A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

As per global definition, clinical remission is defined as a Mayo score less than or equal to (\<=)2 points, with no individual subscore greater than (\>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding \[RB\], endoscopy findings, and physician's global assessment \[PGA\]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant ulcerative colitis (UC) medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: The primary efficacy analysis set (PEAS) consisted of all participants randomized in the induction study.

As per US definition, clinical remission was defined as absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components pertaining to this outcome measure (OM) (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

As per global definition, clinical remission was defined as a Mayo score \<=2 points, with no individual subscore \>1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in UC medication or an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC every 8 weeks (q8w), ustekinumab 90 mg SC every 12 weeks (q12w), or placebo SC.

Per US definition, clinical remission: absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]), without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components pertaining to this OM (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, physical component summary (PCS: calculated from subscales physical functioning, role-physical, bodily pain, and general health) and mental component summary (MCS: calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing component summary score at Week 8 had their last value carried forward.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Change from baseline in CRP concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.

Time frame: Baseline through Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.

The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.

Change from baseline in fecal calprotectin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.

Time frame: Baseline through Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

Change from baseline in fecal lactoferrin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.

Time frame: Baseline through Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward and participants who had missing IBDQ dimension score at designated analysis timepoint had their last value carried forward.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing individual scale at a designated analysis timepoint had their last value carried forward.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline Mayo score carried forward to Week 8 or who had all 4 Mayo subscores missing at Week 8 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 \[normal\] to 3 \[severe\]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants with the partial Mayo score missing at a timepoint had their last available individual partial Mayo subscore carried forward to that timepoint.

Time frame: Baseline through Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure.

The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of event onward or participants who had missing IBDQ score at Week 8 had their last value carried forward.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure (OM).

As per global definition, clinical remission is defined as Mayo score \<=2 points, with no individual subscore \>1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had missing rectal bleeding subscores at Week 8 were considered not to be in clinical remission with a rectal bleeding subscore of 0. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 and/or both stool frequency and rectal bleeding subscores missing at Week 8 were considered not to be in symptomatic remission.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have normal or inactive mucosal disease. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing IBDQ score at either baseline or Week 8 were considered not to have achieved a greater than 20-point improvement.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Global definition of clinical remission: Mayo score\<=2 points, with no individual subscore \>1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score = sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores indicate worsening of disease. BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists and/or vedolizumab at dose approved for treatment of UC and did not respond initially or responded initially but lost response or were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: The primary efficacy analysis set consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

US definition of clinical remission: absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of (normal/ inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]), without PGA. Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores rated 0 (normal) to 3 (severe). BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, Mayo endoscopy subscore) at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review used endoscopy video.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Clinical response was defined as a decrease from induction baseline in the Mayo score by \>=30 percent (%) and \>= 3 points, with either a decrease from baseline in the rectal bleeding subscore \>=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Clinical response: decrease from induction baseline in Mayo score by \>=30% and \>= 3 points, with either decrease from baseline in rectal bleeding subscore \>=1/ rectal bleeding subscore= 0/1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores =worsening of disease. BF: participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

Number of participants with endoscopic healing at week 8 by BF status were reported. Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). BF: Participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response/ were intolerant of medication. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo endoscopy subscore at Week 8 had the last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study.

The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo physician's global assessment subscore at the designated analysis timepoint had the last available value for that subscore carried forward.

Time frame: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study.

The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 = blood alone passed. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo rectal bleeding subscore at the designated analysis timepoint had the last available value for that subscore carried forward.

Time frame: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study.

The stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo stool frequency subscore at the designated analysis timepoint had the last available value for that subscore carried forward.

Time frame: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.

Mucosal healing is defined as having both endoscopic healing (EH) and histologic healing (HH). Endoscopic healing: an endoscopy subscore of 0 (normal or inactive disease) or 1 mild disease (\[erythema, decreased vascular pattern, mild friability\]). Histologic healing: neutrophil infiltration in \<5% of crypts, no crypt destruction, and no erosions or ulcerations or granulation tissue. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or had missing endoscopy score/ were missing any component of histologic healing (that is assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 8 or who had unevaluable biopsy (that is biopsy collected, but could not be assessed due to sample preparation or technical errors) at Week 8 but who did not achieve endoscopic healing, were considered not to have mucosal healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 8

Population: PEAS consisted of all participants randomized in the induction study, with participants whose mucosal healing status was determined at Week 8.

Number of participants with normalized CRP (\<=3 mg/L) up to Week 8 among participants with abnormal CRP (\>3 mg/L) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing CRP value at the designated analysis timepoint were considered not to have normalized CRP.

Time frame: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study, with those participants who were having abnormal CRP at baseline.

Number of participants with normalized fecal calprotectin (\<=250 milligram per kilogram \[mg/kg) up to Week 8 among participants with abnormal fecal calprotectin (\>250 mg/kg) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal calprotectin value at the designated analysis timepoint were considered not to have normalized fecal calprotectin.

Time frame: Up to Week 8

Population: PEAS consisted of all randomized participants in the induction study, with abnormal fecal calprotectin (\>250 mg/kg) at baseline.

Number of participants with normalized fecal lactoferrin (\<=7.24 mcg/g) up to Week 8 among participants with abnormal fecal lactoferrin (\> 7.24 mcg/g) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal lactoferrin value at the designated analysis timepoint were considered not to have normalized fecal lactoferrin.

Time frame: Up to Week 8

Population: PEAS consisted of all participants randomized in the induction study, with those participants who had abnormal fecal lactoferrin at baseline.

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.

Time frame: Baseline and Week 8

Population: PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total Mayo score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Induction Baseline and Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 \[normal\] to 3 \[severe\]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.

Time frame: Baseline through Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, PCS (calculated from subscales physical functioning, role-physical, bodily pain, and general health) and MCS (calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had Week 0 value of IS carried forward from time of event onward and participants with missing component summary score at timepoint had last available value carried forward.

Time frame: Baseline, Weeks 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

Change from Maintenance baseline in CRP concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.

Time frame: Baseline, Weeks 8, 24, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing individual scale score at a timepoint had their last available value carried forward.

Time frame: Baseline, Weeks 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing VAS score at a timepoint had their last available value carried forward.

Time frame: Baseline, Weeks 20 and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

Change from Maintenance baseline in fecal calprotectin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.

Time frame: Baseline, Weeks 8, 24, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Change from Maintenance baseline in fecal lactoferrin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.

Time frame: Baseline, Weeks 8, 24, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had Week 0 value of induction study carried forward from time of event onward and participants with missing individual scale score at timepoint had last available value carried forward.

Time frame: Baseline, Weeks 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy , or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to Week 44 had their Week 0 value of the induction study carried forward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Baseline and Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores), rated as 0 (normal) to 3 (severe). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.

Time frame: Baseline through Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and participants who had missing IBDQ dimension score at a timepoint had their last available value carried forward.

Time frame: Baseline, Week 20, and 44

Population: PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM for specified categories at specified timepoint.

IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing IBDQ score at a timepoint had their last value carried forward.

Time frame: Baseline, Week 20, and 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 and who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 were considered not to be in symptomatic remission from the time of the event onward. Participants who had both stool frequency and rectal bleeding subscores missing at Week 44 were considered not to be in symptomatic remission for that visit. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Number of participants not receiving concomitant corticosteroids at Week 44 among participants who received concomitant corticosteroids at maintenance Baseline were reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 considered to be receiving concomitant corticosteroids at Week 44. Participants who had a missing value in corticosteroid use at Week 44 had their last value carried forward.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, participants who were receiving concomitant corticosteroids at maintenance baseline.

IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as:10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had missing IBDQ score were considered not to have maintained improvement in IBDQ.

Time frame: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants with \>20-point Improvement in IBDQ at the maintenance baseline.

Per global definition, clinical remission was defined as Mayo score \<=2 points, with no individual subscore \>1. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to have achieved OM of clinical remission and not receiving corticosteroids at Week 44. Participants who had missing value in corticosteroid use at Week 44 had their last value carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w/ placebo SC.

US definition of clinical remission: absolute stool number \<=3, rectal bleeding subscore 0 (no blood seen), Mayo endoscopy subscore of 0(normal or inactive disease)/ 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in corticosteroid-free clinical remission at Week 44. Participants with missing value in corticosteroid use at Week 44 had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Global definition of clinical remission: Mayo score \<=2 points, with no individual subscore \>1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated 0(normal) to 3(severe). Total score=sum of 4 subscores, range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/AE of worsening of UC before Week 44 considered not to achieved OM of clinical remission and not receiving concomitant corticosteroids (corticosteroid-free clinical remission). Participants with all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Participants missing value in corticosteroid use had their last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, participants who were receiving concomitant corticosteroids at maintenance baseline.

US definition of clinical remission: absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and Mayo endoscopy subscore of 0(normal/ inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]), without PGA. Absolute stool number is average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated as 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and endoscopy subscore) at Week 44 were considered not in clinical remission. Participants with missing value in corticosteroid use had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were receiving concomitant corticosteroids at maintenance baseline.

Global definition of clinical remission: Mayo score \<=2 points, with no individual subscore \>1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.

US definition of clinical remission: absolute stool number \<=3, Mayo rectal bleeding subscore: 0 (no blood seen), Mayo endoscopy subscore: 0(normal/ inactive disease) or 1(mild disease \[erythema, decreased vascular pattern, mild friability\]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0(normal) to 3(severe). BF: participants received 1/ more TNF antagonists/ vedolizumab for treatment of UC, not responded initially/ responded initially but lost response/ were intolerant of medicines. Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect /due to AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components (absolute stool number, rectal bleeding and endoscopy) at Week 44 were not in clinical remission. Endoscopy subscore assessed during central review used video of endoscopy.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.

Global definition of clinical remission: Mayo score \<=2 points, with no individual subscore \>1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Participants who were not in clinical remission at any time points when endoscopic scores were collected before Week 44 were considered not to be in clinical remission up to Week 44. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.

US definition of clinical remission: absolute stool number \<=3, Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in clinical remission. Participants not in clinical remission at any time point when endoscopic scores collected before Week 44 considered not in clinical remission up to Week 44. Endoscopy subscore assessed during central review of video of endoscopy was used.

Time frame: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.

Clinical response: decrease from induction baseline in Mayo score by \>= 30% and \>= 3 points, with either decrease from induction baseline in rectal bleeding subscore \>=1 or rectal bleeding subscore of 0 or 1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5= mild; 6 to 10= moderate; 11 to 12= severe; higher scores indicate worsening of disease. Participants who lost clinical response at any time before Week 44, had prohibited change in UC medication, ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Clinical response: decrease from IS baseline in Mayo score by \>=30% and \>=3 points, with either decrease from baseline in RB subscore \>=1/ RB subscore of 0/ 1. Mayo score have 4 subscores (SF, RB, endoscopy findings, PGA), rated 0(normal) to 3(severe). Total score=sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment: 1/ more TNF antagonists/ vedolizumab for treating UC, no respond initially/responded initially but lost response/ medication intolerant. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsen UC before Week 44, had all 4 Mayo subscores miss at Week44/ lost clinical response at any time before Week44 were not in clinical response upto Week44. Endoscopy subscore assessed during central review used endoscopy video.

Time frame: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It was defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Participants who had prohibited change in UC medication, an ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who had achieved endoscopic healing at maintenance baseline.

Number of participants with endoscopic healing at week 44 by BF status were reported. Endoscopic healing is improvement in endoscopic appearance of mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]). BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response, or were intolerant of medication. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy, or used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 =normal/ inactive disease, 1 =mild disease (erythema, decreased vascular pattern, mild friability), 2 =moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 =severe disease (spontaneous bleeding, ulceration). Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had Week 0 value of induction study carried forward from time of event onward and who had missing endoscopy subscores at timepoint had last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.

Time frame: Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.

Time frame: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool \<half time, 2 = obvious blood with stool most of time, and 3 = blood alone passed. Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing Mayo subscores at timepoint had last available value for that subscore carried forward.

Time frame: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.

Time frame: Up to Week 44

Population: PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.