Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).

ST2, a serum biomarker, was collected at Week 6. Endoscopic Mayo subscore is one of 4 components that comprise the total Mayo Score, a scale for assessing ulcerative colitis (UC) activity. Endoscopic Mayo subscore ranges from 0-3: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). A higher score indicates more severe disease. Moderate correlation was defined as a Spearman correlation (rs) coefficient between -0.5 to -0.3 or 0.3 to 0.5.

Time frame: Week 6

Population: Analysis population includes all participants who had received study medication, had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 6 endoscopic Mayo subscore.

ST2, a serum biomarker, was collected at Week 6. Geboes index, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.

Time frame: Week 6

Population: Analysis population includes all participants who had received study medication, had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 6 Geboes index score.

ST2, a serum biomarker, was collected at Week 6. ST2 levels were used to determine whether or not there is a correlation with endoscopic or histologic activity, or a clinical response to treatment in participants with moderate to severe Ulcerative Colitis.

Time frame: Week 6

Population: Participants with available Week 6 ST2 data.

ST2, a serum biomarker, was collected at Baseline and Week 6. Comparison of participants who achieved endoscopic response \[endoscopic Mayo subscore 0 or 1\] at Week 6 and maintained response through Week 16 versus participants who did not maintain response throughout Week 16, regarding serum soluble ST2 at baseline, Week 6 and change between baseline and Week 6.

Time frame: Baseline, Week 6

Population: Analysis population includes all participants who had received study medication and achieved endoscopic response at Week 6.

ST2, a serum biomarker, was collected at Baseline and Week 6. Active Ulcerative Colitis was defined as an endoscopic Mayo subscore ≥2 and inactive Ulcerative Colitis was defined as an endoscopic Mayo subscore of 0 or 1.

Time frame: Baseline, Week 6

Population: Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity at Week 6.

UCEIS© is a 3-item (vascular pattern, bleeding and erosion/ulceration) validated tool for assessing endoscopic severity of UC. Each item has 3 or 4 levels of severity and is given a score. The scores for each individual item are combined into a total score ranging from 1 to 11. A higher score indicates increased endoscopic severity of UC. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.

Time frame: Week 6 and Week 16

Population: Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and UCEIS overall score at Week 6 and Week 16.

ST2, a serum biomarker, was collected at Week 6 and Week 16. The total Mayo Score, is a scale for assessing UC activity and is the sum of 4 subscores (assessment of stool frequency \[0-3\], rectal bleeding \[0-3\], Physician's Global Assessment \[0-3\], and endoscopic Mayo subscore \[0-3\]) and has values that range from 0 to 12. Clinical remission: ≤2 points with no individual subscore \> 1; Mildly active disease: 3-5 points; Moderately active disease: 6-10 points; Severely active disease: 11-12 points. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.

Time frame: Weeks 6 and 16

Population: Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and total Mayo score at Weeks 6 and 16.

ST2, a serum biomarker, was collected at Week 16. Endoscopic Mayo subscore is one of 4 components that comprise the total Mayo Score, a scale for assessing ulcerative colitis (UC) activity. Endoscopic Mayo subscore ranges from 0-3: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.

Time frame: Week 16

Population: Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 16 endoscopic Mayo subscore.

ST2 and faecal calprotectin, serum biomarkers, were collected at Week 6 and Week 16. Faecal calprotectin is a surrogate marker for the presence of intestinal inflammation and response to treatment in participants with Inflammatory Bowel Disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.

Time frame: Baseline, Weeks 6 and 16

Population: Analysis population includes all participants who had received study medication and had a valid faecal calprotectin assessment at time point (Baseline, Week 6, and Week 16).

ST2, a serum biomarker, was collected at Week 16. Geboes index, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.

Time frame: Week 16

Population: Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 16 Geboes index score.

ST2, a serum biomarker, was collected at Week 16. ST2 levels were used to determine whether or not there is a correlation with endoscopic or histologic activity, or a clinical response to treatment in participants with moderate to severe Ulcerative Colitis.

Time frame: Week 16

Population: Participants with available Week 16 ST2 data.