A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)

Percentage of participants with active CD were 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 points. 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 ranged from 0 to 600 points. Higher score indicated more severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score was 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 indicated more severe disease.

Time frame: Day 1

Population: Analysis dataset for disease activity included all participants who fulfilled selection criteria, provided the written informed consent, were without major study protocol deviations, had completed the Day 1 assessment, and who had no ostomy.

Percentage of participants with active disease UC disease were observed, where UC was defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score was composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0 to 3 that are summed to give a total score that ranges from 0 to 12. The pMayo score was previously compared with the full Mayo score and categorized participants as being in remission (score of 0 to 2), having mild disease (pMayo of 3 or 4) or moderate to severe disease (pMayo of \>=5).

Time frame: Day 1

Population: Analysis dataset for disease activity included all participants who fulfilled selection criteria, provided the written informed consent, were without major study protocol deviations, had completed the Day 1 assessment, and who had no ostomy.

The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of two parameters: location and behavior of the disease activity. There were four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) was combined with L4 where disease sites coexisted. There were 4 different categories for the behavior of the disease activity: Behavior 1 (B1) was non stenosing or non penetrating; Behavior 2 (B2) was stenosing; Behavior 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

Time between the beginning of IBD treatment until the end of treatment. For participants with ongoing IBD treatment at Day 1, stop date was considered as Day 1 date visit. Various types of therapies for IBD included salicylic derivates, corticosteroids, immunosuppressors, biologic therapy, antibiotics, nutrition support and others. One participant could use more than one therapy.

Time frame: Within previous 3 years including Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Participants available for this outcome measure at given time period were included for assessment.

IBDQ was a 32-item questionnaire that measured 4 dimensions: bowel systems, emotional health, systemic systems, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the average of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best function.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Participants available for this outcome measure at given time period were included for assessment.

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: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

WPAI assessed impact of IBD on work productivity and daily activities in past 7 days. WPAI questions were: 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 generates 4 component scores: percentage of work time missed (absenteeism), percentage of impairment while working (presenteeism), percentage of overall work impairment (absenteeism and presenteeism combined), and percentage of activity impairment. Percentage of impairment while working was calculated based on 1 item: (Q5) to what degree did disease impair productivity while working in past 7 days. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). Data was calculated by following formula: Q5/10\*100 (converted to percent), where higher numbers indicated greater impairment and less productivity.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Here overall number of participants analyzed are participants evaluable for this outcome measure.

WPAI assessed impact of IBD on work productivity and daily activities in past 7 days. WPAI questions were: if currently employed, 2) hours (hrs) missed due to disease, 3) hrs missed other reasons, 4) hrs actually worked, 5) degree disease affected productivity while working, 6) degree disease affected regular activities. WPAI generates 4 component scores: percentage (%) of work time missed (absenteeism), % of impairment while working (presenteeism), % of overall work impairment (absenteeism and presenteeism combined), and % of activity impairment. % of total activity impairment was calculated based on: (Q6) in past 7 days, how much did your health problems affect your ability to do your regular daily activities, other than work at a job. Item was measured on scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). Data was calculated by: Q6/10\*100 (converted to percent), where higher numbers indicated greater impairment and less productivity.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

WPAI assessed impact of IBD on work productivity and daily activities in past 7 days. WPAI questions were: if currently employed, 2) hours (hrs) missed due to disease, 3) hrs missed other reasons, 4) hrs actually worked, 5) degree disease affected productivity while working, 6) degree disease affected regular activities. WPAI generates 4 component scores: percentage (%) of work time missed (absenteeism), % of impairment while working (presenteeism), % of overall work impairment (absenteeism and presenteeism combined), and % of activity impairment. TWPI was calculated based on 3 items: (Q2) number of hrs missed from work due to health problems in the past 7 days; (Q4) number of actual work hrs in past 7 days; and (Q5) to what degree did disease impair productivity while working in past 7 days. Data was calculated by: Q2/(Q2+Q4)+(\[1-(Q2/\[Q2+Q4\])\*(Q5/10\])\*100 (converted to %). Data is presented as impairment percentage, with higher numbers indicating greater impairment/less productivity.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period.

WPAI assessed impact of IBD on work productivity and daily activities in past 7 days. WPAI questions were: 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 generates 4 component scores: percentage of work time missed (absenteeism), percentage of impairment while working (presenteeism), percentage of overall work impairment (absenteeism and presenteeism combined), and percentage of activity impairment. Work time missed was calculated based on 2 items: (Q2) number of hours missed from work due to health problems in the past 7 days; and (Q4) number of actual work hours in past 7 days. Data was calculated by following formula:Q2/(Q2+Q4)\*100 (converted to %), where higher numbers indicated greater impairment and less productivity.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Here overall number of participants analyzed are participants evaluable for this outcome measure.

Participants were stratified based on gender, professional status, educational level and income.

Time frame: Day 1

Population: Analysis dataset for disease activity included all participants who fulfilled selection criteria, provided the written informed consent, were without major study protocol deviations, had completed the Day 1 assessment, and who had no ostomy.

Medical history was defined as an EIM or non-EIM according to the investigator's judgement.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

Anthropometric information included height, weight and body mass index (BMI). BMI ranges: underweight (BMI less than \[\<\] 18.50 kilogram per square meter (kg/m\^2), normal range (BMI between 18.50 and 24.99 kg/m\^2), overweight (BMI between 25.00 and 29.99 kg/m\^2), obese (BMI \>=30.00 kg/m\^2).

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

Biologic therapies included infliximab, adalimumab, vedolizumab, certolizumab, golimumab, and ustekimumab. For participants with ongoing biologic therapy at Day 1, stop date was considered as Day 1 date visit.

Time frame: Within previous 3 years including Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided written informed consent, were without major protocol deviations, and who had completed Day 1 assessment. Here overall number of participants analyzed are participants who had biologic therapies, and who were available for assessment at given time period.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

Time frame: Within previous 3 years including Day 1

Population: Analysis dataset for disease activity included all participants who fulfilled selection criteria, provided the written informed consent, were without major study protocol deviations, had completed the Day 1 assessment, and who had no ostomy.

Healthcare resources included drug therapies, imaging and laboratory testing, surgeries, hospitalizations and consultations.

Time frame: Within previous 3 years including Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

Various types of therapies for IBD included salicylic derivatives, corticosteroids, immunosuppressors, biologic therapy, antibiotics, nutrition support and others. One participant could use more than one therapy.

Time frame: Within previous 3 years including Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

Time frame: Day 1

Population: Due to change in planned analysis, data was not collected and analyzed. Percentage of participants who quit job due to IBD and have not been able to return to work was not calculated since this variable was not captured in case report form.

The SF-36 evaluated 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 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score was generated which ranged between 0 and 100, with higher scores indicating a better quality of life. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score was generated which ranged between 0 and 100, with higher scores indicating a better quality of life.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Participants available for this outcome measure at given time period were included for the assessment.

EQ-5D considered five attributes of quality of life evaluation, that is, mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension had five possible levels: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems), and; 5 (extreme problems). EQ-5D also included an additional visual analogic scale (EQ-VAS), which ranged from 0 to 100, where 0 indicated worst imaginable health state and 100 was best imaginable health state.

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment.

Montreal classification index for UC was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent of inflammation: Extent 1 (E1) =Ulcerative distal UC proctitis and proctosigmoiditis, Extent 2 (E2) =Left-sided mucosa inflammation extending up to splenic flexure and Extent 3 (E3) =Pancolitis mucosa inflammation up to proximal transverse colon and beyond. Severity of UC as S0=Clinical remission (asymptomatic),S1 =Mild UC (passage of four or fewer stools/day \[with or without blood\],absence of any systemic illness, and normal inflammatory markers),S2 =Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity),S3 =Severe UC (passage of at least 6 bloody stools daily, pulse rate of at least 90 beats per minute, temperature of at least 37.5 degree Celsius, hemoglobin of \<10.5 gram per 100 milliliter (g/100mL), and erythrocyte sedimentation rate (ESR) of at least 30 millimeter per hour (mm/h).

Time frame: Day 1

Population: Analysis dataset by IBD included all participants who fulfilled selection criteria, provided the written informed consent, were without major protocol deviations, and who had completed the Day 1 assessment. Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period.