mostly Satisfied to any Questions
70.0
(64.6 to 75.3)
67.8
(62.4 to 73.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments Effectiveness of Medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.165
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 5.7
Confidence Interval (2-Sided) 95%
-2.4 to 13.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments Effectiveness over Time of Medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
-1.4 to 14.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments Long Term Safety of Medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
-3.4 to 12.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments Overall Satisfaction with Medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.215
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 4.9
Confidence Interval (2-Sided) 95%
-3.1 to 13.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ixekizumab, Adalimumab
Comments Mostly Satisfied to any Questions
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Difference
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-5.5 to 9.7
Estimation Comments [Not Specified]
29.Other Pre-specified Outcome
Title Number of Participants Who Answered "Yes" to Any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)
Hide Description

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
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixekizumab Adalimumab
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 283 283
Measure Type: Count of Participants
Unit of Measure: Participants
9 7
Time Frame Up To Week 52
Adverse Event Reporting Description 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
 
Arm/Group Title Ixekizumab Adalimumab Ixekizumab Follow-up Adalimumab Follow-up
Hide Arm/Group Description

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.

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. Follow-up: Participants did not receive drug during the Post-Treatment Follow-Up Period.
All-Cause Mortality
Ixekizumab Adalimumab Ixekizumab Follow-up Adalimumab Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/283 (0.00%)      0/283 (0.00%)      0/265 (0.00%)      0/260 (0.00%)    
Hide Serious Adverse Events
Ixekizumab Adalimumab Ixekizumab Follow-up Adalimumab Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/283 (4.24%)      35/283 (12.37%)      7/265 (2.64%)      4/260 (1.54%)    
Blood and lymphatic system disorders         
Anaemia  1  0/283 (0.00%)  0 0/283 (0.00%)  0 0/265 (0.00%)  0 1/260 (0.38%)  1
Cardiac disorders         
Angina unstable  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Atrial fibrillation  1  1/283 (0.35%)  1 1/283 (0.35%)  1 0/265 (0.00%)  0 1/260 (0.38%)  1
Atrial flutter  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
Cardiac failure congestive  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
Myocardial infarction  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
Myocardial ischaemia  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Gastrointestinal disorders         
Acute abdomen  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Gastritis  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
General disorders         
Asthenia  1  0/283 (0.00%)  0 0/283 (0.00%)  0 0/265 (0.00%)  0 1/260 (0.38%)  1
Injection site rash  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Non-cardiac chest pain  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Pyrexia  1  2/283 (0.71%)  2 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis chronic  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Cholelithiasis  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Infections and infestations         
Abscess  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Appendicitis  1  1/283 (0.35%)  1 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Arthritis bacterial  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Cellulitis  1  1/283 (0.35%)  1 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Large intestine infection  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Lower respiratory tract infection  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Lymph node tuberculosis  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Meningitis viral  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Pneumonia  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Pneumonia legionella  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Pyelonephritis  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Pyoderma  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
Sepsis  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Staphylococcal sepsis  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
Viral infection  1  0/283 (0.00%)  0 0/283 (0.00%)  0 0/265 (0.00%)  0 1/260 (0.38%)  1
Injury, poisoning and procedural complications         
Ankle fracture  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Fall  1  0/283 (0.00%)  0 2/283 (0.71%)  2 0/265 (0.00%)  0 0/260 (0.00%)  0
Hip fracture  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Humerus fracture  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Maternal exposure during pregnancy  1  0/121 (0.00%)  0 1/133 (0.75%)  1 0/111 (0.00%)  0 0/123 (0.00%)  0
Road traffic accident  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Tendon rupture  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Upper limb fracture  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Investigations         
Hepatic enzyme increased  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Metabolism and nutrition disorders         
Diabetic ketoacidosis  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Bursitis  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Osteoarthritis  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Pain in extremity  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Gastrointestinal stromal tumour  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Pituitary tumour benign  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Rectal adenocarcinoma  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Squamous cell carcinoma of skin  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
Nervous system disorders         
Haemorrhagic stroke  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Polyneuropathy  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Radiologically isolated syndrome  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Sciatica  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Seizure  1  0/283 (0.00%)  0 0/283 (0.00%)  0 0/265 (0.00%)  0 1/260 (0.38%)  1
Transient ischaemic attack  1  1/283 (0.35%)  1 0/283 (0.00%)  0 0/265 (0.00%)  0 0/260 (0.00%)  0
Psychiatric disorders         
Depression  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Renal failure  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Reproductive system and breast disorders         
Menometrorrhagia  1  1/121 (0.83%)  1 0/133 (0.00%)  0 0/111 (0.00%)  0 0/123 (0.00%)  0
Prostatitis  1  0/162 (0.00%)  0 1/150 (0.67%)  1 0/154 (0.00%)  0 0/137 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
Vocal cord thickening  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
Skin and subcutaneous tissue disorders         
Erythrodermic psoriasis  1  0/283 (0.00%)  0 0/283 (0.00%)  0 1/265 (0.38%)  1 0/260 (0.00%)  0
Vascular disorders         
Necrosis ischaemic  1  0/283 (0.00%)  0 1/283 (0.35%)  2 0/265 (0.00%)  0 0/260 (0.00%)  0
Peripheral artery occlusion  1  0/283 (0.00%)  0 1/283 (0.35%)  1 0/265 (0.00%)  0 0/260 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ixekizumab Adalimumab Ixekizumab Follow-up Adalimumab Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/283 (22.97%)      44/283 (15.55%)      8/265 (3.02%)      5/260 (1.92%)    
General disorders         
Injection site reaction  1  16/283 (5.65%)  30 4/283 (1.41%)  9 0/265 (0.00%)  0 0/260 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  38/283 (13.43%)  46 23/283 (8.13%)  26 5/265 (1.89%)  5 3/260 (1.15%)  3
Upper respiratory tract infection  1  18/283 (6.36%)  21 18/283 (6.36%)  23 3/265 (1.13%)  3 2/260 (0.77%)  2
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03151551    
Other Study ID Numbers: 16687
I1F-MC-RHCF ( Other Identifier: Eli Lilly and Company )
2016-004585-25 ( EudraCT Number )
First Submitted: May 4, 2017
First Posted: May 12, 2017
Results First Submitted: February 22, 2019
Results First Posted: April 2, 2019
Last Update Posted: November 3, 2020