Trial Outcomes & Findings for A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice (NCT NCT02499263)

NCT ID: NCT02499263

Last Updated: 2019-11-01

Results Overview

Durable clinical response was defined as reduction in complete Full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Week 8 and 56. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

• Recruitment status: COMPLETED
• Target enrollment: 150 participants
• Primary outcome timeframe: Week 56
• Results posted on: 2019-11-01

Participant Flow

There were 150 participants enrolled; 4 were not treated and hence 146 were included in the intent to treat (ITT) set.

Participant milestones

Measure	Adalimumab Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Overall Study STARTED	146
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	62

Reasons for withdrawal

Measure	Adalimumab Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Overall Study Lost to Follow-up	9
Overall Study Participant's withdrawal of consent	4
Overall Study Lack of Efficacy	22
Overall Study investigator's judgment	12
Overall Study Adverse Events/Serious Adverse Events	11
Overall Study Participant's decision	3
Overall Study Pregnancy	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Age, Continuous	44.96 years STANDARD_DEVIATION 14.91 • n=146 Participants
Sex: Female, Male Female	50 Participants n=146 Participants
Sex: Female, Male Male	96 Participants n=146 Participants

PRIMARY outcome

Timeframe: Week 56

Population: ITT set: all participants that were intended to be treated with adalimumab. At Week 8, all participants who had received adalimumab treatment at least once were included and at Week 56, all participants who had clinical response at Week 8 were included. A participant was a Week 8 responder if they had a clinical response at Week 8.

Durable clinical response was defined as reduction in complete Full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Week 8 and 56. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=76 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56	53.95 percentage of participants Interval 42.13 to 65.45

PRIMARY outcome

Timeframe: Week 8

Population: ITT set: all participants that were intended to be treated with adalimumab. At Week 8, all participants who had received adalimumab treatment at least once were included and at Week 56, all participants who had clinical response at Week 8 were included.

Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Clinical Response at Week 8	52.05 percentage of participants Interval 43.64 to 60.38

PRIMARY outcome

Timeframe: Week 24

Population: ITT set

Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 24. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Clinical Response at Week 24	54.11 percentage of participants Interval 45.67 to 62.38

PRIMARY outcome

Timeframe: Week 56

Population: ITT set

Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Clinical Response at Week 56	37.67 percentage of participants Interval 29.79 to 46.06

SECONDARY outcome

Timeframe: Week 8

Population: ITT set

Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Clinical Remission at Week 8	23.97 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: ITT set

Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Clinical Remission at Week 56	21.92 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.

Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8	23.97 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.

Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=76 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56	35.53 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT set

Steroid free remission was defined as participants who were in remission without the use of systemic steroids from Visit 1 (Baseline) prior to assessment.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Steroid-free Remission at Week 8	12.33 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: ITT set

Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Steroid-free Remission at Week 56	21.23 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.

Steroid-free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 8	12.33 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.

Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=76 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56	34.21 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT set.

Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Steroid-free Response at Week 8	30.82 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: ITT set.

Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Steroid-free Response at Week 56	36.30 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.

Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment (in Week 8 clinical responders).Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8	30.82 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.

Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 12 weeks prior to assessment (in Week 8 clinical responders). A participant was a Week 8 responder if they had a clinical response at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=76 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56	51.32 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT set

Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at week 8. Endoscopic findings were scored on a scale from 0 to 3 as follows:

0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Mucosal Healing at Week 8	39.04 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: ITT set

Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 as follows:

0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants With Mucosal Healing at Week 56	30.14 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.

Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 8. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease). Negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8	39.04 percentage of participants

SECONDARY outcome

Timeframe: Week 56

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.

Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease). Negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=76 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56	46.05 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: ITT set of participants who were clinical responders at Week 56

The partial Mayo score is based on the Mayo score, which is a tool designed to measure disease activity for ulcerative colitis.

The partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in partial Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=55 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56	1.89 score on a scale Standard Deviation 1.61

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: ITT set of participants who were clinical responders at Week 56 with evaluable data for this Outcome Measure.

Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=46 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56	3.17 score on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline, Week 56

Population: ITT set of participants who were clinical responders at Week 56

Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=55 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders at Week 56	2.38 score on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: Week 8

Population: ITT set.

Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Fecal Calprotectin Level at Week 8	456.89 mg/kg Standard Deviation 480.65

SECONDARY outcome

Timeframe: Week 56

Population: ITT set.

Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.

Outcome measures

Measure	Adalimumab n=146 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Fecal Calprotectin Level at Week 56	380.17 mg/kg Standard Deviation 466.93

SECONDARY outcome

Timeframe: Week 8

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome.

Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.

Outcome measures

Measure	Adalimumab n=67 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8	336.33 mg/kg Standard Deviation 450.33

SECONDARY outcome

Timeframe: Week 56

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome.

Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.

Outcome measures

Measure	Adalimumab n=36 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8	281.87 mg/kg Standard Deviation 375.15

SECONDARY outcome

Timeframe: Week 8

Population: ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome

Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=50 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 56	464.58 mg/kg Standard Deviation 511.81

SECONDARY outcome

Timeframe: Week 56

Population: ITT set of participants who were clinical responders at Week 56 and had evaluable data for this outcome

Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Measure	Adalimumab n=38 Participants Adalimumab 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56	415.40 mg/kg Standard Deviation 490.94

SECONDARY outcome

Timeframe: Week 0, Week 8, Week 56

Population: This endpoint was not completed due to lack of data collection.

Composition of fecal microbiota (16S ribosomal ribonucleic acid (rRNA) gene sequencing) was measured at Week 0, Week 8, and Week 56. Fecal bacterial composition was determined using 16S sequencing. The obtained sequences were analyzed using the Ezbiocloud database and 16S microbiome pipeline to assess composition and diversity.

Outcome measures

Outcome data not reported

Adverse Events

Adalimumab

Serious events: 9 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab n=146 participants at risk Adalimumab administered at 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Gastrointestinal disorders Colitis ulcerative	2.1% 3/146 • Number of events 3 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
Gastrointestinal disorders Abdominal pain	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
Infections and infestations Pneumonia	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
Infections and infestations Pulmonary tuberculosis	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
Injury, poisoning and procedural complications Femur fracture	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
Renal and urinary disorders Renal failure	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.

Other adverse events

Measure	Adalimumab n=146 participants at risk Adalimumab administered at 160 mg at week 0, 80 mg at week 2, and then 40 mg every other week per the Korean label.
Gastrointestinal disorders Haematochezia	1.4% 2/146 • Number of events 2 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
Infections and infestations Cytomegalovirus infection	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
General disorders Injection site reaction	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.
Skin and subcutaneous tissue disorders Swelling face	0.68% 1/146 • Number of events 1 • Safety data were collected from the time of the participant's registration into the study until 70 days after study completion. Serious adverse events (SAEs) were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 70 days following the intake of the last dose of adalimumab taken during the study. As per the study protocol, all SAEs and adverse events (AEs) leading to adalimumab discontinuation were actively solicited. Any non-serious AEs were collected as spontaneous reports if AbbVie was notified. All SAEs and AEs leading to adalimumab discontinuation during this study period were reported to AbbVie regardless of their causal relationship to adalimumab.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER