Trial Outcomes & Findings for Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U) (NCT NCT02187172)

NCT ID: NCT02187172

Last Updated: 2019-08-15

Results Overview

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 43 participants
• Primary outcome timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
• Results posted on: 2019-08-15

Participant Flow

Participant milestones

Measure	Ustekinumab Randomized to receive Ustekinumab (Stelara) from day 0 until week 12 (randomized controlled trial (RCT) phase). Continue to receive ustekinumab for additional 40 weeks for a total of 52 weeks of ustekinumab. The end of study is at Week 52 for this arm.	Placebo Randomized to receive Placebo from day 0 until week 12 (RCT phase). Receive ustekinumab from week 12 until week 64 for a total of 52 weeks of ustekinumab. The end of study is at Week 64 for this arm.
Overall Study STARTED	22	21
Overall Study RCT Phase Completed	22	19
Overall Study COMPLETED	19	15
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	Ustekinumab Randomized to receive Ustekinumab (Stelara) from day 0 until week 12 (randomized controlled trial (RCT) phase). Continue to receive ustekinumab for additional 40 weeks for a total of 52 weeks of ustekinumab. The end of study is at Week 52 for this arm.	Placebo Randomized to receive Placebo from day 0 until week 12 (RCT phase). Receive ustekinumab from week 12 until week 64 for a total of 52 weeks of ustekinumab. The end of study is at Week 64 for this arm.
Overall Study Lost to Follow-up	1	2
Overall Study Lack of Efficacy	1	2
Overall Study Adverse Event	0	1
Overall Study Physician Decision	1	1

Baseline Characteristics

Only applicable in patients with psoriatic arthritis

Baseline characteristics by cohort

Measure	Ustekinumab (Stelara) n=22 Participants Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter. Ustekinumab	Placebo n=21 Participants Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator. Ustekinumab Placebo	Total n=43 Participants Total of all reporting groups
Age, Continuous	39.45 years STANDARD_DEVIATION 13.6 • n=22 Participants	45.33 years STANDARD_DEVIATION 12.76 • n=21 Participants	42.33 years STANDARD_DEVIATION 13.38 • n=43 Participants
Sex: Female, Male Female	6 Participants n=22 Participants	7 Participants n=21 Participants	13 Participants n=43 Participants
Sex: Female, Male Male	16 Participants n=22 Participants	14 Participants n=21 Participants	30 Participants n=43 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=22 Participants	2 Participants n=21 Participants	4 Participants n=43 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=22 Participants	19 Participants n=21 Participants	38 Participants n=43 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=22 Participants	0 Participants n=21 Participants	1 Participants n=43 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Asian	1 Participants n=22 Participants	2 Participants n=21 Participants	3 Participants n=43 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Black or African American	2 Participants n=22 Participants	5 Participants n=21 Participants	7 Participants n=43 Participants
Race (NIH/OMB) White	19 Participants n=22 Participants	12 Participants n=21 Participants	31 Participants n=43 Participants
Race (NIH/OMB) More than one race	0 Participants n=22 Participants	2 Participants n=21 Participants	2 Participants n=43 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants	0 Participants n=21 Participants	0 Participants n=43 Participants
Body Mass Index	33.24 kg/m^2 STANDARD_DEVIATION 7.95 • n=22 Participants	33.32 kg/m^2 STANDARD_DEVIATION 6.29 • n=21 Participants	33.28 kg/m^2 STANDARD_DEVIATION 7.1 • n=43 Participants
Medical History Arthritis	0 participants n=22 Participants	1 participants n=21 Participants	1 participants n=43 Participants
Medical History Coronary Artery Disease	1 participants n=22 Participants	1 participants n=21 Participants	2 participants n=43 Participants
Medical History Depression	2 participants n=22 Participants	2 participants n=21 Participants	4 participants n=43 Participants
Medical History Diabetes	0 participants n=22 Participants	1 participants n=21 Participants	1 participants n=43 Participants
Medical History Hyperlipidemia	5 participants n=22 Participants	2 participants n=21 Participants	7 participants n=43 Participants
Medical History Stroke	1 participants n=22 Participants	0 participants n=21 Participants	1 participants n=43 Participants
Medical History Statin Use	3 participants n=22 Participants	3 participants n=21 Participants	6 participants n=43 Participants
Body Surface Area (BSA)	26.18 percentage of total body surface area STANDARD_DEVIATION 17.51 • n=22 Participants	23.71 percentage of total body surface area STANDARD_DEVIATION 15.58 • n=21 Participants	24.98 percentage of total body surface area STANDARD_DEVIATION 16.45 • n=43 Participants
Psoriasis Area Severity Index (PASI) score	20.03 composite score STANDARD_DEVIATION 7.47 • n=22 Participants	19.82 composite score STANDARD_DEVIATION 7.64 • n=21 Participants	19.93 composite score STANDARD_DEVIATION 7.46 • n=43 Participants
Physician Global Assessment (PGA)	3.5 calculated score STANDARD_DEVIATION 0.57 • n=22 Participants	3.38 calculated score STANDARD_DEVIATION 0.8 • n=21 Participants	3.44 calculated score STANDARD_DEVIATION 0.69 • n=43 Participants
Psoriasis duration	16.45 years STANDARD_DEVIATION 11.02 • n=22 Participants	20.29 years STANDARD_DEVIATION 14.41 • n=21 Participants	18.13 years STANDARD_DEVIATION 12.58 • n=43 Participants
Psoriasis treatment history Biologics	10 participants n=22 Participants	9 participants n=21 Participants	19 participants n=43 Participants
Psoriasis treatment history Systemics	6 participants n=22 Participants	2 participants n=21 Participants	8 participants n=43 Participants
Psoriasis treatment history Phototherapy	10 participants n=22 Participants	9 participants n=21 Participants	19 participants n=43 Participants
Psoriatic Arthritis (PsA) present	1 Participants n=22 Participants	6 Participants n=21 Participants	7 Participants n=43 Participants
Age at PsA diagnosis	22 years STANDARD_DEVIATION 0 • n=1 Participants • Only applicable in patients with psoriatic arthritis	43.6 years STANDARD_DEVIATION 14.33 • n=5 Participants • Only applicable in patients with psoriatic arthritis	40 years STANDARD_DEVIATION 15.56 • n=6 Participants • Only applicable in patients with psoriatic arthritis

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).

Outcome measures

Measure	Ustekinumab (RCT Period) n=22 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Vascular Inflammation	-0.1015 TBR max Standard Error 0.0465	0.1442 TBR max Standard Error 0.0137	-0.0151 TBR max Standard Error 0.0353

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on ICAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)	10.83 ng/mL Standard Error 26.30	75.80 ng/mL Standard Error 37.19	6.65 ng/mL Standard Error 22.24

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VCAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)	-20.36 ng/mL Standard Error 18.39	60.53 ng/mL Standard Error 24.76	-1.99 ng/mL Standard Error 14.11

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on CRP, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)	-2886.57 ng/mL Standard Error 2851.16	140.64 ng/mL Standard Error 1108.54	-1974.63 ng/mL Standard Error 1659.11

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Ferritin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: Ferritin	-12.32 ng/mL Standard Error 39.16	-32.97 ng/mL Standard Error 27.40	47.00 ng/mL Standard Error 35.84

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on SAA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: Serum Amyloid A (SAA)	-7687.80 ng/mL Standard Error 7389.00	196.49 ng/mL Standard Error 203.34	-3782.54 ng/mL Standard Error 4073.25

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on INF-g,, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: Interferon-gamma (INF-g)	-0.03 pg/mL Standard Error 2.25	0.04 pg/mL Standard Error 0.95	-1.09 pg/mL Standard Error 1.09

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MCP-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: Monocyte Chemoattractant Protein-1 (MCP-1)	-14.66 pg/mL Standard Error 15.51	0.13 pg/mL Standard Error 12.09	-7.24 pg/mL Standard Error 11.47

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on TNF-a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: Tumor Necrosis Factor-alpha (TNF-a)	-0.22 pg/mL Standard Error 0.51	0.68 pg/mL Standard Error 0.44	-0.67 pg/mL Standard Error 0.34

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on GlycA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: GlycA	-0.70 umol/L Standard Error 7.42	3.44 umol/L Standard Error 8.76	-8.35 umol/L Standard Error 8.41

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-1b, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: Interleukin (IL)-1b	0.07 pg/mL Standard Error 0.38	0.60 pg/mL Standard Error 0.34	-0.31 pg/mL Standard Error 0.11

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-2ra, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: IL-2ra	-79.07 ng/mL Standard Error 28.51	-8.31 ng/mL Standard Error 15.48	71.72 ng/mL Standard Error 132.87

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-12/23, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: IL-12/23	196.84 pg/mL Standard Error 43.59	5.35 pg/mL Standard Error 4.63	171.21 pg/mL Standard Error 20.30

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-17a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: IL-17a	-1.46 pg/mL Standard Error 0.39	1.17 pg/mL Standard Error 0.94	-1.15 pg/mL Standard Error 0.32

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-18, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: IL-18	301.21 pg/mL Standard Error 483.77	456.52 pg/mL Standard Error 487.49	-407.43 pg/mL Standard Error 180.70

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-6, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: IL-6	-0.45 pg/mL Standard Error 0.22	0.02 pg/mL Standard Error 0.33	-0.38 pg/mL Standard Error 0.21

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-8, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Inflammatory Biomarker Levels: IL-8	2.46 pg/mL Standard Error 3.35	19.33 pg/mL Standard Error 16.02	-2.23 pg/mL Standard Error 1.71

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Triglycerides	0.48 mg/dL Standard Error 9.42	-1.58 mg/dL Standard Error 8.70	10.55 mg/dL Standard Error 8.26

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Total cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Total Cholesterol	12.57 mg/dL Standard Error 5.04	-6.63 mg/dL Standard Error 5.45	-0.79 mg/dL Standard Error 4.14

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: High-density Lipoprotein (HDL) Cholesterol	2.24 mg/dL Standard Error 1.31	-1.42 mg/dL Standard Error 1.46	1.92 mg/dL Standard Error 1.42

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: HDL Particle Number	-0.02 nmol/L Standard Error 0.69	-1.27 nmol/L Standard Error 0.77	0.91 nmol/L Standard Error 0.72

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: HDL Particle Size	0.08 nm Standard Error 0.05	0.19 nm Standard Error 0.10	0.17 nm Standard Error 0.07

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Large-HDL Particle Number	0.46 nmol/L Standard Error 0.38	0.33 nmol/L Standard Error 0.47	0.51 nmol/L Standard Error 0.36

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Small-HDL Particle Number	-0.02 nmol/L Standard Error 1.15	-2.52 nmol/L Standard Error 1.25	0.21 nmol/L Standard Error 0.84

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Medium-HDL Particle Number	-0.56 nmol/L Standard Error 1.21	0.81 nmol/L Standard Error 1.17	0.17 nmol/L Standard Error 0.97

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Large Medium-HDL Particle Number	0.02 nmol/L Standard Error 1.26	1.14 nmol/L Standard Error 1.43	0.77 nmol/L Standard Error 1.00

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Low-density Lipoprotein (LDL) Cholesterol	12.52 mg/dL Standard Error 4.21	-8.84 mg/dL Standard Error 5.25	-2.92 mg/dL Standard Error 4.07

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: LDL Particle Number	112.67 nmol/L Standard Error 46.44	-118.11 nmol/L Standard Error 52.45	-31.89 nmol/L Standard Error 41.71

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: LDL Particle Size	0.20 nmol/L Standard Error 0.11	0.15 nmol/L Standard Error 0.13	0.03 nmol/L Standard Error 0.11

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Small-LDL Particle Number	24.36 nmol/L Standard Error 38.72	-22.61 nmol/L Standard Error 40.61	4.68 nmol/L Standard Error 33.85

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Large-LDL Particle Number	28.95 nmol/L Standard Error 26.87	21.95 nmol/L Standard Error 41.87	-24.76 nmol/L Standard Error 32.59

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Very large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Very Large-LDL Particle Number	93.95 nmol/L Standard Error 45.38	-100.74 nmol/L Standard Error 48.29	-29.16 nmol/L Standard Error 38.01

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Very Low-density Lipoprotein (VLDL) Particle Size	3.19 nmol/L Standard Error 2.19	0.04 nmol/L Standard Error 1.69	1.50 nmol/L Standard Error 1.41

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: VLDL Particle Number	-9.32 nmol/L Standard Error 4.85	7.42 nmol/L Standard Error 4.34	-0.11 nmol/L Standard Error 3.37

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: VLDL Triglycerides	-4.88 mg/dL Standard Error 8.85	4.33 mg/dL Standard Error 7.57	11.14 mg/dL Standard Error 7.33

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Small-VLDL Particle Number	-5.84 nmol/L Standard Error 2.72	9.87 nmol/L Standard Error 5.27	-0.50 nmol/L Standard Error 2.07

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Medium-VLDL Particle Number	-3.50 nmol/L Standard Error 2.98	-3.84 nmol/L Standard Error 3.50	-1.86 nmol/L Standard Error 2.43

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Large Medium-VLDL Particle Number	-2.89 nmol/L Standard Error 3.33	-2.97 nmol/L Standard Error 3.98	0.38 nmol/L Standard Error 2.59

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Large-VLDL Particle Number	0.29 nmol/L Standard Error 0.86	0.57 nmol/L Standard Error 0.99	2.30 nmol/L Standard Error 1.08

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Intermediate-density Lipoprotein (IDL) Particle Number	50.86 nmol/L Standard Error 25.89	-101.79 nmol/L Standard Error 36.04	-2.97 nmol/L Standard Error 25.70

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Cholesterol efflux capacity, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Cholesterol Efflux Capacity	0.09 unitless (see description) Standard Error 0.03	0.03 unitless (see description) Standard Error 0.03	0.04 unitless (see description) Standard Error 0.03

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Apolipoprotein-B, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Apolipoprotein-B	0.11 ug/mL Standard Error 0.09	-0.04 ug/mL Standard Error 0.09	0.10 ug/mL Standard Error 0.06

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Fetuin-A, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Lipid Biomarker Levels: Fetuin-A	10.22 ug/mL Standard Error 29.47	-38.21 ug/mL Standard Error 56.05	-49.56 ug/mL Standard Error 27.84

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Adiponectin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Metabolic Biomarker Levels: Adiponectin	0.04 ug/mL Standard Error 0.79	0.32 ug/mL Standard Error 0.77	0.38 ug/mL Standard Error 0.51

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Leptin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Metabolic Biomarker Levels: Leptin	8022.19 pg/mL Standard Error 2576.52	4701.61 pg/mL Standard Error 2184.57	6926.25 pg/mL Standard Error 2257.84

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Insulin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Metabolic Biomarker Levels: Insulin	36.19 pg/mL Standard Error 116.40	105.13 pg/mL Standard Error 51.42	-7.96 pg/mL Standard Error 85.98

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Glucose, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Outcome measures

Measure	Ustekinumab (RCT Period) n=22 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=39 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Metabolic Biomarker Levels: Glucose	2.41 mg/dL Standard Error 3.34	-1.79 mg/dL Standard Error 4.02	3.41 mg/dL Standard Error 3.43

PRIMARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

Population: The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite "Total" group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HOMA-IR, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=38 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Metabolic Biomarker Levels: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	0.07 unitless (see description) Standard Error 1.37	0.55 unitless (see description) Standard Error 0.49	-0.07 unitless (see description) Standard Error 0.89

SECONDARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI75, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Binary measure of change in psoriasis activity; 75% or greater reduction in PASI score compared to baseline.

Outcome measures

Measure	Ustekinumab (RCT Period) n=22 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=39 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Number of Participants Achieving PASI75 (75% or Greater Reduction in PASI Score)	17 Participants	2 Participants	28 Participants

SECONDARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI90, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Binary measure of change in psoriasis activity; 90% or greater reduction in PASI score compared to baseline.

Outcome measures

Measure	Ustekinumab (RCT Period) n=22 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=39 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Number of Participants Achieving PASI90 (90% or Greater Reduction in PASI Score)	9 Participants	0 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PGA clear/almost clear, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

Binary measure of psoriasis disease activity at measurement time points; Physician Global Assessment score <1.5 (clear/almost clear)

Outcome measures

Measure	Ustekinumab (RCT Period) n=22 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=39 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear	14 Participants	2 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MEDFICTS, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument, has been provided as part of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guidelines as a free tool to use for proper cardiovascular diet assessment. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day).

Outcome measures

Measure	Ustekinumab (RCT Period) n=22 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=19 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=41 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Patient-Reported Outcomes: MEDFICTS	-5.68 MEDFICTS score Standard Error 3.97	-14.00 MEDFICTS score Standard Error 4.98	8.32 MEDFICTS score Standard Error 6.30

SECONDARY outcome

Timeframe: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)

To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IPAQ, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).

IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.

Outcome measures

Measure	Ustekinumab (RCT Period) n=21 Participants Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Placebo (RCT Period) n=16 Participants Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.	Total (Active Treatment Period) n=37 Participants Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.
Change in Patient-reported Physical Activity Assessments: IPAQ	73.69 MET-minutes/week Standard Error 808.45	853.28 MET-minutes/week Standard Error 562.37	-779.59 MET-minutes/week Standard Error 1049.99

Adverse Events

Ustekinumab (Stelara)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo (RCT Period)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo (Active Treatment Period)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ustekinumab (Stelara) n=22 participants at risk Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter. From Baseline to Week 52.	Placebo (RCT Period) n=21 participants at risk Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator. From Baseline to Week 12 (RCT period only).	Placebo (Active Treatment Period) n=19 participants at risk Placebo arm after crossing over to receive ustekinumab, following the same dosing schedule of the Ustekinumab arm. From Week 12 to Week 64 (52 weeks of active treatment period).
Reproductive system and breast disorders Endometritis	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Cardiac disorders Hypotension	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Vascular disorders Stroke	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Vascular disorders Vasovagal reaction	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.

Other adverse events

Measure	Ustekinumab (Stelara) n=22 participants at risk Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter. From Baseline to Week 52.	Placebo (RCT Period) n=21 participants at risk Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator. From Baseline to Week 12 (RCT period only).	Placebo (Active Treatment Period) n=19 participants at risk Placebo arm after crossing over to receive ustekinumab, following the same dosing schedule of the Ustekinumab arm. From Week 12 to Week 64 (52 weeks of active treatment period).
Immune system disorders Allergies to foods, food additives, drugs and other chemicals	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	10.5% 2/19 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Psychiatric disorders Anxiety	9.1% 2/22 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/19 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Musculoskeletal and connective tissue disorders Back pain	9.1% 2/22 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/19 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Infections and infestations Common cold	27.3% 6/22 • Number of events 6 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	10.5% 2/19 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Nervous system disorders Dizziness	9.1% 2/22 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/19 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Ear and labyrinth disorders External ear pain	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Musculoskeletal and connective tissue disorders Fracture	9.1% 2/22 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/19 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Musculoskeletal and connective tissue disorders Pain/Pain in extremity	4.5% 1/22 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/19 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	9.1% 2/22 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Infections and infestations Upper respiratory infection	50.0% 11/22 • Number of events 11 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	14.3% 3/21 • Number of events 3 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	21.1% 4/19 • Number of events 4 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Infections and infestations Urinary tract infection	9.1% 2/22 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/19 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Reproductive system and breast disorders Uterine hemorrhage	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Hepatobiliary disorders Alkaline Phosphatase Increased	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Psychiatric disorders Anhedonia	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Skin and subcutaneous tissue disorders Blistering	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Skin and subcutaneous tissue disorders Dermatitis Irritant Contact	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Skin and subcutaneous tissue disorders Dysplastic Nevus	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Ear and labyrinth disorders Ear And Labyrinth Disorders/Ear Pain	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	10.5% 2/19 • Number of events 2 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Gastrointestinal disorders Gastritis	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Hepatobiliary disorders Hepatic Lesion	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Vascular disorders Hypertension	4.5% 1/22 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Infections and infestations Latent Tuberculosis	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Musculoskeletal and connective tissue disorders Pain	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Psychiatric disorders Panic Attack	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Infections and infestations Pyelonephritis	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Skin and subcutaneous tissue disorders Rash/Rash Acneiform/Maculo-Papular	4.5% 1/22 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	15.8% 3/19 • Number of events 3 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Gastrointestinal disorders Stomach pain	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
General disorders Toothache	4.5% 1/22 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Infections and infestations Trichomoniasis	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Reproductive system and breast disorders Uterine Fibroids Enlarged	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Infections and infestations Viral Infection	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.
Skin and subcutaneous tissue disorders Would Healing Delayed	0.00% 0/22 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	0.00% 0/21 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.	5.3% 1/19 • Number of events 1 • 52 weeks for Ustekinumab arm, 64 weeks for Placebo arm. For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study. A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.

Additional Information

Dr. Joel Gelfand

University of Pennsylvania

Phone: 215-662-3514

Email: joel.gelfand@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place