TABLE 2.
Demographics and Clinical Characteristics Among RCT Participants and Non-RCT Participants Enrolled in IBD Partners
| RCT Participants | Non-RCT Participants | P | |
|---|---|---|---|
| Total patients, n (%) | 1119 (7.6%) | 13,628 (92.4%) | |
| Female (%) | 71.1% | 71.9% | 0.575 |
| Disease classification (% CDa) | 72.9% | 63.5% | <0.001 |
| Ageb, mean (SD) | 45.5 (14.1) | 42.2 (14.8) | <0.001 |
| 18–35 | 27.7% | 39.2% | |
| 36–74 | 70.7% | 59.6% | |
| 75+ | 1.3% | 1.1% | |
| Race (%) | 0.647 | ||
| Black/African American | 1.9% | 2.3% | |
| White/Caucasian | 89.4% | 88.7% | |
| Other/missing | 8.8% | 9.0% | |
| Hispanic/Latino ethnicity (%) | 2.3% | 3.1% | 0.143 |
| College education (%)c | 89.7% | 88.6% | 0.037 |
| University/academic practice (%) | 22.7% | 14.5% | <0.001 |
| Medical history | |||
| Total hospitalizations, mean (SD) | 4.3 (2.1) | 3.3 (1.9) | <0.001 |
| IBD-related hospitalization (%) | 81.3% | 63.0% | <0.001 |
| IBD-related surgery (%) | 58.6% | 35.9% | <0.001 |
| IBD medication history | |||
| Steroid exposure (%) | 97.2% | 90.1% | <0.001 |
| 5-ASA exposure (%) | 96.1% | 89.4% | <0.001 |
| Anti-TNF exposure (%) | 75.3% | 49.5% | <0.001 |
| Vedolizumab exposure (%) | 36.6% | 7.6% | <0.001 |
| Ustekinumab exposure (%) | 25.6% | 5.8% | <0.001 |
| Natalizumab exposure (%) | 14.0% | 0.8% | <0.001 |
| “Poor” or worse in Well-Beingd (%) | 26.1% | 17.4% | <0.001 |
| PROMISeT-score, mean (SD) | |||
| Anxiety | 54.3 (9.7) | 54 (9.7) | 0.285 |
| Depression | 52.8 (9.6) | 51.9 (9.6) | 0.007 |
| Fatigue | 58.1 (10.5) | 55.8 (11.0) | <0.001 |
| Pain inteference | 55.6 (10.7) | 53.7 (10.3) | <0.001 |
| Social satisfaction | 46.3 (10.1) | 47.9 (9.9) | <0.001 |
| Disease activity | |||
| Disease duration (years), mean (SD) | 19.7 (12.5) | 13.2 (12.11) | <0.001 |
| sCDAI score, mean (SD)f | 187.0 (113.9) | 153.6 (103.2) | <0.001 |
| SCCAI score, mean (SD)g | 4.4 (3.2) | 3.8 (3.0) | 0.002 |
| Steroid-free remission (%)h | 34.5% | 46.4% | <0.001 |
aCD, Crohn’s disease.
bFor RCT participants, age at first participation in a clinical trial; for non-RCT participants, age at first completed survey in IBD Partners.
cDefined as “some college” or more.
dResponse to the General Well-Being questionnaire on IBD Partners.
ePROMIS, Patient-reported outcome measurement information system measured in T-scores, with mean 50 and SD 10 in the general population. Higher scores signal more of the domain measured.
fsCDAI (short Crohn’s Disease Activity Index) assesses abdominal pain, stool patterns, and overall well-being, with increasing values indicating worse disease. Remission is defined by less than 150 points on a scale from 0 to 450.
gSCCAI (Simple Clinical Colitis Activity Index) assesses bowel frequency, urgency, hematochezia, general health, and extracolonic manifestations, with increasing values indicating worse disease. Remission is defined by ≤2 points on a scale from 0 to 19.
hDefined as no use of steroids and either sCDAI <150 or SCCAI ≤2.