Trial Outcomes & Findings for A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting (NCT NCT01550965)

NCT ID: NCT01550965

Last Updated: 2018-07-02

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 463 participants
• Primary outcome timeframe: Week 0 (baseline) and Week 26
• Results posted on: 2018-07-02

Participant Flow

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).

Participant milestones

Measure	Participants Receiving Adalimumab Adults with active ulcerative colitis (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.
Overall Study STARTED	463
Overall Study COMPLETED	353
Overall Study NOT COMPLETED	110

Reasons for withdrawal

Measure	Participants Receiving Adalimumab Adults with active ulcerative colitis (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.
Overall Study Adverse Event	26
Overall Study Withdrawal by Subject	10
Overall Study Lost to Follow-up	2
Overall Study Lack of Efficacy	59
Overall Study Other	13

Baseline Characteristics

A Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting

Baseline characteristics by cohort

Measure	Participants Receiving Adalimumab n=461 Participants 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.
Age, Continuous	41.8 years STANDARD_DEVIATION 13.75 • n=5 Participants
Sex: Female, Male Female	206 Participants n=5 Participants
Sex: Female, Male Male	255 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0 (baseline) and Week 26

Population: All participants in the ITT population with evaluable data.

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).

Outcome measures

Measure	Participants Receiving Adalimumab n=460 Participants 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.
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score	17.4 units on a scale Standard Deviation 14.48

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=461 Participants 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.
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=461 Participants 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.
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=461 Participants 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.
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

SECONDARY outcome

Timeframe: 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.

Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information.

Outcome measures

Measure	Participants Receiving Adalimumab n=158 Participants 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.
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

SECONDARY outcome

Timeframe: Week 0 (baseline) and Week 26

Population: All participants in the ITT population with evaluable data.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=452 Participants 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.
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
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
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=453 Participants 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.
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
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
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

SECONDARY outcome

Timeframe: Week 26

Population: All participants in the ITT population with evaluable data.

Participants with absence of blood in stool were reported.

Outcome measures

Measure	Participants Receiving Adalimumab n=461 Participants 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.
Percentage of Participants With Absence of Blood in Stool	56.6 percentage of participants

SECONDARY outcome

Timeframe: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26

Population: All participants in the ITT population with evaluable data.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=460 Participants 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.
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
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
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
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

SECONDARY outcome

Timeframe: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26

Population: All participants in the ITT population with evaluable data.

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).

Outcome measures

Measure	Participants Receiving Adalimumab n=461 Participants 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.
Mean Change From Baseline in Physician's Global Assessment (PGA) Week 2	-0.6 units on a scale Standard Deviation 0.69
Mean Change From Baseline in Physician's Global Assessment (PGA) Week 8	-1.1 units on a scale Standard Deviation 0.85
Mean Change From Baseline in Physician's Global Assessment (PGA) Week 18	-0.9 units on a scale Standard Deviation 0.95
Mean Change From Baseline in Physician's Global Assessment (PGA) Week 26	-1.1 units on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26

Population: All participants in the ITT population with evaluable data.

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).

Outcome measures

Measure	Participants Receiving Adalimumab n=461 Participants 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.
Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) Week 2	-3.2 units on a scale Standard Deviation 2.55
Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) Week 8	-4.1 units on a scale Standard Deviation 3.33
Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) Week 18	-3.0 units on a scale Standard Deviation 3.79
Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) Week 26	-4.1 units on a scale Standard Deviation 3.88

SECONDARY outcome

Timeframe: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26

Population: All participants in the ITT population with evaluable data.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=454 Participants 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.
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
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
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
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

SECONDARY outcome

Timeframe: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26

Population: All participants in the ITT population with evaluable data.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=227 Participants 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.
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
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
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
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

SECONDARY outcome

Timeframe: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26

Population: All participants in the ITT population with evaluable data.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=234 Participants 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.
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
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
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
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

SECONDARY outcome

Timeframe: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26

Population: All participants in the ITT population with evaluable data.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=225 Participants 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.
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
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
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 35.10
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

SECONDARY outcome

Timeframe: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26

Population: All participants in the ITT population with evaluable data.

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.

Outcome measures

Measure	Participants Receiving Adalimumab n=446 Participants 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.
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
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
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
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

Adverse Events

PARTICIPANTS RECEIVING ADALIMUMAB

Serious events: 67 serious events

Other events: 178 other events

Deaths: 0 deaths

Serious adverse events

Measure	PARTICIPANTS RECEIVING ADALIMUMAB n=463 participants at risk 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.
Blood and lymphatic system disorders ANAEMIA	0.43% 2/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Blood and lymphatic system disorders PANCYTOPENIA	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Cardiac disorders SILENT MYOCARDIAL INFARCTION	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Endocrine disorders HYPERTHYROIDISM	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Gastrointestinal disorders COLITIS ULCERATIVE	8.9% 41/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Gastrointestinal disorders DIARRHOEA	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Gastrointestinal disorders MEGACOLON	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
General disorders ACCIDENTAL DEATH	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
General disorders ASTHENIA	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations APPENDICITIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations CELLULITIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations CYTOMEGALOVIRUS INFECTION	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations GASTROENTERITIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations HERPES ZOSTER	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations OSTEOMYELITIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations OTITIS MEDIA	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations PYELONEPHRITIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations RECTAL ABSCESS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations SINUSITIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations WOUND SEPSIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Injury, poisoning and procedural complications ANKLE FRACTURE	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Injury, poisoning and procedural complications PNEUMOTHORAX TRAUMATIC	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Musculoskeletal and connective tissue disorders OSTEITIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA OF EYELID	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TESTICULAR SEMINOMA (PURE)	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Nervous system disorders CEREBRAL HAEMORRHAGE	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Nervous system disorders DIZZINESS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Nervous system disorders INTRACRANIAL VENOUS SINUS THROMBOSIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Pregnancy, puerperium and perinatal conditions FOETAL DEATH	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Pregnancy, puerperium and perinatal conditions FOETAL DISTRESS SYNDROME	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Psychiatric disorders DEPRESSION	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Skin and subcutaneous tissue disorders DERMATOSIS	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Skin and subcutaneous tissue disorders PRURITUS GENERALISED	0.22% 1/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Surgical and medical procedures ABORTION INDUCED	0.43% 2/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).

Other adverse events

Measure	PARTICIPANTS RECEIVING ADALIMUMAB n=463 participants at risk 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.
Gastrointestinal disorders COLITIS ULCERATIVE	13.2% 61/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Gastrointestinal disorders NAUSEA	6.3% 29/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Infections and infestations NASOPHARYNGITIS	8.0% 37/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.1% 33/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Nervous system disorders HEADACHE	13.0% 60/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	5.8% 27/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	5.4% 25/463 • Adverse Events were collected from the time of study drug administration to 70 days after last dose of study drug (up to 36 weeks). Serious Adverse Events were also collected from the time that informed consent was obtained until 70 days after last dose (up to 39 weeks).

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