A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) total score \< (less than) 150. The CDAI measures the severity of active disease using 8 disease variables: stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations, presence or absence of fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight. Each variable is assigned a specific weight/multiplier, and the weighted values are summed to produce a CDAI total score. CDAI total scores can range from 0 to 600, with higher scores indicating more severe disease.

Time frame: Week 52

Population: All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

Time frame: Week 52

Population: All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item participant completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Responses are graded on a 7-point Likert scale in which 7 denotes not a problem at all and 1 denotes a very severe problem. IBDQ total score is calculated as the sum of all questions. Total scores range from 32 to 224; a higher score indicates a better quality of life.

Time frame: Baseline, Week 52

Population: All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

C-Reactive Protein is a biomarker of systemic inflammation measured in the blood, with elevated levels indicating increased inflammatory activity in the body.

Time frame: Week 12

Population: All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study, and had evaluable C-Reactive Protein data.

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

Time frame: Week 12

Population: All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study, and had evaluable fecal calprotectin data.

Alternate endoscopic remission is defined as SES-CD Total Score ≤4 with at least a 2-point reduction from the AMAM study baseline and no subscore \>1. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore \>1 is defined as no individual assessment score \>1 across all 20 individual assessments.

Time frame: Week 52

Population: All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

Clinical response by Patient Reported Outcome (PRO) was defined as a ≥30% decrease from baseline in stool frequency (SF) and/or abdominal pain (AP) score, with neither symptom worsening from baseline. SF was measured as the number of liquid or very soft stools per day. AP was scored daily on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.

Time frame: Week 52

Population: All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.