Trial Outcomes & Findings for An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age (NCT NCT02698475)

Last Updated: 2021-11-01

Results Overview

The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. Treatment Failure (TF) criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

44 participants

Primary outcome timeframe

Week 12

Results posted on

2021-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Ustekinumab Standard Dosage Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (\<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg, and 90 mg for participants with weight \> 100 kg. Participants had a safety follow-up till Week 56 (Main study period). During long-term extension (LTE) period, participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a q12w regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264.
Main Study Period STARTED	44
Main Study Period COMPLETED	41
Main Study Period NOT COMPLETED	3
Long-Term Extension Period STARTED	28
Long-Term Extension Period COMPLETED	0
Long-Term Extension Period NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Ustekinumab Standard Dosage Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (\<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg, and 90 mg for participants with weight \> 100 kg. Participants had a safety follow-up till Week 56 (Main study period). During long-term extension (LTE) period, participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a q12w regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264.
Main Study Period Lack of Efficacy	1
Main Study Period Protocol Violation	2
Long-Term Extension Period Lost to Follow-up	1
Long-Term Extension Period Trial Site Terminated by Sponsor	1
Long-Term Extension Period Withdrawal by Subject	3
Long-Term Extension Period Due to Long Term Extension Protocol-Specified Criteria	22
Long-Term Extension Period Other	1

Baseline Characteristics

An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ustekinumab Standard Dosage n=44 Participants Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (\<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg, and 90 mg for participants with weight \> 100 kg. Participants had a safety follow-up till Week 56 (Main study period). During long-term extension (LTE) period, participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a q12w regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264.
Age, Continuous	8.9 years STANDARD_DEVIATION 1.74 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	40 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Region of Enrollment Belgium	4 Participants n=5 Participants
Region of Enrollment Canada	2 Participants n=5 Participants
Region of Enrollment Germany	7 Participants n=5 Participants
Region of Enrollment Hungary	10 Participants n=5 Participants
Region of Enrollment Netherlands	1 Participants n=5 Participants
Region of Enrollment Poland	12 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full analysis set (FAS): all enrolled and treated participants who received at least 1 injection of ustekinumab (partial or complete). Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=44 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12	77.3 percentage of participants Interval 62.2 to 88.5

SECONDARY outcome

Timeframe: Week 12

Population: FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.

PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with \>=75% improvement in PASI from baseline were considered PASI 75 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=44 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12	84.1 percentage of participants Interval 69.9 to 93.4

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS. For participants meeting one or more TF criteria, were considered to have 0 improvement from baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure at both baseline and Week 12.

CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=42 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12	-6.3 units on a scale Standard Deviation 6.43

SECONDARY outcome

Timeframe: Week 12

Population: FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.

PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72 (disease severity). A higher score indicates more severe disease. Participants with \>=90% improvement in PASI from baseline were considered PASI 90 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=44 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants Who Achieved PASI 90 Response at Week 12	63.6 percentage of participants Interval 47.8 to 77.6

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 28, 40, and 52

Population: FAS. Participants who met 1 or more TF criteria were considered as non-responders after TF. In addition, participants with missing data at Week 12 were also considered as non-responders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.

The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=44 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 4: PGA Score 0	4.8 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 4: PGA Score 0 or 1	33.3 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 8: PGA Score 0 or 1	63.4 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 8: PGA Score 0 or 1 or 2	85.4 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 12: PGA Score 0	38.6 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 12: PGA Score 0 or 1	77.3 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 12: PGA Score 0 or 1 or 2	90.9 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 16: PGA Score 0	45.2 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 16: PGA Score 0 or 1	85.7 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 16: PGA Score 0 or 1 or 2	95.2 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 28: PGA Score 0 or 1 or 2	95.2 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 40: PGA Score 0	52.4 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 40: PGA Score 0 or 1	76.2 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 40: PGA Score 0 or 1 or 2	90.5 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 52: PGA Score 0	56.1 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 52: PGA Score 0 or 1	75.6 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 52: PGA Score 0 or 1 or 2	90.2 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 4: PGA Score 0 or 1 or 2	66.7 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 8: PGA Score 0	26.8 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 28: PGA Score 0	45.2 percentage of participants
Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 28: PGA Score 0 or 1	83.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 28, 40, and 52

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as \>=50%, \>=75%, \>=90%, and 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=44 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 8: PASI 75	58.5 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 8: PASI 50	82.9 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 12: PASI 100	34.1 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 12: PASI 90	63.6 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 16: PASI 90	66.7 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 16: PASI 50	97.6 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 28: PASI 100	38.1 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 28: PASI 75	92.9 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 40: PASI 90	78.6 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 40: PASI 75	90.5 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 40: PASI 50	92.9 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 52: PASI 90	70.7 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 52: PASI 75	87.8 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 52: PASI 50	92.7 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 4: PASI 100	2.4 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 4: PASI 90	16.7 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 4: PASI 75	26.2 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 4: PASI 50	52.4 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 8: PASI 100	17.1 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 8: PASI 90	43.9 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 12: PASI 75	84.1 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 12: PASI 50	93.2 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 16: PASI 100	40.5 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 16: PASI 75	83.3 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 28: PASI 90	81.0 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 28: PASI 50	92.9 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 40: PASI 100	42.9 percentage of participants
Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 52: PASI 100	53.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, 12, 16, 28, 40, 52

Population: FAS. For participants meeting one or more TF criteria, were considered to have 0% improvement from baseline. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 100 responders were defined as 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=44 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 4	52.9 percent change Standard Deviation 27.33
Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 8	78.9 percent change Standard Deviation 21.44
Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 12	89.7 percent change Standard Deviation 13.80
Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 16	90.4 percent change Standard Deviation 13.77
Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 28	90.4 percent change Standard Deviation 21.55
Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 40	89.9 percent change Standard Deviation 23.01
Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52 Week 52	89.1 percent change Standard Deviation 24.28

SECONDARY outcome

Timeframe: Week 12

Population: FAS. Participants meeting one or more TF criteria were considered as non-responders.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as \>=50%, \>=75%, \>=90%, and 100% improvement in PASI component from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=44 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Induration: PASI 75	77.3 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Scaling: PASI 75	84.1 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Scaling: PASI 50	90.9 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Erythema: PASI 100	38.6 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Erythema: PASI 90	61.4 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Erythema: PASI 75	81.8 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Head: PASI 100	52.3 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Head: PASI 50	93.2 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Trunk: PASI 100	61.4 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Upper extremities: PASI 90	65.9 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Lower extremities: PASI 75	72.7 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Lower extremities: PASI 50	93.2 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Induration: PASI 100	43.2 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Induration: PASI 90	61.4 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Induration: PASI 50	93.2 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Scaling: PASI 100	38.6 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Scaling: PASI 90	63.6 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Erythema: PASI 50	93.2 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Head: PASI 90	65.9 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Head: PASI 75	79.5 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Trunk: PASI 90	61.4 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Trunk: PASI 75	79.5 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Trunk: PASI 50	88.6 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Upper extremities: PASI 100	65.9 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Upper extremities: PASI 75	79.5 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Upper extremities: PASI 50	84.1 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Lower extremities: PASI 100	68.2 percentage of participants
Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12 Lower extremities: PASI 90	68.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, 28, 52

Population: FAS. Participants who met TF criteria prior to Week 12 were assigned 0 change. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.

CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=44 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 Week 4	-4.1 units on a scale Standard Deviation 4.88
Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 Week 12	-6.3 units on a scale Standard Deviation 6.43
Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 Week 28	-6.6 units on a scale Standard Deviation 5.79
Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52 Week 52	-6.4 units on a scale Standard Deviation 6.10

SECONDARY outcome

Timeframe: Week 12

Population: FAS with CDLQI score \> 1 at baseline. Participants who met 1 or more TF criteria prior to Week 12 or with missing data were considered as nonresponders.

CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=39 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1	61.5 percentage of participants Interval 44.6 to 76.6

SECONDARY outcome

Timeframe: Weeks 4, 12, 28, and 52

Population: FAS with CDLQI \> 1 at baseline. Participants who met 1 or more TF criteria were considered as nonresponders after TF. In addition, participants with missing data at Week 12 were considered as nonresponders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.

CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=39 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 Week 4	37.8 percentage of participants
Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 Week 12	61.5 percentage of participants
Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 Week 28	62.2 percentage of participants
Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1 Week 52	58.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS. Participants who met TF criteria prior to Week 12 were assigned 0 change. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.

CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=42 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Change From Baseline in CDLQI Component Scores at Week 12 Symptoms and feelings	-1.9 units on a scale Standard Deviation 1.81
Change From Baseline in CDLQI Component Scores at Week 12 Leisure	-1.7 units on a scale Standard Deviation 2.19
Change From Baseline in CDLQI Component Scores at Week 12 School or holidays	-0.5 units on a scale Standard Deviation 0.80
Change From Baseline in CDLQI Component Scores at Week 12 Personal relationships	-0.8 units on a scale Standard Deviation 1.71
Change From Baseline in CDLQI Component Scores at Week 12 Sleep	-0.4 units on a scale Standard Deviation 0.91
Change From Baseline in CDLQI Component Scores at Week 12 Treatment	-0.9 units on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Weeks 80, 104, 128, 152, 176

Population: FAS; all participants enrolled in the LTE who received at least an injection of ustekinumab at Week 56 (partial or complete). Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed): participants evaluated at given timepoints.

The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicated worse disease.

Outcome measures

Outcome measures
Measure	Ustekinumab Standard Dose (Main Study) n=25 Participants Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg. Participants had a safety follow-up till Week 56.
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 104: PGA score 0	50 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 80: PGA score 0	64 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 80: PGA score 0 or 1	80 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 80: PGA score 0 or 1 or 2	100 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 104: PGA score 0 or 1	70 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 104: PGA score 0 or 1 or 2	100 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 128: PGA score 0	60 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 128: PGA score 0 or 1	80 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 128: PGA score 0 or 1 or 2	95 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 152: PGA score 0	53.8 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 152: PGA score 0 or 1	61.5 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 152: PGA score 0 or 1 or 2	100 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 176: PGA score 0	33.3 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 176: PGA score 0 or 1	66.7 percentage of participants
Percentage of Participants With PGA Score of Cleared (0), Cleared (0) or Minimal (1), Cleared (0) or Minimal (1) or Mild (2) at Weeks 80, 104, 128, 152, and 176 Week 176: PGA score 0 or 1 or 2	100 percentage of participants

Adverse Events

Ustekinumab Standard Dosage (Main Study)

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Ustekinumab Standard Dosage (Long-Term Extension [LTE])

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ustekinumab Standard Dosage (Main Study) n=44 participants at risk Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (\<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg, and 90 mg for participants with weight \> 100 kg. Participants had a safety follow-up till Week 56.	Ustekinumab Standard Dosage (Long-Term Extension [LTE]) n=28 participants at risk Participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a every 12 weeks (q12w) regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg.
Infections and infestations Infectious Mononucleosis	2.3% 1/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	0.00% 0/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Injury, poisoning and procedural complications Eyelid Injury	2.3% 1/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	0.00% 0/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	3.6% 1/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Psychiatric disorders Attention Deficit/Hyperactivity Disorder	2.3% 1/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	0.00% 0/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.

Other adverse events

Additional Information

Senior Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ustekinumab Standard Dosage (Main Study) n=44 participants at risk Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (\<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg, and 90 mg for participants with weight \> 100 kg. Participants had a safety follow-up till Week 56.	Ustekinumab Standard Dosage (Long-Term Extension [LTE]) n=28 participants at risk Participants who had a beneficial response from ustekinumab treatment continued receiving ustekinumab weight based dose in a every 12 weeks (q12w) regimen from Week 56 onwards until commercially available or marketing authorization being denied or up to Week 264. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight \<60 kg, 45 mg for participants with weight \>=60 kg to \<=100 kg, and 90 mg for participants with weight \>100 kg.
Gastrointestinal disorders Abdominal Pain	6.8% 3/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	0.00% 0/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Gastrointestinal disorders Vomiting	0.00% 0/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	7.1% 2/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
General disorders Injection Site Erythema	13.6% 6/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	7.1% 2/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Infections and infestations Gastroenteritis	6.8% 3/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	10.7% 3/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Infections and infestations Nasopharyngitis	25.0% 11/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	28.6% 8/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Infections and infestations Otitis Media	6.8% 3/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	7.1% 2/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Infections and infestations Pharyngitis	13.6% 6/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	3.6% 1/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Infections and infestations Respiratory Tract Infection	0.00% 0/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	7.1% 2/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Infections and infestations Tonsillitis	9.1% 4/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	0.00% 0/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Infections and infestations Upper Respiratory Tract Infection	13.6% 6/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	7.1% 2/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Infections and infestations Viral Upper Respiratory Tract Infection	2.3% 1/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	7.1% 2/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	10.7% 3/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 2/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	10.7% 3/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	2.3% 1/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	10.7% 3/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
Skin and subcutaneous tissue disorders Psoriasis	6.8% 3/44 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.	0.00% 0/28 • Up to Week 264 The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.