Trial Outcomes & Findings for A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis (NCT NCT01945086)
NCT ID: NCT01945086
Last Updated: 2016-03-09
Results Overview
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90 percent \[%\]-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2016-03-09
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
24
|
28
|
|
Overall Study
COMPLETED
|
26
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 8.77 • n=7 Participants
|
33.0 years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 9.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. Last Observation Carried Forward (LOCF) method was used to impute the missing data.
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90 percent \[%\]-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12
|
-37.54 percent change
Standard Deviation 37.592
|
-38.62 percent change
Standard Deviation 32.684
|
-39.39 percent change
Standard Deviation 38.710
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.
The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Number of Participants With an Investigator's Global Assessment (IGA) Score of "Clear" or "Almost Clear" at Week 12
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS population was used for analysis. LOCF method was used to impute the missing data. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively.
The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD. It will be evaluated by participant diary kept twice daily,in the morning(morning daily score\[MDS\]) and evening (Evening Daily Score\[EDS\]). The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching. The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12
Change at Week 12 (EDS [n=27, 23, 28])
|
-2.07 units on a scale
Standard Deviation 2.624
|
-1.91 units on a scale
Standard Deviation 3.253
|
-2.14 units on a scale
Standard Deviation 4.517
|
|
Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12
Baseline (MDS [n=27, 24, 28])
|
8.97 units on a scale
Standard Deviation 3.784
|
10.03 units on a scale
Standard Deviation 4.615
|
8.71 units on a scale
Standard Deviation 3.752
|
|
Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12
Change at Week 12 (MDS [n=27, 24, 28])
|
-1.58 units on a scale
Standard Deviation 3.030
|
-1.68 units on a scale
Standard Deviation 3.286
|
-2.59 units on a scale
Standard Deviation 3.716
|
|
Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12
Baseline (EDS [n=27, 23, 28])
|
10.43 units on a scale
Standard Deviation 3.569
|
11.22 units on a scale
Standard Deviation 4.371
|
9.45 units on a scale
Standard Deviation 3.697
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.
The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
Baseline
|
6.3 units on a scale
Standard Deviation 3.74
|
6.4 units on a scale
Standard Deviation 4.58
|
6.6 units on a scale
Standard Deviation 3.74
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
Change at Week 12
|
-0.6 units on a scale
Standard Deviation 3.96
|
-1.7 units on a scale
Standard Deviation 3.48
|
-1.7 units on a scale
Standard Deviation 4.56
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20 and 24Population: FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively.
The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 2:>=50% Decrease (n=27,24,28)
|
3 participants
|
2 participants
|
7 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 2:>=75% Decrease (n=27,24,28)
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 4:>=50% Decrease (n=27,24,27)
|
7 participants
|
2 participants
|
9 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 4:>=75% Decrease (n=27,24,27)
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 8:>=50% Decrease (n=27,24,27)
|
10 participants
|
5 participants
|
10 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 8:>=75% Decrease (n=27,24,27)
|
5 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 12:>=50% Decrease (n=27,24,27)
|
11 participants
|
9 participants
|
10 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 12:>=75% Decrease (n=27,24,27)
|
4 participants
|
2 participants
|
5 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 16:>=50% Decrease (n=26,24,27)
|
11 participants
|
10 participants
|
12 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 16:>=75% Decrease (n=26,24,27)
|
5 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 20:>=50% Decrease (n=26,24,26)
|
12 participants
|
8 participants
|
12 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 20:>=75% Decrease (n=26,24,26)
|
6 participants
|
3 participants
|
5 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 24:>=50% Decrease (n=26,24,27)
|
8 participants
|
8 participants
|
12 participants
|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Week 24:>=75% Decrease (n=26,24,27)
|
4 participants
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20 and 24Population: FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively.
The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Baseline (n=27, 24, 28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Week 2 (n=27, 24, 28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Week 4 (n=27, 24, 27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Week 8 (n=27, 24, 27)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Week 12 (n=27, 24, 27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Week 16 (n=26, 24, 27)
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Week 20 (n=26, 24, 26)
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Week 24 (n=26, 24, 27)
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20 and 24Population: FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively.
The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Week 2 (n=27, 24, 28)
|
2 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Week 4 (n=27, 24, 27)
|
5 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Week 8 (n=27, 24, 27)
|
7 participants
|
3 participants
|
7 participants
|
|
Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Week 12 (n=27, 24, 27)
|
7 participants
|
7 participants
|
7 participants
|
|
Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Week 16 (n=26, 24, 27)
|
6 participants
|
5 participants
|
7 participants
|
|
Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Week 20 (n=26, 24, 26)
|
6 participants
|
6 participants
|
7 participants
|
|
Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Week 24 (n=26, 24, 27)
|
3 participants
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20 and 24Population: FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively.
The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Number of Participants in IGA
Baseline: Clear (n=27,24,28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 24: Mild disease (n=26,24,27)
|
1 participants
|
4 participants
|
6 participants
|
|
Number of Participants in IGA
Week 24: Moderate disease (n=26,24,27)
|
9 participants
|
7 participants
|
10 participants
|
|
Number of Participants in IGA
Week 4: Mild disease (n=27,24,27)
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants in IGA
Baseline: Almost clear (n=27,24,28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Baseline: Mild disease (n=27,24,28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Baseline: Moderate disease (n=27,24,28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Baseline: Severe disease (n=27,24,28)
|
22 participants
|
21 participants
|
24 participants
|
|
Number of Participants in IGA
Baseline: Very severe disease (n=27,24,28)
|
5 participants
|
3 participants
|
4 participants
|
|
Number of Participants in IGA
Week 2: Clear (n=27,24,28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 2: Almost clear (n=27,24,28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 2: Mild disease (n=27,24,28)
|
1 participants
|
0 participants
|
4 participants
|
|
Number of Participants in IGA
Week 2: Moderate disease (n=27,24,28)
|
8 participants
|
5 participants
|
7 participants
|
|
Number of Participants in IGA
Week 2: Severe disease (n=27,24,28)
|
16 participants
|
16 participants
|
16 participants
|
|
Number of Participants in IGA
Week 2: Very severe disease (n=27,24,28)
|
2 participants
|
3 participants
|
1 participants
|
|
Number of Participants in IGA
Week 4: Clear (n=27,24,27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 4: Almost clear (n=27,24,27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 4: Moderate disease (n=27,24,27)
|
11 participants
|
8 participants
|
11 participants
|
|
Number of Participants in IGA
Week 4: Severe disease (n=27,24,27)
|
13 participants
|
15 participants
|
12 participants
|
|
Number of Participants in IGA
Week 4: Very severe disease (n=27,24,27)
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants in IGA
Week 8: Clear (n=27,24,27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 8: Almost clear (n=27,24,27)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants in IGA
Week 8: Mild disease (n=27,24,27)
|
6 participants
|
1 participants
|
4 participants
|
|
Number of Participants in IGA
Week 8: Moderate disease (n=27,24,27)
|
10 participants
|
12 participants
|
11 participants
|
|
Number of Participants in IGA
Week 8: Severe disease (n=27,24,27)
|
10 participants
|
10 participants
|
8 participants
|
|
Number of Participants in IGA
Week 8: Very severe disease (n=27,24,27)
|
1 participants
|
1 participants
|
3 participants
|
|
Number of Participants in IGA
Week 12: Clear (n=27,24,27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 12: Almost clear (n=27,24,27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 12: Mild disease (n=27,24,27)
|
6 participants
|
5 participants
|
6 participants
|
|
Number of Participants in IGA
Week 12: Moderate disease (n=27,24,27)
|
10 participants
|
8 participants
|
11 participants
|
|
Number of Participants in IGA
Week 12: Severe disease (n=27,24,27)
|
10 participants
|
9 participants
|
7 participants
|
|
Number of Participants in IGA
Week 12: Very severe disease (n=27,24,27)
|
1 participants
|
2 participants
|
3 participants
|
|
Number of Participants in IGA
Week 16: Clear (n=26,24,27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 16: Almost clear (n=26,24,27)
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants in IGA
Week 16: Mild disease (n=26,24,27)
|
3 participants
|
3 participants
|
5 participants
|
|
Number of Participants in IGA
Week 16: Moderate disease (n=26,24,27)
|
9 participants
|
9 participants
|
12 participants
|
|
Number of Participants in IGA
Week 16: Severe disease (n=26,24,27)
|
11 participants
|
10 participants
|
6 participants
|
|
Number of Participants in IGA
Week 16: Very severe disease (n=26,24,27)
|
1 participants
|
2 participants
|
3 participants
|
|
Number of Participants in IGA
Week 20: Clear (n=26,24,26)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 20: Almost clear (n=26,24,26)
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants in IGA
Week 20: Mild disease (n=26,24,26)
|
3 participants
|
3 participants
|
5 participants
|
|
Number of Participants in IGA
Week 20: Moderate disease (n=26,24,26)
|
9 participants
|
9 participants
|
12 participants
|
|
Number of Participants in IGA
Week 20: Severe disease (n=26,24,26)
|
11 participants
|
10 participants
|
6 participants
|
|
Number of Participants in IGA
Week 20: Very severe disease (n=26,24,26)
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Participants in IGA
Week 24: Clear (n=26,24,27)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants in IGA
Week 24: Almost clear (n=26,24,27)
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants in IGA
Week 24: Severe disease (n=26,24,27)
|
12 participants
|
10 participants
|
8 participants
|
|
Number of Participants in IGA
Week 24: Very severe disease (n=26,24,27)
|
2 participants
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20 and 24Population: FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively. LOCF method was not applied to impute the missing data.
The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Percent Change From Baseline in EASI Total Score
Week 2 (n=27,24,28)
|
-24.29 percent change
Standard Deviation 25.402
|
-13.85 percent change
Standard Deviation 21.391
|
-25.72 percent change
Standard Deviation 24.728
|
|
Percent Change From Baseline in EASI Total Score
Week 4 (n=27,24,27)
|
-31.69 percent change
Standard Deviation 28.936
|
-21.13 percent change
Standard Deviation 24.097
|
-29.19 percent change
Standard Deviation 30.409
|
|
Percent Change From Baseline in EASI Total Score
Week 8 (n=27,24,27)
|
-36.06 percent change
Standard Deviation 35.840
|
-31.15 percent change
Standard Deviation 28.012
|
-34.49 percent change
Standard Deviation 38.857
|
|
Percent Change From Baseline in EASI Total Score
Week 12 (n=27,24,27)
|
-37.54 percent change
Standard Deviation 37.592
|
-38.62 percent change
Standard Deviation 32.684
|
-40.84 percent change
Standard Deviation 38.655
|
|
Percent Change From Baseline in EASI Total Score
Week 16 (n=26,24,27)
|
-39.97 percent change
Standard Deviation 40.572
|
-38.43 percent change
Standard Deviation 34.202
|
-44.39 percent change
Standard Deviation 40.154
|
|
Percent Change From Baseline in EASI Total Score
Week 20 (n=26,24,26)
|
-41.03 percent change
Standard Deviation 43.495
|
-40.59 percent change
Standard Deviation 31.666
|
-46.24 percent change
Standard Deviation 41.817
|
|
Percent Change From Baseline in EASI Total Score
Week 24 (n=26,24,27)
|
-35.93 percent change
Standard Deviation 40.524
|
-38.83 percent change
Standard Deviation 35.697
|
-46.19 percent change
Standard Deviation 41.791
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20 and 24Population: FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively.
The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 2: Erythema (n=27,24,28)
|
-19.51 percent change
Standard Deviation 21.533
|
-12.03 percent change
Standard Deviation 13.049
|
-19.13 percent change
Standard Deviation 19.091
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 4: Erythema (n=27,24,27)
|
-23.24 percent change
Standard Deviation 25.710
|
-17.17 percent change
Standard Deviation 15.346
|
-21.51 percent change
Standard Deviation 16.334
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 8: Erythema (n=27,24,27)
|
-29.19 percent change
Standard Deviation 27.937
|
-24.13 percent change
Standard Deviation 18.549
|
-25.38 percent change
Standard Deviation 21.390
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 12: Erythema (n=27,24,27)
|
-30.06 percent change
Standard Deviation 29.751
|
-29.73 percent change
Standard Deviation 25.421
|
-29.89 percent change
Standard Deviation 21.895
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 16: Erythema (n=26,24,27)
|
-32.36 percent change
Standard Deviation 32.911
|
-28.36 percent change
Standard Deviation 30.209
|
-34.57 percent change
Standard Deviation 21.759
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 20: Erythema (n=26,24,26)
|
-31.81 percent change
Standard Deviation 31.413
|
-32.43 percent change
Standard Deviation 26.550
|
-34.84 percent change
Standard Deviation 23.922
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 24: Erythema (n=26,24,27)
|
-28.37 percent change
Standard Deviation 30.243
|
-28.65 percent change
Standard Deviation 27.249
|
-37.25 percent change
Standard Deviation 23.711
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 2: Induration (n=27,24,28)
|
-11.99 percent change
Standard Deviation 34.591
|
-12.32 percent change
Standard Deviation 14.315
|
-22.17 percent change
Standard Deviation 24.515
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 4: Induration (n=27,24,27)
|
-15.82 percent change
Standard Deviation 39.898
|
-16.58 percent change
Standard Deviation 17.491
|
-24.96 percent change
Standard Deviation 26.132
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 8: Induration (n=27,24,27)
|
-19.80 percent change
Standard Deviation 43.965
|
-24.16 percent change
Standard Deviation 22.658
|
-26.98 percent change
Standard Deviation 29.825
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 12: Induration (n=27,24,27)
|
-21.23 percent change
Standard Deviation 49.075
|
-26.78 percent change
Standard Deviation 29.282
|
-35.42 percent change
Standard Deviation 29.943
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 16: Induration (n=26,24,27)
|
-24.34 percent change
Standard Deviation 51.739
|
-25.82 percent change
Standard Deviation 32.690
|
-38.98 percent change
Standard Deviation 26.767
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 20: Induration (n=26,24,26)
|
-27.89 percent change
Standard Deviation 53.568
|
-27.21 percent change
Standard Deviation 29.162
|
-40.58 percent change
Standard Deviation 31.136
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 24: Induration (n=26,24,27)
|
-22.45 percent change
Standard Deviation 50.002
|
-26.71 percent change
Standard Deviation 31.240
|
-40.06 percent change
Standard Deviation 30.864
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 2: Excoriation (n=27,23,28)
|
-20.65 percent change
Standard Deviation 21.825
|
-11.82 percent change
Standard Deviation 19.872
|
-23.91 percent change
Standard Deviation 25.419
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 4: Excoriation (n=27,23,27)
|
-26.38 percent change
Standard Deviation 28.258
|
-18.40 percent change
Standard Deviation 19.323
|
-29.73 percent change
Standard Deviation 28.764
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 8: Excoriation (n=27,23,27)
|
-30.56 percent change
Standard Deviation 35.800
|
-25.58 percent change
Standard Deviation 27.607
|
-35.02 percent change
Standard Deviation 30.400
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 12: Excoriation (n=27,23,27)
|
-31.29 percent change
Standard Deviation 37.259
|
-30.66 percent change
Standard Deviation 36.517
|
-38.33 percent change
Standard Deviation 27.953
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 16: Excoriation (n=26,23,27)
|
-33.11 percent change
Standard Deviation 40.899
|
-25.50 percent change
Standard Deviation 41.929
|
-44.25 percent change
Standard Deviation 27.690
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 20: Excoriation (n=26,23,26)
|
-33.23 percent change
Standard Deviation 42.648
|
-23.55 percent change
Standard Deviation 36.947
|
-40.67 percent change
Standard Deviation 33.036
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 24: Excoriation (n=26,23,27)
|
-26.40 percent change
Standard Deviation 37.853
|
-22.74 percent change
Standard Deviation 37.555
|
-42.07 percent change
Standard Deviation 33.992
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 2: Lichenification (n=267,24,28)
|
-14.90 percent change
Standard Deviation 20.292
|
-8.46 percent change
Standard Deviation 16.879
|
-15.87 percent change
Standard Deviation 18.500
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 4: Lichenification(n=27,24,27)
|
-23.38 percent change
Standard Deviation 25.947
|
-10.21 percent change
Standard Deviation 23.359
|
-20.24 percent change
Standard Deviation 24.284
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 8: Lichenification (n=27,24,27)
|
-26.52 percent change
Standard Deviation 28.515
|
-19.40 percent change
Standard Deviation 22.871
|
-28.07 percent change
Standard Deviation 27.887
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 12: Lichenification (n=27,24,27)
|
-28.62 percent change
Standard Deviation 31.241
|
-24.36 percent change
Standard Deviation 29.272
|
-33.06 percent change
Standard Deviation 25.443
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 16: Lichenification (n=26,24,27)
|
-32.64 percent change
Standard Deviation 34.378
|
-22.18 percent change
Standard Deviation 34.489
|
-37.47 percent change
Standard Deviation 27.046
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 20: Lichenification (n=26,24,26)
|
-33.24 percent change
Standard Deviation 35.094
|
-23.36 percent change
Standard Deviation 43.750
|
-41.71 percent change
Standard Deviation 30.241
|
|
Percent Change From Baseline in EASI Sign of Disease Components
Week 24: Lichenification (n=26,24,27)
|
-32.05 percent change
Standard Deviation 33.470
|
-20.96 percent change
Standard Deviation 45.278
|
-40.19 percent change
Standard Deviation 26.696
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 20 and 24Population: FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively.
The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 2: Head/neck (n=27,24,28)
|
-20.28 percent change
Standard Deviation 22.410
|
-6.97 percent change
Standard Deviation 24.488
|
-29.50 percent change
Standard Deviation 9.492
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 4: Head/neck (n=27,24,27)
|
-26.22 percent change
Standard Deviation 36.637
|
-17.46 percent change
Standard Deviation 25.632
|
-34.15 percent change
Standard Deviation 32.087
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 8: Head/neck (n=27,24,27)
|
-29.34 percent change
Standard Deviation 64.066
|
-34.27 percent change
Standard Deviation 27.380
|
-38.65 percent change
Standard Deviation 28.580
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 12: Head/neck (n=27,24,27)
|
-32.82 percent change
Standard Deviation 52.925
|
-36.28 percent change
Standard Deviation 39.256
|
-45.34 percent change
Standard Deviation 25.282
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 16: Head/neck (n=26,24,27)
|
-37.27 percent change
Standard Deviation 58.582
|
-38.31 percent change
Standard Deviation 37.155
|
-52.12 percent change
Standard Deviation 23.578
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 20: Head/neck (n=26,24,26)
|
-35.20 percent change
Standard Deviation 59.298
|
-42.63 percent change
Standard Deviation 38.094
|
-46.30 percent change
Standard Deviation 35.652
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 24: Head/neck (n=26,24,27)
|
-24.84 percent change
Standard Deviation 89.446
|
-37.20 percent change
Standard Deviation 39.828
|
-49.63 percent change
Standard Deviation 28.510
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 2: Upper limbs (n=27,24,28)
|
-26.64 percent change
Standard Deviation 29.149
|
-14.47 percent change
Standard Deviation 22.285
|
-28.53 percent change
Standard Deviation 26.760
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 4: Upper limbs (n=27,24,27)
|
-33.25 percent change
Standard Deviation 38.613
|
-21.62 percent change
Standard Deviation 23.746
|
-30.26 percent change
Standard Deviation 29.646
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 8: Upper limbs (n=27,24,27)
|
-44.58 percent change
Standard Deviation 38.100
|
-32.57 percent change
Standard Deviation 28.600
|
-38.11 percent change
Standard Deviation 37.205
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 12: Upper limbs (n=27,24,27)
|
-40.64 percent change
Standard Deviation 42.146
|
-36.55 percent change
Standard Deviation 35.946
|
-47.01 percent change
Standard Deviation 39.135
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 16: Upper limbs (n=26,24,27)
|
-42.01 percent change
Standard Deviation 45.743
|
-32.55 percent change
Standard Deviation 47.614
|
-42.94 percent change
Standard Deviation 42.543
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 20: Upper limbs (n=26,24,26)
|
-41.48 percent change
Standard Deviation 46.700
|
-37.71 percent change
Standard Deviation 36.660
|
-48.20 percent change
Standard Deviation 37.501
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 24: Upper limbs (n=26,24,27)
|
-39.61 percent change
Standard Deviation 45.005
|
-39.36 percent change
Standard Deviation 36.535
|
-50.89 percent change
Standard Deviation 39.446
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 2: Trunk (n=27,24,28)
|
-27.82 percent change
Standard Deviation 27.633
|
-18.16 percent change
Standard Deviation 22.783
|
-21.84 percent change
Standard Deviation 33.368
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 4: Trunk (n=27,24,27)
|
-34.42 percent change
Standard Deviation 34.730
|
-20.59 percent change
Standard Deviation 26.028
|
-23.51 percent change
Standard Deviation 46.987
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 8: Trunk (n=27,24,27)
|
-32.28 percent change
Standard Deviation 49.544
|
-27.99 percent change
Standard Deviation 29.551
|
-29.26 percent change
Standard Deviation 54.157
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 12: Trunk (n=27,24,27)
|
-33.38 percent change
Standard Deviation 57.021
|
-36.89 percent change
Standard Deviation 35.351
|
-31.65 percent change
Standard Deviation 54.961
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 16: Trunk (n=26,24,27)
|
-35.33 percent change
Standard Deviation 59.694
|
-28.96 percent change
Standard Deviation 41.260
|
-37.87 percent change
Standard Deviation 54.763
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 20: Trunk (n=26,24,26)
|
-36.37 percent change
Standard Deviation 62.253
|
-32.68 percent change
Standard Deviation 36.306
|
-41.92 percent change
Standard Deviation 58.260
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 24: Trunk (n=26,24,27)
|
-28.39 percent change
Standard Deviation 59.596
|
-31.25 percent change
Standard Deviation 40.207
|
-39.77 percent change
Standard Deviation 56.008
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 2: Lower limbs (n=27,24,28)
|
-19.84 percent change
Standard Deviation 29.862
|
-9.17 percent change
Standard Deviation 32.015
|
-26.15 percent change
Standard Deviation 26.073
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 4: Lower limbs (n=27,24,27)
|
-26.46 percent change
Standard Deviation 33.485
|
-21.32 percent change
Standard Deviation 33.541
|
-33.12 percent change
Standard Deviation 37.005
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 8: Lower limbs (n=27,24,27)
|
-31.23 percent change
Standard Deviation 46.154
|
-31.88 percent change
Standard Deviation 36.302
|
-27.56 percent change
Standard Deviation 82.889
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 12: Lower limbs (n=27,24,27)
|
-34.79 percent change
Standard Deviation 45.961
|
-42.01 percent change
Standard Deviation 35.358
|
-32.39 percent change
Standard Deviation 83.114
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 16: Lower limbs (n=26,24,27)
|
-36.98 percent change
Standard Deviation 48.713
|
-46.30 percent change
Standard Deviation 34.942
|
-36.87 percent change
Standard Deviation 84.182
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 20: Lower limbs (n=26,24,26)
|
-38.06 percent change
Standard Deviation 53.187
|
-45.50 percent change
Standard Deviation 34.350
|
-38.92 percent change
Standard Deviation 86.354
|
|
Percent Change From Baseline of Body Region Scores in EASI
Week 24: Lower limbs (n=26,24,27)
|
-33.60 percent change
Standard Deviation 50.984
|
-41.55 percent change
Standard Deviation 40.522
|
-39.80 percent change
Standard Deviation 87.186
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 20 and 24Population: FAS population was used for analysis. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each specific time point for each arm respectively.
The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 3=severe, on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 Participants
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 Participants
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Baseline: Erythema (n=27,24,28)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 2: Erythema (n=27,24,28)
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 4: Erythema (n=27,24,27)
|
4 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 8: Erythema (n=27,24,27)
|
4 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 12: Erythema (n=27,24,27)
|
5 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 16: Erythema (n=26,24,27)
|
4 participants
|
4 participants
|
7 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 20: Erythema (n=26,24,26)
|
4 participants
|
4 participants
|
5 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 24: Erythema (n=26,24,27)
|
5 participants
|
3 participants
|
6 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Baseline: Induration (n=27,24,28)
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 2: Induration (n=27,24,28)
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 4: Induration (n=27,24,27)
|
5 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 8: Induration (n=27,24,27)
|
4 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 12: Induration (n=27,24,27)
|
3 participants
|
6 participants
|
7 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 16: Induration (n=26,24,27)
|
6 participants
|
5 participants
|
8 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 20: Induration (n=26,24,26)
|
7 participants
|
3 participants
|
7 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 24: Induration (n=26,24,27)
|
5 participants
|
3 participants
|
8 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Baseline: Excoriation (n=27,24,28)
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 2: Excoriation (27,24,28)
|
2 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 4: Excoriation (n=27,24,27)
|
5 participants
|
2 participants
|
7 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 8: Excoriation (n=27,24,27)
|
5 participants
|
3 participants
|
7 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 12: Excoriation (n=27,24,27)
|
4 participants
|
9 participants
|
6 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 16: Excoriation (n=26,24,27)
|
7 participants
|
7 participants
|
9 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 20: Excoriation (n=26,24,26)
|
7 participants
|
4 participants
|
7 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 24: Excoriation (n=26,24,27)
|
4 participants
|
5 participants
|
8 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Baseline: Lichenification (n=27,24,28)
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 2: Lichenification (n=27,24,28)
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 4: Lichenification (n=27,24,27)
|
4 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 8: Lichenification (n=27,24,27)
|
4 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 12: Lichenification (n=27,24,27)
|
4 participants
|
6 participants
|
5 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 16: Lichenification (n=26,24,27)
|
6 participants
|
4 participants
|
8 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 20: Lichenification (n=26,24,26)
|
6 participants
|
4 participants
|
7 participants
|
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Week 24: Lichenification (n=26,24,27)
|
5 participants
|
5 participants
|
7 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Ustekinumab 45 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Ustekinumab 90 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
|
Ustekinumab 45 mg
n=24 participants at risk
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
|
Ustekinumab 90 mg
n=28 participants at risk
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
25.9%
7/27
|
25.0%
6/24
|
21.4%
6/28
|
|
Infections and infestations
Impetigo
|
0.00%
0/27
|
4.2%
1/24
|
3.6%
1/28
|
|
Infections and infestations
Cellulitis
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Infections and infestations
Erysipelas
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Infections and infestations
Herpes simplex
|
3.7%
1/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Infections and infestations
Influenza
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Infections and infestations
Otitis externa
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Infections and infestations
Skin infection
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Infections and infestations
Kaposi's varicelliform eruption
|
3.7%
1/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Infections and infestations
Oral herpes
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.7%
1/27
|
8.3%
2/24
|
3.6%
1/28
|
|
Nervous system disorders
Dizziness
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Nervous system disorders
Headache
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Eye disorders
Blepharitis
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Eye disorders
Conjunctivitis allergic
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.4%
2/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.7%
1/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Hepatobiliary disorders
Fatty liver alcoholic
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
29.6%
8/27
|
16.7%
4/24
|
10.7%
3/28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/27
|
4.2%
1/24
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Erythema ab igne
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
2/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
2/27
|
0.00%
0/24
|
0.00%
0/28
|
|
General disorders
Malaise
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27
|
0.00%
0/24
|
7.1%
2/28
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/27
|
4.2%
1/24
|
0.00%
0/28
|
|
Investigations
Hepatic enzyme increased
|
3.7%
1/27
|
0.00%
0/24
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/27
|
0.00%
0/24
|
3.6%
1/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER