Trial Outcomes & Findings for Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris (NCT NCT01999868)
NCT ID: NCT01999868
Last Updated: 2019-01-15
Results Overview
The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + \[(Baseline PASI -Week 12 PASI)/2\]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
COMPLETED
PHASE2
108 participants
Post-randomization (Week 12 to 88)
2019-01-15
Participant Flow
148 participants were screened and 108 of those participants were enrolled at 8 sites in the US and 2 sites in Canada between March 2014 and April 2016
Enrolled participants received open-label ustekinumab in the lead-in phase (Week 0 to 12). Participants with at least 75% reduction in Psoriasis Area Severity Index (PASI) score at Week 12 compared to Week 0 were eligible for the blinded treatment phase (Week 12 to 40).
Participant milestones
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
Ustekinumab, Not Randomized
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase but were not randomized to a blinded treatment group.
|
|---|---|---|---|
|
Lead-in Phase (Week 0 - 12)
STARTED
|
45
|
46
|
17
|
|
Lead-in Phase (Week 0 - 12)
COMPLETED
|
45
|
46
|
12
|
|
Lead-in Phase (Week 0 - 12)
NOT COMPLETED
|
0
|
0
|
5
|
|
Blinded Treatment Phase (Week 12 - 40)
STARTED
|
45
|
46
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
COMPLETED
|
27
|
35
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
NOT COMPLETED
|
18
|
11
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
STARTED
|
27
|
35
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
COMPLETED
|
4
|
6
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
NOT COMPLETED
|
23
|
29
|
0
|
Reasons for withdrawal
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
Ustekinumab, Not Randomized
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase but were not randomized to a blinded treatment group.
|
|---|---|---|---|
|
Lead-in Phase (Week 0 - 12)
Lost to Follow-up
|
0
|
0
|
5
|
|
Blinded Treatment Phase (Week 12 - 40)
Adverse Event
|
1
|
1
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
Lost to Follow-up
|
3
|
4
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
Pregnancy
|
0
|
1
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
Withdrawal by Subject
|
0
|
2
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
Met study drug Discontinuation Criteria
|
1
|
2
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
Met psoriasis relapse criterion
|
8
|
1
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
Transportation issues
|
1
|
0
|
0
|
|
Blinded Treatment Phase (Week 12 - 40)
Worsening psoriasis
|
4
|
0
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
Adverse Event
|
0
|
1
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
Lost to Follow-up
|
0
|
1
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
Withdrawal by Subject
|
1
|
2
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
Met psoriasis relapse criterion
|
10
|
19
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
Terminated early from study in error
|
0
|
2
|
0
|
|
Blinded Observation Phase (Week 40 - 88)
Worsening psoriasis
|
12
|
4
|
0
|
Baseline Characteristics
Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
Ustekinumab, Not Randomized
n=17 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase but were not randomized to a blinded treatment group.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
6 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
11 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Psoriasis Area Severity Index (PASI) Score
|
19.2 units on a scale
STANDARD_DEVIATION 8.1 • n=5 Participants
|
20.0 units on a scale
STANDARD_DEVIATION 8.2 • n=7 Participants
|
21.2 units on a scale
STANDARD_DEVIATION 7.7 • n=5 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 8.1 • n=4 Participants
|
|
Psoriasis Area Severity Index (PASI) (Randomization Strata)
Low (12 - 20)
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Psoriasis Area Severity Index (PASI) (Randomization Strata)
High (>20)
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Physician's Global Assessment (PGA) Score
|
3.5 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Physician's Global Assessment (PGA) Score (Categorical)
Cleared or Minimal (PGA <1.5)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Physician's Global Assessment (PGA) Score (Categorical)
Worse than Minimal (PGA ≥ 1.5)
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Dermatology Life Quality Index (DLQI) Score
|
14.2 units on a scale
STANDARD_DEVIATION 8.1 • n=5 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 7.0 • n=7 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 7.7 • n=4 Participants
|
PRIMARY outcome
Timeframe: Post-randomization (Week 12 to 88)Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + \[(Baseline PASI -Week 12 PASI)/2\]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse)
Week 12-88
|
91.1 percentage of participants
|
87.0 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse)
Week 12-40
|
55.6 percentage of participants
|
30.4 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse)
Week 28-88
|
88.9 percentage of participants
|
84.2 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse)
Week 40-88
|
84.6 percentage of participants
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: Post-randomization (Week 12 to 88)Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI -Week 12 PASI). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were considered to have not experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse)
Week 12-88
|
75.6 percentage of participants
|
52.2 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse)
Week 12-40
|
42.2 percentage of participants
|
10.9 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse)
Week 28-88
|
83.3 percentage of participants
|
60.5 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse)
Week 40-88
|
80.8 percentage of participants
|
63.9 percentage of participants
|
SECONDARY outcome
Timeframe: Post-randomization (Week 12 to 88)Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI -Week 12 PASI). Participants who terminated early due to reasons other than psoriasis relapse or worsening psoriasis were considered to have a missing relapse status at time of drop-out and were excluded from the analyses. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status)
Week 12-88
|
89.5 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status)
Week 12-40
|
48.7 percentage of participants
|
13.5 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status)
Week 28-88
|
88.2 percentage of participants
|
79.3 percentage of participants
|
|
Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status)
Week 40-88
|
84.0 percentage of participants
|
79.3 percentage of participants
|
SECONDARY outcome
Timeframe: Post-randomization (Week 12 to 88)Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + \[(Baseline PASI -Week 12 PASI)/2\]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Time to Psoriasis Relapse (Treating Drop-Outs as Relapse)
|
28 weeks
Interval 24.0 to 40.0
|
40 weeks
Interval 32.0 to 44.0
|
SECONDARY outcome
Timeframe: Post-randomization (Week 12 to 88)Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + \[(Baseline PASI -Week 12 PASI)/2\]). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were censored at the time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Time to Psoriasis Relapse (Treating Drop-Outs as Censored)
|
28 weeks
Interval 28.0 to 40.0
|
48 weeks
Interval 44.0 to 56.0
|
SECONDARY outcome
Timeframe: Week 40, Week 88Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Percentage of participants who were classified as cleared or minimal in the Physician's Global Assessment (PGA) average score at the specified post-randomization time point. The PGA assesses the severity of the psoriasis in 3 components: induration, erythema and scaling. Each component is given a score ranging from 0 to 5 based on the majority of the participant's psoriasis lesions, with higher scores indicating worse disease. A PGA average score \< 1.5 was classified as "cleared or minimal."
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Percentage of Participants Who Were Cleared or Minimal in the Physician's Global Assessment (PGA)
Week 40
|
26.9 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants Who Were Cleared or Minimal in the Physician's Global Assessment (PGA)
Week 88
|
75.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40, Week 88Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Change in the Dermatology Life Quality Index (DLQI) score from Week 12 to the specified post-randomization time point. DLQI is a 10-question, participant-reported questionnaire that assesses quality of life with respect to skin conditions in the areas of symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question measures the level of effect that the skin condition has on quality of life, and responses range from 'Not at all' (score = 0) to 'Very much' (score = 3). The overall score is the sum of the scores for all 10 questions and ranges from 0-30, with higher scores indicating worse quality of life.
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI)
Week 40
|
2.2 Units on a Scale
Standard Deviation 5.3
|
0.6 Units on a Scale
Standard Deviation 3.9
|
|
Change in Dermatology Life Quality Index (DLQI)
Week 88
|
-4.3 Units on a Scale
Standard Deviation 3.7
|
0.0 Units on a Scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Lead-In Phase (Week 0 to 12)Population: The safety population includes all participants who received at least one dose of treatment after enrollment.
Number of participants who experienced adverse events (AEs) during the lead-in phase (Week 0 to 12), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol.
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=108 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
All AEs
|
30 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
AEs indicated as serious
|
2 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
AEs with an outcome of death
|
0 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
AEs of special interest
|
0 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
Grade 2 AEs
|
28 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
Grade 3 AEs
|
2 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
Grade 4 AEs
|
0 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
Grade 1 Psoriatic Arthritis AEs
|
2 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
Grade 2 Psoriatic Arthritis AEs
|
0 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
Grade 3 Psoriatic Arthritis AEs
|
0 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
AEs that lead to study drug discontinuation
|
0 Number of participants
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)
AEs related to open label Ustekinumab
|
11 Number of participants
|
—
|
SECONDARY outcome
Timeframe: Lead-In Phase (Week 0 to 12)Population: The safety population includes all participants who received at least one dose of treatment after enrollment.
Number of adverse events (AEs) that occurred during the lead-in phase (Week 0 to 12), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol.
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=108 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
All AEs
|
51 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
AEs indicated as serious
|
2 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
AEs with an outcome of death
|
0 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
AEs of special interest
|
0 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
Grade 2 AEs
|
47 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
Grade 3 AEs
|
2 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
Grade 4 AEs
|
0 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
Grade 1 Psoriatic Arthritis AEs
|
2 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
Grade 2 Psoriatic Arthritis AEs
|
0 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
Grade 3 Psoriatic Arthritis AEs
|
0 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
AEs that lead to study drug discontinuation
|
0 Number of Events
|
—
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)
AEs related to open label Ustekinumab
|
20 Number of Events
|
—
|
SECONDARY outcome
Timeframe: From randomization (Week 12) to last safety follow-up visit (up to Week 100)Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Number of participants who experienced adverse events (AEs) during the post-randomization phase (Week 12 to 100), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol. AEs that started prior to randomization but became serious after randomization were included in the counts for the post-randomization time period.
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
All AEs
|
28 Number of participants
|
22 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
AEs indicated as serious
|
2 Number of participants
|
5 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
AEs with an outcome of death
|
0 Number of participants
|
0 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
AEs of special interest
|
2 Number of participants
|
1 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
Grade 2 AEs (CTCAE)
|
27 Number of participants
|
20 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
Grade 3 AEs (CTCAE)
|
4 Number of participants
|
7 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
Grade 4 AEs (CTCAE)
|
0 Number of participants
|
2 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
Grade 1 Psoriatic Arthritis AEs
|
0 Number of participants
|
0 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
Grade 2 Psoriatic Arthritis AEs
|
2 Number of participants
|
1 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
Grade 3 Psoriatic Arthritis AEs
|
0 Number of participants
|
0 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
AEs that lead to study drug discontinuation
|
1 Number of participants
|
2 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
AEs related to open-label Ustekinumab
|
5 Number of participants
|
8 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
AEs related to Ustekinumab/Ustekinumab Placebo
|
7 Number of participants
|
9 Number of participants
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)
AEs related to Abatacept/Abatacept Placebo
|
11 Number of participants
|
11 Number of participants
|
SECONDARY outcome
Timeframe: From randomization (Week 12) to last safety follow-up visit (up to Week 100)Population: The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.
Number of adverse events (AEs) that occurred during the post-randomization phase (Week 12 to 100), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol. AEs that started prior to randomization but became serious after randomization were included in the counts for the post-randomization time period.
Outcome measures
| Measure |
Ustekinumab, Abatacept + Ustekinumab Placebo
n=45 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Ustekinumab, Ustekinumab + Abatacept Placebo
n=46 Participants
Participants received 2 subcutaneous injections of open-label ustekinumab (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
All AEs
|
59 Number of Events
|
59 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
AEs indicated as serious
|
2 Number of Events
|
9 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
AEs with an outcome of death
|
0 Number of Events
|
0 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
AEs of special interest
|
2 Number of Events
|
1 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
Grade 2 AEs (CTCAE)
|
53 Number of Events
|
47 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
Grade 3 AEs (CTCAE)
|
4 Number of Events
|
7 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
Grade 4 AEs (CTCAE)
|
0 Number of Events
|
4 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
Grade 1 Psoriatic Arthritis AEs
|
0 Number of Events
|
0 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
Grade 2 Psoriatic Arthritis AEs
|
2 Number of Events
|
1 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
Grade 3 Psoriatic Arthritis AEs
|
0 Number of Events
|
0 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
AEs that lead to study drug discontinuation
|
1 Number of Events
|
3 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
AEs related to open-label Ustekinumab
|
5 Number of Events
|
11 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
AEs related to Ustekinumab/Ustekinumab Placebo
|
9 Number of Events
|
17 Number of Events
|
|
Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)
AEs related to Abatacept/Abatacept Placebo
|
15 Number of Events
|
20 Number of Events
|
Adverse Events
UST Open Label
Post Randomization: UST, ABA/UST Placebo
Post Randomization: UST, UST/ABA Placebo
Serious adverse events
| Measure |
UST Open Label
n=108 participants at risk
Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase.
|
Post Randomization: UST, ABA/UST Placebo
n=45 participants at risk
Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (ABA) (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Post Randomization: UST, UST/ABA Placebo
n=46 participants at risk
Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept (ABA) placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.93%
1/108 • Number of events 1 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
0.00%
0/46 • Week 0 to Week 100
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/108 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
2.2%
1/46 • Number of events 1 • Week 0 to Week 100
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/108 • Week 0 to Week 100
|
2.2%
1/45 • Number of events 1 • Week 0 to Week 100
|
0.00%
0/46 • Week 0 to Week 100
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/108 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
2.2%
1/46 • Number of events 1 • Week 0 to Week 100
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/108 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
2.2%
1/46 • Number of events 1 • Week 0 to Week 100
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/108 • Week 0 to Week 100
|
2.2%
1/45 • Number of events 1 • Week 0 to Week 100
|
0.00%
0/46 • Week 0 to Week 100
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/108 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
2.2%
1/46 • Number of events 1 • Week 0 to Week 100
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.93%
1/108 • Number of events 1 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
0.00%
0/46 • Week 0 to Week 100
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/108 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
2.2%
1/46 • Number of events 1 • Week 0 to Week 100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/108 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
2.2%
1/46 • Number of events 1 • Week 0 to Week 100
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/108 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
2.2%
1/46 • Number of events 2 • Week 0 to Week 100
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/108 • Week 0 to Week 100
|
0.00%
0/45 • Week 0 to Week 100
|
2.2%
1/46 • Number of events 1 • Week 0 to Week 100
|
Other adverse events
| Measure |
UST Open Label
n=108 participants at risk
Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase.
|
Post Randomization: UST, ABA/UST Placebo
n=45 participants at risk
Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of abatacept (ABA) (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.
|
Post Randomization: UST, UST/ABA Placebo
n=46 participants at risk
Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing \<=100 kg at study entry or 90 mg for those weighing \>100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and received blinded treatment of ustekinumab (45 mg if \<=100 kg or 90 mg if \>100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept (ABA) placebo subcutaneous injections weekly from Week 12 to 39.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
4/108 • Number of events 4 • Week 0 to Week 100
|
2.2%
1/45 • Number of events 1 • Week 0 to Week 100
|
10.9%
5/46 • Number of events 9 • Week 0 to Week 100
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/108 • Week 0 to Week 100
|
11.1%
5/45 • Number of events 5 • Week 0 to Week 100
|
4.3%
2/46 • Number of events 2 • Week 0 to Week 100
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place