Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis (NCT NCT02561806)
NCT ID: NCT02561806
Last Updated: 2020-06-17
Results Overview
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
COMPLETED
PHASE3
302 participants
Week 12
2020-06-17
Participant Flow
Induction period occurring from week 0 to week 12 followed by maintenance period occurring week 12 to week 52 followed by post-treatment follow-up period occurring from last treatment period visit (week 52) or Early termination visit, for a minimum of 12 weeks following that visit.
Participant milestones
| Measure |
Ustekinumab
45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Induction Period
STARTED
|
166
|
136
|
|
Induction Period
Received At Least One Dose of Study Drug
|
166
|
135
|
|
Induction Period
COMPLETED
|
164
|
131
|
|
Induction Period
NOT COMPLETED
|
2
|
5
|
|
Maintenance Period
STARTED
|
164
|
131
|
|
Maintenance Period
COMPLETED
|
151
|
123
|
|
Maintenance Period
NOT COMPLETED
|
13
|
8
|
|
Post-Treatment Follow-up
STARTED
|
157
|
60
|
|
Post-Treatment Follow-up
COMPLETED
|
155
|
59
|
|
Post-Treatment Follow-up
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ustekinumab
45 milligram (mg) ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
160 mg ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Induction Period
Adverse Event
|
0
|
2
|
|
Induction Period
Lack of Efficacy
|
1
|
0
|
|
Induction Period
Withdrawal by Subject
|
0
|
2
|
|
Induction Period
Site staff became unblinded
|
1
|
0
|
|
Induction Period
Randomized but not treated
|
0
|
1
|
|
Maintenance Period
Adverse Event
|
2
|
1
|
|
Maintenance Period
Lack of Efficacy
|
3
|
1
|
|
Maintenance Period
Lost to Follow-up
|
2
|
2
|
|
Maintenance Period
Protocol Violation
|
1
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
5
|
3
|
|
Maintenance Period
Site staff became unblinded
|
0
|
1
|
|
Post-Treatment Follow-up
Lost to Follow-up
|
1
|
1
|
|
Post-Treatment Follow-up
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
All randomized participants who had baseline data.
Baseline characteristics by cohort
| Measure |
Ustekinumab
n=166 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
|
Ixekizumab
n=136 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections will be used for blinding.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 Years
STANDARD_DEVIATION 13.25 • n=166 Participants
|
42.7 Years
STANDARD_DEVIATION 12.67 • n=136 Participants
|
43.4 Years
STANDARD_DEVIATION 12.99 • n=302 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=166 Participants
|
46 Participants
n=136 Participants
|
100 Participants
n=302 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=166 Participants
|
90 Participants
n=136 Participants
|
202 Participants
n=302 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=166 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=302 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=166 Participants
|
4 Participants
n=136 Participants
|
9 Participants
n=302 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=166 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=302 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=166 Participants
|
3 Participants
n=136 Participants
|
4 Participants
n=302 Participants
|
|
Race (NIH/OMB)
White
|
157 Participants
n=166 Participants
|
125 Participants
n=136 Participants
|
282 Participants
n=302 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=166 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=302 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=166 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=302 Participants
|
|
Region of Enrollment
Hungary
|
12 Participants
n=166 Participants
|
11 Participants
n=136 Participants
|
23 Participants
n=302 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=166 Participants
|
2 Participants
n=136 Participants
|
6 Participants
n=302 Participants
|
|
Region of Enrollment
Switzerland
|
6 Participants
n=166 Participants
|
5 Participants
n=136 Participants
|
11 Participants
n=302 Participants
|
|
Region of Enrollment
Spain
|
13 Participants
n=166 Participants
|
12 Participants
n=136 Participants
|
25 Participants
n=302 Participants
|
|
Region of Enrollment
Canada
|
27 Participants
n=166 Participants
|
25 Participants
n=136 Participants
|
52 Participants
n=302 Participants
|
|
Region of Enrollment
Austria
|
6 Participants
n=166 Participants
|
6 Participants
n=136 Participants
|
12 Participants
n=302 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=166 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=302 Participants
|
|
Region of Enrollment
Sweden
|
4 Participants
n=166 Participants
|
2 Participants
n=136 Participants
|
6 Participants
n=302 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=166 Participants
|
2 Participants
n=136 Participants
|
6 Participants
n=302 Participants
|
|
Region of Enrollment
Poland
|
21 Participants
n=166 Participants
|
17 Participants
n=136 Participants
|
38 Participants
n=302 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=166 Participants
|
4 Participants
n=136 Participants
|
8 Participants
n=302 Participants
|
|
Region of Enrollment
France
|
25 Participants
n=166 Participants
|
23 Participants
n=136 Participants
|
48 Participants
n=302 Participants
|
|
Region of Enrollment
Germany
|
40 Participants
n=166 Participants
|
26 Participants
n=136 Participants
|
66 Participants
n=302 Participants
|
|
Weight
|
89.4 Kilogram
STANDARD_DEVIATION 24.5 • n=166 Participants
|
85.8 Kilogram
STANDARD_DEVIATION 20.30 • n=136 Participants
|
87.8 Kilogram
STANDARD_DEVIATION 22.90 • n=302 Participants
|
|
Weight Categorical
<= 100 kg
|
121 Participants
n=166 Participants • All randomized participants who had baseline data.
|
104 Participants
n=135 Participants • All randomized participants who had baseline data.
|
225 Participants
n=301 Participants • All randomized participants who had baseline data.
|
|
Weight Categorical
> 100 kg
|
45 Participants
n=166 Participants • All randomized participants who had baseline data.
|
31 Participants
n=135 Participants • All randomized participants who had baseline data.
|
76 Participants
n=301 Participants • All randomized participants who had baseline data.
|
|
BMI
|
29.7 kg/m^2
STANDARD_DEVIATION 6.97 • n=166 Participants • All randomized participants who had baseline data.
|
28.8 kg/m^2
STANDARD_DEVIATION 5.55 • n=135 Participants • All randomized participants who had baseline data.
|
29.3 kg/m^2
STANDARD_DEVIATION 6.38 • n=301 Participants • All randomized participants who had baseline data.
|
|
Duration of psoriasis
|
18.2 years
STANDARD_DEVIATION 12.0 • n=166 Participants
|
18.0 years
STANDARD_DEVIATION 11.14 • n=136 Participants
|
18.1 years
STANDARD_DEVIATION 11.60 • n=302 Participants
|
|
Age group at psoriasis onset
<40 years (Type 1 psoriasis)
|
134 Participants
n=166 Participants
|
113 Participants
n=136 Participants
|
247 Participants
n=302 Participants
|
|
Age group at psoriasis onset
>=40 years (Type 2 psoriasis)
|
32 Participants
n=166 Participants
|
23 Participants
n=136 Participants
|
55 Participants
n=302 Participants
|
|
Psoriasis Area & Severity Index (PASI)
|
19.8 units on a scale
STANDARD_DEVIATION 9.02 • n=166 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 8.15 • n=136 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 8.62 • n=302 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Outcome measures
| Measure |
Ustekinumab
n=166 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=136 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
|
42.2 percentage of participants
|
72.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Outcome measures
| Measure |
Ustekinumab
n=166 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=136 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline
|
68.7 percentage of participants
|
88.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Outcome measures
| Measure |
Ustekinumab
n=166 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=136 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline
|
14.5 percentage of participants
|
36 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants with baseline sPGA \>=3 \& received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Outcome measures
| Measure |
Ustekinumab
n=166 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=134 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline
|
57.2 percentage of participants
|
83.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for sPGA (0). Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps.
Outcome measures
| Measure |
Ustekinumab
n=166 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=136 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Percentage of Participants With a sPGA (0) Remission
|
18.1 percentage of participants
|
41.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug \& had a baseline \& post-baseline measurement for BSA affected by Ps. mBOCF: Participants who discontinued treatment due to Adverse Event (AE) were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. ANCOVA model with modified baseline observation carried forward (mBOCF) was used to produce Least Square (LS) mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=164 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=135 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis
|
-16.92 Percent Body Surface Affected
Interval -18.5 to -15.34
|
-22.55 Percent Body Surface Affected
Interval -24.34 to -20.76
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants(Pts) who had psoriasis in palmoplantar regions at baseline \& received at least 1 dose of study drug \& had baseline \& post-baseline PPASI data. mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, Pts who discontinued due to other reasons were imputed by their last observation.
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=28 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=35 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score
|
-8.34 units on a scale
Interval -9.64 to -7.03
|
-10.31 units on a scale
Interval -11.63 to -8.99
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who had psoriasis in scalp region at baseline \& received at least 1 dose of study drug \& had baseline \& post-baseline PSSI data. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (\<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=152 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=119 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score
|
-16.00 units on a scale
Interval -17.24 to -14.77
|
-19.29 units on a scale
Interval -20.67 to -17.92
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who had nail psoriasis at baseline \& received at least 1 dose of study drug and had baseline \& post-baseline NAPSI measurement. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps \& fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal \& longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) \& fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed \& fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=103 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=84 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score
|
-5.02 units on a scale
Interval -7.19 to -2.84
|
-12.24 units on a scale
Interval -14.72 to -9.77
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for Itch NRS. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=165 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=135 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in Itch Numeric Rating Scale (NRS)
|
-4.12 units on a scale
Interval -4.51 to -3.74
|
-4.56 units on a scale
Interval -4.98 to -4.14
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for skin pain VAS. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
Skin Pain VAS is a participant administered scale designed to measure skin pain from psoriasis using a 100-millimeter (mm) horizontal VAS. Overall severity of a participant's skin pain from psoriasis at the present time is indicated by placing a single mark on the horizontal scale (0 = no skin pain; 100 = severe skin pain). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=165 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=135 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)
|
-29.92 mm
Interval -32.81 to -27.04
|
-33.32 mm
Interval -36.44 to -30.2
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for DLQI. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life.
Outcome measures
| Measure |
Ustekinumab
n=166 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=136 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1)
|
44.6 percentage of participants
|
61.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for HADS depression subscale. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=162 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=134 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale
|
-0.96 units on a scale
Interval -1.38 to -0.54
|
-1.20 units on a scale
Interval -1.65 to -0.74
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for HADS anxiety subscale. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=162 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=134 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.
|
-0.90 units on a scale
Interval -1.37 to -0.43
|
-1.27 units on a scale
Interval -1.8 to -0.73
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF-36 PCS score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=164 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=133 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;
|
3.10 units on a scale
Interval 1.97 to 4.23
|
5.03 units on a scale
Interval 3.8 to 6.26
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF36 MCS score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=164 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=133 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score
|
2.36 units on a scale
Interval 0.87 to 3.86
|
2.96 units on a scale
Interval 1.33 to 4.59
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PatGA. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=164 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=135 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline on Patient Global Assessment of Disease Severity (PatGA)
|
-2.60 units on a scale
Interval -2.78 to -2.42
|
-3.07 units on a scale
Interval -3.26 to -2.88
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L "Bolt On" PSO-Index. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health). ANCOVA model was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=165 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=134 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index
|
0.11 units on a scale
Interval 0.09 to 0.13
|
0.15 units on a scale
Interval 0.13 to 0.17
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L VAS. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=163 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=134 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS
|
8.75 mm
Interval 5.77 to 11.74
|
12.24 mm
Interval 9.01 to 15.46
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug \& had baseline \& post-baseline EQ-5D 5L UK population-based index score measurement. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The EQ-5D-5L descriptive system comprises 5 dimensions, each with 5 levels. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension. This produced patient-level index scores between -0.594 and 1.0 (worse to better health). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=165 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=134 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score
|
0.12 units on a scale
Interval 0.09 to 0.15
|
0.15 units on a scale
Interval 0.12 to 0.18
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO absenteeism score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work \& WPAI-PSO absenteeism score is derived from these questions. Each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=90 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=87 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism
|
-1.42 units on a scale
Interval -4.55 to 1.72
|
-0.46 units on a scale
Interval -3.51 to 2.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO presenteeism score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work \& WPAI-PSO Presenteeism score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=98 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=92 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism
|
-15.53 units on a scale
Interval -18.33 to -12.72
|
-16.91 units on a scale
Interval -19.71 to -14.11
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO work impairment score. mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work \& WPAI-PSO work impairment score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=90 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=87 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score.
|
-15.05 units on a scale
Interval -19.25 to -10.85
|
-16.27 units on a scale
Interval -20.39 to -12.16
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants(Pts) who received at least 1 dose of study drug \& had baseline \& post-baseline data for WPAI-PSO impairment in activities performed outside work. mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, pts who discontinued due to other reasons were imputed by their last observation.
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work \& WPAI-PSO impairment in activities performed outside of work score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.
Outcome measures
| Measure |
Ustekinumab
n=154 Participants
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections was used for blinding.
|
Ixekizumab
n=127 Participants
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52. Placebo for ustekinumab injections was used for blinding.
|
|---|---|---|
|
Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work
|
-19.14 units on a scale
Interval -21.79 to -16.48
|
-23.06 units on a scale
Interval -26.04 to -20.09
|
Adverse Events
Ustekinumab - Induction
Ixekizumab - Induction
Ustekinumab - Maintenance
Ixekizumab - Maintenance
Ustekinumab - Post Treatment Follow up
Ixekizumab - Post Treatment Follow up
Serious adverse events
| Measure |
Ustekinumab - Induction
n=166 participants at risk
45 milligram (mg) Ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg. Placebo for Ixekizumab injection was used for blinding.
|
Ixekizumab - Induction
n=135 participants at risk
160 mg Ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg Ixekizumab given as a single SC injection once every 2 weeks.
Placebo for Ustekinumab injection was used for blinding.
|
Ustekinumab - Maintenance
n=164 participants at risk
45 milligram (mg) Ustekinumab given as Subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg. Placebo for Ixekizumab injection was used for blinding.
|
Ixekizumab - Maintenance
n=131 participants at risk
80 mg Ixekizumab given as a single SC injection once every 4 weeks. Placebo for Ustekinumab injection was used for blinding.
|
Ustekinumab - Post Treatment Follow up
n=157 participants at risk
Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
|
Ixekizumab - Post Treatment Follow up
n=60 participants at risk
Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.61%
1/164 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.76%
1/131 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.76%
1/131 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.64%
1/157 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.76%
1/131 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.76%
1/131 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.61%
1/164 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.76%
1/131 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.74%
1/135 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.61%
1/164 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.76%
1/131 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.61%
1/164 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.61%
1/164 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.76%
1/131 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.64%
1/157 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.74%
1/135 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
0.00%
0/135
All randomized participants who received at least one dose study drug.
|
0.61%
1/164 • Number of events 1
All randomized participants who received at least one dose study drug.
|
0.00%
0/131
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
Other adverse events
| Measure |
Ustekinumab - Induction
n=166 participants at risk
45 milligram (mg) Ustekinumab given as subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg. Placebo for Ixekizumab injection was used for blinding.
|
Ixekizumab - Induction
n=135 participants at risk
160 mg Ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg Ixekizumab given as a single SC injection once every 2 weeks.
Placebo for Ustekinumab injection was used for blinding.
|
Ustekinumab - Maintenance
n=164 participants at risk
45 milligram (mg) Ustekinumab given as Subcutaneous (SC) injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg. Placebo for Ixekizumab injection was used for blinding.
|
Ixekizumab - Maintenance
n=131 participants at risk
80 mg Ixekizumab given as a single SC injection once every 4 weeks. Placebo for Ustekinumab injection was used for blinding.
|
Ustekinumab - Post Treatment Follow up
n=157 participants at risk
Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
|
Ixekizumab - Post Treatment Follow up
n=60 participants at risk
Participants were allowed to continue the treatment administered during the blinded period or any other psoriasis treatment.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
0.00%
0/166
All randomized participants who received at least one dose study drug.
|
7.4%
10/135 • Number of events 15
All randomized participants who received at least one dose study drug.
|
0.00%
0/164
All randomized participants who received at least one dose study drug.
|
1.5%
2/131 • Number of events 4
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Infections and infestations
Nasopharyngitis
|
20.5%
34/166 • Number of events 39
All randomized participants who received at least one dose study drug.
|
17.0%
23/135 • Number of events 27
All randomized participants who received at least one dose study drug.
|
24.4%
40/164 • Number of events 52
All randomized participants who received at least one dose study drug.
|
27.5%
36/131 • Number of events 47
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
8/166 • Number of events 8
All randomized participants who received at least one dose study drug.
|
2.2%
3/135 • Number of events 3
All randomized participants who received at least one dose study drug.
|
6.7%
11/164 • Number of events 16
All randomized participants who received at least one dose study drug.
|
6.1%
8/131 • Number of events 8
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
4/166 • Number of events 5
All randomized participants who received at least one dose study drug.
|
1.5%
2/135 • Number of events 2
All randomized participants who received at least one dose study drug.
|
5.5%
9/164 • Number of events 11
All randomized participants who received at least one dose study drug.
|
3.8%
5/131 • Number of events 5
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Nervous system disorders
Headache
|
7.2%
12/166 • Number of events 17
All randomized participants who received at least one dose study drug.
|
5.2%
7/135 • Number of events 9
All randomized participants who received at least one dose study drug.
|
7.3%
12/164 • Number of events 19
All randomized participants who received at least one dose study drug.
|
7.6%
10/131 • Number of events 17
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
|
Vascular disorders
Hypertension
|
2.4%
4/166 • Number of events 4
All randomized participants who received at least one dose study drug.
|
1.5%
2/135 • Number of events 2
All randomized participants who received at least one dose study drug.
|
6.7%
11/164 • Number of events 11
All randomized participants who received at least one dose study drug.
|
3.1%
4/131 • Number of events 5
All randomized participants who received at least one dose study drug.
|
0.00%
0/157
All randomized participants who received at least one dose study drug.
|
0.00%
0/60
All randomized participants who received at least one dose study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60