The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.
This study is a secondary analysis using data from participants in the IBD Partners and SPARC-IBD cohorts. Data received from IBD Partners consists of patient-reported outcomes gathered via online surveys (baseline and 6-month follow-ups). Data received from SPARC-IBD consists of patient-reported outcomes gathered via surveys (baseline and follow-ups) as well as data from clinical records.
Study Type
OBSERVATIONAL
Enrollment
465
Crohn's & Colitis Foundation
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
PROMIS Measures of Pain Interference
NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health).
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
PROMIS Measures of Fatigue
NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue (poorer health).
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Number of Participants With Index Medication Persistence
Medication persistence was defined as continuing index medication.
Time frame: 4-10 months after medication initiation
Number of Participants Using Corticosteroids at Follow-Up
Participants who reported using corticosteroids.
Time frame: 4-10 months after medication initiation
Short Crohn's Disease Activity Index (sCDAI)
Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patients' symptoms using only a questionnaire, which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, stool frequency, and general well-being reported as a total score. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI with scores ranging from 0 to 600, such that scores,\<150 define remission, 150 to 219 mild activity, 220 to 450 moderate activity, and greater than 450 severe activity.
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Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Mayo Clinic Score
The Mayo Clinic Score (MCS) asks 2 questions about (1) stool frequency and (2) rectal bleeding with an overall score range (0-6). Higher scores reflect more disease symptomatology.
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
PROMIS Social Satisfaction Score
NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of social satisfaction. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score for social satisfaction indicates better health.
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)