An observational study in Colitis, Ulcerative and Crohn Disease, sponsored by Takeda. Completed at 26 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by Takeda · Observational
The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.
This is a retrospective, non-interventional study of participants with CD or UC. The study will review the medical charts of participants who have initiated the first or second line treatment with vedolizumab or another biologic agent (infliximab, adalimumab, or golimumab [UC only]) (index event) during the eligibility period to evaluate the treatment effectiveness, treatment patterns, health care utilization and safety of vedolizumab, and to provide the real-world treatment landscape with anti-TNF alpha therapies.
The study will enroll approximately 400 participants, with 200 participants in each treatment cohort. All participants will be enrolled into two observational groups:
The data for participants will be collected in two main periods:
This multi-center trial will be conducted in Spain and Portugal. The overall time for data collection in the study will be approximately 12 months and the overall duration of the study is approximately 24 months.
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's enrollment of 409 is above the median of 158 across 404 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.
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Participants diagnosed with moderate to severe UC or CD, and have initiated first or second line treatment with vedolizumab and other biologics between January 2017 and the date of site initiation.
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Exclusion Criteria:
Participants diagnosed with UC or CD, who have initiated vedolizumab treatment between January 2017 until date of site initiation from the 25 participating sites will be observed from the date of UC or CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date is defined as the date when vedolizumab treatment was initiated.
Participants diagnosed with UC or CD, who have initiated other biologic treatment (infliximab, adalimumab, or golimumab \[UC only\]) between January 2017 until date of site initiation from the 25 participating sites will be observed from the date of UC or CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date is defined as the date when other biologic treatment was initiated.
Percentage of Participants With One or More Treatment Intensifications for CD Participants
Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.
Time frame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Percentage of Participants With One or More Treatment Intensifications for UC Participants
Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.
Time frame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Number of Participants With Reasons for Treatment Modifications in CD Participants
Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Number of Participants With Reasons for Treatment Modifications in UC Participants
Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Percentage of Participants Who Discontinued Index Therapy for CD Participants
Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Percentage of Participants Who Discontinued Index Therapy for UC Participants
Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation
Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Time to Switching for Vedolizumab Participants
Time to switching was defined as time from index treatment initiation until a participant initiated another biologic treatment (Vedolizumab, infliximab, adalimumab, or golimumab \[UC only\], tofacitinib, certolizumab and ustekinumab). Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Time to Discontinuation for CD Participants
Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Time to Discontinuation for UC Participants
Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Percentage of Participants With Clinical Response at 14 Weeks for CD Participants
Clinical response in CD participants was evaluated using Harvey-Bradshaw index (HBI) scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score less than or equal to (\<=) 4 or reduction of greater than or equal to (\>=) 3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: At 14 weeks post-index (assessment time window 10 to 18 weeks)
Percentage of Participants With Clinical Response at 52 Weeks for CD Participants
Clinical response in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score of \<=4 or reduction of \>=3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: At 52 weeks post-index (assessment time window 46 to 58 weeks)
Percentage of Participants With Clinical Response at 14 Weeks for UC Participants
Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical response was defined as partial mayo score of less than (\<) 4 or reduction of \>= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
Time frame: At 14 weeks post-index (assessment time window 10 to 18 weeks)
Percentage of Participants With Clinical Response at 52 Weeks for UC Participants
Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. The clinical response was defined as partial mayo score of \<4 or reduction of \>= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 46 to 58 weeks)
Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants
Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of \<=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
Time frame: At 14 weeks post-index (assessment time window 10 to 18 weeks)
Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants
Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of \<=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 46 to 58 weeks)
Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants
Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of \<2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
Time frame: At 14 weeks post-index (assessment time window 10 to 18 weeks)
Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants
Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of \<2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 46 to 58 weeks)
Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants
Biochemical remission based on CRP was defined as CRP level of \<5 milligram per liter (mg/L). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside greater than (\>) 0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
Time frame: At 14 weeks post-index (assessment time window >0 to 38 weeks)
Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants
Biochemical remission based on CRP was defined as CRP level of \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants
Biochemical remission based on CRP was defined as CRP level \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
Time frame: At 14 weeks post-index (assessment time window >0 to 38 weeks)
Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants
Biochemical remission based on CRP was defined as CRP level of \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants
Biochemical remission based on FCP was defined as FCP level of \<250 microgram per gram (mcg/g). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
Time frame: At 14 weeks post-index (assessment time window >0 to 38 weeks)
Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants
Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants
Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
Time frame: At 14 weeks post-index (assessment time window >0 to 38 weeks)
Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants
Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants
Endoscopic response for CD participants was evaluated using simple endoscopic index for Crohn's disease (SES-CD) score. SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD score \<=2 or based on physician assessment (for UC and CD both). SES-CD score at index date \>0 relative difference was calculated (100\*\[Index date-52 weeks assessment\]/Index date) and relative difference of \>= 50% was considered response. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
Time frame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants
Endoscopic response in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants
Endoscopic remission for CD participants was evaluated using SES-CD score. The SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD score \<=2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants
Endoscopic remission in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
Time frame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Percentage of Participants With Adverse Events and Serious Adverse Events
Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. The PS-IPTW method was used for balancing the cohorts. Percentage of participants determined after applying this method are reported in 'Adverse events' and 'Serious adverse events' categories in this outcome measure.
Time frame: Index event period up to 6 months post-index treatment discontinuation
Incidence Rate of Adverse Events and Serious Adverse Events
Incidence rate was based on per 100 participants-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.
Time frame: Index event period up to 6 months post-index treatment discontinuation
Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events
Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. Percentage of participants with treatment related adverse events and related treatment serious adverse events were reported.
Time frame: Index event period up to 6 months post-index treatment discontinuation
Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events
Incidence rate was based on per 100 participant-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.
Time frame: Index event period up to 6 months post-index treatment discontinuation
Percentage of Participants With Infections, Serious Infections and Malignancies
Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. Percentage of participants with infections, serious infections and malignancies were reported.
Time frame: Index event period up to 6 months post-index treatment discontinuation
Incidence Rate of Infections, Serious Infections and Malignancies
Incidence rate was based on per 100 participant-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.
Time frame: Index event period up to 6 months post-index treatment discontinuation
Participants took part in the study at 25 investigative sites in Spain and Portugal from 19 February 2019 to 21 February 2022.
| Milestone | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha |
|---|---|---|
| Started | 185 | 224 |
| Completed | 172 | 212 |
| Not completed | 13 | 12 |
| Withdrew: Lost to follow-up (at least 12 months) | 13 | 10 |
| Withdrew: Missing | 0 | 2 |
Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With One or More Treatment Intensifications for CD Participants | 30.7 | 42.1 |
Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With One or More Treatment Intensifications for UC Participants | 43.5 | 39.5 |
Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| Participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Participants discontinued treatment in first-line group — Absence of primary response | 6 | 6 |
| Participants discontinued treatment in first-line group — Lost of response | 2 | 13 |
| Participants discontinued treatment in first-line group — Partial response | 2 | 3 |
| Participants discontinued treatment in first-line group — Adverse event | 4 | 10 |
| Participants discontinued treatment in first-line group — Remission | 0 | 1 |
| Participants discontinued treatment in first-line group — Other reasons | 3 | 5 |
| Participants discontinued treatment in first-line group — Missing | 0 | 0 |
| Participants discontinued treatment in second-line group — Absence of primary response | 6 | 2 |
| Participants discontinued treatment in second-line group — Lost of response | 1 | 7 |
| Participants discontinued treatment in second-line group — Partial response | 0 | 1 |
| Participants discontinued treatment in second-line group — Adverse event | 0 | 6 |
| Participants discontinued treatment in second-line group — Remission | 0 | 0 |
| Participants discontinued treatment in second-line group — Other reasons | 2 | 4 |
| Participants discontinued treatment in second-line group — Missing | 0 | 0 |
Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| Participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Participants discontinued treatment in first-line group — Absence of primary response | 8 | 9 |
| Participants discontinued treatment in first-line group — Lost of response | 6 | 6 |
| Participants discontinued treatment in first-line group — Partial response | 0 | 2 |
| Participants discontinued treatment in first-line group — Adverse event | 0 | 3 |
| Participants discontinued treatment in first-line group — Remission | 0 | 3 |
| Participants discontinued treatment in first-line group — Other reasons | 4 | 6 |
| Participants discontinued treatment in first-line group — Missing | 1 | 0 |
| Participants discontinued treatment in second-line group — Absence of primary response | 3 | 2 |
| Participants discontinued treatment in second-line group — Lost of response | 5 | 8 |
| Participants discontinued treatment in second-line group — Partial response | 1 | 3 |
| Participants discontinued treatment in second-line group — Adverse event | 1 | 0 |
| Participants discontinued treatment in second-line group — Remission | 1 | 1 |
| Participants discontinued treatment in second-line group — Other reasons | 2 | 1 |
| Participants discontinued treatment in second-line group — Missing | 0 | 0 |
Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants Who Discontinued Index Therapy for CD Participants | 38.8 | 49.3 |
Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants Who Discontinued Index Therapy for UC Participants | 39.6 | 50.0 |
Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| Participants | Cohort 1: CD Participants, Vedolizumab | Cohort 1: UC Participants, Vedolizumab |
|---|---|---|
| Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation | 20 | 16 |
Time to switching was defined as time from index treatment initiation until a participant initiated another biologic treatment (Vedolizumab, infliximab, adalimumab, or golimumab \[UC only\], tofacitinib, certolizumab and ustekinumab). Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| months | Cohort 1: CD Participants, Vedolizumab | Cohort 1: UC Participants, Vedolizumab |
|---|---|---|
| Time to Switching for Vedolizumab Participants | 11.29 (6.49 to 14.23) | 8.62 (6.55 to 16.16) |
Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| months | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Time to Discontinuation for CD Participants | 7.1 (5.6 to 12.5) | 10.7 (7.1 to 20.2) |
Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| months | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Time to Discontinuation for UC Participants | 9.0 (6.1 to 15.6) | 10.1 (5.7 to 15.2) |
Clinical response in CD participants was evaluated using Harvey-Bradshaw index (HBI) scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score less than or equal to (\<=) 4 or reduction of greater than or equal to (\>=) 3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Clinical Response at 14 Weeks for CD Participants | 68.1 (4.1 to —) | 88.2 (3.7 to —) |
Clinical response in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score of \<=4 or reduction of \>=3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Clinical Response at 52 Weeks for CD Participants | 74.8 (2.3 to —) | 69.8 (2.5 to —) |
Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical response was defined as partial mayo score of less than (\<) 4 or reduction of \>= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Clinical Response at 14 Weeks for UC Participants | 81.2 (2.3 to —) | 80.5 (2.5 to —) |
Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. The clinical response was defined as partial mayo score of \<4 or reduction of \>= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Clinical Response at 52 Weeks for UC Participants | 75.6 (7.3 to —) | 73.2 (6.0 to —) |
Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of \<=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants | 56.2 (7.3 to —) | 79.3 (6.0 to —) |
Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of \<=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants | 51.3 | 66.5 |
Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of \<2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants | 52.2 | 54.7 |
Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of \<2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants | 56.6 | 62.0 |
Biochemical remission based on CRP was defined as CRP level of \<5 milligram per liter (mg/L). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside greater than (\>) 0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants | 69.1 (24.50 to —) | 74.6 (38.01 to —) |
Biochemical remission based on CRP was defined as CRP level of \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants | 72.9 (24.50 to —) | 73.4 (38.01 to —) |
Biochemical remission based on CRP was defined as CRP level \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants | 58.5 | 77.2 |
Biochemical remission based on CRP was defined as CRP level of \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants | 60.4 | 85.2 |
Biochemical remission based on FCP was defined as FCP level of \<250 microgram per gram (mcg/g). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants | 72.9 (26.57 to —) | 73.4 (23.86 to —) |
Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants | 45.7 (26.57 to —) | 73.4 (23.86 to —) |
Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants | 60.4 | 85.2 |
Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants | 59.7 | 53.7 |
Endoscopic response for CD participants was evaluated using simple endoscopic index for Crohn's disease (SES-CD) score. SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD score \<=2 or based on physician assessment (for UC and CD both). SES-CD score at index date \>0 relative difference was calculated (100\*\[Index date-52 weeks assessment\]/Index date) and relative difference of \>= 50% was considered response. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants | 69.7 | 65.7 |
Endoscopic response in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants | 44.8 | 78.2 |
Endoscopic remission for CD participants was evaluated using SES-CD score. The SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD score \<=2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants | 43.5 | 40.5 |
Endoscopic remission in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.
| percentage of participants | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|
| Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants | 35.5 | 36.6 |
Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. The PS-IPTW method was used for balancing the cohorts. Percentage of participants determined after applying this method are reported in 'Adverse events' and 'Serious adverse events' categories in this outcome measure.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|---|---|
| Adverse event | 50.7 | 58.4 | 33.4 | 55.0 |
| Serious adverse event | 26.5 | 23.2 | 16.9 | 23.9 |
Incidence rate was based on per 100 participants-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.
| events per 100 participant-years | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|---|---|
| Adverse event | 8.53 (98.6 to —) | 9.53 (187.8 to —) | 8.83 (112.5 to —) | 10.64 (133.5 to —) |
| Serious adverse event | 4.62 | 2.31 | 4.17 | 3.21 |
Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. Percentage of participants with treatment related adverse events and related treatment serious adverse events were reported.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|---|---|
| Adverse events related to treatment | 11.6 | 19.6 | 2.1 | 8.5 |
| Serious adverse events related to treatment | 2.3 | 5.5 | 0.8 | 0.5 |
Incidence rate was based on per 100 participant-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.
| events per 100 participant-years | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|---|---|
| Adverse events related to treatment | 1.15 | 2.70 | 0.23 | 1.10 |
| Serious adverse events related to treatment | 0.29 | 0.53 | 0.09 | 0.06 |
Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic. Percentage of participants with infections, serious infections and malignancies were reported.
| percentage of participants | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|---|---|
| Percentage of Participants With Infections, Serious Infections and Malignancies | 4.1 | 19.8 | 6.4 | 17.8 |
Incidence rate was based on per 100 participant-year. Index event period was defined as the period of time within which participants with UC or CD initiated first or second line treatment with vedolizumab or other biologic.
| events per 100 participant-years | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|---|---|
| Incidence Rate of Infections, Serious Infections and Malignancies | 0.48 | 1.75 | 0.75 | 2.42 |
Collected over Index event period up to 6 months post-index treatment discontinuation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | 0/83 (0%) | 23/83 (27.7%) | 20/83 (24.1%) |
| Cohort 2, CD Participants: Anti-TNF Alpha | 0/127 (0%) | 26/127 (20.5%) | 49/127 (38.6%) |
| Cohort 1, UC Participants: Vedolizumab | 9/102 (8.8%) | 16/102 (15.7%) | 18/102 (17.6%) |
| Cohort 2, UC Participants: Anti-TNF Alpha | 3/97 (3.1%) | 21/97 (21.6%) | 31/97 (32%) |
| Event | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|---|---|
| Condition aggravatedGeneral disorders | 4/83 | 1/127 | 0/102 | 3/97 |
| Colitis ulcerativeGastrointestinal disorders | 0/83 | 0/127 | 2/102 | 4/97 |
| Crohn's diseaseGastrointestinal disorders | 3/83 | 2/127 | 0/102 | 1/97 |
| Intestinal obstructionGastrointestinal disorders | 3/83 | 2/127 | 0/102 | 0/97 |
| Abdominal painGastrointestinal disorders | 2/83 | 1/127 | 1/102 | 0/97 |
| Pancreatitis acuteGastrointestinal disorders | 2/83 | 0/127 | 0/102 | 0/97 |
| Rectal haemorrhageGastrointestinal disorders | 2/83 | 1/127 | 0/102 | 0/97 |
| Ileocaecal resectionSurgical and medical procedures | 2/83 | 0/127 | 0/102 | 0/97 |
| Upper respiratory tract infectionInfections and infestations | 2/83 | 0/127 | 0/102 | 0/97 |
| PyrexiaGeneral disorders | 0/83 | 3/127 | 1/102 | 1/97 |
| Event | Cohort 1, CD Participants: Vedolizumab | Cohort 2, CD Participants: Anti-TNF Alpha | Cohort 1, UC Participants: Vedolizumab | Cohort 2, UC Participants: Anti-TNF Alpha |
|---|---|---|---|---|
| Colitis ulcerativeGastrointestinal disorders | 0/83 | 1/127 | 5/102 | 7/97 |
| Crohn's diseaseGastrointestinal disorders | 3/83 | 8/127 | 0/102 | 4/97 |
| PsoriasisSkin and subcutaneous tissue disorders | 1/83 | 4/127 | 0/102 | 0/97 |
| AstheniaGeneral disorders | 0/83 | 4/127 | 1/102 | 3/97 |
| VomitingGastrointestinal disorders | 2/83 | 2/127 | 0/102 | 0/97 |
| DiarrhoeaGastrointestinal disorders | 2/83 | 3/127 | 1/102 | 1/97 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/83 | 2/127 | 1/102 | 2/97 |
| Abdominal painGastrointestinal disorders | 1/83 | 3/127 | 0/102 | 0/97 |
| GastroenteritisInfections and infestations | 1/83 | 3/127 | 1/102 | 1/97 |
| FolliculitisInfections and infestations | 0/83 | 3/127 | 0/102 | 1/97 |
All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Age, Customized(Participants) | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha | Total |
|---|---|---|---|
| 18 to 92 Years | 185 | 224 | 409 |
| Sex: Female, Male(Participants) | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha | Total |
|---|---|---|---|
| Female | 81 | 85 | 166 |
| Male | 104 | 139 | 243 |
| Race and Ethnicity Not Collected(Participants) | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha | Total |
|---|---|---|---|
| Spain | 159 | 199 | 358 |
| Portugal | 26 | 25 | 51 |
| Body Mass Index (BMI)(kilogram per square meter (Kg/m^2)) | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha | Total |
|---|---|---|---|
| Mean | 24.8 ± 4.3 | 24.5 ± 4.0 | 24.6 ± 4.2 |
| Smoking Status(Participants) | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha | Total |
|---|---|---|---|
| Never Smoked | 74 | 113 | 187 |
| Former Smoker | 61 | 66 | 127 |
| Current Smoker | 26 | 35 | 61 |
| Treatment History for CD Participants(Participants) | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha | Total |
|---|---|---|---|
| Corticosteroids | 37 | 61 | 98 |
| Immunomodulators | 36 | 63 | 99 |
| Antibiotics | 7 | 17 | 24 |
| 5-aminosalicylic acid (5-ASA) | 28 | 34 | 62 |
| Other | 14 | 46 | 60 |
| Treatment History for UC Participants(Participants) | Cohort 1: Vedolizumab | Cohort 2: Anti-TNF Alpha | Total |
|---|---|---|---|
| Corticosteroids | 57 | 66 | 123 |
| Corticosteroids Immunomodulators | 42 | 44 | 86 |
| Immunomodulators | 4 | 8 | 12 |
| 5-ASA | 68 | 73 | 141 |
| Other | 25 | 27 | 52 |
9 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
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