Colitis, Ulcerative, Crohn Disease
Conditions
Keywords
Drug Therapy
Brief summary
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.
Detailed description
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: * Cohort 1: Vedolizumab * Cohort 2: Other Biologics The data for participants will be collected in two main periods: * Pre-index Event Period: From the data of diagnosis of UC/CD until one day prior to the date when vedolizumab or other biologic treatment was initiated during the eligibility period. * Post-index Event Period: From the date when vedolizumab or other biologic treatment was initiated during the eligibility period until the earliest of 6 months (post-index treatment discontinuation, death of participants, lost-to-follow up, or date of chart abstraction initiation. 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.
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of moderate to severe UC or CD documented in the medical chart. 2. Received at least one dose of vedolizumab or other biologic (infliximab, adalimumab, or golimumab \[UC only\]) during the eligibility period. 3. Received the biologic treatment as first-line or second line biologic for UC or CD. 4. Has a minimum of six months of follow-up between date of starting biologic therapy (index event) and the date of completion of the participant pre-selection registry.
Exclusion criteria
1. Received vedolizumab or another biologic as part of an interventional clinical trial ever in their lifetime (includes index treatment). 2. Index treatment was another biologic therapy other than vedolizumab, infliximab, adalimumab, or golimumab (UC only). 3. Initiated index treatment as combination therapy with two biologic agents. 4. The biologic was prescribed for treatment of perianal disease. 5. Received biologic therapy before the index period for a disease other than inflammatory bowel disease. 6. Medical chart is unavailable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reasons for Treatment Modifications in CD Participants | 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) | Index date was defined as the date when vedolizumab or other biologic treatment was initiated. |
| Percentage of Participants With One or More Treatment Intensifications for CD Participants | 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) | 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 With One or More Treatment Intensifications for UC Participants | 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) | 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. |
| Number of Participants With Reasons for Treatment Modifications in UC Participants | 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) | Index date was defined as the date when vedolizumab or other biologic treatment was initiated. |
| Percentage of Participants Who Discontinued Index Therapy for CD Participants | 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) | 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 Who Discontinued Index Therapy for UC Participants | 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) | 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. |
| Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation | 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) | 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 to Switching for Vedolizumab Participants | 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 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 to Discontinuation for CD Participants | 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 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 to Discontinuation for UC Participants | 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) | 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. |
| Percentage of Participants With Clinical Response at 14 Weeks for CD Participants | At 14 weeks post-index (assessment time window 10 to 18 weeks) | 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 With Biochemical Remission Based on CRP at 14 Weeks for UC Participants | At 14 weeks post-index (assessment time window >0 to 38 weeks) | 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 With Clinical Response at 52 Weeks for CD Participants | At 52 weeks post-index (assessment time window 46 to 58 weeks) | 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 With Clinical Response at 14 Weeks for UC Participants | At 14 weeks post-index (assessment time window 10 to 18 weeks) | 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 With Clinical Response at 52 Weeks for UC Participants | At 52 weeks post-index (assessment time window 46 to 58 weeks) | 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 With Clinical Remission at 14 Weeks for CD Participants | At 14 weeks post-index (assessment time window 10 to 18 weeks) | 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 With Clinical Remission at 52 Weeks for CD Participants | At 52 weeks post-index (assessment time window 46 to 58 weeks) | 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 With Clinical Remission at 14 Weeks for UC Participants | At 14 weeks post-index (assessment time window 10 to 18 weeks) | 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 With Clinical Remission at 52 Weeks for UC Participants | At 52 weeks post-index (assessment time window 46 to 58 weeks) | 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 With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants | At 14 weeks post-index (assessment time window >0 to 38 weeks) | 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 With Biochemical Remission Based on CRP at 52 Weeks for CD Participants | At 52 weeks post-index (assessment time window 28 to 76 weeks) | 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 With Biochemical Remission Based on CRP at 52 Weeks for UC Participants | At 52 weeks post-index (assessment time window 28 to 76 weeks) | 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 With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants | At 14 weeks post-index (assessment time window >0 to 38 weeks) | 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 With Biochemical Remission Based on FCP at 52 Weeks for CD Participants | At 52 weeks post-index (assessment time window 28 to 76 weeks) | 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 With Biochemical Remission Based on FCP at 14 Weeks for UC Participants | At 14 weeks post-index (assessment time window >0 to 38 weeks) | 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 With Biochemical Remission Based on FCP at 52 Weeks for UC Participants | At 52 weeks post-index (assessment time window 28 to 76 weeks) | 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 With Endoscopic Response at 52 Weeks for CD Participants | At 52 weeks post-index (assessment time window 28 to 76 weeks) | 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 With Endoscopic Response at 52 Weeks for UC Participants | At 52 weeks post-index (assessment time window 28 to 76 weeks) | 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 With Endoscopic Remission at 52 Weeks for CD Participants | At 52 weeks post-index (assessment time window 28 to 76 weeks) | 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 With Endoscopic Remission at 52 Weeks for UC Participants | At 52 weeks post-index (assessment time window 28 to 76 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events and Serious Adverse Events | Index event period up to 6 months post-index treatment discontinuation | 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. |
| Incidence Rate of Adverse Events and Serious Adverse Events | Index event period up to 6 months post-index treatment discontinuation | 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. |
| Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Index event period up to 6 months post-index treatment discontinuation | 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. |
| Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Index event period up to 6 months post-index treatment discontinuation | 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. |
| Percentage of Participants With Infections, Serious Infections and Malignancies | Index event period up to 6 months post-index treatment discontinuation | 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. |
| Incidence Rate of Infections, Serious Infections and Malignancies | Index event period up to 6 months post-index treatment discontinuation | 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. |
Countries
Portugal, Spain
Participant flow
Recruitment details
Participants took part in the study at 25 investigative sites in Spain and Portugal from 19 February 2019 to 21 February 2022.
Pre-assignment details
Participants diagnosed with Crohn's disease (CD) or ulcerative colitis (UC) and who initiated first or second line biologic treatment with vedolizumab or another biologic between January 2017 until date of site initiation were enrolled and observed retrospectively in this medical chart review study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Vedolizumab Participants diagnosed with UC or CD, who had initiated first or second-line treatment with vedolizumab between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period 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 in post-index event period 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 was defined as the date when vedolizumab treatment was initiated. | 185 |
| Cohort 2: Anti-TNF Alpha Participants diagnosed with UC or CD, who had initiated first or second-line treatment with another biologic treatment (TNF alpha: infliximab, adalimumab, or golimumab \[UC only\]) between January 2017 until date of site initiation (eligibility period) were observed in the pre-index event period 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 in post-index event period 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 was defined as the date when other biologic treatment was initiated. | 224 |
| Total | 409 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up (at least 12 months) | 13 | 10 |
| Overall Study | Missing | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Cohort 2: Anti-TNF Alpha | Cohort 1: Vedolizumab |
|---|---|---|---|
| Age at First Ever CD Diagnosis | 39.5 years STANDARD_DEVIATION 17.5 | 35.0 years STANDARD_DEVIATION 16 | 47.6 years STANDARD_DEVIATION 17.3 |
| Age at First Ever UC diagnosis | 41.1 years STANDARD_DEVIATION 17.5 | 37.6 years STANDARD_DEVIATION 14.8 | 44.6 years STANDARD_DEVIATION 19.2 |
| Age, Customized 18 to 92 Years | 409 Participants | 224 Participants | 185 Participants |
| Body Mass Index (BMI) | 24.6 kilogram per square meter (Kg/m^2) STANDARD_DEVIATION 4.2 | 24.5 kilogram per square meter (Kg/m^2) STANDARD_DEVIATION 4 | 24.8 kilogram per square meter (Kg/m^2) STANDARD_DEVIATION 4.3 |
| Location of Intestinal Involvement at Diagnosis in CD Participants Colonic | 27 Participants | 17 Participants | 10 Participants |
| Location of Intestinal Involvement at Diagnosis in CD Participants Ileal | 104 Participants | 53 Participants | 51 Participants |
| Location of Intestinal Involvement at Diagnosis in CD Participants Ileocolonic | 77 Participants | 55 Participants | 22 Participants |
| Location of Intestinal Involvement at Diagnosis in CD Participants Upper Gastrointestinal Tract | 21 Participants | 13 Participants | 8 Participants |
| Location of UC at Diagnosis Extensive Colitis (Proximal to Hepatic Flexure) | 84 Participants | 44 Participants | 40 Participants |
| Location of UC at Diagnosis Left-sided (Distal to Splenic flexure) | 66 Participants | 31 Participants | 35 Participants |
| Location of UC at Diagnosis Proctitis/proctosigmoiditis | 40 Participants | 17 Participants | 23 Participants |
| Number of Fistulas in CD Participants | 1.3 number of fistulas STANDARD_DEVIATION 0.5 | 1.2 number of fistulas STANDARD_DEVIATION 0.4 | 1.4 number of fistulas STANDARD_DEVIATION 0.8 |
| Participants With and Without Active Fistulas at Diagnosis in CD Participants Participants with Active Fistulas at Diagnosis in CD Participants | 35 Participants | 27 Participants | 8 Participants |
| Participants With and Without Active Fistulas at Diagnosis in CD Participants Participants Without Active Fistulas at Diagnosis in CD Participants | 147 Participants | 80 Participants | 67 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Portugal | 51 Participants | 25 Participants | 26 Participants |
| Region of Enrollment Spain | 358 Participants | 199 Participants | 159 Participants |
| Sex: Female, Male Female | 166 Participants | 85 Participants | 81 Participants |
| Sex: Female, Male Male | 243 Participants | 139 Participants | 104 Participants |
| Smoking Status Current Smoker | 61 Participants | 35 Participants | 26 Participants |
| Smoking Status Former Smoker | 127 Participants | 66 Participants | 61 Participants |
| Smoking Status Never Smoked | 187 Participants | 113 Participants | 74 Participants |
| Treatment History for CD Participants 5-aminosalicylic acid (5-ASA) | 62 Participants | 34 Participants | 28 Participants |
| Treatment History for CD Participants Antibiotics | 24 Participants | 17 Participants | 7 Participants |
| Treatment History for CD Participants Corticosteroids | 98 Participants | 61 Participants | 37 Participants |
| Treatment History for CD Participants Immunomodulators | 99 Participants | 63 Participants | 36 Participants |
| Treatment History for CD Participants Other | 60 Participants | 46 Participants | 14 Participants |
| Treatment History for UC Participants 5-ASA | 141 Participants | 73 Participants | 68 Participants |
| Treatment History for UC Participants Corticosteroids | 123 Participants | 66 Participants | 57 Participants |
| Treatment History for UC Participants Corticosteroids Immunomodulators | 86 Participants | 44 Participants | 42 Participants |
| Treatment History for UC Participants Immunomodulators | 12 Participants | 8 Participants | 4 Participants |
| Treatment History for UC Participants Other | 52 Participants | 27 Participants | 25 Participants |
| Type of Active Fistulas at Diagnosis in CD Participants Anal | 20 Participants | 17 Participants | 3 Participants |
| Type of Active Fistulas at Diagnosis in CD Participants Enterocutaneous | 4 Participants | 2 Participants | 2 Participants |
| Type of Active Fistulas at Diagnosis in CD Participants Internal | 6 Participants | 4 Participants | 2 Participants |
| Type of Active Fistulas at Diagnosis in CD Participants Rectovaginal | 2 Participants | 2 Participants | 0 Participants |
| Type of Disease Behavior at Diagnosis Inflammatory in CD Participants Anal | 14 Participants | 12 Participants | 2 Participants |
| Type of Disease Behavior at Diagnosis Inflammatory in CD Participants Inflammatory | 111 Participants | 74 Participants | 37 Participants |
| Type of Disease Behavior at Diagnosis Inflammatory in CD Participants Penetrating | 28 Participants | 19 Participants | 9 Participants |
| Type of Disease Behavior at Diagnosis Inflammatory in CD Participants Stricturing | 71 Participants | 35 Participants | 36 Participants |
| Type of Inflammatory Bowel Disease (IBD) CD | 210 Participants | 127 Participants | 83 Participants |
| Type of Inflammatory Bowel Disease (IBD) UC | 199 Participants | 97 Participants | 102 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 / 83 | 0 / 127 | 9 / 102 | 3 / 97 |
| other Total, other adverse events | 20 / 83 | 49 / 127 | 18 / 102 | 31 / 97 |
| serious Total, serious adverse events | 23 / 83 | 26 / 127 | 16 / 102 | 21 / 97 |
Outcome results
Primary
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)
Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. This outcome measure was planned to be assessed only for Cohort 1: Vedolizumab group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1, CD 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 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation | 16 Participants |
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure and number analyzed signified participants who were evaluable for specified categories of this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Absence of primary response | 6 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Lost of response | 2 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Partial response | 2 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Adverse event | 4 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Remission | 0 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Other reasons | 3 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Missing | 0 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Adverse event | 0 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Remission | 0 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Other reasons | 2 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Missing | 0 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Absence of primary response | 6 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Lost of response | 1 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Partial response | 0 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Missing | 0 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Absence of primary response | 6 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Adverse event | 6 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Lost of response | 13 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Lost of response | 7 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Partial response | 3 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Remission | 0 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Adverse event | 10 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Absence of primary response | 2 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Remission | 1 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Other reasons | 4 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Other reasons | 5 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in second-line group | Partial response | 1 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in CD Participants | Participants discontinued treatment in first-line group | Missing | 0 Participants |
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure and number analyzed signified participants who were evaluable for specified categories of this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Absence of primary response | 3 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Absence of primary response | 8 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Lost of response | 5 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Remission | 0 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Partial response | 1 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Partial response | 0 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Adverse event | 1 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Other reasons | 4 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Remission | 1 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Lost of response | 6 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Other reasons | 2 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Missing | 0 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Missing | 1 Participants |
| Cohort 1, CD Participants: Vedolizumab | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Adverse event | 0 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Absence of primary response | 9 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Lost of response | 6 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Partial response | 2 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Adverse event | 3 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Remission | 3 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Other reasons | 6 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in first-line group | Missing | 0 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Absence of primary response | 2 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Lost of response | 8 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Partial response | 3 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Adverse event | 0 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Remission | 1 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Missing | 0 Participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Number of Participants With Reasons for Treatment Modifications in UC Participants | Participants discontinued treatment in second-line group | Other reasons | 1 Participants |
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants Who Discontinued Index Therapy for CD Participants | 38.8 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants Who Discontinued Index Therapy for CD Participants | 49.3 percentage of participants |
p-value: =0.164895% CI: [0.35, 1.19]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants Who Discontinued Index Therapy for UC Participants | 39.6 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants Who Discontinued Index Therapy for UC Participants | 50.0 percentage of participants |
p-value: =0.173295% CI: [0.36, 1.2]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants | 69.1 percentage of participants |
| 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 | 74.6 percentage of participants |
p-value: =0.445895% CI: [0.38, 1.54]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants | 58.5 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants | 77.2 percentage of participants |
p-value: =0.010495% CI: [0.21, 0.81]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants | 72.9 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants | 73.4 percentage of participants |
p-value: =0.947195% CI: [0.47, 2.04]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants | 60.4 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants | 85.2 percentage of participants |
p-value: =0.001195% CI: [0.12, 0.59]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants | 60.4 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants | 85.2 percentage of participants |
p-value: =0.001195% CI: [0.12, 0.59]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants | 45.7 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants | 73.4 percentage of participants |
p-value: =0.010495% CI: [0.12, 0.75]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants | 59.7 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants | 53.7 percentage of participants |
p-value: =0.5495% CI: [0.59, 2.78]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants | 72.9 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants | 73.4 percentage of participants |
Comparison: CD Participantsp-value: =0.947195% CI: [0.47, 2.04]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants | 56.2 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants | 79.3 percentage of participants |
p-value: =0.005195% CI: [0.16, 0.72]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants | 52.2 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants | 54.7 percentage of participants |
p-value: =0.762995% CI: [0.47, 1.74]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants | 51.3 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants | 66.5 percentage of participants |
p-value: =0.065395% CI: [0.27, 1.04]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants | 56.6 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants | 62.0 percentage of participants |
p-value: =0.489595% CI: [0.43, 1.5]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. As pre-specified in the statistical analysis plan (SAP), the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Clinical Response at 14 Weeks for CD Participants | 68.1 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Clinical Response at 14 Weeks for CD Participants | 88.2 percentage of participants |
p-value: =0.007195% CI: [0.12, 0.71]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Clinical Response at 14 Weeks for UC Participants | 81.2 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Clinical Response at 14 Weeks for UC Participants | 80.5 percentage of participants |
p-value: =0.91595% CI: [0.46, 2.36]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Clinical Response at 52 Weeks for CD Participants | 74.8 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Clinical Response at 52 Weeks for CD Participants | 69.8 percentage of participants |
p-value: =0.480995% CI: [0.64, 2.55]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Clinical Response at 52 Weeks for UC Participants | 75.6 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Clinical Response at 52 Weeks for UC Participants | 73.2 percentage of participants |
p-value: =0.725495% CI: [0.56, 2.28]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants | 43.5 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants | 40.5 percentage of participants |
p-value: =0.858495% CI: [0.29, 4.36]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants | 35.5 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants | 36.6 percentage of participants |
p-value: =0.947495% CI: [0.24, 3.78]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants | 69.7 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants | 65.7 percentage of participants |
p-value: =0.812395% CI: [0.26, 5.66]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants | 44.8 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants | 78.2 percentage of participants |
p-value: =0.028295% CI: [0.06, 0.85]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With One or More Treatment Intensifications for CD Participants | 30.7 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With One or More Treatment Intensifications for CD Participants | 42.1 percentage of participants |
p-value: =0.1320295% CI: [0.32, 1.16]Regression, Logistic
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With One or More Treatment Intensifications for UC Participants | 43.5 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With One or More Treatment Intensifications for UC Participants | 39.5 percentage of participants |
p-value: =0.586195% CI: [0.65, 2.13]Regression, Logistic
Primary
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)
Population: All participants with CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Time to Discontinuation for CD Participants | 7.1 months |
| Cohort 2, CD Participants: Anti-TNF Alpha | Time to Discontinuation for CD Participants | 10.7 months |
Comparison: CD: Vedolizumab Versus Other Biologicalp-value: =0.2011Log Rank Test Adjusted by PS-IPTW
Primary
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)
Population: All participants with UC that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Time to Discontinuation for UC Participants | 9.0 months |
| Cohort 2, CD Participants: Anti-TNF Alpha | Time to Discontinuation for UC Participants | 10.1 months |
p-value: =0.6939Log Rank Test Adjusted by PS-IPTW
Primary
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)
Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. This outcome measure was planned to be assessed only for Cohort 1: Vedolizumab group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Time to Switching for Vedolizumab Participants | 11.29 months |
| Cohort 2, CD Participants: Anti-TNF Alpha | Time to Switching for Vedolizumab Participants | 8.62 months |
Secondary
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
Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Incidence Rate of Adverse Events and Serious Adverse Events | Adverse event | 8.53 events per 100 participant-years |
| Cohort 1, CD Participants: Vedolizumab | Incidence Rate of Adverse Events and Serious Adverse Events | Serious adverse event | 4.62 events per 100 participant-years |
| Cohort 2, CD Participants: Anti-TNF Alpha | Incidence Rate of Adverse Events and Serious Adverse Events | Serious adverse event | 2.31 events per 100 participant-years |
| Cohort 2, CD Participants: Anti-TNF Alpha | Incidence Rate of Adverse Events and Serious Adverse Events | Adverse event | 9.53 events per 100 participant-years |
| Cohort 1, UC Participants: Vedolizumab | Incidence Rate of Adverse Events and Serious Adverse Events | Adverse event | 8.83 events per 100 participant-years |
| Cohort 1, UC Participants: Vedolizumab | Incidence Rate of Adverse Events and Serious Adverse Events | Serious adverse event | 4.17 events per 100 participant-years |
| Cohort 2, UC Participants: Anti-TNF Alpha | Incidence Rate of Adverse Events and Serious Adverse Events | Adverse event | 10.64 events per 100 participant-years |
| Cohort 2, UC Participants: Anti-TNF Alpha | Incidence Rate of Adverse Events and Serious Adverse Events | Serious adverse event | 3.21 events per 100 participant-years |
Comparison: Adverse eventp-value: =0.478495% CI: [0.66, 1.22]Poisson Regression
Comparison: Adverse eventp-value: =0.261695% CI: [0.6, 1.15]Poisson Regression
Comparison: Serious adverse eventp-value: =0.007795% CI: [1.2, 3.34]Poisson Regression
Comparison: Serious adverse eventp-value: =0.304695% CI: [0.79, 2.14]Poisson Regression
Secondary
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
Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Incidence Rate of Infections, Serious Infections and Malignancies | 0.48 events per 100 participant-years |
| Cohort 2, CD Participants: Anti-TNF Alpha | Incidence Rate of Infections, Serious Infections and Malignancies | 1.75 events per 100 participant-years |
| Cohort 1, UC Participants: Vedolizumab | Incidence Rate of Infections, Serious Infections and Malignancies | 0.75 events per 100 participant-years |
| Cohort 2, UC Participants: Anti-TNF Alpha | Incidence Rate of Infections, Serious Infections and Malignancies | 2.42 events per 100 participant-years |
p-value: =0.015295% CI: [0.1, 0.78]Poisson Regression
p-value: =0.801295% CI: [0.05, 48.44]Poisson Regression
Secondary
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
Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Adverse events related to treatment | 1.15 events per 100 participant-years |
| Cohort 1, CD Participants: Vedolizumab | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Serious adverse events related to treatment | 0.29 events per 100 participant-years |
| Cohort 2, CD Participants: Anti-TNF Alpha | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Serious adverse events related to treatment | 0.53 events per 100 participant-years |
| Cohort 2, CD Participants: Anti-TNF Alpha | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Adverse events related to treatment | 2.70 events per 100 participant-years |
| Cohort 1, UC Participants: Vedolizumab | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Adverse events related to treatment | 0.23 events per 100 participant-years |
| Cohort 1, UC Participants: Vedolizumab | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Serious adverse events related to treatment | 0.09 events per 100 participant-years |
| Cohort 2, UC Participants: Anti-TNF Alpha | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Adverse events related to treatment | 1.10 events per 100 participant-years |
| Cohort 2, UC Participants: Anti-TNF Alpha | Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Serious adverse events related to treatment | 0.06 events per 100 participant-years |
Comparison: Adverse events related to treatmentp-value: =0.023995% CI: [0.2, 0.89]Poisson Regression
Comparison: Adverse events related to treatmentp-value: =0.037395% CI: [0.05, 0.91]Poisson Regression
Comparison: Serious adverse events related to treatmentp-value: =0.42695% CI: [0.12, 2.49]Poisson Regression
Comparison: Serious adverse events related to treatmentp-value: =0.801295% CI: [0.05, 48.44]Poisson Regression
Secondary
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
Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Adverse Events and Serious Adverse Events | Adverse event | 50.7 percentage of participants |
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Adverse Events and Serious Adverse Events | Serious adverse event | 26.5 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Adverse Events and Serious Adverse Events | Serious adverse event | 23.2 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Adverse Events and Serious Adverse Events | Adverse event | 58.4 percentage of participants |
| Cohort 1, UC Participants: Vedolizumab | Percentage of Participants With Adverse Events and Serious Adverse Events | Adverse event | 33.4 percentage of participants |
| Cohort 1, UC Participants: Vedolizumab | Percentage of Participants With Adverse Events and Serious Adverse Events | Serious adverse event | 16.9 percentage of participants |
| Cohort 2, UC Participants: Anti-TNF Alpha | Percentage of Participants With Adverse Events and Serious Adverse Events | Adverse event | 55.0 percentage of participants |
| Cohort 2, UC Participants: Anti-TNF Alpha | Percentage of Participants With Adverse Events and Serious Adverse Events | Serious adverse event | 23.9 percentage of participants |
Comparison: Adverse eventp-value: =0.310395% CI: [0.4, 1.34]Regression, Logistic
Comparison: Adverse eventp-value: =0.004595% CI: [0.22, 0.76]Regression, Logistic
Comparison: Serious adverse eventp-value: =0.628795% CI: [0.59, 2.42]Regression, Logistic
Comparison: Serious adverse eventp-value: =0.249595% CI: [0.31, 1.36]Regression, Logistic
Secondary
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
Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Infections, Serious Infections and Malignancies | 4.1 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Infections, Serious Infections and Malignancies | 19.8 percentage of participants |
| Cohort 1, UC Participants: Vedolizumab | Percentage of Participants With Infections, Serious Infections and Malignancies | 6.4 percentage of participants |
| Cohort 2, UC Participants: Anti-TNF Alpha | Percentage of Participants With Infections, Serious Infections and Malignancies | 17.8 percentage of participants |
p-value: =0.004495% CI: [0.05, 0.58]Regression, Logistic
p-value: =0.021595% CI: [0.12, 0.84]Regression, Logistic
Secondary
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
Population: All participants with UC or CD that met all the inclusion criteria and none of exclusion were enrolled in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Adverse events related to treatment | 11.6 percentage of participants |
| Cohort 1, CD Participants: Vedolizumab | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Serious adverse events related to treatment | 2.3 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Serious adverse events related to treatment | 5.5 percentage of participants |
| Cohort 2, CD Participants: Anti-TNF Alpha | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Adverse events related to treatment | 19.6 percentage of participants |
| Cohort 1, UC Participants: Vedolizumab | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Adverse events related to treatment | 2.1 percentage of participants |
| Cohort 1, UC Participants: Vedolizumab | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Serious adverse events related to treatment | 0.8 percentage of participants |
| Cohort 2, UC Participants: Anti-TNF Alpha | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Adverse events related to treatment | 8.5 percentage of participants |
| Cohort 2, UC Participants: Anti-TNF Alpha | Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events | Serious adverse events related to treatment | 0.5 percentage of participants |
Comparison: Adverse events related to treatmentp-value: =0.168195% CI: [0.22, 1.3]Regression, Logistic
Comparison: Adverse events related to treatmentp-value: =0.064595% CI: [0.05, 1.09]Regression, Logistic
Comparison: Serious adverse events related to treatmentp-value: =0.314595% CI: [0.06, 2.51]Regression, Logistic
Comparison: Serious adverse events related to treatmentp-value: =0.819795% CI: [0.05, 47.11]Regression, Logistic