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A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03129100
Recruitment Status : Completed
First Posted : April 26, 2017
Results First Posted : June 18, 2021
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Axial Spondyloarthritis
Interventions Drug: Ixekizumab
Drug: Placebo
Enrollment 773
Recruitment Details
  • Lead-In (Period 1): 24 weeks (Week 0 to Week 24)
  • Extension Period including Double-Blind, Placebo-Controlled, Randomized Withdrawal-Retreatment (RWR) (Period 2): 40 weeks (Week 24 to Week 64)
  • Long-Term Extension Period (Period 3): 40 weeks (Week 64 to Week 104)
  • Post-Treatment Follow-Up (Period 4): at least 12 weeks and up to 24 weeks after the date of the participant's ETV or last regularly scheduled visit.
Pre-assignment Details In Period 2, participants who did not achieve sustained remission were assigned to Group A and continued to receive the ixekizumab(IXE) dose regimen that they were receiving during Period 1. Participants who did achieve sustained remission were assigned to Group B (Randomized Withdrawal Extension(RWE) period) and were randomized 2:1 to either continue their IXE dose or to withdraw to placebo. Participants who experienced a flare in group B were retreated with IXE in Retreatment Extension Period.
Arm/Group Title IXE 80Q4W-Lead-in Period IXE80Q2W-Lead-in Period IXE80Q4W-Group A Extension Period IXE80Q2W-Group A Extension Period IXE80Q4W-Group B-Randomized Withdrawal Extension Period IXE80Q2W-Group B-Randomized Withdrawal Extension Period Placebo-Group B-Randomized Withdrawal Extension Period IXE80Q2W/IXE80Q2W-Retreatment Extension Period IXE80Q4W/IXE80Q4W-Retreatment Extension Period PBO/IXE80Q2W-Retreatment Extension Period PBO/IXE80Q4W-Retreatment Extension Period IXE80Q2W-group A Long-term Extension Period IXE80Q4W-group A Long-term Extension Period IXE80Q2W-Group B-Randomized Withdrawal Long-term Extension Period IXE80Q4W-Group B-Randomized Withdrawal Long-term Extension Period PBO-Group B-Randomized Withdrawal Long-term Extension Period IXE80Q2W/IXE80Q2W-Retreatment Long-term Extension Period IXE80Q4W/IXE80Q4W-Retreatment Long-term Extension Period PBO/IXE80Q2W-Retreatment Long-term Extension Period PBO/IXE80Q4W-Retreatment Long-term Extension Period IXE80Q4W-Group A-Escalation Period IXE80Q4W-Randomized Withdrawal Escalation Period PBO-Randomized Withdrawal Escalation Period PBO-follow-up Period IXE80Q4W-follow-up Period IXE80Q2W-follow-up Period
Hide Arm/Group Description Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W) for up to week 24. Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24. Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period. Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period. Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period. Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period. Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period. Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period. Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period. Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period. Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period. Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2. Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2. Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2. Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2. Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2. Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period. Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period. Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period. Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period. Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3. Participants in Group B receiving Ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W. Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W. Participants did not receive any intervention during Follow-up period. Participants did not receive any intervention during Follow-up period. Participants did not receive any intervention during Follow-up period.
Period Title: Lead-In Period (Period 1)
Started 350 423 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Received at Least One Dose of Study Drug 348 423 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 335 406 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 15 17 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             2             6             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             8             8             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             3             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Surgery Programmed             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Period Title: Period2 Extension Period (Group A and B)
Started 0 [1] 0 [1] 255 [2] 318 [2] 48 [3] 54 [3] 53 [3] 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Received at Least One Dose of Study Drug 0 0 255 318 47 54 53 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 0 0 234 312 42 45 32 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 21 6 6 9 21 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             2             1             0             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Death             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             13             5             1             1             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Physician Decision             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             0             0             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             2             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Experienced Flare             0             0             0             0             5             6             19             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
[1]
Only Extension Period participants were included.
[2]
Participants who entered extension period (Group A).
[3]
Participants who entered extension period (Group B).
Period Title: Period 2 (Retreatment Extension Period)
Started 0 0 0 0 0 0 0 6 [1] 5 [1] 9 [1] 10 [1] 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 0 0 0 0 0 0 0 6 5 8 10 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
[1]
Participants who experienced flare in Group B Extension period.
Period Title: Period3-Long-Term Extension Period A & B
Started 0 0 0 0 0 0 0 0 [1] 0 [1] 0 [1] 0 [1] 306 [1] 177 [1] 45 [1] 42 [1] 30 [1] 0 0 0 0 0 0 0 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0 0 287 146 40 37 21 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 19 31 5 5 9 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             0             0             6             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             12             7             4             2             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             1             0             1             1             0             0             0             0             0             0             0             0             0             0             0
Lack of Efficacy             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0
Escalated to IXE80Q2W             0             0             0             0             0             0             0             0             0             0             0             0             24             0             2             8             0             0             0             0             0             0             0             0             0             0
[1]
This period is to report Long-Term Extension Period participants
Period Title: Period 3 (Flare)
Started 0 0 0 0 0 0 0 0 0 0 0 0 [1] 0 [1] 0 [1] 0 [1] 0 [1] 6 [1] 4 [1] 11 [1] 15 [1] 0 0 0 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 2 11 12 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 3 0 0 0 0 0 0
Reason Not Completed
Escalated to IXE80Q2W             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             0             3             0             0             0             0             0             0
[1]
This period is to report participants who experienced a flare in Period 3.
Period Title: Period 3 (Dose Escalation)
Started 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 [1] 0 [1] 0 [1] 0 [1] 77 [1] 5 [1] 4 [1] 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 73 5 4 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             0             0             0             0             0
Physician Decision             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0
Lack of Efficacy             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0
[1]
Participants who are eligible for dose escalations.
Period Title: Period 4 (Post Treatment Follow-up)
Started 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 [1] 0 [1] 0 [1] 25 [1] 223 [1] 453 [1]
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 22 198 411
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 25 42
Reason Not Completed
Death             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             2
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             3             20             37
COVID 19 Restrictions             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2             0
Missed follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1
Other             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             2
[1]
This period is to report Follow-Up period participants.
Arm/Group Title IXE80Q4W-Group A Extension Period IXE80Q2W-Group A Extension Period IXE80Q4W-Group B-Randomized Withdrawal Extension Period IXE80Q2W-Group B-Randomized Withdrawal Extension Period Placebo-Group B-Randomized Withdrawal Extension Period Total
Hide Arm/Group Description Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) for up to week 24. Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24. Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period. Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period. Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period. Total of all reporting groups
Overall Number of Baseline Participants 255 318 48 54 53 728
Hide Baseline Analysis Population Description
All randomized participants from extension period (period 2).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 318 participants 48 participants 54 participants 53 participants 728 participants
<=18 years 0 0 0 0 0 0
Between 18 and 65 years 240 302 48 53 52 695
>=65 years 15 16 0 1 1 33
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 318 participants 48 participants 54 participants 53 participants 728 participants
Female 68 95 10 14 15 202
Male 187 223 38 40 38 526
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 318 participants 48 participants 54 participants 53 participants 728 participants
Hispanic or Latino 61 86 7 14 11 179
Not Hispanic or Latino 166 204 31 35 39 475
Unknown or Not Reported 28 28 10 5 3 74
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 318 participants 48 participants 54 participants 53 participants 728 participants
American Indian or Alaska Native 14 11 2 5 4 36
Asian 54 50 15 15 13 147
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0
Black or African American 0 2 0 0 0 2
White 183 247 31 31 35 527
More than one race 3 8 0 3 1 15
Unknown or Not Reported 1 0 0 0 0 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 318 participants 48 participants 54 participants 53 participants 728 participants
Argentina 11 18 1 1 2 33
Romania 1 3 0 1 0 5
Hungary 3 2 1 1 0 7
United States 14 30 1 3 2 50
Czechia 37 35 5 4 4 85
Japan 7 9 1 3 1 21
United Kingdom 4 6 0 1 0 11
Spain 5 4 0 1 0 10
Russia 16 30 6 7 6 65
Canada 3 2 1 0 2 8
Netherlands 0 2 0 0 0 2
South Korea 28 23 10 7 8 76
Austria 1 1 0 1 0 3
Taiwan 17 16 3 5 2 43
Finland 0 5 0 1 2 8
Brazil 7 16 0 0 0 23
Poland 50 67 13 7 13 150
Italy 0 1 0 0 0 1
Mexico 40 38 5 11 8 102
Israel 5 3 0 0 1 9
France 4 4 0 0 0 8
Germany 2 3 1 0 2 8
1.Primary Outcome
Title Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)
Hide Description

A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2.

ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

Time Frame Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Arm/Group Title Combined IXE Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 102 53
Measure Type: Number
Unit of Measure: Percentage of participants
83.3 54.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined IXE, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.35
Confidence Interval (2-Sided) 95%
2.03 to 9.35
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who do Not Experience a Flare
Hide Description

A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2.

ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

Time Frame Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Measure Type: Number
Unit of Measure: Percentage of participants
83.3 83.3 54.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.28
Confidence Interval (2-Sided) 95%
1.66 to 11.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.42
Confidence Interval (2-Sided) 95%
1.77 to 11.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
Hide Description

The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where: 0 = normal; 1 = sclerosis, squaring or erosion; 2 = syndesmophyte; 3 = bony bridge.

By the scoring system of mSASSS of the spinal x-rays, a total of 24 sites were scored on the lateral cervical and lumbar spine: the anterior corners of the vertebrae from lower border of C2 to upper border T1 (inclusive), and from lower border of T12 to upper border of S1 (inclusive). Each corner was scored from 0 to 3, resulting in a range from 0 [no change] to 72 [progression].

Time Frame Baseline, 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Ixekizumab structure population who have been treated with ixekizumab for at least 24 months.
Arm/Group Title IXE80Q4W IXE80Q2W Combined IXE
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W).
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W).
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) and two weeks (Q2W).
Overall Number of Participants Analyzed 115 115 230
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
0.41  (2.102) 0.23  (1.387) 0.32  (1.779)
4.Secondary Outcome
Title Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response
Hide Description

ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain.

The following ASAS domains are used:

Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).

Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).

Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.

Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).

Time Frame Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Measure Type: Number
Unit of Measure: Percentage of participants
81.3 81.5 50.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.51
Confidence Interval (2-Sided) 95%
1.78 to 11.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.61
Confidence Interval (2-Sided) 95%
1.88 to 11.31
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving an ASAS40 Response
Hide Description

ASAS40 is defined as a ≥40% improvement and an absolute improvement from baseline of ≥2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. The following ASAS domains are used:

Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).

Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).

Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.

Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).

Time Frame Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Measure Type: Number
Unit of Measure: Percentage of Participants
79.2 79.6 43.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.17
Confidence Interval (2-Sided) 95%
2.11 to 12.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.23
Confidence Interval (2-Sided) 95%
2.20 to 12.47
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units
Hide Description

ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness

+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

Time Frame Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Measure Type: Number
Unit of Measure: Percentage of participants
79.2 74.1 45.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.60
Confidence Interval (2-Sided) 95%
1.90 to 11.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.55
Confidence Interval (2-Sided) 95%
1.56 to 8.09
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units)
Hide Description ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Time Frame Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Measure Type: Number
Unit of Measure: Percentage of participants
60.4 53.7 24.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.92
Confidence Interval (2-Sided) 95%
2.07 to 11.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.61
Confidence Interval (2-Sided) 95%
1.57 to 8.32
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Individual Components of the ASAS Criteria
Hide Description

Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).

Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).

Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Patient Global -5.1  (0.38) -5.0  (0.36) -3.0  (0.36)
Spinal Pain -5.1  (0.39) -4.8  (0.37) -3.0  (0.36)
BASFI -4.35  (0.316) -4.19  (0.301) -2.79  (0.301)
Inflammation -5.20  (0.336) -4.83  (0.319) -3.03  (0.317)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments Patient Global
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-3.1 to -1.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments Patient Global
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-2.9 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments Spinal Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-3.1 to -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments Spinal Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.8 to -0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments BASFI
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.55
Confidence Interval (2-Sided) 95%
-2.39 to -0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.421
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments BASFI
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.40
Confidence Interval (2-Sided) 95%
-2.20 to -0.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.409
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments Inflammation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.17
Confidence Interval (2-Sided) 95%
-3.05 to -1.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.448
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments Inflammation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-2.66 to -0.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.433
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
Hide Description The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.
Time Frame Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Measure Type: Number
Unit of Measure: Percentage of participants
81.3 75.9 45.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.34
Confidence Interval (2-Sided) 95%
2.13 to 13.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.07
Confidence Interval (2-Sided) 95%
1.75 to 9.45
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
Hide Description High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: milligram per liter (mg/L)
-12.952  (1.4666) -11.074  (1.3861) -5.094  (1.3696)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.858
Confidence Interval (2-Sided) 95%
-11.729 to -3.987
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.9586
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.979
Confidence Interval (2-Sided) 95%
-9.655 to -2.304
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.8600
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Hide Description

BASMI is a combined index comprising of the following 5 clinical measurements of spinal mobility in participants with radiographic axial spondyloarthritis (rad-axSpA).

  1. Lateral Spinal Flexion
  2. Tragus-to-wall distance
  3. Lumbar Flexion (modified Schober)
  4. Maximal intermalleolar distance and
  5. Cervical rotation.

The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the participant's limitation of movement due to their AS. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.

Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.69  (0.080) -0.73  (0.075) -0.50  (0.073)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.40 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.104
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.43 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.099
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Chest Expansion in Centimeters
Hide Description Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While participants have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: centimeter (cm)
0.77  (0.256) 0.53  (0.243) 0.67  (0.236)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.757
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.56 to 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.335
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.77 to 0.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.322
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Occiput to Wall Distance
Hide Description The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: cm
-0.78  (0.260) -0.66  (0.239) -0.38  (0.235)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.236
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-1.07 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.338
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.92 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.319
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Hide Description The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with Baseline MASES score >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 29 36 35
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.55  (0.352) -3.62  (0.315) -3.48  (0.302)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.885
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.98 to 0.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.459
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.735
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.95 to 0.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.410
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score
Hide Description The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SPARCC score >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 22 30 30
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.23  (0.388) -3.34  (0.338) -2.71  (0.335)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.294
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.53 to 0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.501
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.54 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.453
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints
Hide Description The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline TJC >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 27 33 23
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-6.1  (0.76) -5.3  (0.74) -4.0  (0.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-4.3 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-3.3 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.02
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints
Hide Description The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SJC >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 16 21 15
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.6  (0.67) -3.9  (0.59) -2.7  (0.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.7 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-3.0 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.88
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With Anterior Uveitis or Uveitis Flares
Hide Description Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
Time Frame Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and regardless of history of anterior uveitis.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Measure Type: Number
Unit of Measure: Percentage of Participants
4.2 5.6 5.7
19.Secondary Outcome
Title Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
Hide Description The fatigue severity NRS is a participant administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.2  (0.31) -4.3  (0.29) -3.5  (0.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.5 to 0.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.5 to -0.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)
Hide Description The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.68  (0.362) -3.28  (0.344) -2.80  (0.342)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.83 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.479
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.307
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-1.40 to 0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.465
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
Hide Description The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
13.2954  (1.1210) 13.1030  (1.0457) 10.6934  (1.0366)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.6021
Confidence Interval (2-Sided) 95%
-0.3011 to 5.5053
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.4684
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.4096
Confidence Interval (2-Sided) 95%
-0.3541 to 5.1734
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.3978
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in SF-36 Mental Component Summary (MCS) Score
Hide Description The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
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Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.1766  (0.8968) 4.6404  (0.8369) 2.3396  (0.8314)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.477
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.8370
Confidence Interval (2-Sided) 95%
-1.4864 to 3.1605
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.1752
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.3009
Confidence Interval (2-Sided) 95%
0.0880 to 4.5138
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.1192
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in ASAS Health Index (ASAS HI)
Hide Description The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the participant needs to respond to with either "I agree" (score 1) or "I do not agree (score 0)." A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Time Frame Baseline, Week 64
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
Arm/Group Title IXE80Q4W IXE80Q2W Placebo
Hide Arm/Group Description:
Participants received 80 mg of Ixekizumab subcutaneously every four weeks (Q4W) during the randomized withdrawal extension period.
Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) during the randomized withdrawal extension period.
Participants received placebo subcutaneously during the randomized withdrawal extension period.
Overall Number of Participants Analyzed 48 54 53
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.64  (0.393) -4.37  (0.368) -3.64  (0.370)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IXE80Q4W, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-2.02 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.520
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IXE80Q2W, Placebo
Comments [Not Specified]
Type of Statistical Test