A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants

Crohn Disease Clinical Trial

— EVOLVE-IBERIA  

Official title:

Vedolizumab and Anti-TNFs Outcomes in Real-World Biologic Ulcerative Colitis and Crohn's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710486
• Other study ID #: Vedolizumab-5047
• Secondary ID: U1111-1218-0768T
• Status: Completed
• Start date: February 19, 2019
• Est. completion date: February 21, 2022

Study information

• Verified date: December 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: February 21, 2022
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer

Locations

Country	Name	City	State
Portugal	Hospital do Espirito Santo de Evora	Evora
Portugal	Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria	Lisboa
Portugal	Hospital Beatriz Angelo	Loures	Lisboa
Portugal	Centro Hospitalar de Entre Douro e Vouga	Santa Maria da Feira	Aveiro
Portugal	Hospital Distrital de Santarem	Santarem
Spain	Hospital General Universitario de Alicante	Alicante	Comunidad Valenciana
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluna
Spain	Hospital de Sant Joan Despi - Moises Broggi	Barcelona	Cataluna
Spain	Hospital Universitari Parc Tauli	Barcelona	Cataluna
Spain	Hospital Vall d'Hebron	Barcelona	Cataluna
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona	Cataluna
Spain	Hospital Universitario de Leon	Leon	Castilla Y Leon
Spain	Hospital Clinico San Carlos	Madrid	Comunidad De Madrid
Spain	Hospital de La Princesa	Madrid	Comunidad De Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid	Comunidad De Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid	Comunidad De Madrid
Spain	Hospital Universitario de La Paz	Madrid	Comunidad De Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid	Comunidad De Madrid
Spain	Hospital Universitario Central de Asturias (HUCA)	Oviedo	Asturias
Spain	Hospital Universitari Son Espases	Palma	Islas Baleares
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca	Salamanca	Castilla Y Leon
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife	Islas Canarias
Spain	Hospital Clinico Universitario de Valencia	Valencia	Comunidad Valenciana
Spain	Hospital de Manises	Valencia	Comunidad Valenciana
Spain	Hospital Universitario y Politecnico La Fe	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	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)
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.	At 14 weeks post-index (assessment time window 10 to 18 weeks)
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.	At 52 weeks post-index (assessment time window 46 to 58 weeks)
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.	At 14 weeks post-index (assessment time window 10 to 18 weeks)
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.	At 52 weeks post-index (assessment time window 46 to 58 weeks)
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.	At 14 weeks post-index (assessment time window 10 to 18 weeks)
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.	At 52 weeks post-index (assessment time window 46 to 58 weeks)
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.	At 14 weeks post-index (assessment time window 10 to 18 weeks)
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.	At 52 weeks post-index (assessment time window 46 to 58 weeks)
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.	At 14 weeks post-index (assessment time window >0 to 38 weeks)
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.	At 52 weeks post-index (assessment time window 28 to 76 weeks)
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.	At 14 weeks post-index (assessment time window >0 to 38 weeks)
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.	At 52 weeks post-index (assessment time window 28 to 76 weeks)
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.	At 14 weeks post-index (assessment time window >0 to 38 weeks)
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.	At 52 weeks post-index (assessment time window 28 to 76 weeks)
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.	At 14 weeks post-index (assessment time window >0 to 38 weeks)
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.	At 52 weeks post-index (assessment time window 28 to 76 weeks)
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.	At 52 weeks post-index (assessment time window 28 to 76 weeks)
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.	At 52 weeks post-index (assessment time window 28 to 76 weeks)
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.	At 52 weeks post-index (assessment time window 28 to 76 weeks)
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.	At 52 weeks post-index (assessment time window 28 to 76 weeks)
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.	Index event period up to 6 months post-index treatment discontinuation
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.	Index event period up to 6 months post-index treatment discontinuation
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.	Index event period up to 6 months post-index treatment discontinuation
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.	Index event period up to 6 months post-index treatment discontinuation
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.	Index event period up to 6 months post-index treatment discontinuation
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.	Index event period up to 6 months post-index treatment discontinuation