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Trial record 12 of 29 for:    LY2439821

A Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P1)

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ClinicalTrials.gov Identifier: NCT01695239
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : October 27, 2016
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis, Arthritic
Interventions Drug: Ixekizumab
Drug: Placebo
Drug: Adalimumab
Enrollment 417
Recruitment Details  
Pre-assignment Details The Double-Blind Treatment Period was Week 0 up to Week 24 (Inadequate responders (IR) Week 16-24) followed by the combined extension period and long-term extension period from Week 24 to Week 156.
Arm/Group Title Placebo (PBO) Adalimumab (ADA) Q2W Ixe Q4W Ixe Q2W Inadequate Responders (IR)/Ixe Q4W IR/Ixe Q2W IR PBO Washout PBO Washout Ixe Q4W/Ixe Q4W Ixe Q2W/Ixe Q2W Placebo Post-Treatment Follow-up Period Adalimumab Post-Treatment Follow-up Period Ixekizumab 80mg Q4W Post-Treatment Follow-up Period Ixekizumab 80mg Q2W Post-Treatment Follow-up Period
Hide Arm/Group Description Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24. Placebo Week 16 inadequate responders (IRs) re-randomized to ixekizumab 80 mg every 4 weeks (Q4W) received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab Q4W IRs received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Placebo IRs re-randomized to ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab 80 mg Q2W IRs received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Adalimumab Q2W IRs re-randomized to ixekizumab 80 mg Q4W or ixekizumab 80 mg Q2W. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 16. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 18 to Week 22. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Adalimumab Q2W participants re-randomized to ixekizumab 80 mg Q4W or ixekizumab Q2W Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 24. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 26 to Week 30. Participants received a dose of 80 mg of ixekizumab given as 1 SC injection at Week 32. Participants continuing on 1 injection of ixekizumab 80 mg Q4W starting on Week 24 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 28 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 32 and ending on Week 156 alternating with placebo injections Q4W starting on Week 34 and ending on Week 154. Participants continuing on 1 injection of ixekizumab 80 mg Q2W starting on Week 24 and ending on Week 156. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg Q2W at Week 16 and Week 24. Placebo washout participants who re-randomized at Week 16 receive a starting dose of 160 mg ixekizumab given as 2 SC injections of 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 28 and ending on Week 156. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 32 and ending on Week 156. Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period. Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period. Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period. Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
Period Title: Double-Blind (DB) Treatment Period
Started 106 101 107 103 0 0 0 0 0 0 0 0 0 0
Received at Least 1 Dose of Study Drug 106 101 107 102 0 0 0 0 0 0 0 0 0 0
Classified as Inadequate Responder (IR) 27 9 11 10 0 0 0 0 0 0 0 0 0 0
Completed 91 97 97 96 0 0 0 0 0 0 0 0 0 0
Not Completed 15 4 10 7 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Entry Criteria Not Met             1             1             3             4             0             0             0             0             0             0             0             0             0             0
Adverse Event             2             2             2             3             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             4             0             2             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             3             1             1             0             0             0             0             0             0             0             0             0             0             0
Sponsor Decision             3             0             1             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             1             0             1             0             0             0             0             0             0             0             0             0             0             0
Protocol Violation             1             0             0             0             0             0             0             0             0             0             0             0             0             0
Period Title: IR Participants (Week 16 Up To Week 24)
Started 0 [1] 0 [1] 0 [1] 0 [1] 24 [2] 24 [3] 9 [4] 0 0 0 0 0 0 0
Completed 0 0 0 0 24 24 9 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0
[1]
Only inadequate responders were included.
[2]
IR from placebo who re-randomized to ixeQ4W and IR from ixeQ4W.
[3]
IR from placebo who re-randomized to ixeQ2W and IR from ixeQ2W.
[4]
Adalimumab Q2W (IR) who re-randomized to IxeQ2W or IxeQ4W and PBO for ixe and adalimumab.
Period Title: Placebo Washout (Week 24 Up To Week 32)
Started 0 0 0 0 0 [1] 0 [1] 0 [1] 88 [2] 0 0 0 0 0 0
Completed 0 0 0 0 0 0 0 77 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 11 0 0 0 0 0 0
Reason Not Completed
Lack of Efficacy             0             0             0             0             0             0             0             9             0             0             0             0             0             0
Adverse Event             0             0             0             0             0             0             0             1             0             0             0             0             0             0
Entry Criteria Not Met             0             0             0             0             0             0             0             1             0             0             0             0             0             0
[1]
Only included PBO washout participants.
[2]
Adalimumab Q2W responders who re-randomized to IxeQ2W or IxeQ4W and PBO for ixe and adalimumab.
Period Title: Extension Long-Term Extension Periods
Started 0 0 0 0 0 0 0 0 [1] 187 [2] 183 [3] 0 0 0 0
Completed 0 0 0 0 0 0 0 0 121 122 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 66 61 0 0 0 0
Reason Not Completed
Lack of Efficacy             0             0             0             0             0             0             0             0             37             31             0             0             0             0
Adverse Event             0             0             0             0             0             0             0             0             15             21             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             6             7             0             0             0             0
Physician Decision             0             0             0             0             0             0             0             0             3             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             2             1             0             0             0             0
Sponsor Decision             0             0             0             0             0             0             0             0             2             1             0             0             0             0
Death             0             0             0             0             0             0             0             0             1             0             0             0             0             0
[1]
Only included combined extension participants.
[2]
IxeQ4W who re-randomized to ixeQ4W.
[3]
IxeQ2W who re-randomized to ixeQ2W.
Period Title: Post-Treatment Follow-Up Period
Started 0 0 0 0 0 0 0 0 0 [1] 0 [1] 20 [2] 1 [3] 165 [4] 171 [5]
Completed 0 0 0 0 0 0 0 0 0 0 20 0 156 166
Not Completed 0 0 0 0 0 0 0 0 0 0 0 1 9 5
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             1             6             3
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             1             1
Physician Decision             0             0             0             0             0             0             0             0             0             0             0             0             2             0
Protocol Violation             0             0             0             0             0             0             0             0             0             0             0             0             0             1
[1]
Only included post-treatment follow-up participants.
[2]
Participants who discontinued early and received PBO.
[3]
Participants who discontinued early and received adalimumab.
[4]
IxeQ4W participants who entered post-treatment follow-up.
[5]
IxeQ2W participants who entered post-treatment follow-up.
Arm/Group Title Placebo ADA Q2W Ixe Q4W Ixe Q2W Total
Hide Arm/Group Description Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24. Total of all reporting groups
Overall Number of Baseline Participants 106 101 107 103 417
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 101 participants 107 participants 103 participants 417 participants
50.60  (12.32) 48.58  (12.43) 49.07  (10.07) 49.79  (12.62) 49.52  (11.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 101 participants 107 participants 103 participants 417 participants
Female 58 50 62 55 225
Male 48 51 45 48 192
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 101 participants 107 participants 103 participants 417 participants
American Indian or Alaska Native 2 3 2 2 9
Asian 5 3 2 5 15
Native Hawaiian or Other Pacific Islander 0 0 0 0 0
Black or African American 0 0 0 0 0
White 99 95 102 96 392
More than one race 0 0 1 0 1
Unknown or Not Reported 0 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 101 participants 107 participants 103 participants 417 participants
Hispanic or Latino 6 5 5 4 20
Not Hispanic or Latino 92 83 94 87 356
Unknown or Not Reported 8 13 8 12 41
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 101 participants 107 participants 103 participants 417 participants
Russia 9 7 10 8 34
United States 22 21 20 20 83
Japan 4 2 2 4 12
Ukraine 9 7 9 10 35
United Kingdom 3 5 5 4 17
Spain 4 2 3 4 13
Canada 1 1 2 0 4
Czechia 22 25 23 22 92
Netherlands 1 0 1 0 2
Belgium 2 2 0 1 5
Poland 16 14 15 15 60
Mexico 3 4 3 2 12
France 1 0 1 1 3
Bulgaria 3 4 5 4 16
Estonia 6 7 8 8 29
1.Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])
Hide Description ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 101 107 103
Measure Type: Number
Unit of Measure: percentage of participants
30.2 57.4 57.9 62.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Adalimumab Q2W
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab Q4W
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab Q2W
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving ACR20 Response
Hide Description ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 101 107 103
Measure Type: Number
Unit of Measure: percentage of participants
31.1 51.5 57.0 60.2
3.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response
Hide Description ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 101 107 103
Measure Type: Number
Unit of Measure: percentage of participants
15.1 38.6 40.2 46.6
4.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score
Hide Description ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 101 107 103
Measure Type: Number
Unit of Measure: percentage of participants
5.7 25.7 23.4 34.0
5.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
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 HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline HAQ-DI data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 105 97 103 98
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.1797  (0.0524) -0.3712  (0.0510) -0.4431  (0.0503) -0.4963  (0.0507)
6.Secondary Outcome
Title Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])
Hide Description The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post baseline mTSS data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 101 107 103
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.49  (0.086) 0.10  (0.085) 0.17  (0.082) 0.08  (0.083)
7.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)
Hide Description The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 67 68 73 59
Measure Type: Number
Unit of Measure: percentage of participants
PASI 75 7.5 33.8 75.3 69.5
PASI 90 1.5 22.1 52.1 57.6
PASI 100 1.5 14.7 31.5 40.7
8.Secondary Outcome
Title Change From Baseline in Leeds Enthesitis Index (LEI)
Hide Description The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 57 55 70 56
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.8  (0.24) -0.8  (0.24) -0.9  (0.21) -1.5  (0.24)
9.Secondary Outcome
Title Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
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 was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 67 68 73 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.2  (0.27) -1.4  (0.28) -2.6  (0.27) -2.8  (0.30)
10.Secondary Outcome
Title Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
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 rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline fatigue NRS data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 103 97 101 97
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.3  (0.25) -1.5  (0.24) -1.6  (0.24) -1.9  (0.24)
11.Secondary Outcome
Title Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)
Hide Description JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 91 95 97 96
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Joint Space Narrowing Score 0.07  (0.031) 0.01  (0.031) 0.04  (0.030) 0.01  (0.030)
Bone Erosion Score 0.44  (0.077) 0.12  (0.077) 0.15  (0.075) 0.08  (0.075)
12.Secondary Outcome
Title Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])
Hide Description SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 99 95 98 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
PCS Score 2.94  (0.958) 6.78  (0.904) 7.45  (0.894) 8.24  (0.898)
MCS Score 2.67  (1.013) 4.22  (0.943) 4.86  (0.933) 3.39  (0.936)
13.Secondary Outcome
Title Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])
Hide Description The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline QIDS-SR16 data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 101 98 102 99
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.9  (0.36) -1.6  (0.33) -0.8  (0.32) -0.7  (0.32)
14.Secondary Outcome
Title Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease
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 milligram/liter (mg/L), and Participant’s Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) 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 analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline and post baseline DAS28-CRP data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 104 99 106 99
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.835  (0.1307) -1.743  (0.1215) -1.955  (0.1206) -2.036  (0.1225)
15.Secondary Outcome
Title Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)
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 which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 101 107 103
Measure Type: Number
Unit of Measure: percentage of participants
32.1 58.4 57.9 66.0
16.Secondary Outcome
Title Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline
Hide Description The sPGA is the physician’s determination of the severity of the participant’s psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 41 37 52 41
Measure Type: Number
Unit of Measure: percentage of participants
17.1 62.2 65.4 73.2
17.Secondary Outcome
Title Percent Change From Baseline in Body Surface Area (BSA)
Hide Description The investigator evaluated 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 analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 99 94 100 91
Least Squares Mean (Standard Error)
Unit of Measure: percent change in BSA
-2.7  (1.36) -9.5  (1.35) -12.0  (1.32) -10.6  (1.39)
18.Secondary Outcome
Title Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score 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 analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 69 68 66 69
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.4  (1.66) -10.7  (1.49) -14.0  (1.54) -15.5  (1.49)
19.Secondary Outcome
Title Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)
Hide Description The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference 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. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 39 23 54 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-25.4  (6.53) -57.1  (7.84) -57.1  (5.67) -48.3  (6.31)
20.Secondary Outcome
Title Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Hide Description The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 75 73 85 71
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.25  (0.268) -2.42  (0.249) -2.74  (0.234) -2.91  (0.251)
21.Secondary Outcome
Title Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)
Hide Description Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and post baseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.
Arm/Group Title Placebo Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 103 107 100
Measure Type: Number
Unit of Measure: participants
Treatment Emergent (TE) 0 6 5
NAb 0 0 0
22.Secondary Outcome
Title Percent Change in American College of Rheumatology-N (ACR-N) Score
Hide Description The ACR-N score is a continuous measure of clinical, laboratory, and functional outcomes that characterizes the percentage of improvement from baseline in disease activity and the lowest of either a) the percent change in tender joint count (TJC) b) the percent change in swollen joint count (SJC), or c) the median percent change of the remaining 5 ACR core criteria. An ACR-N score of X has improvement of at least X% in both TJC and SJC and a median improvement of at least X% in 5 criteria: patient’s assessment of arthritis pain, PatGA, PGA, HAQ-DI and hs-CRP. ACR-N is calculated by allowing for negative results which indicate worsening. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment.
Time Frame Baseline, 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with post-baseline ACR data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 101 107 103
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-4.182  (6.1417) 28.517  (5.9189) 33.509  (5.8905) 30.391  (5.9736)
23.Secondary Outcome
Title Change From Baseline in Tender Joint Counts (TJC)
Hide Description TJC is calculated based on tenderness response of 68 joints. TJC possible values range from 0 to 68. A lower TJC indicated less joint tenderness. A higher TJC indicated more joint tenderness. 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. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post-baseline TJC data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 100 107 102
Least Squares Mean (Standard Error)
Unit of Measure: joint counts
-4.7  (1.14) -10.1  (1.10) -11.9  (1.08) -13.6  (1.09)
24.Secondary Outcome
Title Change From Baseline in Swollen Joint Counts (SJC)
Hide Description SJC is calculated based on swelling response of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joint swelling. A higher SJC indicated more joint swelling. 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 Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post-baseline SJC data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 100 107 102
Least Squares Mean (Standard Error)
Unit of Measure: joint counts
-3.5  (0.62) -6.1  (0.59) -7.0  (0.59) -8.3  (0.59)
25.Secondary Outcome
Title Change From Baseline in Patient's Assessment of Pain VAS
Hide Description The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post-baseline patient's assessment of pain data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 105 99 104 98
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-14.0  (2.68) -30.0  (2.52) -29.6  (2.51) -31.6  (2.54)
26.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS
Hide Description Participants scored their overall assessment of their PsA activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post-baseline patient's global assessment of disease activity data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 105 99 104 98
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-14.8  (2.65) -31.6  (2.49) -33.8  (2.48) -35.6  (2.50)
27.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity VAS
Hide Description The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 0 to 100 mm horizontal VAS. The scale ranged from 0 no disease activity to 100 extremely active disease activity. The scores were measured to the nearest millimeter from the left. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post-baseline physician's global assessment of disease activity data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 100 88 96 95
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-24.2  (2.14) -34.7  (2.10) -38.5  (2.06) -42.0  (1.99)
28.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP)
Hide Description CRP milligram/liter (mg/L) was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with baseline and post-baseline CRP data.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 106 101 107 103
Least Squares Mean (Standard Error)
Unit of Measure: milligram/liter (mg/L)
-3.873  (1.4292) -7.512  (1.2674) -8.804  (1.2602) -8.942  (1.2552)
29.Secondary Outcome
Title Change From Baseline in Leeds Enthesitis Index (LEI)
Hide Description The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 57 56 70 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.8  (0.26) -0.9  (0.23) -1.3  (0.21) -1.4  (0.24)
30.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)
Hide Description The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.
Time Frame Week 24
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Hide Analysis Population Description
All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 38 61 60 49
Measure Type: Number
Unit of Measure: percentage of participants
PASI 75 Number Analyzed 7 participants 37 participants 52 participants 45 participants
10.9 55.2 71.2 80.4
PASI 90 Number Analyzed 4 participants 25 participants 41 participants 38 participants
6.3 37.3 56.2 67.9
PASI 100 Number Analyzed 2 participants 16 participants 31 participants 30 participants
3.1 23.9 42.5 53.6
31.Secondary Outcome
Title Change From Baseline in Itching Severity Using 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 was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.
Time Frame Baseline, Week 24
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Hide Analysis Population Description
All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.
Arm/Group Title Placebo Adalimumab Q2W Ixekizumab Q4W Ixekizumab Q2W
Hide Arm/Group Description:
Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Overall Number of Participants Analyzed 67 68 73 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.3  (0.32) -1.7  (0.29) -2.9  (0.29) -2.8  (0.31)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
 
Arm/Group Title Placebo (PBO) Double-Blind Period Adalimumab (ADA) Double-Blind Period Ixe Q2W Double-Blind Period Ixe Q4W Double-Blind Period IR IXE Q4W IR IXE Q2W IR PBO Washout PBO Washout IXE Q4W IXE Q2W PBO Post-Treatment Follow-Up Period Adalimumab Post-Treatment Follow-up Period IXE Q4W Post-Treatment Follow-up Period IXE Q2W Post-Treatment Follow-up Period
Hide Arm/Group Description Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24 Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W or Placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24. Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Ixekizumab every 4 weeks (IxeQ4W) and IR IxeQ4W participants received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 24 to Week 156.

Placebo and IR placebo (PBO) Washout participants re-randomized to Ixekizumab 80 mg Q4W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of alternating placebo for ixekizumab or ixekizumab Q2W from Week 26 to Week 156.

PBO Washout participants re-randomized to ixekizumab 80 mg Q4W received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 32 to Week 156.

Ixekizumab Q2W (IxeQ2W) and IR IxeQ2W participants received one SC injection of 80 mg of ixekizumab Q2W from Week 24 to Week 156.

Placebo and IR PBO Washout participants re-randomized to Ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 26 to Week 156.

PBO Washout participants re-randomized to ixekizumab 80 mg Q2W received one SC injection of 80 mg of ixekizumab Q2W from Week 32 to Week 156.

Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period. Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period. Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period. Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
All-Cause Mortality
Placebo (PBO) Double-Blind Period Adalimumab (ADA) Double-Blind Period Ixe Q2W Double-Blind Period Ixe Q4W Double-Blind Period IR IXE Q4W IR IXE Q2W IR PBO Washout PBO Washout IXE Q4W IXE Q2W PBO Post-Treatment Follow-Up Period Adalimumab Post-Treatment Follow-up Period IXE Q4W Post-Treatment Follow-up Period IXE Q2W Post-Treatment Follow-up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (PBO) Double-Blind Period Adalimumab (ADA) Double-Blind Period Ixe Q2W Double-Blind Period Ixe Q4W Double-Blind Period IR IXE Q4W IR IXE Q2W IR PBO Washout PBO Washout IXE Q4W IXE Q2W PBO Post-Treatment Follow-Up Period Adalimumab Post-Treatment Follow-up Period IXE Q4W Post-Treatment Follow-up Period IXE Q2W Post-Treatment Follow-up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/106 (1.89%)      5/101 (4.95%)      6/107 (5.61%)      3/102 (2.94%)      0/24 (0.00%)      0/24 (0.00%)      0/9 (0.00%)      1/88 (1.14%)      28/187 (14.97%)      19/183 (10.38%)      0/20 (0.00%)      0/1 (0.00%)      2/165 (1.21%)      2/171 (1.17%)    
Cardiac disorders                             
Acute myocardial infarction  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Atrial fibrillation  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  2 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Cardiac disorder  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  2 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Coronary artery disease  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 2/183 (1.09%)  2 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Coronary artery occlusion  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Myocardial ischaemia  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  2 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Eye disorders                             
Retinal detachment  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Gastrointestinal disorders                             
Abdominal pain  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Colitis ulcerative  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  5 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Duodenitis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Gastric ulcer  1  0/106 (0.00%)  0 1/101 (0.99%)  2 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Gastrointestinal inflammation  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Impaired gastric emptying  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 1/102 (0.98%)  2 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Irritable bowel syndrome  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 1/171 (0.58%)  1
Oesophagitis  1  0/106 (0.00%)  0 1/101 (0.99%)  2 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Pancreatitis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 1/107 (0.93%)  1 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Pancreatitis acute  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Hepatobiliary disorders                             
Cholecystitis acute  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 2/187 (1.07%)  2 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Cholelithiasis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 1/107 (0.93%)  1 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Immune system disorders                             
Anaphylactic reaction  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 1/165 (0.61%)  1 0/171 (0.00%)  0
Infections and infestations                             
Arthritis bacterial  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Cellulitis  1  0/106 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Chronic tonsillitis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Gastroenteritis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 1/107 (0.93%)  1 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Gastroenteritis clostridial  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Gastroenteritis rotavirus  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Herpes zoster  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 1/102 (0.98%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Latent tuberculosis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Lower respiratory tract infection  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Oesophageal candidiasis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 1/102 (0.98%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Pneumonia  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 2/187 (1.07%)  2 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Pneumonia mycoplasmal  1  0/106 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Upper respiratory tract infection  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Injury, poisoning and procedural complications                             
Anastomotic stenosis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Clavicle fracture  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Fall  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  2 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Fibula fracture  1  0/106 (0.00%)  0 0/101 (0.00%)  0 1/107 (0.93%)  1 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Humerus fracture  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Joint dislocation  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  3 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Ligament injury  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Limb injury  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Lumbar vertebral fracture  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Meniscus injury  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Perirenal haematoma  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Post procedural haematoma  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Tendon rupture  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Investigations                             
Hepatic enzyme increased  1  1/106 (0.94%)  1 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Metabolism and nutrition disorders                             
Obesity  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  2 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Musculoskeletal and connective tissue disorders                             
Intervertebral disc protrusion  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Lumbar spinal stenosis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 1/107 (0.93%)  1 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Osteoarthritis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Psoriatic arthropathy  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 1/165 (0.61%)  1 0/171 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                             
Acoustic neuroma  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Breast cancer  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Invasive ductal breast carcinoma  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Large intestine benign neoplasm  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Melanocytic naevus  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 1/187 (0.53%)  1 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Parathyroid tumour benign  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 1/183 (0.55%)  1 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Prostate cancer  1  0/48 (0.00%)  0 0/51 (0.00%)  0 0/45 (0.00%)  0 0/47 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0 0/1 (0.00%)  0 0/50 (0.00%)  0 0/78 (0.00%)  0 0/92 (0.00%)  0 0/10 (0.00%)  0 0/1 (0.00%)  0 0/71 (0.00%)  0 1/87 (1.15%)  1
Nervous system disorders                             
Carotid artery occlusion  1  0/106 (0.00%)  0 1/101 (0.99%)  1 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 0/9 (0.00%)  0 0/88 (0.00%)  0 0/187 (0.00%)  0 0/183 (0.00%)  0 0/20 (0.00%)  0 0/1 (0.00%)  0 0/165 (0.00%)  0 0/171 (0.00%)  0
Carotid artery stenosis  1  0/106 (0.00%)  0 0/101 (0.00%)  0 0/107 (0.00%)  0 0/102 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0