Ulcerative Colitis
Conditions
Keywords
Quality of Life, Costs of Ulcerative Colitis, Health Care Utilization
Brief summary
This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in participants with ulcerative colitis (UC).
Detailed description
This was a single arm, open-label, multicenter study. The primary objectives were to study the effect of adalimumab on QOL (as measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), the utilization of health care resources, and the costs of care for subjects with UC who were treated with adalimumab in the usual clinical practice setting. The secondary objectives were to further assess the effect of adalimumab on disease activity and to collect additional safety data in subjects with UC.
Interventions
BIOLOGICALAdalimumab
Adalimumab pre-filled syringe, administered by subcutaneous injection
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Participants had to be a male or female between the ages of 18 and 75 years old at the time of the Screening Visit. 2. Participants who had a diagnosis of ulcerative colitis (UC) greater than 90 days prior to baseline (week 0) and failed conventional treatment. 3. Participants diagnosis of active UC was confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy. 4. Participants who had active UC with a Physicians Global Assessment (PGA) score of 2 or 3 and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤ 45 at baseline (week 0). 5. Concurrent therapy was required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP)) and, in the judgment of the investigator, had failed to respond to or could not tolerate their treatment. Participants had to be on a concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below): * Stable oral corticosteroid dose (prednisone ≥ 20 mg/day or equivalent) for at least 14 days prior to baseline, or * Stable oral corticosteroid dose (prednisone \< 20 mg/day) for at least 21 days prior to baseline, and/or * At least a consecutive 12 weeks (84 days) course of AZA or 6-MP prior to baseline.
Exclusion criteria
1. Participants who had a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery. 2. Participants received previous treatment with adalimumab or previous participation in an adalimumab clinical study. 3. Participants who had previously used infliximab or any anti- tumor necrosis factor (TNF) agent within 56 days of baseline (week 0). 4. Participants who had previously used infliximab or any anti-TNF agent and had not clinically responded at any time (primary non-responder) unless they experienced a treatment limiting reaction. 5. Participants who had received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of baseline (week 0). 6. Participants who had received intravenous (IV) corticosteroids within 14 days of Screening or during the screening period. 7. Participants who had a current diagnosis of fulminant colitis and/or toxic megacolon.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score | Week 0 (baseline) and Week 26 | The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). |
| Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs | 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) | Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization | 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) | Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information. |
| Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM) | Week 0 (baseline) and Week 26 | TSQM is a questionnaire to be completed by the participants to determine their satisfaction of the medications for ulcerative colitis including the study drug. The TSQM is a 14-item subject-rated scale that evaluates the effectiveness, side effects, convenience, and global satisfaction of the medication over the past 2-3 weeks. Each of the 14 questions are scored from 1 (worst) to 7 points (best); and each of the domains are scored from 0 (less satisfaction) to 100 (better satisfaction). N = participants with evaluable baseline and post-baseline data. |
| Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures | 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) | UC-related outpatient utilization was determined from the health care utilization information. Outpatient utilization was the number of procedures/surgeries performed during outpatient visits. Participants without any outpatient utilization were excluded. |
| Percentage of Participants With Absence of Blood in Stool | Week 26 | Participants with absence of blood in stool were reported. |
| Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time | Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 | The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, used to detect changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). N = participants with evaluable baseline and post-baseline data. |
| Mean Change From Baseline in Physician's Global Assessment (PGA) | Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 | The Physician's Global Assessment was used to measure the participant's disease activity. The physician considered the participant's reported information such as number of stools, rectal bleeding, abdominal discomfort, and functional assessment during the previous day prior to the visit, and other observations such as physical findings, and the participant's performance status at the time of the visit. Based on the above information the investigator made an overall assessment of participant's current severity of UC using the ordinal scale from 0 (normal) to 3 (severe disease). |
| Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs) | 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) | Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications. |
| Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score | Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 | EQ-5D-5L Total Score provides a descriptive profile of health status. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems). A unique EQ-5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from -0.594 to 1, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. N = participants with evaluable baseline and post-baseline data. |
| Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed | Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 | WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of work time missed data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data. |
| Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working | Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 | WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of impairment while working data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data. |
| Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage | Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 | WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The overall work impairment data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data. |
| Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment | Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 | WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. N = participants with evaluable baseline and post-baseline data. |
| Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) | Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26 | The SCCAI measures disease activity as assessed by the investigator and includes the following 6 items: bowel frequency (day), bowel frequency (night), urgency of defecation, blood in stool, general well-being and extra colonic features. The score ranges from 0 (best) to 19 points (worst). |
| Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs | 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months) | UC-related direct and indirect health care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments, medications and indirect costs based on WPAI. |
Participant flow
Pre-assignment details
A total of 463 participants were enrolled: 461 in the intent to treat (ITT) population were analyzed for efficacy (excluding 2 due to lack of post-baseline measurement data); 463 were analyzed for safety (participants who had received at least one dose of study drug).
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving Adalimumab Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response. | 461 |
| Total | 461 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 26 |
| Overall Study | Lack of Efficacy | 59 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 13 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Participants Receiving Adalimumab |
|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 13.75 |
| Sex: Female, Male Female | 206 Participants |
| Sex: Female, Male Male | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 178 / 463 |
| serious Total, serious adverse events | 67 / 463 |
Outcome results
Primary
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score
The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).
Time frame: Week 0 (baseline) and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score | 17.4 units on a scale | Standard Deviation 14.48 |
Comparison: Hypothesis testing for the first ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.p-value: <0.00195% CI: [16.08, 18.73]paired t-test, 2 sided
Primary
Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs
Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.
Time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs | -1383.8 Pound Sterling (GBP) | Standard Deviation 2213.06 |
Comparison: Hypothesis testing for the second ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.p-value: <0.00195% CI: [-1586.36, -1181.26]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score
EQ-5D-5L Total Score provides a descriptive profile of health status. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems). A unique EQ-5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from -0.594 to 1, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. N = participants with evaluable baseline and post-baseline data.
Time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score | Week 8 (N=454) | 0.1 units on a scale | Standard Deviation 0.21 |
| Participants Receiving Adalimumab | Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score | Week 2 (N=452) | 0.1 units on a scale | Standard Deviation 0.18 |
| Participants Receiving Adalimumab | Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score | Week 18 (N=454) | 0.1 units on a scale | Standard Deviation 0.22 |
| Participants Receiving Adalimumab | Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score | Week 26 (N=454) | 0.1 units on a scale | Standard Deviation 0.23 |
Comparison: Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 2.p-value: <0.00195% CI: [0.08, 0.11]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 8.p-value: <0.00195% CI: [0.11, 0.15]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.p-value: <0.00195% CI: [0.1, 0.14]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 26.p-value: <0.00195% CI: [0.12, 0.17]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)
TSQM is a questionnaire to be completed by the participants to determine their satisfaction of the medications for ulcerative colitis including the study drug. The TSQM is a 14-item subject-rated scale that evaluates the effectiveness, side effects, convenience, and global satisfaction of the medication over the past 2-3 weeks. Each of the 14 questions are scored from 1 (worst) to 7 points (best); and each of the domains are scored from 0 (less satisfaction) to 100 (better satisfaction). N = participants with evaluable baseline and post-baseline data.
Time frame: Week 0 (baseline) and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM) | Effectiveness (N=452) | 24.4 units on a scale | Standard Deviation 31.09 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM) | Side Effects (N=449) | 18.9 units on a scale | Standard Deviation 38.06 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM) | Convenience (N=451) | 6.2 units on a scale | Standard Deviation 24.87 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM) | Global Satisfaction (N=449) | 22.6 units on a scale | Standard Deviation 32.84 |
Comparison: Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness.p-value: <0.00195% CI: [21.5, 27.25]Paired t-test, 2 sided
Comparison: Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects.p-value: <0.00195% CI: [15.42, 22.48]Paired t-test, 2 sided
Comparison: Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience.p-value: <0.00195% CI: [3.89, 8.5]Paired t-test, 2 sided)
Comparison: Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction.p-value: <0.00195% CI: [19.55, 25.64]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in Physician's Global Assessment (PGA)
The Physician's Global Assessment was used to measure the participant's disease activity. The physician considered the participant's reported information such as number of stools, rectal bleeding, abdominal discomfort, and functional assessment during the previous day prior to the visit, and other observations such as physical findings, and the participant's performance status at the time of the visit. Based on the above information the investigator made an overall assessment of participant's current severity of UC using the ordinal scale from 0 (normal) to 3 (severe disease).
Time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Physician's Global Assessment (PGA) | Week 2 | -0.6 units on a scale | Standard Deviation 0.69 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Physician's Global Assessment (PGA) | Week 8 | -1.1 units on a scale | Standard Deviation 0.85 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Physician's Global Assessment (PGA) | Week 18 | -0.9 units on a scale | Standard Deviation 0.95 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Physician's Global Assessment (PGA) | Week 26 | -1.1 units on a scale | Standard Deviation 0.97 |
Comparison: Statistical analysis for mean change in PGA from week 0 to week 2.p-value: <0.00195% CI: [-0.69, -0.57]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in PGA from week 0 to week 8.p-value: <0.00195% CI: [-1.16, -1]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in PGA from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.p-value: <0.00195% CI: [-0.95, -0.77]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in PGA from week 0 to week 26.p-value: <0.00195% CI: [-1.23, -1.06]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time
The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, used to detect changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). N = participants with evaluable baseline and post-baseline data.
Time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time | Week 2 (N=457) | 11.1 units on a scale | Standard Deviation 9.81 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time | Week 8 (N=459) | 15.4 units on a scale | Standard Deviation 12.83 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time | Week 18 (N=459) | 14.8 units on a scale | Standard Deviation 13.06 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time | Week 26 (N=460) | 17.4 units on a scale | Standard Deviation 14.48 |
Comparison: Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 2.p-value: <0.00195% CI: [10.21, 12.02]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 8.p-value: <0.00195% CI: [14.2, 16.56]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).p-value: <0.00195% CI: [13.57, 15.96]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 26.p-value: <0.00195% CI: [16.08, 18.73]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)
The SCCAI measures disease activity as assessed by the investigator and includes the following 6 items: bowel frequency (day), bowel frequency (night), urgency of defecation, blood in stool, general well-being and extra colonic features. The score ranges from 0 (best) to 19 points (worst).
Time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) | Week 2 | -3.2 units on a scale | Standard Deviation 2.55 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) | Week 8 | -4.1 units on a scale | Standard Deviation 3.33 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) | Week 18 | -3.0 units on a scale | Standard Deviation 3.79 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) | Week 26 | -4.1 units on a scale | Standard Deviation 3.88 |
Comparison: Statistical analysis for mean change in total SCCAI from week 0 to week 2.p-value: <0.00195% CI: [-3.46, -2.99]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in total SCCAI from week 0 to week 8.p-value: <0.00195% CI: [-4.37, -3.76]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in total SCCAI from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.p-value: <0.00195% CI: [-3.36, -2.66]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in total SCCAI from week 0 to week 26.p-value: <0.00195% CI: [-4.43, -3.72]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage
WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The overall work impairment data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.
Time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage | Week 2 (N= 211) | -18.3 percentage of overall work impairment | Standard Deviation 27.72 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage | Week 8 (N= 225) | -26.5 percentage of overall work impairment | Standard Deviation 34.56 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage | Week 18 (N= 223) | -25.3 percentage of overall work impairment | Standard Deviation 35.1 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage | Week 26 (N= 221) | -29.2 percentage of overall work impairment | Standard Deviation 32.32 |
Comparison: Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 2.p-value: <0.00195% CI: [-22.1, -14.57]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 8.p-value: <0.00195% CI: [-31.08, -22]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.p-value: <0.00195% CI: [-29.97, -20.7]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 26.p-value: <0.00195% CI: [-33.5, -24.93]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment
WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. N = participants with evaluable baseline and post-baseline data.
Time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment | Week 2 (N=435) | -18.2 percentage of activity impairment | Standard Deviation 24.55 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment | Week 8 (N=446) | -25.4 percentage of activity impairment | Standard Deviation 30.84 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment | Week 18 (N=446) | -24.4 percentage of activity impairment | Standard Deviation 31.35 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment | Week 26 (N-446) | -27.2 percentage of activity impairment | Standard Deviation 32.83 |
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 2.p-value: <0.00195% CI: [-20.47, -15.85]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 8.p-value: <0.00195% CI: [-28.3, -22.56]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).p-value: <0.00195% CI: [-27.33, -21.5]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 26.p-value: <0.00195% CI: [-30.28, -24.16]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working
WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of impairment while working data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.
Time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working | Week 2 (N=221) | -16.6 percentage of impairment while working | Standard Deviation 25.94 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working | Week 8 (N=234) | -22.9 percentage of impairment while working | Standard Deviation 30.91 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working | Week 18 (N=232) | -21.7 percentage of impairment while working | Standard Deviation 30.98 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working | Week 26 (N=229) | -24.5 percentage of impairment while working | Standard Deviation 29.78 |
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 2.p-value: <0.00195% CI: [-20, -13.12]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 8.p-value: <0.00195% CI: [-26.93, -18.97]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).p-value: <0.00195% CI: [-25.69, -17.67]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 26.p-value: <0.00195% CI: [-28.33, -20.58]Paired t-test, 2 sided
Secondary
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed
WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of work time missed data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.
Time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed | Week 2 (N=214) | -8.6 percentage of work time missed | Standard Deviation 25.55 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed | Week 8 (N=227) | -12.2 percentage of work time missed | Standard Deviation 30.97 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed | Week 18 (N=225) | -11.6 percentage of work time missed | Standard Deviation 32.04 |
| Participants Receiving Adalimumab | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed | Week 26 (N=223) | -11.4 percentage of work time missed | Standard Deviation 30.85 |
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 8.p-value: <0.00195% CI: [-16.27, -8.16]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).p-value: <0.00195% CI: [-15.82, -7.4]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 26.p-value: <0.00195% CI: [-15.5, -7.35]Paired t-test, 2 sided
Comparison: Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 2.p-value: <0.00195% CI: [-12.07, -5.18]Paired t-test, 2 sided
Secondary
Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)
Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.
Time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs) | -1297.8 Pound Sterling (GBP) | Standard Deviation 2888.89 |
p-value: <0.00195% CI: [-1562.17, -1033.36]Paired t-test, 2 sided
Secondary
Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization
Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information.
Time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization | -7.3 Days | Standard Deviation 16.06 |
p-value: <0.00195% CI: [-9.83, -4.78]Paired t-test, 2 sided
Secondary
Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs
UC-related direct and indirect health care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments, medications and indirect costs based on WPAI.
Time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs | -4308.3 Pound Sterling (GBP) | Standard Deviation 7394.75 |
p-value: <0.00195% CI: [-4985.13, -3631.51]Paired t-test, 2 sided
Secondary
Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures
UC-related outpatient utilization was determined from the health care utilization information. Outpatient utilization was the number of procedures/surgeries performed during outpatient visits. Participants without any outpatient utilization were excluded.
Time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Receiving Adalimumab | Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures | Overall | -4.8 Procedures/ Surgeries | Standard Deviation 6.25 |
| Participants Receiving Adalimumab | Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures | During emergency department visits | 0.0 Procedures/ Surgeries | Standard Deviation 1.09 |
| Participants Receiving Adalimumab | Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures | During primary care doctor visits | -0.9 Procedures/ Surgeries | Standard Deviation 2.82 |
Comparison: Statistical analysis for overall UC-related outpatient utilization.p-value: <0.00195% CI: [-5.42, -4.27]Paired t-test, 2 sided
Comparison: Statistical analysis for overall UC-related outpatient utilization during emergency department visits.p-value: 0.8395% CI: [-0.11, 0.09]Paired t-test, 2 sided
Comparison: Statistical analysis for overall UC-related outpatient utilization during primary care doctor visits.p-value: <0.00195% CI: [-1.18, -0.66]Paired t-test, 2 sided
Secondary
Percentage of Participants With Absence of Blood in Stool
Participants with absence of blood in stool were reported.
Time frame: Week 26
Population: All participants in the ITT population with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving Adalimumab | Percentage of Participants With Absence of Blood in Stool | 56.6 percentage of participants |
Comparison: Statistical analysis for percentage of participants with absence of blood in stool from week 0 to week 26.p-value: <0.001McNemar