Colitis, Ulcerative
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
Detailed description
This is a post-marketing, non-interventional study of participants with moderate to severe UC. The study will review medical records of participants who have initiated medical treatment with vedolizumab intravenous during the defined eligibility period under routine clinical practice to provide the real world data on the effectiveness and safety of vedolizumab intravenous. The study will enroll approximately 100 participants. All participants will be enrolled in one observational group: Vedolizumab Both retrospective and prospective data will be collected in the index period, with prospective data collected for treatment baseline visit and follow up visits. The multi-center trial will be conducted in Republic of Korea. The overall duration of study will be approximately 15 months.
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Moderately to severely active UC and having failed TNF-alpha antagonist therapy.
Exclusion criteria
1. Was treated with vedolizumab intravenous outside of the locally approved label in South Korea. 2. Was enrolled in an Interventional Intestinal Bowel Disease clinical trial at time of using vedolizumab intravenous.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score | Week 6 | Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease. |
| Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs) | From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months) | — |
| Percentage of Participants With Pregnancy During the Study | From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score | Week 14 | Clinical response was defined as a reduction of at least 3 points and a decrease of at least 30% from the baseline mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease. |
| Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score | Weeks 6 and 14 | Clinical remission was defined as a total mayo score of less than or equal to (\<=) 2 with no sub-score greater than (\>) 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease. |
| Percentage of Participants With Mucosal Healing at Weeks 6 and 14 | Weeks 6 and 14 | Mucosal healing was defined as Mayo endoscopic sub-score of 0 or 1 compared to baseline. Mayo score was an instrument designed to measure disease activity of UC. Endoscopic findings was a sub-score of complete Mayo score, which ranges from 0 to 3 (0= Normal or inactive disease; 1= Mild disease; 2= Moderate disease; 3= Severe disease), with higher scores indicating more severe disease. |
Countries
South Korea
Participant flow
Recruitment details
Participants took part in the study at 13 investigative sites in South Korea from 17 August 2017 to 18 December 2018.
Pre-assignment details
Participants with a diagnosis of moderately to severely active ulcerative colitis (UC), having failed tumor necrosis factor-alpha (TNF-alpha) antagonist therapy and who have been prescribed vedolizumab intravenously under standard clinical practice were enrolled in this observational study.
Participants by arm
| Arm | Count |
|---|---|
| Vedolizumab Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first. | 105 |
| Total | 105 |
Baseline characteristics
| Characteristic | Vedolizumab | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 10 Participants | — |
| Age, Categorical Between 18 and 65 years | 95 Participants | — |
| Body Mass Index (BMI) | 22.0 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.47 | — |
| Body Weight | 61.4 kilogram (kg) STANDARD_DEVIATION 12 | — |
| Comorbidities Autoimmune hepatitis | 1 Participants | — |
| Comorbidities Diabetes mellitus | 2 Participants | — |
| Comorbidities Hypertension | 5 Participants | — |
| Comorbidities Rheumatoid arthritis | 1 Participants | — |
| Family History Crohn's disease | 0 Participants | — |
| Family History UC- Parent | 1 Participants | — |
| Family History UC- Siblings | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Korea, Republic Of | 105 Participants | — |
| Sex: Female, Male Female | 38 Participants | — |
| Sex: Female, Male Male | 67 Participants | — |
| Smoking Status Current smoker | 4 Participants | — |
| Smoking Status Former smoker | 31 Participants | — |
| Smoking Status Never smoked | 62 Participants | — |
| Smoking Status Unknown | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 105 |
| other Total, other adverse events | 16 / 105 |
| serious Total, serious adverse events | 5 / 105 |
Outcome results
Primary
Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)
Time frame: From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
Population: The SAS consisted all enrolled participants who received at least one documented dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vedolizumab | Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs) | AESIs | 4.76 percentage of participants |
| Vedolizumab | Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs) | SAEs | 4.76 percentage of participants |
Primary
Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score
Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Time frame: Week 6
Population: The full analysis set (FAS) consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vedolizumab | Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score | 55.8 percentage of participants |
Primary
Percentage of Participants With Pregnancy During the Study
Time frame: From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)
Population: The SAS consisted all enrolled participants who received at least one documented dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vedolizumab | Percentage of Participants With Pregnancy During the Study | 0.00 percentage of participants |
Secondary
Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score
Clinical remission was defined as a total mayo score of less than or equal to (\<=) 2 with no sub-score greater than (\>) 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Time frame: Weeks 6 and 14
Population: The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, n (number analyzed) signifies number of participants who were analyzed at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vedolizumab | Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score | Week 6 | 18.2 percentage of participants |
| Vedolizumab | Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score | Week 14 | 39.4 percentage of participants |
Secondary
Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score
Clinical response was defined as a reduction of at least 3 points and a decrease of at least 30% from the baseline mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease.
Time frame: Week 14
Population: The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vedolizumab | Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score | 73.2 percentage of participants |
Secondary
Percentage of Participants With Mucosal Healing at Weeks 6 and 14
Mucosal healing was defined as Mayo endoscopic sub-score of 0 or 1 compared to baseline. Mayo score was an instrument designed to measure disease activity of UC. Endoscopic findings was a sub-score of complete Mayo score, which ranges from 0 to 3 (0= Normal or inactive disease; 1= Mild disease; 2= Moderate disease; 3= Severe disease), with higher scores indicating more severe disease.
Time frame: Weeks 6 and 14
Population: The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, n (number analyzed) signifies number of participants who were analyzed at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vedolizumab | Percentage of Participants With Mucosal Healing at Weeks 6 and 14 | Week 6 | 22.2 percentage of participants |
| Vedolizumab | Percentage of Participants With Mucosal Healing at Weeks 6 and 14 | Week 14 | 49.2 percentage of participants |