Dermatitis, Atopic
Conditions
Keywords
Dermatitis, Atopic, Eczema, Ustekinumab, CNTO1275, STELARA
Brief summary
The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab compared with placebo (inactive medication) in adult Japanese participants with severe atopic dermatitis.
Detailed description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), multicenter, parallel group study (each participant group receives different treatments simultaneously). Participants will be randomly assigned in a 1:1:1 ratio to receive either ustekinumab 45 mg, ustekinumab 90 mg, or placebo. The study will consist of a screening period, a 12-week double-blind treatment period, and a 12-week follow-up period. During the double-blind treatment period, participants will receive one subcutaneous injection of study medication at Week 0 and Week 4. Participants will return to the study center for 7 evaluation visits on Weeks 2, 4, 8, 12, 16, 20, and 24. Clinical response will be evaluated by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), photography, and Dermatology Life Quality Index (DLQI). Participants will record their itch condition twice daily using the participant daily diary from 2 weeks prior to randomization until Week 12. Blood samples will be drawn at time periods during the screening, double-blind treatment, and follow-up periods. Participant safety will be monitored throughout the study. Participants are permitted to use concomitant topical medications, as defined in the protocol and without any increase in dose, from 4 weeks prior to randomization through to the end of the treatment period. After Week 12, additional treatment can be started or the dose of concomitant medications can be increased, if no improvement in clinical response is observed; in these cases EASI, IGA, and photography evaluations will be stopped. The study duration for each participant is expected to be approximately 30 weeks. Ustekinumab (also known as STELARA) is an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23 and is approved as a treatment for moderate to severe plaque-type psoriasis; this study will examine whether ustekinumab can provide benefit in atopic dermatitis and assess for any risks or side effects.
Interventions
DRUGUstekinumab
Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.
DRUGPlacebo
Participants will receive SC injections of placebo at Week 0 and Week 4.
OTHERConcomitant topical medications for atopic dermatitis
Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study. However, the dosage cannot be increased and new medications cannot be added until after Week 12.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must be Japanese * Must have a diagnosis of atopic dermatitis, with childhood onset (under age of 13), in accordance with the definition and diagnostic criteria of the Japanese Dermatological Association and must have pruritus and eczematous changes; the condition must be chronic or chronically relapsing in nature * Inadequate response to, or not willing to use strong treatment with a topical corticosteroid and/or a topical calcineurin inhibitor and/or phototherapy * Must meet all the following criteria regarding severity of atopic dermatitis: Rajka-Langeland score of 8 to 9; severe or very severe disease as defined in standard treatment guidelines; an Eczema Area and Severity Index (EASI) score of \>= 12; and an Investigator's Global Assessment (IGA) score of severe disease or very severe disease * Must conform to the following tuberculosis (TB) screening criteria: no history of latent or active TB prior to screening; no signs or symptoms suggestive of active TB; no recent close contact with a person with active TB; and a negative Interferon Gamma Release Assay (IGRA) result within 2 months prior to the first administration of study drug
Exclusion criteria
* History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results * Has an indeterminate initial and repeat IGRA result or a newly positive IGRA result and is unwilling or unable to undergo TB prophylaxis treatment * Has received any of the following medications or therapies within 4 weeks prior to randomization: systemic non-steroid immunosuppressive or immunomodulatory drugs; systemic corticosteroids; high daily dose of inhaled corticosteroids; topical corticosteroids of strongest potency for atopic dermatitis; topical antihistamines (including topical doxepin); topical anesthetics; topical nonsteroidal anti-inflammatory drugs; topical counter-irritants (eg, capsaicin, menthol, wintergreen oil); antidepressants or antipsychotics; soporifics; phototherapy including ultraviolet A , ultraviolet B, and psoralen with ultraviolet A (PUVA); hyposensitization (desensitization) therapy * Has changed the dose and dosing regimen within 4 weeks prior to randomization of any of the following drugs: topical corticosteroid (excluding the strongest potency) for atopic dermatitis; topical calcineurin inhibitor; emollients; anti-leukotriene therapies (including therapies for other allergic indications); systemic histamine H1 blocker (including sleep medications with antihistamine properties); sodium cromoglicate; suplatast tosilate; tranilast; thromboxane A2 inhibitors; and topical or oral herbal preparations for the treatment of atopic dermatitis * Has received any of the following biologic agents within the following time periods: any marketed immunomodulatory biologic within a period of 3 months or 5 half-lives, whichever is longer, prior to randomization; a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275), briakinumab (ABT-874), guselkumab (CNTO 1959) or MK-3222 at any point in time; or an experimental biologic therapy within the previous 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 | Baseline and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Baseline and Week 12 | 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. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 | Baseline and Week 12 | 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. |
| Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline | Week 2, 4, 8, 12, 16, 20 and 24 | 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. |
| Number of Participants With an IGA Score of Clear or Almost Clear | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 | 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). |
| Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 2, 4, 8, 12, 16, 20 and 24 | 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). |
| Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12 | Week 12 | 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). |
| Percent Change From Baseline in EASI Total Score | Week 2, 4, 8, 12, 16, 20 and 24 | 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. |
| Percent Change From Baseline in EASI Sign of Disease Components | Week 2, 4, 8, 12, 16, 20 and 24 | 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. |
| Percent Change From Baseline of Body Region Scores in EASI | Week 2, 4, 8, 12, 16, 20 and 24 | 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. |
| Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 | 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. |
| Number of Participants in IGA | Baseline, Week 2, 4, 8, 12, 16, 20 and 24 | 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). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4. | 27 |
| Ustekinumab 45 mg Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4. | 24 |
| Ustekinumab 90 mg Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. | 28 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Ustekinumab 45 mg | Ustekinumab 90 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 10.05 | 37.5 years STANDARD_DEVIATION 8.77 | 33.0 years STANDARD_DEVIATION 8.85 | 34.2 years STANDARD_DEVIATION 9.39 |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 9 Participants | 24 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 19 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 27 | 18 / 24 | 16 / 28 |
| serious Total, serious adverse events | 0 / 27 | 0 / 24 | 0 / 28 |
Outcome results
Primary
Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 | -37.54 percent change | Standard Deviation 37.592 |
| Ustekinumab 45 mg | Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 | -38.62 percent change | Standard Deviation 32.684 |
| Ustekinumab 90 mg | Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 | -39.39 percent change | Standard Deviation 38.71 |
Secondary
Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 3.03 |
| Placebo | 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 |
| Placebo | 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 |
| Ustekinumab 45 mg | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Baseline (EDS [n=27, 23, 28]) | 11.22 units on a scale | Standard Deviation 4.371 |
| Ustekinumab 45 mg | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Change at Week 12 (EDS [n=27, 23, 28]) | -1.91 units on a scale | Standard Deviation 3.253 |
| Ustekinumab 45 mg | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Baseline (MDS [n=27, 24, 28]) | 10.03 units on a scale | Standard Deviation 4.615 |
| Ustekinumab 45 mg | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Change at Week 12 (MDS [n=27, 24, 28]) | -1.68 units on a scale | Standard Deviation 3.286 |
| Ustekinumab 90 mg | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Change at Week 12 (MDS [n=27, 24, 28]) | -2.59 units on a scale | Standard Deviation 3.716 |
| Ustekinumab 90 mg | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Baseline (EDS [n=27, 23, 28]) | 9.45 units on a scale | Standard Deviation 3.697 |
| Ustekinumab 90 mg | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Baseline (MDS [n=27, 24, 28]) | 8.71 units on a scale | Standard Deviation 3.752 |
| Ustekinumab 90 mg | Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 | Change at Week 12 (EDS [n=27, 23, 28]) | -2.14 units on a scale | Standard Deviation 4.517 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Ustekinumab 45 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 | Baseline | 6.4 units on a scale | Standard Deviation 4.58 |
| Ustekinumab 45 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 | Change at Week 12 | -1.7 units on a scale | Standard Deviation 3.48 |
| Ustekinumab 90 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 | Baseline | 6.6 units on a scale | Standard Deviation 3.74 |
| Ustekinumab 90 mg | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 | Change at Week 12 | -1.7 units on a scale | Standard Deviation 4.56 |
Secondary
Number of Participants in IGA
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).
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants in IGA | Week 4: Moderate disease (n=27,24,27) | 11 participants |
| Placebo | Number of Participants in IGA | Week 24: Almost clear (n=26,24,27) | 2 participants |
| Placebo | Number of Participants in IGA | Week 16: Mild disease (n=26,24,27) | 3 participants |
| Placebo | Number of Participants in IGA | Week 4: Severe disease (n=27,24,27) | 13 participants |
| Placebo | Number of Participants in IGA | Baseline: Very severe disease (n=27,24,28) | 5 participants |
| Placebo | Number of Participants in IGA | Week 16: Almost clear (n=26,24,27) | 2 participants |
| Placebo | Number of Participants in IGA | Week 4: Very severe disease (n=27,24,27) | 1 participants |
| Placebo | Number of Participants in IGA | Week 24: Severe disease (n=26,24,27) | 12 participants |
| Placebo | Number of Participants in IGA | Week 16: Clear (n=26,24,27) | 0 participants |
| Placebo | Number of Participants in IGA | Week 8: Clear (n=27,24,27) | 0 participants |
| Placebo | Number of Participants in IGA | Week 24: Clear (n=26,24,27) | 0 participants |
| Placebo | Number of Participants in IGA | Week 12: Very severe disease (n=27,24,27) | 1 participants |
| Placebo | Number of Participants in IGA | Week 8: Almost clear (n=27,24,27) | 0 participants |
| Placebo | Number of Participants in IGA | Week 2: Clear (n=27,24,28) | 0 participants |
| Placebo | Number of Participants in IGA | Week 12: Severe disease (n=27,24,27) | 10 participants |
| Placebo | Number of Participants in IGA | Week 8: Mild disease (n=27,24,27) | 6 participants |
| Placebo | Number of Participants in IGA | Baseline: Mild disease (n=27,24,28) | 0 participants |
| Placebo | Number of Participants in IGA | Week 12: Moderate disease (n=27,24,27) | 10 participants |
| Placebo | Number of Participants in IGA | Week 8: Moderate disease (n=27,24,27) | 10 participants |
| Placebo | Number of Participants in IGA | Week 20: Very severe disease (n=26,24,26) | 2 participants |
| Placebo | Number of Participants in IGA | Week 12: Mild disease (n=27,24,27) | 6 participants |
| Placebo | Number of Participants in IGA | Week 8: Severe disease (n=27,24,27) | 10 participants |
| Placebo | Number of Participants in IGA | Week 12: Almost clear (n=27,24,27) | 0 participants |
| Placebo | Number of Participants in IGA | Week 8: Very severe disease (n=27,24,27) | 1 participants |
| Placebo | Number of Participants in IGA | Week 2: Almost clear (n=27,24,28) | 0 participants |
| Placebo | Number of Participants in IGA | Week 12: Clear (n=27,24,27) | 0 participants |
| Placebo | Number of Participants in IGA | Week 24: Very severe disease (n=26,24,27) | 2 participants |
| Placebo | Number of Participants in IGA | Week 20: Severe disease (n=26,24,26) | 11 participants |
| Placebo | Number of Participants in IGA | Week 2: Mild disease (n=27,24,28) | 1 participants |
| Placebo | Number of Participants in IGA | Week 20: Moderate disease (n=26,24,26) | 9 participants |
| Placebo | Number of Participants in IGA | Week 2: Moderate disease (n=27,24,28) | 8 participants |
| Placebo | Number of Participants in IGA | Week 24: Moderate disease (n=26,24,27) | 9 participants |
| Placebo | Number of Participants in IGA | Week 20: Mild disease (n=26,24,26) | 3 participants |
| Placebo | Number of Participants in IGA | Week 2: Severe disease (n=27,24,28) | 16 participants |
| Placebo | Number of Participants in IGA | Baseline: Moderate disease (n=27,24,28) | 0 participants |
| Placebo | Number of Participants in IGA | Week 20: Almost clear (n=26,24,26) | 2 participants |
| Placebo | Number of Participants in IGA | Week 2: Very severe disease (n=27,24,28) | 2 participants |
| Placebo | Number of Participants in IGA | Baseline: Almost clear (n=27,24,28) | 0 participants |
| Placebo | Number of Participants in IGA | Week 20: Clear (n=26,24,26) | 0 participants |
| Placebo | Number of Participants in IGA | Week 4: Clear (n=27,24,27) | 0 participants |
| Placebo | Number of Participants in IGA | Week 24: Mild disease (n=26,24,27) | 1 participants |
| Placebo | Number of Participants in IGA | Baseline: Severe disease (n=27,24,28) | 22 participants |
| Placebo | Number of Participants in IGA | Week 16: Very severe disease (n=26,24,27) | 1 participants |
| Placebo | Number of Participants in IGA | Week 4: Almost clear (n=27,24,27) | 0 participants |
| Placebo | Number of Participants in IGA | Week 16: Severe disease (n=26,24,27) | 11 participants |
| Placebo | Number of Participants in IGA | Week 4: Mild disease (n=27,24,27) | 2 participants |
| Placebo | Number of Participants in IGA | Baseline: Clear (n=27,24,28) | 0 participants |
| Placebo | Number of Participants in IGA | Week 16: Moderate disease (n=26,24,27) | 9 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 16: Very severe disease (n=26,24,27) | 2 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 24: Mild disease (n=26,24,27) | 4 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 2: Mild disease (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 4: Almost clear (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Baseline: Clear (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Baseline: Almost clear (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Baseline: Mild disease (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Baseline: Moderate disease (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Baseline: Severe disease (n=27,24,28) | 21 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Baseline: Very severe disease (n=27,24,28) | 3 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 2: Clear (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 2: Almost clear (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 2: Moderate disease (n=27,24,28) | 5 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 2: Severe disease (n=27,24,28) | 16 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 2: Very severe disease (n=27,24,28) | 3 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 4: Clear (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 8: Severe disease (n=27,24,27) | 10 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 4: Mild disease (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 4: Moderate disease (n=27,24,27) | 8 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 4: Severe disease (n=27,24,27) | 15 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 4: Very severe disease (n=27,24,27) | 1 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 8: Clear (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 8: Almost clear (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 8: Mild disease (n=27,24,27) | 1 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 8: Moderate disease (n=27,24,27) | 12 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 8: Very severe disease (n=27,24,27) | 1 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 12: Clear (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 12: Almost clear (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 12: Mild disease (n=27,24,27) | 5 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 12: Moderate disease (n=27,24,27) | 8 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 12: Severe disease (n=27,24,27) | 9 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 12: Very severe disease (n=27,24,27) | 2 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 16: Clear (n=26,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 16: Mild disease (n=26,24,27) | 3 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 16: Moderate disease (n=26,24,27) | 9 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 16: Severe disease (n=26,24,27) | 10 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 16: Almost clear (n=26,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 20: Clear (n=26,24,26) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 20: Almost clear (n=26,24,26) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 20: Mild disease (n=26,24,26) | 3 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 20: Moderate disease (n=26,24,26) | 9 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 20: Severe disease (n=26,24,26) | 10 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 20: Very severe disease (n=26,24,26) | 2 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 24: Clear (n=26,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 24: Almost clear (n=26,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 24: Moderate disease (n=26,24,27) | 7 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 24: Severe disease (n=26,24,27) | 10 participants |
| Ustekinumab 45 mg | Number of Participants in IGA | Week 24: Very severe disease (n=26,24,27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 16: Almost clear (n=26,24,27) | 1 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 4: Moderate disease (n=27,24,27) | 11 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 24: Clear (n=26,24,27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 16: Mild disease (n=26,24,27) | 5 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 4: Mild disease (n=27,24,27) | 2 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Baseline: Severe disease (n=27,24,28) | 24 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 16: Moderate disease (n=26,24,27) | 12 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 4: Almost clear (n=27,24,27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 24: Severe disease (n=26,24,27) | 8 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 16: Severe disease (n=26,24,27) | 6 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 4: Clear (n=27,24,27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 24: Almost clear (n=26,24,27) | 1 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 16: Very severe disease (n=26,24,27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 2: Very severe disease (n=27,24,28) | 1 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Baseline: Moderate disease (n=27,24,28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 20: Clear (n=26,24,26) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 2: Severe disease (n=27,24,28) | 16 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 24: Mild disease (n=26,24,27) | 6 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 20: Almost clear (n=26,24,26) | 1 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 2: Moderate disease (n=27,24,28) | 7 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Baseline: Mild disease (n=27,24,28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 20: Mild disease (n=26,24,26) | 5 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 2: Mild disease (n=27,24,28) | 4 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Baseline: Clear (n=27,24,28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 20: Moderate disease (n=26,24,26) | 12 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 2: Almost clear (n=27,24,28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 8: Very severe disease (n=27,24,27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 24: Moderate disease (n=26,24,27) | 10 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 12: Clear (n=27,24,27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 8: Severe disease (n=27,24,27) | 8 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 20: Severe disease (n=26,24,26) | 6 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 12: Almost clear (n=27,24,27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 8: Moderate disease (n=27,24,27) | 11 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 2: Clear (n=27,24,28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 12: Mild disease (n=27,24,27) | 6 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 8: Mild disease (n=27,24,27) | 4 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Baseline: Almost clear (n=27,24,28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 12: Moderate disease (n=27,24,27) | 11 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 8: Almost clear (n=27,24,27) | 1 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 20: Very severe disease (n=26,24,26) | 2 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 12: Severe disease (n=27,24,27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 8: Clear (n=27,24,27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Baseline: Very severe disease (n=27,24,28) | 4 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 12: Very severe disease (n=27,24,27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 4: Very severe disease (n=27,24,27) | 2 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 24: Very severe disease (n=26,24,27) | 2 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 16: Clear (n=26,24,27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants in IGA | Week 4: Severe disease (n=27,24,27) | 12 participants |
Secondary
Number of Participants With an IGA Score of Clear or Almost Clear
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).
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With an IGA Score of Clear or Almost Clear | Baseline (n=27, 24, 28) | 0 participants |
| Placebo | Number of Participants With an IGA Score of Clear or Almost Clear | Week 2 (n=27, 24, 28) | 0 participants |
| Placebo | Number of Participants With an IGA Score of Clear or Almost Clear | Week 4 (n=27, 24, 27) | 0 participants |
| Placebo | Number of Participants With an IGA Score of Clear or Almost Clear | Week 8 (n=27, 24, 27) | 0 participants |
| Placebo | Number of Participants With an IGA Score of Clear or Almost Clear | Week 12 (n=27, 24, 27) | 0 participants |
| Placebo | Number of Participants With an IGA Score of Clear or Almost Clear | Week 16 (n=26, 24, 27) | 2 participants |
| Placebo | Number of Participants With an IGA Score of Clear or Almost Clear | Week 20 (n=26, 24, 26) | 2 participants |
| Placebo | Number of Participants With an IGA Score of Clear or Almost Clear | Week 24 (n=26, 24, 27) | 1 participants |
| Ustekinumab 45 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 4 (n=27, 24, 27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 20 (n=26, 24, 26) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 8 (n=27, 24, 27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 12 (n=27, 24, 27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 16 (n=26, 24, 27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Baseline (n=27, 24, 28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 2 (n=27, 24, 28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 24 (n=26, 24, 27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 4 (n=27, 24, 27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 2 (n=27, 24, 28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Baseline (n=27, 24, 28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 8 (n=27, 24, 27) | 1 participants |
| Ustekinumab 90 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 20 (n=26, 24, 26) | 1 participants |
| Ustekinumab 90 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 16 (n=26, 24, 27) | 1 participants |
| Ustekinumab 90 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 12 (n=27, 24, 27) | 0 participants |
| Ustekinumab 90 mg | Number of Participants With an IGA Score of Clear or Almost Clear | Week 24 (n=26, 24, 27) | 1 participants |
Secondary
Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12
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).
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12 | 0 participants |
| Ustekinumab 45 mg | Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12 | 0 participants |
| Ustekinumab 90 mg | Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12 | 0 participants |
Secondary
Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
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).
Time frame: Week 2, 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 4 (n=27, 24, 27) | 5 participants |
| Placebo | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 16 (n=26, 24, 27) | 6 participants |
| Placebo | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 12 (n=27, 24, 27) | 7 participants |
| Placebo | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 2 (n=27, 24, 28) | 2 participants |
| Placebo | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 24 (n=26, 24, 27) | 3 participants |
| Placebo | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 20 (n=26, 24, 26) | 6 participants |
| Placebo | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 8 (n=27, 24, 27) | 7 participants |
| Ustekinumab 45 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 12 (n=27, 24, 27) | 7 participants |
| Ustekinumab 45 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 2 (n=27, 24, 28) | 1 participants |
| Ustekinumab 45 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 4 (n=27, 24, 27) | 2 participants |
| Ustekinumab 45 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 8 (n=27, 24, 27) | 3 participants |
| Ustekinumab 45 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 16 (n=26, 24, 27) | 5 participants |
| Ustekinumab 45 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 20 (n=26, 24, 26) | 6 participants |
| Ustekinumab 45 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 24 (n=26, 24, 27) | 4 participants |
| Ustekinumab 90 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 16 (n=26, 24, 27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 4 (n=27, 24, 27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 24 (n=26, 24, 27) | 6 participants |
| Ustekinumab 90 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 20 (n=26, 24, 26) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 12 (n=27, 24, 27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 8 (n=27, 24, 27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline | Week 2 (n=27, 24, 28) | 4 participants |
Secondary
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
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.
Time frame: Week 2, 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Ustekinumab 45 mg | 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) | 8 participants |
| Ustekinumab 45 mg | 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) | 1 participants |
| Ustekinumab 45 mg | 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) | 9 participants |
| Ustekinumab 45 mg | 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) | 2 participants |
| Ustekinumab 45 mg | 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 |
| Ustekinumab 45 mg | 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) | 10 participants |
| Ustekinumab 45 mg | 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 |
| Ustekinumab 45 mg | 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) | 0 participants |
| Ustekinumab 45 mg | 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) | 2 participants |
| Ustekinumab 45 mg | 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) | 3 participants |
| Ustekinumab 45 mg | 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) | 4 participants |
| Ustekinumab 45 mg | 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) | 2 participants |
| Ustekinumab 45 mg | 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) | 0 participants |
| Ustekinumab 45 mg | 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) | 5 participants |
| Ustekinumab 90 mg | 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) | 12 participants |
| Ustekinumab 90 mg | 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 |
| Ustekinumab 90 mg | 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 |
| Ustekinumab 90 mg | 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 |
| Ustekinumab 90 mg | 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) | 3 participants |
| Ustekinumab 90 mg | 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) | 5 participants |
| Ustekinumab 90 mg | 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) | 0 participants |
| Ustekinumab 90 mg | 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) | 10 participants |
| Ustekinumab 90 mg | 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) | 5 participants |
| Ustekinumab 90 mg | 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) | 7 participants |
| Ustekinumab 90 mg | 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) | 5 participants |
| Ustekinumab 90 mg | 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) | 9 participants |
| Ustekinumab 90 mg | 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) | 3 participants |
| Ustekinumab 90 mg | 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) | 12 participants |
Secondary
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
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.
Time frame: Baseline, Week 2, 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Induration (n=27,24,28) | 1 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Excoriation (n=27,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Induration (n=26,24,27) | 5 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Excoriation (n=27,24,27) | 5 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Induration (n=27,24,27) | 5 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Erythema (n=27,24,28) | 0 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Excoriation (n=27,24,27) | 5 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Induration (n=27,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Lichenification (n=27,24,28) | 1 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Excoriation (27,24,28) | 2 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Induration (n=27,24,27) | 3 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Lichenification (n=26,24,26) | 6 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Excoriation (n=27,24,28) | 0 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Induration (n=26,24,27) | 6 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Lichenification (n=27,24,28) | 0 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Induration (n=26,24,26) | 7 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Lichenification (n=27,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Erythema (n=27,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Lichenification (n=26,24,27) | 6 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Lichenification (n=27,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Erythema (n=27,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Lichenification (n=26,24,27) | 5 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Erythema (n=27,24,27) | 5 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Erythema (n=27,24,28) | 1 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Excoriation (n=26,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Erythema (n=26,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Excoriation (n=26,24,26) | 7 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Erythema (n=26,24,26) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Excoriation (n=26,24,27) | 7 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Erythema (n=26,24,27) | 5 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Lichenification (n=27,24,27) | 4 participants |
| Placebo | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Induration (n=27,24,28) | 1 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Excoriation (n=27,24,27) | 2 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Erythema (n=26,24,27) | 4 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Erythema (n=26,24,26) | 4 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Excoriation (n=27,24,27) | 9 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Erythema (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Erythema (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Erythema (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Erythema (n=27,24,27) | 1 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Erythema (n=27,24,27) | 5 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Erythema (n=26,24,27) | 3 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Induration (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Induration (n=27,24,28) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Induration (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Induration (n=27,24,27) | 1 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Induration (n=27,24,27) | 6 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Induration (n=26,24,27) | 5 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Induration (n=26,24,26) | 3 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Induration (n=26,24,27) | 3 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Excoriation (n=27,24,28) | 1 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Excoriation (27,24,28) | 2 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Excoriation (n=27,24,27) | 3 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Excoriation (n=26,24,27) | 7 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Excoriation (n=26,24,26) | 4 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Excoriation (n=26,24,27) | 5 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Lichenification (n=27,24,28) | 1 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Lichenification (n=27,24,28) | 1 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Lichenification (n=27,24,27) | 0 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Lichenification (n=27,24,27) | 2 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Lichenification (n=27,24,27) | 6 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Lichenification (n=26,24,27) | 4 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Lichenification (n=26,24,26) | 4 participants |
| Ustekinumab 45 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Lichenification (n=26,24,27) | 5 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Excoriation (n=27,24,27) | 6 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Erythema (n=26,24,26) | 5 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Lichenification (n=26,24,26) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Excoriation (n=26,24,27) | 9 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Erythema (n=26,24,27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Lichenification (n=27,24,27) | 5 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Excoriation (n=26,24,26) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Erythema (n=27,24,27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Erythema (n=27,24,27) | 1 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Excoriation (n=26,24,27) | 8 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Lichenification (n=27,24,28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Erythema (n=27,24,28) | 0 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Excoriation (n=27,24,27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Lichenification (n=26,24,27) | 8 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Lichenification (n=27,24,28) | 2 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Erythema (n=26,24,27) | 6 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 16: Induration (n=26,24,27) | 8 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Erythema (n=27,24,28) | 1 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 20: Induration (n=26,24,26) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Lichenification (n=27,24,27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Induration (n=26,24,27) | 8 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 12: Induration (n=27,24,27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 24: Lichenification (n=26,24,27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Excoriation (n=27,24,28) | 1 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Induration (n=27,24,27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Lichenification (n=27,24,27) | 2 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Excoriation (27,24,28) | 4 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 4: Induration (n=27,24,27) | 3 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 2: Induration (n=27,24,28) | 2 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Erythema (n=27,24,27) | 2 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Week 8: Excoriation (n=27,24,27) | 7 participants |
| Ustekinumab 90 mg | Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) | Baseline: Induration (n=27,24,28) | 0 participants |
Secondary
Percent Change From Baseline in EASI Sign of Disease Components
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.
Time frame: Week 2, 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Erythema (n=27,24,27) | -23.24 percent change | Standard Deviation 25.71 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Excoriation (n=27,23,27) | -30.56 percent change | Standard Deviation 35.8 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Lichenification (n=26,24,27) | -32.05 percent change | Standard Deviation 33.47 |
| Placebo | 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 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 16: Induration (n=26,24,27) | -25.82 percent change | Standard Deviation 32.69 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 20: Excoriation (n=26,23,26) | -23.55 percent change | Standard Deviation 36.947 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Excoriation (n=26,23,27) | -22.74 percent change | Standard Deviation 37.555 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 2: Lichenification (n=267,24,28) | -8.46 percent change | Standard Deviation 16.879 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Lichenification(n=27,24,27) | -10.21 percent change | Standard Deviation 23.359 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Lichenification (n=27,24,27) | -19.40 percent change | Standard Deviation 22.871 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 12: Lichenification (n=27,24,27) | -24.36 percent change | Standard Deviation 29.272 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 16: Lichenification (n=26,24,27) | -22.18 percent change | Standard Deviation 34.489 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 20: Lichenification (n=26,24,26) | -23.36 percent change | Standard Deviation 43.75 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Lichenification (n=26,24,27) | -20.96 percent change | Standard Deviation 45.278 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 2: Erythema (n=27,24,28) | -12.03 percent change | Standard Deviation 13.049 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Erythema (n=27,24,27) | -17.17 percent change | Standard Deviation 15.346 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Erythema (n=27,24,27) | -24.13 percent change | Standard Deviation 18.549 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 12: Erythema (n=27,24,27) | -29.73 percent change | Standard Deviation 25.421 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 16: Erythema (n=26,24,27) | -28.36 percent change | Standard Deviation 30.209 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 20: Erythema (n=26,24,26) | -32.43 percent change | Standard Deviation 26.55 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Erythema (n=26,24,27) | -28.65 percent change | Standard Deviation 27.249 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 2: Induration (n=27,24,28) | -12.32 percent change | Standard Deviation 14.315 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Induration (n=27,24,27) | -16.58 percent change | Standard Deviation 17.491 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Induration (n=27,24,27) | -24.16 percent change | Standard Deviation 22.658 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 12: Induration (n=27,24,27) | -26.78 percent change | Standard Deviation 29.282 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 16: Excoriation (n=26,23,27) | -25.50 percent change | Standard Deviation 41.929 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 20: Induration (n=26,24,26) | -27.21 percent change | Standard Deviation 29.162 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Induration (n=26,24,27) | -26.71 percent change | Standard Deviation 31.24 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 2: Excoriation (n=27,23,28) | -11.82 percent change | Standard Deviation 19.872 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Excoriation (n=27,23,27) | -18.40 percent change | Standard Deviation 19.323 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Excoriation (n=27,23,27) | -25.58 percent change | Standard Deviation 27.607 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 12: Excoriation (n=27,23,27) | -30.66 percent change | Standard Deviation 36.517 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Lichenification (n=26,24,27) | -40.19 percent change | Standard Deviation 26.696 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 16: Excoriation (n=26,23,27) | -44.25 percent change | Standard Deviation 27.69 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Induration (n=27,24,27) | -26.98 percent change | Standard Deviation 29.825 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 20: Lichenification (n=26,24,26) | -41.71 percent change | Standard Deviation 30.241 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Excoriation (n=27,23,27) | -29.73 percent change | Standard Deviation 28.764 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 12: Induration (n=27,24,27) | -35.42 percent change | Standard Deviation 29.943 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 16: Lichenification (n=26,24,27) | -37.47 percent change | Standard Deviation 27.046 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Excoriation (n=26,23,27) | -42.07 percent change | Standard Deviation 33.992 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 16: Induration (n=26,24,27) | -38.98 percent change | Standard Deviation 26.767 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 12: Lichenification (n=27,24,27) | -33.06 percent change | Standard Deviation 25.443 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 12: Excoriation (n=27,23,27) | -38.33 percent change | Standard Deviation 27.953 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 20: Induration (n=26,24,26) | -40.58 percent change | Standard Deviation 31.136 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Lichenification (n=27,24,27) | -28.07 percent change | Standard Deviation 27.887 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Excoriation (n=27,23,27) | -35.02 percent change | Standard Deviation 30.4 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Induration (n=26,24,27) | -40.06 percent change | Standard Deviation 30.864 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 16: Erythema (n=26,24,27) | -34.57 percent change | Standard Deviation 21.759 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 12: Erythema (n=27,24,27) | -29.89 percent change | Standard Deviation 21.895 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Lichenification(n=27,24,27) | -20.24 percent change | Standard Deviation 24.284 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 20: Erythema (n=26,24,26) | -34.84 percent change | Standard Deviation 23.922 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 8: Erythema (n=27,24,27) | -25.38 percent change | Standard Deviation 21.39 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 20: Excoriation (n=26,23,26) | -40.67 percent change | Standard Deviation 33.036 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 24: Erythema (n=26,24,27) | -37.25 percent change | Standard Deviation 23.711 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Erythema (n=27,24,27) | -21.51 percent change | Standard Deviation 16.334 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 2: Excoriation (n=27,23,28) | -23.91 percent change | Standard Deviation 25.419 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 2: Induration (n=27,24,28) | -22.17 percent change | Standard Deviation 24.515 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 2: Erythema (n=27,24,28) | -19.13 percent change | Standard Deviation 19.091 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 2: Lichenification (n=267,24,28) | -15.87 percent change | Standard Deviation 18.5 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Sign of Disease Components | Week 4: Induration (n=27,24,27) | -24.96 percent change | Standard Deviation 26.132 |
Secondary
Percent Change From Baseline in EASI Total Score
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.
Time frame: Week 2, 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in EASI Total Score | Week 4 (n=27,24,27) | -31.69 percent change | Standard Deviation 28.936 |
| Placebo | Percent Change From Baseline in EASI Total Score | Week 16 (n=26,24,27) | -39.97 percent change | Standard Deviation 40.572 |
| Placebo | Percent Change From Baseline in EASI Total Score | Week 12 (n=27,24,27) | -37.54 percent change | Standard Deviation 37.592 |
| Placebo | Percent Change From Baseline in EASI Total Score | Week 2 (n=27,24,28) | -24.29 percent change | Standard Deviation 25.402 |
| Placebo | Percent Change From Baseline in EASI Total Score | Week 24 (n=26,24,27) | -35.93 percent change | Standard Deviation 40.524 |
| Placebo | Percent Change From Baseline in EASI Total Score | Week 20 (n=26,24,26) | -41.03 percent change | Standard Deviation 43.495 |
| Placebo | Percent Change From Baseline in EASI Total Score | Week 8 (n=27,24,27) | -36.06 percent change | Standard Deviation 35.84 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Total Score | Week 12 (n=27,24,27) | -38.62 percent change | Standard Deviation 32.684 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Total Score | Week 2 (n=27,24,28) | -13.85 percent change | Standard Deviation 21.391 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Total Score | Week 4 (n=27,24,27) | -21.13 percent change | Standard Deviation 24.097 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Total Score | Week 8 (n=27,24,27) | -31.15 percent change | Standard Deviation 28.012 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Total Score | Week 16 (n=26,24,27) | -38.43 percent change | Standard Deviation 34.202 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Total Score | Week 20 (n=26,24,26) | -40.59 percent change | Standard Deviation 31.666 |
| Ustekinumab 45 mg | Percent Change From Baseline in EASI Total Score | Week 24 (n=26,24,27) | -38.83 percent change | Standard Deviation 35.697 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Total Score | Week 16 (n=26,24,27) | -44.39 percent change | Standard Deviation 40.154 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Total Score | Week 4 (n=27,24,27) | -29.19 percent change | Standard Deviation 30.409 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Total Score | Week 24 (n=26,24,27) | -46.19 percent change | Standard Deviation 41.791 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Total Score | Week 20 (n=26,24,26) | -46.24 percent change | Standard Deviation 41.817 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Total Score | Week 12 (n=27,24,27) | -40.84 percent change | Standard Deviation 38.655 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Total Score | Week 8 (n=27,24,27) | -34.49 percent change | Standard Deviation 38.857 |
| Ustekinumab 90 mg | Percent Change From Baseline in EASI Total Score | Week 2 (n=27,24,28) | -25.72 percent change | Standard Deviation 24.728 |
Secondary
Percent Change From Baseline of Body Region Scores in EASI
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.
Time frame: Week 2, 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Trunk (n=27,24,27) | -34.42 percent change | Standard Deviation 34.73 |
| Placebo | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Upper limbs (n=27,24,27) | -44.58 percent change | Standard Deviation 38.1 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Upper limbs (n=26,24,26) | -41.48 percent change | Standard Deviation 46.7 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Head/neck (n=27,24,28) | -20.28 percent change | Standard Deviation 22.41 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 16: Trunk (n=26,24,27) | -28.96 percent change | Standard Deviation 41.26 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Lower limbs (n=27,24,27) | -31.88 percent change | Standard Deviation 36.302 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 16: Lower limbs (n=26,24,27) | -46.30 percent change | Standard Deviation 34.942 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Lower limbs (n=26,24,26) | -45.50 percent change | Standard Deviation 34.35 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Head/neck (n=27,24,28) | -6.97 percent change | Standard Deviation 24.488 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Head/neck (n=27,24,27) | -17.46 percent change | Standard Deviation 25.632 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Head/neck (n=27,24,27) | -34.27 percent change | Standard Deviation 27.38 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 12: Head/neck (n=27,24,27) | -36.28 percent change | Standard Deviation 39.256 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 16: Head/neck (n=26,24,27) | -38.31 percent change | Standard Deviation 37.155 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Head/neck (n=26,24,26) | -42.63 percent change | Standard Deviation 38.094 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 24: Head/neck (n=26,24,27) | -37.20 percent change | Standard Deviation 39.828 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Upper limbs (n=27,24,28) | -14.47 percent change | Standard Deviation 22.285 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Upper limbs (n=27,24,27) | -21.62 percent change | Standard Deviation 23.746 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Upper limbs (n=27,24,27) | -32.57 percent change | Standard Deviation 28.6 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 12: Upper limbs (n=27,24,27) | -36.55 percent change | Standard Deviation 35.946 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 16: Upper limbs (n=26,24,27) | -32.55 percent change | Standard Deviation 47.614 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Upper limbs (n=26,24,26) | -37.71 percent change | Standard Deviation 36.66 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 24: Upper limbs (n=26,24,27) | -39.36 percent change | Standard Deviation 36.535 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Trunk (n=27,24,28) | -18.16 percent change | Standard Deviation 22.783 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Trunk (n=27,24,27) | -20.59 percent change | Standard Deviation 26.028 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Trunk (n=27,24,27) | -27.99 percent change | Standard Deviation 29.551 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 12: Trunk (n=27,24,27) | -36.89 percent change | Standard Deviation 35.351 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Trunk (n=26,24,26) | -32.68 percent change | Standard Deviation 36.306 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 24: Trunk (n=26,24,27) | -31.25 percent change | Standard Deviation 40.207 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Lower limbs (n=27,24,28) | -9.17 percent change | Standard Deviation 32.015 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Lower limbs (n=27,24,27) | -21.32 percent change | Standard Deviation 33.541 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 12: Lower limbs (n=27,24,27) | -42.01 percent change | Standard Deviation 35.358 |
| Ustekinumab 45 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 24: Lower limbs (n=26,24,27) | -41.55 percent change | Standard Deviation 40.522 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Upper limbs (n=27,24,28) | -28.53 percent change | Standard Deviation 26.76 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Lower limbs (n=26,24,26) | -38.92 percent change | Standard Deviation 86.354 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Trunk (n=27,24,27) | -29.26 percent change | Standard Deviation 54.157 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 24: Head/neck (n=26,24,27) | -49.63 percent change | Standard Deviation 28.51 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 24: Lower limbs (n=26,24,27) | -39.80 percent change | Standard Deviation 87.186 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 12: Trunk (n=27,24,27) | -31.65 percent change | Standard Deviation 54.961 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Head/neck (n=26,24,26) | -46.30 percent change | Standard Deviation 35.652 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 16: Head/neck (n=26,24,27) | -52.12 percent change | Standard Deviation 23.578 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 16: Trunk (n=26,24,27) | -37.87 percent change | Standard Deviation 54.763 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 12: Head/neck (n=27,24,27) | -45.34 percent change | Standard Deviation 25.282 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 12: Lower limbs (n=27,24,27) | -32.39 percent change | Standard Deviation 83.114 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Trunk (n=26,24,26) | -41.92 percent change | Standard Deviation 58.26 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Head/neck (n=27,24,27) | -38.65 percent change | Standard Deviation 28.58 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 16: Lower limbs (n=26,24,27) | -36.87 percent change | Standard Deviation 84.182 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 24: Trunk (n=26,24,27) | -39.77 percent change | Standard Deviation 56.008 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Lower limbs (n=27,24,27) | -27.56 percent change | Standard Deviation 82.889 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 16: Upper limbs (n=26,24,27) | -42.94 percent change | Standard Deviation 42.543 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Head/neck (n=27,24,27) | -34.15 percent change | Standard Deviation 32.087 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 20: Upper limbs (n=26,24,26) | -48.20 percent change | Standard Deviation 37.501 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 12: Upper limbs (n=27,24,27) | -47.01 percent change | Standard Deviation 39.135 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Lower limbs (n=27,24,28) | -26.15 percent change | Standard Deviation 26.073 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 24: Upper limbs (n=26,24,27) | -50.89 percent change | Standard Deviation 39.446 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 8: Upper limbs (n=27,24,27) | -38.11 percent change | Standard Deviation 37.205 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Lower limbs (n=27,24,27) | -33.12 percent change | Standard Deviation 37.005 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Trunk (n=27,24,28) | -21.84 percent change | Standard Deviation 33.368 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Upper limbs (n=27,24,27) | -30.26 percent change | Standard Deviation 29.646 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 2: Head/neck (n=27,24,28) | -29.50 percent change | Standard Deviation 9.492 |
| Ustekinumab 90 mg | Percent Change From Baseline of Body Region Scores in EASI | Week 4: Trunk (n=27,24,27) | -23.51 percent change | Standard Deviation 46.987 |