Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Conditions
Keywords
Drug Therapy
Brief summary
The main aim of this study is to check the disease activity in people with moderate to severe ulcerative colitis and Crohn's disease. Participants will complete questionnaires about their disease and quality of life on Day 1 clinic visit. They will do this during a standard scheduled appointment with their doctor. Some of this study will also involve collecting information about participants from their medical records.
Detailed description
This is a retrospective, cross-sectional, and non-interventional study of participants with moderate to severe IBD (UC or CD). The study will have a cross-sectional evaluation on Day 1 to provide the real-world data of disease activity, treatment patterns, burden of disease and quality of life in participants with moderate to severe UC or CD. The study will involve an additional retrospective review of medical charts of participants of previous 3 years to describe the IBD treatments and use of other healthcare resources related with the management of UC or DC. The study will enroll approximately 335 participants. All participants will be enrolled in one observational cohort. This multi-center trial will be conducted in Mexico. The overall time for data collection in the study will be approximately 3 years before the start of the study (Day 1).
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. Diagnosed with moderate to severe CD or UC established for at least 6 months prior to Day 1 appointment, based on clinical, endoscopic or image criteria. 2. Participants aged 18 years or older (at the time of diagnosis of moderate to severe UC or CD).
Exclusion criteria
1. Has indeterminate or not classified colitis. 2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Active CD at Day 1 | Day 1 | Percentage of participants with active CD observed, where active CD was defined as Harvey Bradshaw index (HBI) greater than or equal to (\>=) 8 or Crohn's disease active index (CDAI) \>=220. CDAI assessed CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI score was used to measure disease activity of CD and consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicate more severe disease. Percentages are rounded off to whole number at the nearest decimal. |
| Percentage of Participants With Active UC at Day 1 | Day 1 | Percentage of participants with active disease UC disease will be observed, where UC is defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score is composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0 to 2), having mild activity (pMayo of 3 or 4) or moderate to severe activity (pMayo of \>=5). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With CD Based on Clinical Presentation | Day 1 | Number of participants will be reported based on the clinical presentations (location, behavior, perianal disease, achievement of ileal disease and extraintestinal manifestations for CD participants). Clinical presentations that have data for at least one participant in the below categories are reported. Data is reported for participants with CD only. |
| Number of Participants With UC Based on Clinical Presentation | Day 1 | Number of participants will be reported based on the clinical presentations (location, behavior, and extraintestinal manifestations,). Clinical presentations that have data for at least one participant in the below categories are reported. Data is reported for participants with UC only. |
| Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | From 3 years prior to Day 1 until Day 1 | Number of participants will be reported based on the IBD therapies which include aminosalicylates, steroids, immunomodulators, immunosuppressants, biologics, antibiotics, probiotics, and surgeries. A participant can receive more than one IDB therapy. |
| Duration of IBD Therapies | From 3 years prior to Day 1 until Day 1 | Time between the beginning of IBD therapy until the end of treatment or Day 1, whichever comes first. IBD therapies include aminosalicylates, steroids, immunomodulators, immunosuppressants, biologics, antibiotics, probiotics, and surgeries. |
| Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | From 3 years prior to Day 1 until Day 1 | Percentages are rounded off to the nearest single decimal. |
| Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Day 1 | The IBD treatment categories that have data for at least one participant are reported. |
| Number of Participants With HBI >=8 or CDAI >=220 Points Versus HBI <8 or CDAI <220 Points Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in CD Participants | Day 1 | CDAI assessed clinical signs and symptoms: number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0-600 points. Higher score indicates more severe disease. HBI score measures disease activity of CD based on 5 clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicate more severe disease. Socio-demographic variables included age, sex, professional status, educational level, participant income. Clinical variables included duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and EIM. |
| Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants | Day 1 | Mayo score is composed of 4 categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0-2), having mild activity (pMayo of 3-4) or moderate to severe activity (pMayo \>=5). Socio-demographic variables included age, sex, professional status, educational level, participant income. Clinical variables included duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and extraintestinal manifestations (EIM). |
| Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Day 1 | SF-36 is a general quality of life (QoL)-questionnaire, which evaluates 8 health dimensions: physical functioning, bodily pain, role physical (limitations due to physical problems), role emotional (limitations due to personal or emotional problems), mental health, social functioning, vitality, and general health perceptions. Based on these 8 dimensions, two weighted scores were generated: the physical component summary (PCS) score and the mental component summary (MCS) score. Scores range between 0 and 100, with higher scores indicating a better quality of life. Mean score of each component (physical component and mental component) was reported. |
| Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies | From 3 years prior to Day 1 until Day 1 | Percentages are rounded off to the nearest single decimal. |
| Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants | The last 7 days prior to Day 1 | WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean total percentage of work impairment (absenteeism and presentisms) were reported in terms of hours. |
| Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants | The last 7 days prior to Day 1 | WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean work time missed (absenteeism) was reported. |
| Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants | The last 7 days prior to Day 1 | WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean impairment while working (presentisms) was reported. |
| Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants | The last 7 days prior to Day 1 | WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants only answered to questions related to employment status and regular activities impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Mean total activity impairment was reported. |
| Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work | Day 1 | Percentages are rounded off at the nearest single decimal. |
| Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | From 3 years prior to Day 1 until Day 1 | Healthcare resources included hospitalizations, medical appointments, imaging, and laboratory testing. Percentages are rounded off to whole number at the nearest decimal. |
| Total Direct Medical Cost for Participants With UC or CD | From 3 years prior to Day 1 until Day 1 | A cost analysis of Ulcerative Colitis (UC) and Crohn's Disease (CD) was developed, classified by severity as mild and moderate-severe for each of the conditions. Direct medical costs were considered and included the following items: associated comorbidities, intestinal manifestations, surgical procedures, emergency visits, hospitalizations, medical appointments, follow-up studies, and previous pharmacological treatments; this was collected in the study including the number of participants and the proportion of them that presented the items studied. The total direct medical cost for all participants with each of the conditions was obtained, with the average 3-year cost per participant for UC and for CD multiplied by the number of all participants with UC and CD respectively. So, the values reported in the data table below represent the total direct cost for all participants with UC and CD respectively. The total direct cost was in Mexican Peso(MXN). |
| Indirect Cost for Participants With UC or CD | From 3 years prior to Day 1 until Day 1 | A cost analysis of UC and CD was developed, classified by severity as mild and moderate-severe for each condition. Indirect cost was estimated by using number of hours missed from work (absenteeism) multiplied by average hourly labor cost including wages and benefits, to calculate average lost productivity cost per participant due to absenteeism during specified duration. Hours missed from work were assessed by Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answered 6 questions related to work productivity and impairment.The indirect medical cost for all participants with each of the conditions was obtained,with the average 3-year cost per participant for UC and for CD multiplied by the number of all employed participants with UC and CD respectively. So, values reported in data table below represent the indirect cost in totality for all employed participants with UC and CD respectively. The indirect cost is in MXN. |
| Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants | Day 1 | The IBDQ was a 32-item questionnaire that measured 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the sum of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best. The sub-score ranged from 8 to 56 and thus the total score ranged from 32 to 224, where higher score indicating better quality of life. |
| Percentage of Participants With UC or CD Based on Biologic-experience | From 3 years prior to Day 1 until Day 1 | Percentage of participants who have experienced any biologic therapy (examples, infliximab, adalimumab, golimumab, ustekinumab, certolizumab) once or more than once according to medical history until the day 1. Percentages are rounded off to the nearest single decimal. |
Countries
Mexico
Participant flow
Recruitment details
Participants took part in the study at approximately 12 investigative sites in Mexico from 30 August 2021 to 17 May 2022.
Pre-assignment details
Participants with mild to none and moderate to severe inflammatory bowel disease (Ulcerative Colitis or Crohn's Disease) were enrolled in this retrospective observational study. 335 participants were enrolled, but 9 participants had insufficient data to define level of disease activity and they were not included in the analysis. All analysis and comparisons were performed considering 326 participants.
Participants by arm
| Arm | Count |
|---|---|
| Moderate to Severe Crohn's Disease Participants diagnosed with moderate to severe CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the inflammatory bowel disease (IBD) treatments and use of other healthcare resources related with the management of CD. | 43 |
| Mild to None Crohn's Disease Participants diagnosed with mild to none activity of CD were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD. | 52 |
| Moderate to Severe Ulcerative Colitis Participants diagnosed with moderate to severe UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC. | 42 |
| Mild to None Ulcerative Colitis Participants diagnosed with mild to none activity of UC were observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC. | 189 |
| Total | 326 |
Baseline characteristics
| Characteristic | Mild to None Crohn's Disease | Moderate to Severe Ulcerative Colitis | Mild to None Ulcerative Colitis | Total | Moderate to Severe Crohn's Disease |
|---|---|---|---|---|---|
| Age, Continuous | 42.8 years | 43.0 years | 43.4 years | 44.67 years | 49.5 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment Mexico | 52 Participants | 42 Participants | 189 Participants | 326 Participants | 43 Participants |
| Sex: Female, Male Female | 33 Participants | 19 Participants | 114 Participants | 191 Participants | 25 Participants |
| Sex: Female, Male Male | 19 Participants | 23 Participants | 75 Participants | 135 Participants | 18 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 / 43 | 0 / 52 | 0 / 42 | 0 / 189 |
| other Total, other adverse events | 0 / 43 | 0 / 52 | 0 / 42 | 0 / 189 |
| serious Total, serious adverse events | 0 / 43 | 0 / 52 | 0 / 42 | 0 / 189 |
Outcome results
Primary
Percentage of Participants With Active CD at Day 1
Percentage of participants with active CD observed, where active CD was defined as Harvey Bradshaw index (HBI) greater than or equal to (\>=) 8 or Crohn's disease active index (CDAI) \>=220. CDAI assessed CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI score was used to measure disease activity of CD and consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicate more severe disease. Percentages are rounded off to whole number at the nearest decimal.
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data is reported for participants with active CD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Percentage of Participants With Active CD at Day 1 | 45.3 percentage of participants |
Primary
Percentage of Participants With Active UC at Day 1
Percentage of participants with active disease UC disease will be observed, where UC is defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score is composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0 to 2), having mild activity (pMayo of 3 or 4) or moderate to severe activity (pMayo of \>=5).
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data is reported for participants with active UC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Percentage of Participants With Active UC at Day 1 | 18.2 percentage of participants |
Secondary
Duration of IBD Therapies
Time between the beginning of IBD therapy until the end of treatment or Day 1, whichever comes first. IBD therapies include aminosalicylates, steroids, immunomodulators, immunosuppressants, biologics, antibiotics, probiotics, and surgeries.
Time frame: From 3 years prior to Day 1 until Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria. Number analyzed is the number of participants who had a complete duration from start to end date of therapy. Participants with incomplete or missing dates were not included in the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Crohn's Disease | Duration of IBD Therapies | Prednisone | 5.0 months |
| Crohn's Disease | Duration of IBD Therapies | Certolizumab | 15.7 months |
| Crohn's Disease | Duration of IBD Therapies | Azathioprine | 40.3 months |
| Crohn's Disease | Duration of IBD Therapies | Mesalazine (5-ASA) | 42.1 months |
| Crohn's Disease | Duration of IBD Therapies | Other: | 23.8 months |
| Crohn's Disease | Duration of IBD Therapies | Ustekimumab | 66.5 months |
| Crohn's Disease | Duration of IBD Therapies | Adalimumab | 27.5 months |
| Crohn's Disease | Duration of IBD Therapies | Mesalazine Extended release | 31.0 months |
| Crohn's Disease | Duration of IBD Therapies | Infliximab | 10.3 months |
| Crohn's Disease | Duration of IBD Therapies | Hydrocortisone | 0.1 months |
| Crohn's Disease | Duration of IBD Therapies | Sulfasalazine (SSZ) | 0.2 months |
| Crohn's Disease | Duration of IBD Therapies | Metronidazole | 0.2 months |
| Crohn's Disease | Duration of IBD Therapies | Methotrexate | 4.9 months |
| Mild to None Crohn's Disease | Duration of IBD Therapies | Hydrocortisone | 0.1 months |
| Mild to None Crohn's Disease | Duration of IBD Therapies | Mesalazine (5-ASA) | 34.3 months |
| Mild to None Crohn's Disease | Duration of IBD Therapies | Prednisone | 2.9 months |
| Mild to None Crohn's Disease | Duration of IBD Therapies | Azathioprine | 38.6 months |
| Mild to None Crohn's Disease | Duration of IBD Therapies | Infliximab | 62.3 months |
| Mild to None Crohn's Disease | Duration of IBD Therapies | Adalimumab | 34.27 months |
| Mild to None Crohn's Disease | Duration of IBD Therapies | Ustekimumab | 1.0 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Methotrexate | 0.7 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Other: | 2.8 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Adalimumab | 28.6 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Hydrocortisone | 0.2 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Metronidazole | 0.2 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Mesalazine (5-ASA) | 8.4 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Golimumab | 0.3 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Ciprofloxacin | 0.2 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Olsalazine | 60.0 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Sulfasalazine (SSZ) | 33.3 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Budesonide | 2.0 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Prednisone | 1.6 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Infliximab | 21.9 months |
| Moderate to Severe Ulcerative Colitis | Duration of IBD Therapies | Azathioprine | 1.5 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Budesonide | 2.8 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Azathioprine | 45.5 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Hydrocortisone | 0.1 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Metronidazole | 0.2 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Infliximab | 14.2 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Mesalazine (5-ASA) | 54.3 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Adalimumab | 27.5 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Vedolizumab | 9.0 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Other: | 4.5 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Sulfasalazine (SSZ) | 62.3 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Prednisone | 3.0 months |
| Mild to None Ulcerative Colitis | Duration of IBD Therapies | Prednisolone | 3.2 months |
Secondary
Indirect Cost for Participants With UC or CD
A cost analysis of UC and CD was developed, classified by severity as mild and moderate-severe for each condition. Indirect cost was estimated by using number of hours missed from work (absenteeism) multiplied by average hourly labor cost including wages and benefits, to calculate average lost productivity cost per participant due to absenteeism during specified duration. Hours missed from work were assessed by Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answered 6 questions related to work productivity and impairment.The indirect medical cost for all participants with each of the conditions was obtained,with the average 3-year cost per participant for UC and for CD multiplied by the number of all employed participants with UC and CD respectively. So, values reported in data table below represent the indirect cost in totality for all employed participants with UC and CD respectively. The indirect cost is in MXN.
Time frame: From 3 years prior to Day 1 until Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number of participants analyzed is the number of employed participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Indirect Cost for Participants With UC or CD | 394402.91 MXN |
| Mild to None Crohn's Disease | Indirect Cost for Participants With UC or CD | 276419.13 MXN |
| Moderate to Severe Ulcerative Colitis | Indirect Cost for Participants With UC or CD | 77869.29 MXN |
| Mild to None Ulcerative Colitis | Indirect Cost for Participants With UC or CD | 458451.24 MXN |
Secondary
Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants
WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean impairment while working (presentisms) was reported.
Time frame: The last 7 days prior to Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of employed participants with data available for analysis for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants | 33.3 Percentage of Impairment | Standard Deviation 33.85 |
| Mild to None Crohn's Disease | Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants | 30.0 Percentage of Impairment | Standard Deviation 30.4 |
| Moderate to Severe Ulcerative Colitis | Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants | 29.5 Percentage of Impairment | Standard Deviation 22.69 |
| Mild to None Ulcerative Colitis | Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants | 23.1 Percentage of Impairment | Standard Deviation 25.92 |
Secondary
Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants
WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean total percentage of work impairment (absenteeism and presentisms) were reported in terms of hours.
Time frame: The last 7 days prior to Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of employed participants with data available for analysis for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants | 20.337 Percentage of total work impairment | Standard Deviation 19.2252 |
| Mild to None Crohn's Disease | Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants | 21.184 Percentage of total work impairment | Standard Deviation 21.486 |
| Moderate to Severe Ulcerative Colitis | Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants | 24.152 Percentage of total work impairment | Standard Deviation 15.6386 |
| Mild to None Ulcerative Colitis | Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants | 17.700 Percentage of total work impairment | Standard Deviation 19.6796 |
Secondary
Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants
WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Employed participants were evaluated for this outcome measure. Mean work time missed (absenteeism) was reported.
Time frame: The last 7 days prior to Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of employed participants with data available for analysis for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants | 19.873 percentage of work time missed | Standard Deviation 30.6995 |
| Mild to None Crohn's Disease | Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants | 17.285 percentage of work time missed | Standard Deviation 25.1336 |
| Moderate to Severe Ulcerative Colitis | Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants | 9.798 percentage of work time missed | Standard Deviation 16.3332 |
| Mild to None Ulcerative Colitis | Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants | 10.590 percentage of work time missed | Standard Deviation 23.7578 |
Secondary
Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants
WPAI assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The WPAI included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Unemployed participants only answered to questions related to employment status and regular activities impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Mean total activity impairment was reported.
Time frame: The last 7 days prior to Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of employed participants with data available for analysis for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants | 45.7 percentage of total activity impairment | Standard Deviation 35.87 |
| Mild to None Crohn's Disease | Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants | 33.1 percentage of total activity impairment | Standard Deviation 30.76 |
| Moderate to Severe Ulcerative Colitis | Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants | 44.0 percentage of total activity impairment | Standard Deviation 30.45 |
| Mild to None Ulcerative Colitis | Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants | 27.4 percentage of total activity impairment | Standard Deviation 29.53 |
Secondary
Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants
SF-36 is a general quality of life (QoL)-questionnaire, which evaluates 8 health dimensions: physical functioning, bodily pain, role physical (limitations due to physical problems), role emotional (limitations due to personal or emotional problems), mental health, social functioning, vitality, and general health perceptions. Based on these 8 dimensions, two weighted scores were generated: the physical component summary (PCS) score and the mental component summary (MCS) score. Scores range between 0 and 100, with higher scores indicating a better quality of life. Mean score of each component (physical component and mental component) was reported.
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants available for analysis for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Physical Functioning | 64.2 score on a scale | Standard Deviation 28.43 |
| Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Bodily Pain | 52.7 score on a scale | Standard Deviation 28.12 |
| Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Role Physical | 55.5 score on a scale | Standard Deviation 28.87 |
| Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Role Emotional | 55.6 score on a scale | Standard Deviation 28.51 |
| Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Mental Health | 56.6 score on a scale | Standard Deviation 20.43 |
| Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Social Functioning | 53.8 score on a scale | Standard Deviation 29.19 |
| Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Vitality | 43.9 score on a scale | Standard Deviation 20.3 |
| Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | General Health | 43.4 score on a scale | Standard Deviation 20.64 |
| Mild to None Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Social Functioning | 66.6 score on a scale | Standard Deviation 25.09 |
| Mild to None Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Mental Health | 60.9 score on a scale | Standard Deviation 19.82 |
| Mild to None Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Bodily Pain | 65.0 score on a scale | Standard Deviation 27.9 |
| Mild to None Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | General Health | 48.0 score on a scale | Standard Deviation 23.59 |
| Mild to None Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Vitality | 53.7 score on a scale | Standard Deviation 21.23 |
| Mild to None Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Role Emotional | 62.2 score on a scale | Standard Deviation 26.89 |
| Mild to None Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Role Physical | 62.9 score on a scale | Standard Deviation 28.29 |
| Mild to None Crohn's Disease | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Physical Functioning | 77.5 score on a scale | Standard Deviation 24.1 |
| Moderate to Severe Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Vitality | 49.4 score on a scale | Standard Deviation 22.55 |
| Moderate to Severe Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Role Physical | 51.8 score on a scale | Standard Deviation 26.63 |
| Moderate to Severe Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Role Emotional | 57.1 score on a scale | Standard Deviation 28.07 |
| Moderate to Severe Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Mental Health | 56.5 score on a scale | Standard Deviation 22.62 |
| Moderate to Severe Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Social Functioning | 59.2 score on a scale | Standard Deviation 28.7 |
| Moderate to Severe Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | General Health | 43.4 score on a scale | Standard Deviation 22.26 |
| Moderate to Severe Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Physical Functioning | 71.1 score on a scale | Standard Deviation 25.89 |
| Moderate to Severe Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Bodily Pain | 57.5 score on a scale | Standard Deviation 29.36 |
| Mild to None Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Role Physical | 69.9 score on a scale | Standard Deviation 25.43 |
| Mild to None Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Role Emotional | 70.6 score on a scale | Standard Deviation 24.04 |
| Mild to None Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Bodily Pain | 70.6 score on a scale | Standard Deviation 26.09 |
| Mild to None Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Physical Functioning | 81.1 score on a scale | Standard Deviation 22.97 |
| Mild to None Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Mental Health | 64.8 score on a scale | Standard Deviation 19.39 |
| Mild to None Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | General Health | 53.6 score on a scale | Standard Deviation 23.62 |
| Mild to None Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Vitality | 57.2 score on a scale | Standard Deviation 20.56 |
| Mild to None Ulcerative Colitis | Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants | Social Functioning | 69.7 score on a scale | Standard Deviation 26.81 |
Secondary
Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants
The IBDQ was a 32-item questionnaire that measured 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the sum of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best. The sub-score ranged from 8 to 56 and thus the total score ranged from 32 to 224, where higher score indicating better quality of life.
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease | Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants | 144.8 score on a scale | Standard Deviation 42.78 |
| Mild to None Crohn's Disease | Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants | 159.03 score on a scale | Standard Deviation 36 |
| Moderate to Severe Ulcerative Colitis | Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants | 140.2 score on a scale | Standard Deviation 43.67 |
| Mild to None Ulcerative Colitis | Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants | 165.7 score on a scale | Standard Deviation 33.85 |
Secondary
Number of Participants With CD Based on Clinical Presentation
Number of participants will be reported based on the clinical presentations (location, behavior, perianal disease, achievement of ileal disease and extraintestinal manifestations for CD participants). Clinical presentations that have data for at least one participant in the below categories are reported. Data is reported for participants with CD only.
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data is reported for participants with CD only. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants with data available for each category of the clinical presentation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: Stenosing (B2) | 5 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: L1+Isolated Upper GI Tract Disease(L4) | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: Colonic Disease (L2) | 1 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: L2 + L4 | 1 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: Ileocolic(L3) | 4 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: Non stenosing/non penetrating | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: Ileal(L1) | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: B2+Perianal Disease (P) | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: Penetrating (B3) | 1 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: B3+P | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Perianal Disease: None | 4 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Perianal Disease: Indolent Fistula | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Perianal Disease: Active Fistula | 1 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Perianal Disease: Hemorrhoids | 1 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Ileal Disease: Achievement ≥1 | 3 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Ileal Disease: Achievement <1 | 3 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Peripheral arthritis | 3 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Aphthous ulcers | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Episcleritis | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Uveitis | 1 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Osteoporosis | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Anemia | 2 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Hematological alteration | 0 Participants |
| Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Other | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Hematological alteration | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: Ileal(L1) | 9 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Perianal Disease: Active Fistula | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: L1+Isolated Upper GI Tract Disease(L4) | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Episcleritis | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: Colonic Disease (L2) | 5 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Perianal Disease: Hemorrhoids | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: L2 + L4 | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Anemia | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Location: Ileocolic(L3) | 11 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Ileal Disease: Achievement ≥1 | 19 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: Non stenosing/non penetrating | 10 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Uveitis | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: Stenosing (B2) | 12 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Ileal Disease: Achievement <1 | 3 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: B2+Perianal Disease (P) | 2 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Other | 20 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: Penetrating (B3) | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Peripheral arthritis | 4 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Behavior: B3+P | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Osteoporosis | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Perianal Disease: None | 23 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Extraintestinal Manifestations: Aphthous ulcers | 2 Participants |
| Mild to None Crohn's Disease | Number of Participants With CD Based on Clinical Presentation | Perianal Disease: Indolent Fistula | 3 Participants |
Comparison: Extraintestinal manifestations: Hematological alterationp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Otherp-value: =0Chi-squared
Comparison: Location of diseasep-value: =0.0701Chi-squared
Comparison: Disease behaviorp-value: =0.1383Chi-squared
Comparison: Perianal diseasep-value: =0.0478Chi-squared
Comparison: Ileal diseasep-value: =0.1454Chi-squared
Comparison: Extraintestinal manifestations: Peripheral arthritisp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Aphthous ulcersp-value: =0.4992Chi-squared
Comparison: Extraintestinal manifestations: Episcleritisp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Uveitisp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Osteoporosisp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Anemiap-value: =0.2022Chi-squared
Secondary
Number of Participants With HBI >=8 or CDAI >=220 Points Versus HBI <8 or CDAI <220 Points Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in CD Participants
CDAI assessed clinical signs and symptoms: number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0-600 points. Higher score indicates more severe disease. HBI score measures disease activity of CD based on 5 clinical parameters: general well-being, abdominal pain, number of liquid stools/day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicate more severe disease. Socio-demographic variables included age, sex, professional status, educational level, participant income. Clinical variables included duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and EIM.
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data for participants with CD were reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crohn's Disease | Number of Participants With HBI >=8 or CDAI >=220 Points Versus HBI <8 or CDAI <220 Points Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in CD Participants | 43 Participants |
Secondary
Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants
Mayo score is composed of 4 categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0-2), having mild activity (pMayo of 3-4) or moderate to severe activity (pMayo \>=5). Socio-demographic variables included age, sex, professional status, educational level, participant income. Clinical variables included duration and age at diagnosis, steroid dependence or refractoriness, family history, medical history and comorbidities, criteria used for diagnosis, calprotectin and extraintestinal manifestations (EIM).
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data for participants with UC were reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crohn's Disease | Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants | 42 Participants |
Secondary
Number of Participants With UC Based on Clinical Presentation
Number of participants will be reported based on the clinical presentations (location, behavior, and extraintestinal manifestations,). Clinical presentations that have data for at least one participant in the below categories are reported. Data is reported for participants with UC only.
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria. Data is reported for participants with UC only. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants with data available for each category of the clinical presentation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Location - Distal UC: Proctitis(E1) | 2 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Location - Distal UC: Proctosigmoiditis(E1) | 3 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Location - Left sided: Mucosa inflammation extending up to splenic flexure(E2) | 5 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Location - Pancolitis: Mucosa inflammation up to proximal transverse colon and beyond(E3) | 4 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Behavior - clinical remission (asymptomatic)(S0) | 0 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Behavior - mild UC(S1) | 5 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Behavior - moderate UC(S2) | 8 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Behavior - severe UC(S3) | 1 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Peripheral arthritis | 1 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Pyoderma gangrenosum | 0 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Aphthous ulcers | 0 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Primary sclerosing cholangitis | 0 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Osteoporosis | 0 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Anemia | 3 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Hematological alteration | 0 Participants |
| Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Other | 10 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Other | 70 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Location - Distal UC: Proctitis(E1) | 10 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Peripheral arthritis | 23 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Location - Distal UC: Proctosigmoiditis(E1) | 14 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Osteoporosis | 2 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Location - Left sided: Mucosa inflammation extending up to splenic flexure(E2) | 22 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Pyoderma gangrenosum | 2 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Location - Pancolitis: Mucosa inflammation up to proximal transverse colon and beyond(E3) | 52 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Hematological alteration | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Behavior - clinical remission (asymptomatic)(S0) | 43 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Aphthous ulcers | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Behavior - mild UC(S1) | 34 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Anemia | 3 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Behavior - moderate UC(S2) | 18 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Extraintestinal manifestations - Primary sclerosing cholangitis | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC Based on Clinical Presentation | Behavior - severe UC(S3) | 3 Participants |
Comparison: Disease behaviorp-value: =0.0006Chi-squared
Comparison: Location of diseasep-value: =0.2896Chi-squared
Comparison: Extraintestinal manifestations: Peripheral arthritisp-value: =0.089Chi-squared
Comparison: Extraintestinal manifestations: Pyoderma gangrenosump-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Aphthous ulcersp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Primary sclerosing cholangitisp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Osteoporosisp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Anemiap-value: =0.0752Chi-squared
Comparison: Extraintestinal manifestations: Hematological alterationp-value: =1Chi-squared
Comparison: Extraintestinal manifestations: Otherp-value: =0.1032Chi-squared
Secondary
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies
Number of participants will be reported based on the IBD therapies which include aminosalicylates, steroids, immunomodulators, immunosuppressants, biologics, antibiotics, probiotics, and surgeries. A participant can receive more than one IDB therapy.
Time frame: From 3 years prior to Day 1 until Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Prednisolone | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Mesalazine (5-ASA) | 20 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Olsalazine | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Mesalazine extended release | 2 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Hydrocortisone | 4 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Prednisone | 18 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Sulfasalazine (SSZ) | 1 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Budesonide | 5 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Methylprednisolone | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Azathioprine | 14 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | 6-mercaptopurine | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Methotrexate | 4 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Infliximab | 13 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Adalimumab | 21 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Vedolizumab | 1 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Certolizumab | 4 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Golimumab | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Ustekinumab | 13 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Metronidazole | 3 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Ciprofloxacin | 2 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Other | 14 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Salicylic derivatives + Immunosuppressants | 10 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Biologic therapy + Immunosuppressants | 12 Participants |
| Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Salicylic derivatives + Immunosuppressants + Biologic therapy | 19 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Salicylic derivatives + Immunosuppressants + Biologic therapy | 18 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Infliximab | 9 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Mesalazine extended release | 3 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Biologic therapy + Immunosuppressants | 14 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Salicylic derivatives + Immunosuppressants | 19 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Adalimumab | 22 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Methylprednisolone | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Golimumab | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Prednisone | 23 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Vedolizumab | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Olsalazine | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Certolizumab | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Other | 3 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Azathioprine | 19 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Ciprofloxacin | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Mesalazine (5-ASA) | 25 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Budesonide | 9 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | 6-mercaptopurine | 2 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Prednisolone | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Metronidazole | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Sulfasalazine (SSZ) | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Methotrexate | 3 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Hydrocortisone | 3 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Ustekinumab | 8 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | 6-mercaptopurine | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Prednisolone | 2 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Budesonide | 7 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Methylprednisolone | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Azathioprine | 12 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Other | 11 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Ciprofloxacin | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Methotrexate | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Infliximab | 9 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Adalimumab | 4 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Salicylic derivatives + Immunosuppressants | 27 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Vedolizumab | 4 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Certolizumab | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Salicylic derivatives + Immunosuppressants + Biologic therapy | 13 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Golimumab | 2 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Ustekinumab | 2 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Biologic therapy + Immunosuppressants | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Sulfasalazine (SSZ) | 6 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Mesalazine (5-ASA) | 36 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Metronidazole | 2 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Olsalazine | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Mesalazine extended release | 5 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Hydrocortisone | 5 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Prednisone | 19 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Biologic therapy + Immunosuppressants | 4 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Other | 44 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Budesonide | 42 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Sulfasalazine (SSZ) | 14 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | 6-mercaptopurine | 3 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Azathioprine | 81 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Prednisone | 77 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Mesalazine (5-ASA) | 140 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Hydrocortisone | 17 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Methylprednisolone | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Ciprofloxacin | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Olsalazine | 1 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Salicylic derivatives + Immunosuppressants | 122 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Vedolizumab | 9 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Metronidazole | 4 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Certolizumab | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Salicylic derivatives + Immunosuppressants + Biologic therapy | 60 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Adalimumab | 26 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Prednisolone | 3 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Golimumab | 3 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Infliximab | 46 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Methotrexate | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Mesalazine extended release | 52 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies | Ustekinumab | 1 Participants |
Secondary
Number of Participants With UC or CD Introduced With IBD Treatment at Day 1
The IBD treatment categories that have data for at least one participant are reported.
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Infliximab | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Ustekinumab | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Adalimumab | 1 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Vedolizumab | 1 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Sulfasalazine (SSZ) | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Mesalazine extended release | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Ciprofloxacin | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Prednisone | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Budesonide | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Other | 1 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Metronidazole | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Azathioprine | 0 Participants |
| Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Mesalazine (5-ASA) | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Budesonide | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Infliximab | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Mesalazine (5-ASA) | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Ustekinumab | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Prednisone | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Adalimumab | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Other | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Vedolizumab | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Metronidazole | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Ciprofloxacin | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Azathioprine | 1 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Mesalazine extended release | 0 Participants |
| Mild to None Crohn's Disease | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Sulfasalazine (SSZ) | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Mesalazine extended release | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Sulfasalazine (SSZ) | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Mesalazine (5-ASA) | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Adalimumab | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Prednisone | 2 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Budesonide | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Azathioprine | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Infliximab | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Vedolizumab | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Ustekinumab | 0 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Metronidazole | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Ciprofloxacin | 1 Participants |
| Moderate to Severe Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Other | 1 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Ustekinumab | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Budesonide | 3 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Prednisone | 2 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Adalimumab | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Metronidazole | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Mesalazine extended release | 2 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Mesalazine (5-ASA) | 2 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Other | 2 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Ciprofloxacin | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Vedolizumab | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Infliximab | 1 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Azathioprine | 0 Participants |
| Mild to None Ulcerative Colitis | Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 | Sulfasalazine (SSZ) | 2 Participants |
Secondary
Percentage of Participants With UC or CD Based on Biologic-experience
Percentage of participants who have experienced any biologic therapy (examples, infliximab, adalimumab, golimumab, ustekinumab, certolizumab) once or more than once according to medical history until the day 1. Percentages are rounded off to the nearest single decimal.
Time frame: From 3 years prior to Day 1 until Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Percentage of Participants With UC or CD Based on Biologic-experience | 72.0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Biologic-experience | 61.5 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Biologic-experience | 33.0 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Biologic-experience | 33.8 percentage of participants |
Secondary
Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies
Percentages are rounded off to the nearest single decimal.
Time frame: From 3 years prior to Day 1 until Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Poor effectiveness | 34.8 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Unknown | 0 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient access to treatment | 6.9 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient decision | 6.9 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Adverse reaction | 4.6 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient poor adherence | 2.3 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Remission | 0 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Other | 6.9 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Serum level of antidrug | 0 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Comorbidity | 0 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Antibodies | 2.3 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Comorbidity | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Antibodies | 1.9 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Adverse reaction | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient access to treatment | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Remission | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Other | 1.9 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Unknown | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Serum level of antidrug | 1.9 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient poor adherence | 3.8 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient decision | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Poor effectiveness | 15.3 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Serum level of antidrug | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Poor effectiveness | 11.9 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient decision | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Remission | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Unknown | 4.7 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient poor adherence | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Comorbidity | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Adverse reaction | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient access to treatment | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Antibodies | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Other | 11.9 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Comorbidity | 0.5 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Other | 1.0 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Antibodies | 0.5 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient poor adherence | 1.0 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Unknown | 2.1 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Remission | 1.0 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Serum level of antidrug | 0 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient decision | 0 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Poor effectiveness | 9.5 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Patient access to treatment | 0.5 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies | Adverse reaction | 3.7 percentage of participants |
Secondary
Percentage of Participants With UC or CD Categorized Based on Healthcare Resources
Healthcare resources included hospitalizations, medical appointments, imaging, and laboratory testing. Percentages are rounded off to whole number at the nearest decimal.
Time frame: From 3 years prior to Day 1 until Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: IBD Specialist | 67.4 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Hospital Admissions | 37.2 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: Emergency Medical Appointment | 2.3 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Imaging and Laboratory Testing | 60.5 percentage of participants |
| Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: Other Specialist | 4.7 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: Other Specialist | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Hospital Admissions | 17.3 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: IBD Specialist | 59.6 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: Emergency Medical Appointment | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Imaging and Laboratory Testing | 61.5 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Imaging and Laboratory Testing | 52.4 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: Emergency Medical Appointment | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: Other Specialist | 2.4 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Hospital Admissions | 28.6 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: IBD Specialist | 64.3 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: Other Specialist | 4.2 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: IBD Specialist | 66.7 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Medical Appointments: Emergency Medical Appointment | 0 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Hospital Admissions | 12.7 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Categorized Based on Healthcare Resources | Imaging and Laboratory Testing | 67.2 percentage of participants |
Secondary
Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies
Percentages are rounded off to the nearest single decimal.
Time frame: From 3 years prior to Day 1 until Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfill the study eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies | 65.1 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies | 25.0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies | 28.5 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies | 20.1 percentage of participants |
Secondary
Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work
Percentages are rounded off at the nearest single decimal.
Time frame: Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work | 0 percentage of participants |
| Mild to None Crohn's Disease | Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work | 0 percentage of participants |
| Moderate to Severe Ulcerative Colitis | Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work | 4.8 percentage of participants |
| Mild to None Ulcerative Colitis | Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work | 0 percentage of participants |
Secondary
Total Direct Medical Cost for Participants With UC or CD
A cost analysis of Ulcerative Colitis (UC) and Crohn's Disease (CD) was developed, classified by severity as mild and moderate-severe for each of the conditions. Direct medical costs were considered and included the following items: associated comorbidities, intestinal manifestations, surgical procedures, emergency visits, hospitalizations, medical appointments, follow-up studies, and previous pharmacological treatments; this was collected in the study including the number of participants and the proportion of them that presented the items studied. The total direct medical cost for all participants with each of the conditions was obtained, with the average 3-year cost per participant for UC and for CD multiplied by the number of all participants with UC and CD respectively. So, the values reported in the data table below represent the total direct cost for all participants with UC and CD respectively. The total direct cost was in Mexican Peso(MXN).
Time frame: From 3 years prior to Day 1 until Day 1
Population: Enrolled Population Set included all participants who provided written informed consent and fulfilled the study eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crohn's Disease | Total Direct Medical Cost for Participants With UC or CD | 16362506.13 MXN |
| Mild to None Crohn's Disease | Total Direct Medical Cost for Participants With UC or CD | 12611636.50 MXN |
| Moderate to Severe Ulcerative Colitis | Total Direct Medical Cost for Participants With UC or CD | 9673667.75 MXN |
| Mild to None Ulcerative Colitis | Total Direct Medical Cost for Participants With UC or CD | 33842289.53 MXN |