Inflammatory Bowel Disease
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study was to evaluate the impact of the co-morbidities profile on treatment response to biological therapy in inflammatory bowel disease (IBD) participants.
Detailed description
This was a retrospective, non-interventional, observational study that included participants diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013. The study looked at the impact of the co-morbidities on the treatment response in IBD participants. The study enrolled 310 patients included both UC and CD patients. This multicenter trial was conducted in Spain. Investigator collected retrospective data in a single visit from participants who started biologic treatment between June 2011 and June 2013. Time since participants started biological treatment until study visit or until lack of treatment response or until treatment change constituted the reference period for the study.
Interventions
OTHERNo Intervention
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
* Adult participants (aged ≥18). * Were diagnosed with UC or CD according to the World Gastroenterology Organization Practice Guidelines for the Diagnosis and Management of inflammatory bowel disease (IBD) in 2010. * Who were naive to biologics that started treatment with biologics between June 2011 and June 2013. * Participants in whom biological treatment was prescribed according to clinical practice. * Who gave written informed consent.
Exclusion criteria
* Were participating in a clinical trial during the study reference period. * Participant that, according to investigator's criteria was not capable to understand and fill in the study questionnaires or to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy | Up to 10 weeks after start of treatment with biologics | Correlation between co-morbidities profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of 2 points from baseline in Harvey-Bradshaw Indices (HBI) score for CD or Partial Mayo score (PMS) for UC after 10 weeks treatment with anti-tumour necrosis factor (TNF). HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease. |
| Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Up to 6 months after start of treatment with biologics | Correlation between co-morbidities profile and loss of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of IBD Participants With Comorbidities | Day 1 | Participants with CD and UC along with comorbidities were reported. Comorbidity referred to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition. |
| Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy | Up to 10 weeks after start of treatment with biologics | Correlation between extraintestinal manifestations profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of at least 2 points from baseline in HBI score for CD or PMS for UC after 10 weeks treatment with TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease. |
| Percentage of UC Participants With Comorbidities According to the Level of IBD Severity | Day 1 | Participants with UC were classified into IBD severe or non-severe at baseline based on the PMS scores according the following criteria:- PMS score includes 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score is sum of sub scale scores ranging from 0=normal to 9=severe disease. |
| Percentage of CD Participants With Comorbidities According to the Level of IBD Severity | Day 1 | Participants with CD were classified into IBD severe or non-severe at baseline based on the HBI scores according the following criteria:- HBI includes general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease. |
| Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Up to 6 months after start of treatment with biologics | Correlation between extraintestinal manifestations profile and loss of response, adjusted for sociodemographic and clinical profile, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease. |
Countries
Spain
Participant flow
Recruitment details
Participants took part in the study at the 25 investigative sites in Spain from 26 October 2016 to 04 April 2018.
Pre-assignment details
Participants with a diagnosis of ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013, participated in the study. Total 357 participants were registered, out of which only 310 participants were analyzed.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Crohn's Disease Participants with Crohn's disease who received biological treatment between June 2011 and June 2013. | 194 |
| Cohort 2: Ulcerative Colitis Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013. | 116 |
| Total | 310 |
Baseline characteristics
| Characteristic | Cohort 1: Crohn's Disease | Total | Cohort 2: Ulcerative Colitis |
|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 12.8 | 44.9 years STANDARD_DEVIATION 13 | 46.8 years STANDARD_DEVIATION 13.3 |
| Alcohol Abuse No | 189 Participants | 303 Participants | 114 Participants |
| Alcohol Abuse Not Available | 1 Participants | 3 Participants | 2 Participants |
| Alcohol Abuse Yes | 4 Participants | 4 Participants | 0 Participants |
| Level of Education Not Available | 2 Participants | 8 Participants | 6 Participants |
| Level of Education Primary Education | 45 Participants | 75 Participants | 30 Participants |
| Level of Education Secondary Education | 101 Participants | 147 Participants | 46 Participants |
| Level of Education Uneducated | 4 Participants | 6 Participants | 2 Participants |
| Level of Education University Education | 42 Participants | 74 Participants | 32 Participants |
| Race/Ethnicity, Customized Arab | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 189 Participants | 297 Participants | 108 Participants |
| Race/Ethnicity, Customized Gipsy | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Latin | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Available | 1 Participants | 7 Participants | 6 Participants |
| Region of Enrollment Spain | 194 Participants | 310 Participants | 116 Participants |
| Sex/Gender, Customized Female | 90 Participants | 137 Participants | 47 Participants |
| Sex/Gender, Customized Male | 103 Participants | 166 Participants | 63 Participants |
| Sex/Gender, Customized Not Available | 1 Participants | 7 Participants | 6 Participants |
| Smoking Habits Ex-smoker | 52 Participants | 89 Participants | 37 Participants |
| Smoking Habits Non-smoker | 86 Participants | 156 Participants | 70 Participants |
| Smoking Habits Not Available | 1 Participants | 3 Participants | 2 Participants |
| Smoking Habits Smoker | 55 Participants | 62 Participants | 7 Participants |
| Working Status Employed by Other | 115 Participants | 166 Participants | 51 Participants |
| Working Status Housework | 12 Participants | 23 Participants | 11 Participants |
| Working Status Not Available | 2 Participants | 8 Participants | 6 Participants |
| Working Status Other | 1 Participants | 2 Participants | 1 Participants |
| Working Status Permanently Unable to Work | 6 Participants | 9 Participants | 3 Participants |
| Working Status Retired | 16 Participants | 32 Participants | 16 Participants |
| Working Status Self Employed | 15 Participants | 32 Participants | 17 Participants |
| Working Status Student | 6 Participants | 12 Participants | 6 Participants |
| Working Status Temporarily Unable to Work | 4 Participants | 5 Participants | 1 Participants |
| Working Status Unemployed | 17 Participants | 21 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 194 | 0 / 116 |
| other Total, other adverse events | 0 / 194 | 0 / 116 |
| serious Total, serious adverse events | 0 / 194 | 1 / 116 |
Outcome results
Primary
Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
Correlation between co-morbidities profile and loss of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease.
Time frame: Up to 6 months after start of treatment with biologics
Population: Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | IBD | 0.58 odds ratio |
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Corticosteroids | 2.45 odds ratio |
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Myocardial Infarction | 3.30 odds ratio |
Comparison: IBDp-value: 0.044Regression, Logistic
Comparison: Corticosteroidsp-value: 0.003Regression, Logistic
Comparison: Myocardial Infarctionp-value: 0.003Regression, Logistic
Primary
Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy
Correlation between co-morbidities profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of 2 points from baseline in Harvey-Bradshaw Indices (HBI) score for CD or Partial Mayo score (PMS) for UC after 10 weeks treatment with anti-tumour necrosis factor (TNF). HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease.
Time frame: Up to 10 weeks after start of treatment with biologics
Population: Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy | IBD | 0.59 odds ratio |
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy | Corticosteroids | 2.16 odds ratio |
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy | Chronic Obstructive Pulmonary Disease | 2.67 odds ratio |
Comparison: IBDp-value: 0.024Regression, Logistic
Comparison: Corticosteroidsp-value: 0.006Regression, Logistic
Comparison: Chronic Obstructive Pulmonary Diseasep-value: 0.006Regression, Logistic
Secondary
Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy
Correlation between extraintestinal manifestations profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of at least 2 points from baseline in HBI score for CD or PMS for UC after 10 weeks treatment with TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease.
Time frame: Up to 10 weeks after start of treatment with biologics
Population: Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy | 2.08 odds ratio |
Comparison: Corticosteroidsp-value: 0.007Regression, Logistic
Secondary
Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy
Correlation between extraintestinal manifestations profile and loss of response, adjusted for sociodemographic and clinical profile, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease.
Time frame: Up to 6 months after start of treatment with biologics
Population: Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Corticosteroids | 2.57 odds ratio |
| Participants With Inflammatory Bowel Disease (IBD) | Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Skin Disease | 2.73 odds ratio |
Comparison: Corticosteroidsp-value: 0.002Regression, Logistic
Comparison: Skin Diseasep-value: 0.003Regression, Logistic
Secondary
Percentage of CD Participants With Comorbidities According to the Level of IBD Severity
Participants with CD were classified into IBD severe or non-severe at baseline based on the HBI scores according the following criteria:- HBI includes general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, score \<5=remission, 5-7=mild disease, 8-16=moderate disease and \>16=severe disease.
Time frame: Day 1
Population: Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of CD Participants With Comorbidities According to the Level of IBD Severity | Severe Disease | 8.3 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of CD Participants With Comorbidities According to the Level of IBD Severity | Non-Severe Disease | 62.4 percentage of participants |
Secondary
Percentage of IBD Participants With Comorbidities
Participants with CD and UC along with comorbidities were reported. Comorbidity referred to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition.
Time frame: Day 1
Population: Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Cardiovascular Disease | 0.5 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Mild Chronic Hepatopathy | 1.1 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Myocardial Infarction | 2.2 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Diabetes Mellitus | 0.5 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Chronic Obstructive Pulmonary Disease | 3.2 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Diabetes with Lesions in Target Organs | 0.0 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Peripheral Vascular Disease | 1.6 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Solid Tumor | 2.2 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Connective Tissue Disease | 2.7 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Leukemia | 0.0 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Congestive Heart Failure | 1.6 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Lymphoma | 0.5 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Peptic Ulcer Disease | 0.5 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of IBD Participants With Comorbidities | Moderate-Severe Chronic Hepatopathy | 0.5 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Moderate-Severe Chronic Hepatopathy | 0.0 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Myocardial Infarction | 0.9 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Congestive Heart Failure | 0.9 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Peripheral Vascular Disease | 0.0 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Cardiovascular Disease | 2.6 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Chronic Obstructive Pulmonary Disease | 4.4 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Connective Tissue Disease | 3.5 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Peptic Ulcer Disease | 0.9 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Mild Chronic Hepatopathy | 3.5 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Diabetes Mellitus | 5.3 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Diabetes with Lesions in Target Organs | 0.9 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Solid Tumor | 0.9 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Leukemia | 0.9 percentage of participants |
| Cohort 2: Ulcerative Colitis | Percentage of IBD Participants With Comorbidities | Lymphoma | 0.0 percentage of participants |
Secondary
Percentage of UC Participants With Comorbidities According to the Level of IBD Severity
Participants with UC were classified into IBD severe or non-severe at baseline based on the PMS scores according the following criteria:- PMS score includes 3 sub-scores: stool frequency (0=normal to 3=\>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score is sum of sub scale scores ranging from 0=normal to 9=severe disease.
Time frame: Day 1
Population: Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of UC Participants With Comorbidities According to the Level of IBD Severity | Non-Severe Disease | 37.6 percentage of participants |
| Participants With Inflammatory Bowel Disease (IBD) | Percentage of UC Participants With Comorbidities According to the Level of IBD Severity | Severe Disease | 91.7 percentage of participants |