INSIGHT-IBD Pragmatic Study

활성 비교기: Mirikizumab Clinical Care Pathway

Participants receive mirikizumab as part of the IBD Clinical Care Pathway in routine clinical practice. Dosing and administration follow the approved prescribing information for ulcerative colitis or Crohn's disease, with treatment and monitoring per standard of care.

의약품: Mirikizumab

Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.

활성 비교기: Standard Biologic Therapy Clinical Care Pathway

Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice. Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.

의약품: Anti-TNF agents

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

의약품: anti-integrin antibodies

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

의약품: IL-12

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

의약품: IL-23

Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Proportion of Patients Requiring an Increase in IBD Disease Management

The proportion of patients requiring an increase in inflammatory bowel disease (IBD) disease management, defined as a composite of treatment and healthcare resource use, while receiving index therapy.

Change in Disease Activity Measured by Crohn's Disease PRO2 Scores

Change from baseline in disease activity assessed using validated patient-reported outcome measures:

Crohn's Disease Patient-Reported Outcome 2 (CD PRO2), composed of:

Abdominal pain score (range 0-3) Stool frequency (number of bowel movements per day; higher values indicate worse disease activity)

Changes in PRO2 component scores and composite disease activity will be evaluated over time, with decreases from baseline indicating improvement in disease activity.

Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores

Change from baseline in disease activity assessed using validated patient-reported outcome measures:

Ulcerative Colitis Patient-Reported Outcome 2 (UC PRO2), composed of:

Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Total possible combined score range: 0-6, with higher scores indicating worse disease activity

Changes in PRO2 component scores and composite disease activity will be evaluated over time, with decreases from baseline indicating improvement in disease activity.

Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD)

Proportion of participants achieving endoscopic remission assessed using validated endoscopic scoring system:

Simple Endoscopic Score for Crohn's Disease (SES-CD) (range 0-56), where lower scores indicate less endoscopic disease activity and endoscopic remission is defined as a score ≤2

Endoscopic findings are collected as part of routine clinical care, when available.

Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score.

Proportion of participants achieving endoscopic remission assessed using validated endoscopic scoring systems:

Modified Baron Score (ulcerative colitis) (range 0-4), where lower scores indicate less mucosal inflammation and endoscopic remission is defined as a score of 0 (normal mucosa with no visible inflammation)

Endoscopic findings are collected as part of routine clinical care, when available.

Treatment Persistence

Duration of time from treatment initiation to discontinuation of index therapy for any reason, including continued use at pre-specified timepoints.

Proportion of Patients with Dose Escalation

Proportion of patients who discontinue index therapy and/or initiate a subsequent IBD therapy during the study period.

Time to Next Treatment

Time from initiation of index therapy to initiation of a subsequent therapy or discontinuation of index therapy.

Concomitant Medication Use

Proportion of patients receiving concomitant corticosteroids, immunomodulators, or aminosalicylates at baseline and during follow-up, including initiation and discontinuation patterns.

Corticosteroid-Free Time

Duration of time patients remain free from corticosteroid use while receiving index therapy.

Healthcare Resource Utilization

Frequency and rate of IBD-related healthcare utilization

Change in Patient-Reported Outcomes Measured by SIBDQ

Change from baseline in patient-reported outcomes assessed using validated instrument:

Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (range 10-70), where higher scores indicate better health-related quality of life

Changes in scores over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.

Change in Patient-Reported Outcomes Measured by UNRS

Change from baseline in patient-reported outcomes assessed using validated instrument:

Bowel Urgency Numeric Rating Scale (UNRS) (range 0-10), where higher scores indicate worse bowel urgency

Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.

Change in Patient-Reported Outcomes Measured by PROMIS Global Health

Change from baseline in patient-reported outcomes assessed using validated instrument:

PROMIS Global Health (PROMIS-GH) (T-score standardized, mean 50), where higher scores indicate better overall health status

Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.

Change in Patient-Reported Outcomes Measured by SAA

Change from baseline in patient-reported outcomes assessed using validated instrument:

Sexual Activity Avoidance (SAA), where higher scores indicate greater avoidance of sexual activity

Changes in scores over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.

Change in Patient-Reported Outcomes Measured by WPAI:SHP

Change from baseline in patient-reported outcomes assessed using validated instrumens:

Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) (0-100%), where higher percentages indicate greater impairment

Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes.

Proportion of Participants Achieving Clinical Remission Based on Ulcerative Colitis PRO2.

Proportion of participants achieving clinical remission based on validated patient-reported outcome measures:

Ulcerative Colitis Patient-Reported Outcome 2 (UC PRO2), composed of:

Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Lower scores indicate less disease activity; clinical remission is defined as rectal bleeding score = 0 and stool frequency score ≤1

These thresholds represent minimal or no symptoms consistent with clinical remission.

Proportion of Participants Achieving Clinical Remission Based on Crohn's Disease PRO2.

Proportion of participants achieving clinical remission based on validated patient-reported outcome measures: Crohn's Disease Patient-Reported Outcome 2 (UC PRO2), composed of: Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Lower scores indicate less disease activity; clinical remission is defined as rectal bleeding score = 0 and stool frequency score ≤1 These thresholds represent minimal or no symptoms consistent with clinical remission.