Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).
Detailed description
This is a non-interventional, retrospective and prospective study of participants with IBD. This study will collect data to provide accurate and comprehensive information related to treatment patterns associated with biologics use or non-biological therapy in participants with moderate to severe UC and CD in routine clinical practice. The study will have retrospective data collection from past records of participants within the last 2 years before participant's enrollment. The prospective part of the study will include one year of observation and data collection after the participant's enrollment in the study. The study will enroll approximately 2000 participants. Participants will be enrolled in one of the two groups: * UC Participants * CD Participants This multi-center trial will be conducted in Russia, Belarus and Kazakhstan. The overall period of observation in this study will be approximately 12 months. Participants will make 2 visits within their routine practice to the clinic after the enrollment into the study including a final visit at Month 12.
Interventions
None listed
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study. 2. Has a moderate to severe IBD flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. IBD flare(s) must be confirmed in the source documentation. 3. Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy.
Exclusion criteria
1. Current or previous (within the last two years) indeterminate or not classified colitis. 2. Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years. 3. Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial. 4. Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 5. Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | Treatment pattern with biologics agents or non-biological therapy included unique treatments combinations, Like\>5-ASA1(Start with 5-ASA:5-ASA→Systemic biologics \[SB\] +/- STER+/-standard therapy\[ST\]),\>5ASA2(without \[w/o\] STER),\>5ASA3(5-ASA→STER+/-ST),\>5ASA4(5-ASA→IS),\>5ASA 5(5-ASA→5-ASA+/-IS),\>5ASA6(5-ASA→ NOTR),\>5ASA7(5-ASA),\>NOTR1(NOTR→Biologics \[BIO\]+/-ST+/-STER),\>NOTR 2(TR→ST+/-STER),\>NOTR 3(NOTR),\>IS1(IS→SB+STER+/-ST),\>IS2(IS→SB+ST w/o STER),\>IS 3(IS→STER+/-ST),\>IS4(IS→5-ASA),\>IS5(IS→NOTR),\>IS6(IS→5-ASA+IS),\>IS7(IS mono),\>IS+5ASA1(IS+5-ASA→SB +/-ST),\>IS+5ASA2(IS+5-ASA→SB ±ST w/o STER),\>IS+5ASA3(IS+5-ASA→STER+/-ST),\>IS+5ASA4(IS+5-ASA→NOTR),\>IS+5ASA5(IS+5-ASA→IS),\>IS+5ASA6(IS+5-ASA→5-ASA),\>IS+5ASA7(IS+5-ASA),\>BIO1(SB+/-STER+/-ST→withdrawal \[w/d\] of SB+ST+/-STER),\>BIO2(SB+/-STER+/-ST),\>BIO3(SB+/-STER+/-ST→NOTR),\>BIO4(SB+/-STER+/-ST→SB mono),\>STER1(STER+/-ST→w/d of STER+SB+/-ST),\>STER2(STER+/-ST→w/d of STER+ST),\>STER3(STER+/-ST→SB+STER+/-ST),\>STER4(STER+/-ST→NOTR),\>STER5(STER+/-ST). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Stratified by Disease Severity | At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period | Disease Severity was defined using Harvey-Bradshaw Index (HBI) and mayo index. HBI is validated clinical index for evaluation of CD disease severity, including the 5 categories: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score less than (\<) 5 was remission, score 5-7 was mild activity, score 8-16 was moderate, and score \>16 was severe. Mayo index was used for evaluation of UC disease severity. Mayo index is an instrument consisting of 4 categories of: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each sub score graded from 0 to 3. The score ranges from 0 to 12, where score \<2 was remission, score 3-5 was mild, score 6-10 was moderate, and score \>10 was severe. |
| Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | From Baseline Visit (Day 1) up to 12 months | Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, magnetic resonance imaging (MRI) and ultrasound examination. Number of participants whose disease activity was evaluated using the respective methods were reported. |
| Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | From Baseline Visit (Day 1) up to 12 months | Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, MRI and ultrasound examination. Biomarkers was based on evaluation of C-reactive protein (CRP) and/or fecal calprotectin levels. Endoscopy included colonoscopy/rectoromanoscopy/sigmoidoscopy and/or video capsule endoscopy and/or esophagogastroduodenoscopy (in the presence or suspicion of the presence of lesions of the upper gastrointestinal tract in Crohn's disease), X-ray was used for examination of the intestine to exclude stricturing and other lesions, MRI was used for examination of the intestine to exclude stricturing and other lesions using MRI and ultrasound for examination of the intestine to exclude stricturing and other lesions. Number of assessments using different methods in participants with UC and CD disease activity was summarized for specified methods and reported in terms of mean and standard deviation. |
| UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period | The full Mayo index is an instrument to measure disease activity of UC. It consists of 4 parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score ranged from 0 (normal or inactive disease) to 3 (severe activity). The score ranged from 0 to 12, where score \<2 was remission, score 3-5 was mild activity, score 6-10 was moderate activity, and score \>10 was severe activity. Higher scores indicating higher disease activity. |
| CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period | HBI was used for evaluation of CD remission. It is a validated clinical index for CD, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score \<5 was remission, score 5-7 was mild activity, score 8-16 was moderate activity, and score \>16 was severe activity. Higher scores indicating higher disease activity. |
| Number of Participants Stratified by Location of Disease | Within 1 year prior to Baseline (Visit 1) | — |
| Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | — |
| Percentage of Participants Stratified by Achieving the Treatment Goals | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | Treat to target (T2T) approach was used for assessment of treatment goals. A Treat to target approach for UC included clinical remission (defined as resolution of rectal bleeding and diarrhea/altered bowel habit) and endoscopic remission (defined as Mayo endoscopic subscore of 0-1). Biomarker remission (normal C-reactive protein \[CRP\] and calprotectin) was considered as an adjunctive target. Histological remission was considered as an adjunctive goal. Clinical remission for CD was defined as resolution of abdominal pain and diarrhea/altered bowel habit. Endoscopic remission for CD was defined as resolution of ulceration at ileocolonoscopy or resolution of findings of inflammation on cross-sectional imaging in participants who cannot be adequately assessed with ileocolonoscopy. Biomarker remission (normal CRP and faecal calprotectin) was considered as an adjunctive target. |
| Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | Other challenges included absence or inaccessibility of MRI (technical problems), participants financial difficulties, disability and bureaucratic problems, unavailability of biotherapy, limited quotas, referral of participants to other centers, absence of biotherapy treatment quotas, difficulty in performing computed tomography (CT). |
| Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | — |
| Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | Indications for surgical treatment included aggravation, intestinal bleeding, colon perforation, internal fistulas, abdominal cavity infiltrate, Interintestinal or Intraabdominal abscess, strictures in the gastrointestinal tract, anal fissures, and other. Types of surgeries includes both emergency and planned. |
| Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | — |
Countries
Belarus, Kazakhstan, Russia
Participant flow
Recruitment details
Participants took part in the study at the 36 investigative sites in Russia, Belarus and Kazakhstan from 20 July 2018 to 08 November 2021.
Pre-assignment details
Participants diagnosed with moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD) were observed retrospectively within 2 years before enrollment and prospectively one year after enrollment. A total of 1990 participants were enrolled (signed informed consent) into the study, of which 89 were screen failures. 1901 participants started the study and were analyzed in the study.
Participants by arm
| Arm | Count |
|---|---|
| UC Participants Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. | 1,214 |
| CD Participants Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. | 687 |
| Total | 1,901 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Appearance of Exclusion Criteria | 9 | 11 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 15 | 9 |
| Overall Study | Other | 11 | 16 |
| Overall Study | Protocol Deviation | 33 | 31 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | UC Participants | CD Participants | Total |
|---|---|---|---|
| Age at Disease Onset | 34.46 years STANDARD_DEVIATION 13.17 | 30.79 years STANDARD_DEVIATION 13.57 | 33.14 years STANDARD_DEVIATION 13.43 |
| Age, Continuous | 41.44 years STANDARD_DEVIATION 13.63 | 36.44 years STANDARD_DEVIATION 13.9 | 39.63 years STANDARD_DEVIATION 13.93 |
| Clinical Course of IBD Acute Form (Less than 6 months Since the Onset of the Illness) | 13 Participants | 9 Participants | 22 Participants |
| Clinical Course of IBD Chronic Continuous Form (Absence of Remission Longer Than 6 months Despite Adequate Treatment) | 362 Participants | 293 Participants | 655 Participants |
| Clinical Course of IBD Chronic Relapsing Course (With Remission Periods Longer Than 6 months) | 839 Participants | 385 Participants | 1224 Participants |
| Complications of IBD Had Complications of IBD | 111 Participants | 317 Participants | 428 Participants |
| Complications of IBD Had no Complications of IBD | 1103 Participants | 370 Participants | 1473 Participants |
| Disability Had Disability | 392 Participants | 341 Participants | 733 Participants |
| Disability Had no Disability | 822 Participants | 346 Participants | 1168 Participants |
| Employment Status Employed | 702 Participants | 343 Participants | 1045 Participants |
| Employment Status Other | 39 Participants | 22 Participants | 61 Participants |
| Employment Status Pensioner | 133 Participants | 54 Participants | 187 Participants |
| Employment Status Student | 53 Participants | 79 Participants | 132 Participants |
| Employment Status Unemployed | 287 Participants | 189 Participants | 476 Participants |
| Extraintestinal Manifestation (EIM) | 295 Participants | 229 Participants | 524 Participants |
| Family History of Inflammatory Bowel Disease (IBD) With IBD History | 34 Participants | 21 Participants | 55 Participants |
| Family History of Inflammatory Bowel Disease (IBD) Without IBD History | 1180 Participants | 666 Participants | 1846 Participants |
| Had Medical History | 274 Participants | 178 Participants | 452 Participants |
| Race/Ethnicity, Customized Baskirian | 24 Participants | 1 Participants | 25 Participants |
| Race/Ethnicity, Customized Belarusian | 24 Participants | 14 Participants | 38 Participants |
| Race/Ethnicity, Customized Chuvash | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Kazakh | 88 Participants | 21 Participants | 109 Participants |
| Race/Ethnicity, Customized Other | 81 Participants | 36 Participants | 117 Participants |
| Race/Ethnicity, Customized Russian | 858 Participants | 574 Participants | 1432 Participants |
| Race/Ethnicity, Customized Tartarian | 133 Participants | 38 Participants | 171 Participants |
| Race/Ethnicity, Customized Ukrainian | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment Belarus | 30 Participants | 14 Participants | 44 Participants |
| Region of Enrollment Kazakhstan | 121 Participants | 30 Participants | 151 Participants |
| Region of Enrollment Russia | 1063 Participants | 643 Participants | 1706 Participants |
| Sex: Female, Male Female | 582 Participants | 341 Participants | 923 Participants |
| Sex: Female, Male Male | 632 Participants | 346 Participants | 978 Participants |
| Smoking Status Current Smoker | 66 Participants | 75 Participants | 141 Participants |
| Smoking Status Ex-smoker | 211 Participants | 93 Participants | 304 Participants |
| Smoking Status Non-smoker and Never Smoked Before | 937 Participants | 519 Participants | 1456 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 1,214 | 5 / 687 |
| other Total, other adverse events | 48 / 1,214 | 31 / 687 |
| serious Total, serious adverse events | 146 / 1,214 | 84 / 687 |
Outcome results
Primary
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD
Treatment pattern with biologics agents or non-biological therapy included unique treatments combinations, Like\>5-ASA1(Start with 5-ASA:5-ASA→Systemic biologics \[SB\] +/- STER+/-standard therapy\[ST\]),\>5ASA2(without \[w/o\] STER),\>5ASA3(5-ASA→STER+/-ST),\>5ASA4(5-ASA→IS),\>5ASA 5(5-ASA→5-ASA+/-IS),\>5ASA6(5-ASA→ NOTR),\>5ASA7(5-ASA),\>NOTR1(NOTR→Biologics \[BIO\]+/-ST+/-STER),\>NOTR 2(TR→ST+/-STER),\>NOTR 3(NOTR),\>IS1(IS→SB+STER+/-ST),\>IS2(IS→SB+ST w/o STER),\>IS 3(IS→STER+/-ST),\>IS4(IS→5-ASA),\>IS5(IS→NOTR),\>IS6(IS→5-ASA+IS),\>IS7(IS mono),\>IS+5ASA1(IS+5-ASA→SB +/-ST),\>IS+5ASA2(IS+5-ASA→SB ±ST w/o STER),\>IS+5ASA3(IS+5-ASA→STER+/-ST),\>IS+5ASA4(IS+5-ASA→NOTR),\>IS+5ASA5(IS+5-ASA→IS),\>IS+5ASA6(IS+5-ASA→5-ASA),\>IS+5ASA7(IS+5-ASA),\>BIO1(SB+/-STER+/-ST→withdrawal \[w/d\] of SB+ST+/-STER),\>BIO2(SB+/-STER+/-ST),\>BIO3(SB+/-STER+/-ST→NOTR),\>BIO4(SB+/-STER+/-ST→SB mono),\>STER1(STER+/-ST→w/d of STER+SB+/-ST),\>STER2(STER+/-ST→w/d of STER+ST),\>STER3(STER+/-ST→SB+STER+/-ST),\>STER4(STER+/-ST→NOTR),\>STER5(STER+/-ST).
Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 1 | 8 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 6 | 22 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 2 | 15 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >BIO 4 | 9 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 3 | 22 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 4 | 9 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 4 | 6 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >Immunosuppressive (IS) 1 | 2 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 5 | 3 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 7 | 73 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 6 | 8 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 2 | 6 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 7 | 22 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | > 5ASA 3 | 192 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >No IBD Therapy (NO TR) 1 | 69 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 3 | 3 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >NO TR 2 | 217 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >BIO 1 | 28 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >NO TR 3 | 8 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 4 | 2 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >Steroids (STER) 1 | 45 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 5 | 46 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >STER 2 | 95 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 5 | 1 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >STER 3 | 13 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >BIO 2 | 71 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >STER 4 | 14 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 6 | 3 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >STER 5 | 8 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 2 | 38 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | Pattern with combination of biologics (BIO COMB) | 35 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 7 | 1 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | Vedolizumab | 58 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >BIO 3 | 7 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | Other | 22 Participants |
| UC Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | Greater than (>) 5-aminosalicylic acid (5ASA) 1 | 33 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | Other | 19 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | Greater than (>) 5-aminosalicylic acid (5ASA) 1 | 16 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 2 | 14 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | > 5ASA 3 | 30 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 4 | 5 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 5 | 7 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 6 | 8 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >5ASA 7 | 5 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >BIO 1 | 20 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >BIO 2 | 96 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >BIO 3 | 22 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >BIO 4 | 19 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >Immunosuppressive (IS) 1 | 13 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 2 | 20 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 3 | 6 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 4 | 3 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 5 | 5 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 6 | 3 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS 7 | 9 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 1 | 8 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 2 | 9 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 3 | 10 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 4 | 7 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 5 | 3 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 6 | 5 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >IS+5ASA 7 | 9 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >No IBD Therapy (NO TR) 1 | 54 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >NO TR 2 | 76 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >NO TR 3 | 0 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >Steroids (STER) 1 | 35 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >STER 2 | 28 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >STER 3 | 14 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >STER 4 | 6 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | >STER 5 | 2 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | Pattern with combination of biologics (BIO COMB) | 44 Participants |
| CD Participants | Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD | Vedolizumab | 57 Participants |
Secondary
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
HBI was used for evaluation of CD remission. It is a validated clinical index for CD, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score \<5 was remission, score 5-7 was mild activity, score 8-16 was moderate activity, and score \>16 was severe activity. Higher scores indicating higher disease activity.
Time frame: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 1: Remission | 50.31 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 1: Mild Activity | 25.94 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 1: Moderate Activity | 22.50 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 1: Severe Activity | 1.25 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 2: Remission | 67.53 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 2: Mild Activity | 23.71 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 2: Moderate Activity | 8.57 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 2: Severe Activity | 0.20 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 3: Remission | 72.20 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 3: Mild Activity | 20.60 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 3: Moderate Activity | 6.80 percentage of participants |
| UC Participants | CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI | Visit 3: Severe Activity | 0.40 percentage of participants |
Secondary
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity
Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, MRI and ultrasound examination. Biomarkers was based on evaluation of C-reactive protein (CRP) and/or fecal calprotectin levels. Endoscopy included colonoscopy/rectoromanoscopy/sigmoidoscopy and/or video capsule endoscopy and/or esophagogastroduodenoscopy (in the presence or suspicion of the presence of lesions of the upper gastrointestinal tract in Crohn's disease), X-ray was used for examination of the intestine to exclude stricturing and other lesions, MRI was used for examination of the intestine to exclude stricturing and other lesions using MRI and ultrasound for examination of the intestine to exclude stricturing and other lesions. Number of assessments using different methods in participants with UC and CD disease activity was summarized for specified methods and reported in terms of mean and standard deviation.
Time frame: From Baseline Visit (Day 1) up to 12 months
Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | Biomarkers | 4.52 assessments | Standard Deviation 4.88 |
| UC Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | Endoscopy | 2.60 assessments | Standard Deviation 1.57 |
| UC Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | Biopsy | 1.38 assessments | Standard Deviation 1.24 |
| UC Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | X-ray Examination | 0.23 assessments | Standard Deviation 0.59 |
| UC Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | MRI Examination | 0.15 assessments | Standard Deviation 0.46 |
| UC Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | Ultrasound Examination | 0.53 assessments | Standard Deviation 1.32 |
| CD Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | MRI Examination | 1.10 assessments | Standard Deviation 1.44 |
| CD Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | Biomarkers | 6.74 assessments | Standard Deviation 7.11 |
| CD Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | X-ray Examination | 0.62 assessments | Standard Deviation 1.13 |
| CD Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | Endoscopy | 2.31 assessments | Standard Deviation 1.39 |
| CD Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | Ultrasound Examination | 1.10 assessments | Standard Deviation 1.95 |
| CD Participants | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | Biopsy | 1.11 assessments | Standard Deviation 1.16 |
Secondary
Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice
Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, magnetic resonance imaging (MRI) and ultrasound examination. Number of participants whose disease activity was evaluated using the respective methods were reported.
Time frame: From Baseline Visit (Day 1) up to 12 months
Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Biomarkers | 1151 Participants |
| UC Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Endoscopy | 1188 Participants |
| UC Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Biopsy | 901 Participants |
| UC Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | X-ray Examination | 206 Participants |
| UC Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | MRI Examination | 138 Participants |
| UC Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Ultrasound Examination | 283 Participants |
| CD Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | MRI Examination | 369 Participants |
| CD Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Biomarkers | 662 Participants |
| CD Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | X-ray Examination | 239 Participants |
| CD Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Endoscopy | 656 Participants |
| CD Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Ultrasound Examination | 254 Participants |
| CD Participants | Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice | Biopsy | 453 Participants |
Secondary
Number of Participants Stratified by Disease Severity
Disease Severity was defined using Harvey-Bradshaw Index (HBI) and mayo index. HBI is validated clinical index for evaluation of CD disease severity, including the 5 categories: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score less than (\<) 5 was remission, score 5-7 was mild activity, score 8-16 was moderate, and score \>16 was severe. Mayo index was used for evaluation of UC disease severity. Mayo index is an instrument consisting of 4 categories of: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each sub score graded from 0 to 3. The score ranges from 0 to 12, where score \<2 was remission, score 3-5 was mild, score 6-10 was moderate, and score \>10 was severe.
Time frame: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 1: Remission | 211 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 1: Mild | 406 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 1: Moderate | 522 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 1: Severe | 14 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 2: Remission | 576 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 2: Mild | 300 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 3: Remission | 614 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 2: Moderate | 105 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 2: Severe | 3 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 3: Mild | 250 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 3: Moderate | 81 Participants |
| UC Participants | Number of Participants Stratified by Disease Severity | Visit 3: Severe | 0 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 3: Moderate | 34 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 1: Remission | 322 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 3: Mild | 103 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 1: Mild | 166 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 2: Moderate | 43 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 1: Moderate | 144 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 3: Severe | 2 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 1: Severe | 8 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 2: Severe | 1 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 2: Remission | 339 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 3: Remission | 361 Participants |
| CD Participants | Number of Participants Stratified by Disease Severity | Visit 2: Mild | 119 Participants |
Secondary
Number of Participants Stratified by Location of Disease
Time frame: Within 1 year prior to Baseline (Visit 1)
Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC Participants | Number of Participants Stratified by Location of Disease | Lining of the Rectum | 107 Participants |
| UC Participants | Number of Participants Stratified by Location of Disease | Left Side of Colon | 623 Participants |
| UC Participants | Number of Participants Stratified by Location of Disease | Ileum | 0 Participants |
| UC Participants | Number of Participants Stratified by Location of Disease | Colon | 750 Participants |
| UC Participants | Number of Participants Stratified by Location of Disease | Ileum and Colon | 0 Participants |
| UC Participants | Number of Participants Stratified by Location of Disease | Upper Gastrointestinal Tract | 0 Participants |
| CD Participants | Number of Participants Stratified by Location of Disease | Ileum and Colon | 331 Participants |
| CD Participants | Number of Participants Stratified by Location of Disease | Lining of the Rectum | 0 Participants |
| CD Participants | Number of Participants Stratified by Location of Disease | Colon | 183 Participants |
| CD Participants | Number of Participants Stratified by Location of Disease | Left Side of Colon | 0 Participants |
| CD Participants | Number of Participants Stratified by Location of Disease | Upper Gastrointestinal Tract | 4 Participants |
| CD Participants | Number of Participants Stratified by Location of Disease | Ileum | 146 Participants |
Secondary
Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment
Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC Participants | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | If an Exacerbation or Deterioration Developed | 0 Participants |
| UC Participants | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | Every 3 months, as well as in the Development of Exacerbation or Deterioration | 14 Participants |
| UC Participants | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | Every six months, as well as When the Exacerbation or Deterioration | 11 Participants |
| UC Participants | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | Once a year, as well as in the Case of the Development of Exacerbation or Deteriorations | 9 Participants |
| CD Participants | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | Once a year, as well as in the Case of the Development of Exacerbation or Deteriorations | 8 Participants |
| CD Participants | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | If an Exacerbation or Deterioration Developed | 1 Participants |
| CD Participants | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | Every six months, as well as When the Exacerbation or Deterioration | 15 Participants |
| CD Participants | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | Every 3 months, as well as in the Development of Exacerbation or Deterioration | 10 Participants |
Secondary
Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy
Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| UC Participants | Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy | 1203 Participants |
| CD Participants | Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy | 670 Participants |
Secondary
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
Other challenges included absence or inaccessibility of MRI (technical problems), participants financial difficulties, disability and bureaucratic problems, unavailability of biotherapy, limited quotas, referral of participants to other centers, absence of biotherapy treatment quotas, difficulty in performing computed tomography (CT).
Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Unwillingness to Undergo Colonoscopy | 40.0 percentage of participants |
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Difficulties or Unavailability of Certain Drugs | 65.7 percentage of participants |
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Participant's Non-compliance With Drug Therapy | 45.7 percentage of participants |
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Workload of Doctor | 28.6 percentage of participants |
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Participant's Failure to Follow Visit Scheduled With Physician | 40.0 percentage of participants |
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Lack of Participants Record System and Monitoring | 25.7 percentage of participants |
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Resistant Course of Disease | 71.4 percentage of participants |
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Other | 14.3 percentage of participants |
| UC Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Difficulties or Inaccessibility of Colonoscopy | 28.6 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Other | 20.0 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Difficulties or Inaccessibility of Colonoscopy | 28.6 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Unwillingness to Undergo Colonoscopy | 45.7 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Participant's Failure to Follow Visit Scheduled With Physician | 40.0 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Participant's Non-compliance With Drug Therapy | 51.4 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Resistant Course of Disease | 71.4 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Difficulties or Unavailability of Certain Drugs | 57.1 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Workload of Doctor | 22.9 percentage of participants |
| CD Participants | Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice | Lack of Participants Record System and Monitoring | 22.9 percentage of participants |
Secondary
Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD
Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants | Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD | Hospitalizations due to Complications | 2.14 percentage of participants |
| UC Participants | Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD | IBD Related Surgeries | 0.33 percentage of participants |
| UC Participants | Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD | IBD Related Disability | 29.57 percentage of participants |
| CD Participants | Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD | Hospitalizations due to Complications | 3.06 percentage of participants |
| CD Participants | Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD | IBD Related Surgeries | 0.73 percentage of participants |
| CD Participants | Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD | IBD Related Disability | 47.74 percentage of participants |
Secondary
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
Indications for surgical treatment included aggravation, intestinal bleeding, colon perforation, internal fistulas, abdominal cavity infiltrate, Interintestinal or Intraabdominal abscess, strictures in the gastrointestinal tract, anal fissures, and other. Types of surgeries includes both emergency and planned.
Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, number analyzed signifies participants who were evaluable for given categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Colon Perforation | 0.08 percentage of participants |
| UC Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Aggravation | 0.58 percentage of participants |
| UC Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Type of Surgeries: Emergency | 0.16 percentage of participants |
| UC Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Intestinal Bleeding | 0.49 percentage of participants |
| UC Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Type of Surgeries: Planned | 0.25 percentage of participants |
| UC Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Other | 0.99 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Interintestinal or Intraabdominal Abscess | 0.29 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Strictures in the gastrointestinal tract | 1.16 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Anal Fissures | 0.15 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Type of Surgeries: Emergency | 0.29 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Type of Surgeries: Planned | 0.58 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Aggravation | 0.58 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Colon Perforation | 0.15 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Other | 1.16 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Internal Fistulas | 0.15 percentage of participants |
| CD Participants | Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries | Surgical Treatment by Indication: Abdominal Cavity Infiltrate | 0.15 percentage of participants |
Secondary
Percentage of Participants Stratified by Achieving the Treatment Goals
Treat to target (T2T) approach was used for assessment of treatment goals. A Treat to target approach for UC included clinical remission (defined as resolution of rectal bleeding and diarrhea/altered bowel habit) and endoscopic remission (defined as Mayo endoscopic subscore of 0-1). Biomarker remission (normal C-reactive protein \[CRP\] and calprotectin) was considered as an adjunctive target. Histological remission was considered as an adjunctive goal. Clinical remission for CD was defined as resolution of abdominal pain and diarrhea/altered bowel habit. Endoscopic remission for CD was defined as resolution of ulceration at ileocolonoscopy or resolution of findings of inflammation on cross-sectional imaging in participants who cannot be adequately assessed with ileocolonoscopy. Biomarker remission (normal CRP and faecal calprotectin) was considered as an adjunctive target.
Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Population: FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants | Percentage of Participants Stratified by Achieving the Treatment Goals | Clinical Remission | 81.3 percentage of participants |
| UC Participants | Percentage of Participants Stratified by Achieving the Treatment Goals | Endoscopic Remission | 61.2 percentage of participants |
| UC Participants | Percentage of Participants Stratified by Achieving the Treatment Goals | Histological Remission | 29.8 percentage of participants |
| UC Participants | Percentage of Participants Stratified by Achieving the Treatment Goals | Biomarker Remission | 75.9 percentage of participants |
| CD Participants | Percentage of Participants Stratified by Achieving the Treatment Goals | Biomarker Remission | 68.1 percentage of participants |
| CD Participants | Percentage of Participants Stratified by Achieving the Treatment Goals | Clinical Remission | 70.3 percentage of participants |
| CD Participants | Percentage of Participants Stratified by Achieving the Treatment Goals | Histological Remission | 27.4 percentage of participants |
| CD Participants | Percentage of Participants Stratified by Achieving the Treatment Goals | Endoscopic Remission | 50.6 percentage of participants |
Secondary
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
The full Mayo index is an instrument to measure disease activity of UC. It consists of 4 parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score ranged from 0 (normal or inactive disease) to 3 (severe activity). The score ranged from 0 to 12, where score \<2 was remission, score 3-5 was mild activity, score 6-10 was moderate activity, and score \>10 was severe activity. Higher scores indicating higher disease activity.
Time frame: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
Population: FAS included those participants who signed the informed consent form and were analyzed in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 1: Remission | 18.30 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 1: Mild Activity | 35.21 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 1: Moderate Activity | 45.27 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 1: Severe Activity | 1.21 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 2: Remission | 58.54 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 2: Mild Activity | 30.49 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 2: Moderate Activity | 10.67 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 2: Severe Activity | 0.30 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 3: Remission | 64.97 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 3: Mild Activity | 26.46 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 3: Moderate Activity | 8.57 percentage of participants |
| UC Participants | UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index | Visit 3: Severe Activity | 0.00 percentage of participants |