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

Takeda409 enrolled

Overview

The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.

This is a retrospective, non-interventional study of participants with CD or UC. The study will review the medical charts of participants who have initiated the first or second line treatment with vedolizumab or another biologic agent (infliximab, adalimumab, or golimumab \[UC only\]) (index event) during the eligibility period to evaluate the treatment effectiveness, treatment patterns, health care utilization and safety of vedolizumab, and to provide the real-world treatment landscape with anti-TNF alpha therapies. The study will enroll approximately 400 participants, with 200 participants in each treatment cohort. All participants will be enrolled into two observational groups: * 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.

Study Type

OBSERVATIONAL

Enrollment

409

Conditions

Colitis, Ulcerative Crohn Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

Outcomes

Primary Outcomes

Percentage of Participants With One or More Treatment Intensifications for CD Participants

Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.

Time frame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Percentage of Participants With One or More Treatment Intensifications for UC Participants

Time frame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Number of Participants With Reasons for Treatment Modifications in CD Participants

Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

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.

Data from ClinicalTrials.gov

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Centro Hospitalar de Entre Douro e Vouga

Santa Maria da Feira, Aveiro District, Portugal

Hospital Beatriz Angelo

Loures, Lisbon District, Portugal

Hospital do Espirito Santo de Evora

Evora, Portugal

Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria

Lisbon, Portugal

Hospital Distrital de Santarem

Santarém, Portugal

Hospital Universitari Son Espases

Palma, Balearic Islands, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Hospital Universitario de Leon

León, Castille and León, Spain

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

Hospital Vall d'Hebron

Barcelona, Catalonia, Spain

...and 16 more locations

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.

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.

Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation

Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Time frame: From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)

Time to Switching for Vedolizumab Participants

Time to switching was defined as time from index treatment initiation until a participant initiated another biologic treatment (Vedolizumab, infliximab, adalimumab, or golimumab \[UC only\], tofacitinib, certolizumab and ustekinumab). Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Time 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 to Discontinuation for UC Participants

Percentage of Participants With Clinical Response at 14 Weeks for CD Participants

Clinical response in CD participants was evaluated using Harvey-Bradshaw index (HBI) scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score less than or equal to (\<=) 4 or reduction of greater than or equal to (\>=) 3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Time frame: At 14 weeks post-index (assessment time window 10 to 18 weeks)

Percentage of Participants With Clinical Response at 52 Weeks for CD Participants

Clinical response in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score of \<=4 or reduction of \>=3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

Time frame: At 52 weeks post-index (assessment time window 46 to 58 weeks)

Percentage of Participants With Clinical Response at 14 Weeks for UC Participants

Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical response was defined as partial mayo score of less than (\<) 4 or reduction of \>= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Time frame: At 14 weeks post-index (assessment time window 10 to 18 weeks)

Percentage of Participants With Clinical Response at 52 Weeks for UC Participants

Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. The clinical response was defined as partial mayo score of \<4 or reduction of \>= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Time frame: At 52 weeks post-index (assessment time window 46 to 58 weeks)

Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants

Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of \<=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Time frame: At 14 weeks post-index (assessment time window 10 to 18 weeks)

Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants

Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of \<=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Time frame: At 52 weeks post-index (assessment time window 46 to 58 weeks)

Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants

Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of \<2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Time frame: At 14 weeks post-index (assessment time window 10 to 18 weeks)

Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants

Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of \<2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

Time frame: At 52 weeks post-index (assessment time window 46 to 58 weeks)

Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants

Biochemical remission based on CRP was defined as CRP level of \<5 milligram per liter (mg/L). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside greater than (\>) 0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

Time frame: At 14 weeks post-index (assessment time window >0 to 38 weeks)

Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants

Biochemical remission based on CRP was defined as CRP level of \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.