Crohn's Disease, Ulcerative Colitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Patient-Centered Outcomes Research Institute
Crohn's and Colitis Foundation
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age greater than or equal to 18; * diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort); * initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.
Exclusion criteria
* less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Measures of Pain Interference | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) | 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). |
| PROMIS Measures of Fatigue | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Crohn's Disease Activity Index (sCDAI) | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) | 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. |
| Number of Participants With Index Medication Persistence | 4-10 months after medication initiation | Medication persistence was defined as continuing index medication. |
| PROMIS Social Satisfaction Score | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) | 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. |
| Mayo Clinic Score | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) | 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. |
| Number of Participants Using Corticosteroids at Follow-Up | 4-10 months after medication initiation | Participants who reported using corticosteroids. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crohn's Disease (Vedolizumab) Participants with Crohn's disease (CD) who reported taking vedolizumab. | 141 |
| Crohn's Disease (Ustekinumab) Participants with Crohn's disease (CD) who reported taking ustekinumab. | 219 |
| Ulcerative Colitis (Vedolizumab) Participants with Ulcerative colitis (UC) who reported taking vedolizumab. | 72 |
| Ulcerative Colitis (Tofacitinib) Participants with Ulcerative colitis (UC) who reported taking tofacitinib. | 33 |
| Total | 465 |
Baseline characteristics
| Characteristic | Crohn's Disease (Vedolizumab) | Crohn's Disease (Ustekinumab) | Ulcerative Colitis (Vedolizumab) | Ulcerative Colitis (Tofacitinib) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44 years | 45 years | 42.5 years | 38 years | 42 years |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Other or Unknown | 7 Participants | 21 Participants | 11 Participants | 4 Participants | 43 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 129 Participants | 193 Participants | 57 Participants | 28 Participants | 407 Participants |
| Sex/Gender, Customized Data unavailable | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 6 Participants |
| Sex/Gender, Customized Female | 100 Participants | 167 Participants | 48 Participants | 17 Participants | 332 Participants |
| Sex/Gender, Customized Male | 41 Participants | 52 Participants | 20 Participants | 14 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (Vedolizumab) | PROMIS Measures of Fatigue | 54.7 T-score | Standard Deviation 11.73 |
| Crohn's Disease (Ustekinumab) | PROMIS Measures of Fatigue | 54.4 T-score | Standard Deviation 12.31 |
| Ulcerative Colitis (Vedolizumab) | PROMIS Measures of Fatigue | 52.7 T-score | Standard Deviation 11.8 |
| Ulcerative Colitis (Tofacitinib) | PROMIS Measures of Fatigue | 50.6 T-score | Standard Deviation 9.4 |
p-value: 0.778t-test, 2 sided
p-value: 0.357t-test, 2 sided
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (Vedolizumab) | PROMIS Measures of Pain Interference | 51.2 T-score | Standard Deviation 10.17 |
| Crohn's Disease (Ustekinumab) | PROMIS Measures of Pain Interference | 51.6 T-score | Standard Deviation 9.94 |
| Ulcerative Colitis (Vedolizumab) | PROMIS Measures of Pain Interference | 50.1 T-score | Standard Deviation 10.2 |
| Ulcerative Colitis (Tofacitinib) | PROMIS Measures of Pain Interference | 48.2 T-score | Standard Deviation 9 |
p-value: 0.751t-test, 2 sided
p-value: 0.372t-test, 2 sided
Secondary
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)
Population: This outcome applies only to those participants who have ulcerative colitis. All available data are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ulcerative Colitis (Vedolizumab) | Mayo Clinic Score | 1.7 score on a scale | Standard Deviation 1.8 |
| Ulcerative Colitis (Tofacitinib) | Mayo Clinic Score | 1.2 score on a scale | Standard Deviation 1.5 |
p-value: 0.2t-test, 2 sided
Secondary
Number of Participants Using Corticosteroids at Follow-Up
Participants who reported using corticosteroids.
Time frame: 4-10 months after medication initiation
Population: All available data are reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crohn's Disease (Vedolizumab) | Number of Participants Using Corticosteroids at Follow-Up | 27 Participants |
| Crohn's Disease (Ustekinumab) | Number of Participants Using Corticosteroids at Follow-Up | 28 Participants |
| Ulcerative Colitis (Vedolizumab) | Number of Participants Using Corticosteroids at Follow-Up | 15 Participants |
| Ulcerative Colitis (Tofacitinib) | Number of Participants Using Corticosteroids at Follow-Up | 1 Participants |
p-value: 0.103Chi-squared
p-value: 0.025Chi-squared
Secondary
Number of Participants With Index Medication Persistence
Medication persistence was defined as continuing index medication.
Time frame: 4-10 months after medication initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crohn's Disease (Vedolizumab) | Number of Participants With Index Medication Persistence | 119 Participants |
| Crohn's Disease (Ustekinumab) | Number of Participants With Index Medication Persistence | 203 Participants |
| Ulcerative Colitis (Vedolizumab) | Number of Participants With Index Medication Persistence | 63 Participants |
| Ulcerative Colitis (Tofacitinib) | Number of Participants With Index Medication Persistence | 29 Participants |
p-value: 0.012Chi-squared
p-value: 0.956Chi-squared
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (Vedolizumab) | PROMIS Social Satisfaction Score | 49.1 T-score | Standard Deviation 10.59 |
| Crohn's Disease (Ustekinumab) | PROMIS Social Satisfaction Score | 49.3 T-score | Standard Deviation 10.06 |
| Ulcerative Colitis (Vedolizumab) | PROMIS Social Satisfaction Score | 47.5 T-score | Standard Deviation 11 |
| Ulcerative Colitis (Tofacitinib) | PROMIS Social Satisfaction Score | 50.4 T-score | Standard Deviation 10.6 |
p-value: 0.887t-test, 2 sided
p-value: 0.204t-test, 2 sided
Secondary
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.
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Population: This outcome applies only to those participants who have Crohn's disease.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (Vedolizumab) | Short Crohn's Disease Activity Index (sCDAI) | 147 score on a scale | Standard Deviation 89.6 |
| Crohn's Disease (Ustekinumab) | Short Crohn's Disease Activity Index (sCDAI) | 144 score on a scale | Standard Deviation 85.8 |
p-value: 0.785t-test, 2 sided