The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice. The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States. The main questions it aims to answer are: * Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)? * Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy? * Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization. Participants will: * Receive either mirikizumab or standard biologic therapy as part of routine clinical care * Attend follow-up visits at approximately 3, 6, 12, and 18 months * Have clinical data collected from electronic health records and healthcare utilization sources * Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning * Undergo routine laboratory tests and clinical assessments as part of standard care
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
400
Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Arizona Digestive Health
Sun City, Arizona, United States
GI Alliance of Illinois
Glenview, Illinois, United States
Lake Shore Gastro-Gurnee Research
Gurnee, Illinois, United States
Gastroenterology Group of Rochester
Rochester, New York, United States
Texas Digestive Disease Consultants
Cedar Park, Texas, United States
Texas Digestive Disease Consultants
Fort Worth, Texas, United States
Digestive Health Associates
Houston, Texas, United States
Texas Digestive Disease Consultants: Plano
Plano, Texas, United States
Texas Digestive Disease Consultants: San Antonio
San Antonio, Texas, United States
GI Alliance Richmond
Richmond, Virginia, United States
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.
Time frame: Up to 18 months following initiation of 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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
Time frame: Up to 18 months (as available from routine clinical care)
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.
Time frame: Up to 18 months (as available from routine clinical care)
Treatment Persistence
Duration of time from treatment initiation to discontinuation of index therapy for any reason, including continued use at pre-specified timepoints.
Time frame: Up to 18 months
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 frame: Up to 18 months
Time to Next Treatment
Time from initiation of index therapy to initiation of a subsequent therapy or discontinuation of index therapy.
Time frame: Up to 18 months
Concomitant Medication Use
Proportion of patients receiving concomitant corticosteroids, immunomodulators, or aminosalicylates at baseline and during follow-up, including initiation and discontinuation patterns.
Time frame: Baseline through 18 months
Corticosteroid-Free Time
Duration of time patients remain free from corticosteroid use while receiving index therapy.
Time frame: Up to 18 months
Healthcare Resource Utilization
Frequency and rate of IBD-related healthcare utilization
Time frame: Up to 18 months
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
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