Trial Outcomes & Findings for Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes. (NCT NCT05069259)

NCT ID: NCT05069259

Last Updated: 2025-12-19

Results Overview

Clinical response was defined as a reduction in the partial Mayo score (PMS) from baseline of \>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \<= 2 with no subscore \>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

• Recruitment status: TERMINATED
• Target enrollment: 18 participants
• Primary outcome timeframe: Week 8
• Results posted on: 2025-12-19

Participant Flow

Participants with moderately to severely active ulcerative colitis (UC) who were prescribed tofacitinib in real world setting as routine clinical practice across Switzerland were enrolled in this study.

Participant milestones

Measure	All Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Overall Study STARTED	18
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	All Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Overall Study Withdrawal by Subject	1
Overall Study Sponsor decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Age, Continuous	41 Years n=18 Participants
Sex: Female, Male Female	3 Participants n=18 Participants
Sex: Female, Male Male	15 Participants n=18 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Full analysis set (FAS) included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Clinical response was defined as a reduction in the partial Mayo score (PMS) from baseline of >=2 points or achieving clinical remission. Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved Clinical Response at Week 8	63 Percentage of participants Interval 39.0 to 82.0

SECONDARY outcome

Timeframe: Week 8

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved Clinical Remission at Week 8	38 Percentage of participants Interval 18.0 to 61.0

SECONDARY outcome

Timeframe: Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Clinical response was defined as a reduction in the PMS from baseline of >=2 points or achieving clinical remission. Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

Outcome measures

Measure	All Participants n=15 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved Clinical Response at Week 16	73 Percentage of participants Interval 48.0 to 89.0

SECONDARY outcome

Timeframe: Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.

Outcome measures

Measure	All Participants n=15 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved Clinical Remission at Week 16	40 Percentage of participants Interval 20.0 to 64.0

SECONDARY outcome

Timeframe: Week 8

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

IBDQ remission was defined as an IBDQ score >= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=13 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 8	46 Percentage of participants Interval 23.0 to 71.0

SECONDARY outcome

Timeframe: Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

IBDQ remission was defined as an IBDQ score >= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=7 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved IBDQ Remission at Week 16	71 Percentage of participants Interval 36.0 to 92.0

SECONDARY outcome

Timeframe: Week 8

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

IBDQ response was defined as an IBDQ score >=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=13 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved IBDQ Response at Week 8	69 Percentage of participants Interval 42.0 to 87.0

SECONDARY outcome

Timeframe: Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

IBDQ response was defined as an IBDQ score >=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=7 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved IBDQ Response at Week 16	100 Percentage of participants Interval 65.0 to 100.0

SECONDARY outcome

Timeframe: Week 8

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Biochemical remission was defined as a fecal calprotectin (fCAL) concentration <=250 micrograms per gram (mcg/g). fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=9 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved Biochemical Remission at Week 8	11 Percentage of participants Interval 2.0 to 43.0

SECONDARY outcome

Timeframe: Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Biochemical remission was defined as a fCAL concentration <=250 mcg/g. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=6 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Percentage of Participants Who Achieved Biochemical Remission at Week 16	33 Percentage of participants Interval 9.7 to 70.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

The stool frequency patient reported outcome (PRO) was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in Stool Frequency Measured by Mayo Score Stool Frequency Subscore at Weeks 8 and 16 Change at Week 8	0 Score on a scale Interval -1.0 to 1.0
Median Change From Baseline in Stool Frequency Measured by Mayo Score Stool Frequency Subscore at Weeks 8 and 16 Change at Week 16	-1 Score on a scale Interval -2.0 to -1.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in Rectal Bleeding Measured by Mayo Score Rectal Bleeding Subscore at Weeks 8 and 16 Change at Week 8	0 Score on a scale Interval 0.0 to 0.0
Median Change From Baseline in Rectal Bleeding Measured by Mayo Score Rectal Bleeding Subscore at Weeks 8 and 16 Change at Week 16	0 Score on a scale Interval -1.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in Urgency of Defecation Assessed Using Numeric Rating Scale (NRS) at Weeks 8 and 16 Change at Week 8	-1 Score on a scale Interval -2.0 to 0.0
Median Change From Baseline in Urgency of Defecation Assessed Using Numeric Rating Scale (NRS) at Weeks 8 and 16 Change at Week 16	-2 Score on a scale Interval -4.0 to -2.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in Abdominal Pain Assessed Using Pain NRS at Weeks 8 and 16 Change at Week 8	-1 Score on a scale Interval -2.0 to 0.0
Median Change From Baseline in Abdominal Pain Assessed Using Pain NRS at Weeks 8 and 16 Change at Week 16	-2 Score on a scale Interval -3.0 to -1.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11 NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in Quality of Sleep Assessed Using NRS at Weeks 8 and 16 Change at Week 8	2 Score on a scale Interval 0.0 to 3.0
Median Change From Baseline in Quality of Sleep Assessed Using NRS at Weeks 8 and 16 Change at Week 16	3 Score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in Daily Fatigue Assessed Using NRS at Weeks 8 and 16 Change at Week 8	-1 Score on a scale Interval -3.0 to -1.0
Median Change From Baseline in Daily Fatigue Assessed Using NRS at Weeks 8 and 16 Change at Week 16	-3 Score on a scale Interval -4.0 to -1.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

The weekly fatigue was assessed with 13 questions from the functional assessment of chronic illness therapy - fatigue (FACIT-F) version (v)4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in Weekly Fatigue Assessed Using FACIT-F at Weeks 8 and 16 Change at Week 8	12 Score on a scale Interval -1.0 to 14.0
Median Change From Baseline in Weekly Fatigue Assessed Using FACIT-F at Weeks 8 and 16 Change at Week 16	13 Score on a scale Interval 11.0 to 20.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in IBDQ Score (Total) at Weeks 8 and 16 Change at Week 8	35 Score on a scale Interval 11.0 to 54.0
Median Change From Baseline in IBDQ Score (Total) at Weeks 8 and 16 Change at Week 16	48 Score on a scale Interval 44.0 to 77.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=15 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median Change From Baseline in fCAL at Weeks 8 and 16 Change at Week 8	-44 micrograms per gram Interval -392.0 to -12.0
Median Change From Baseline in fCAL at Weeks 8 and 16 Change at Week 16	-24 micrograms per gram Interval -78.0 to 267.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and IBDQ score was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and IBDQ Score Baseline	-0.5 Correlation Coefficient
Correlations Between PMS and IBDQ Score Week 8	-0.8 Correlation Coefficient
Correlations Between PMS and IBDQ Score Week 16	-0.5 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and fCAL concentration was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and fCAL Concentration Baseline	0.4 Correlation Coefficient
Correlations Between PMS and fCAL Concentration Week 8	0.1 Correlation Coefficient
Correlations Between PMS and fCAL Concentration Week 16	-0.8 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between stool frequency PRO and fCAL concentration was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The mayo score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Stool Frequency and fCAL Concentration Baseline	0.5 Correlation Coefficient
Correlations Between Stool Frequency and fCAL Concentration Week 8	0 Correlation Coefficient
Correlations Between Stool Frequency and fCAL Concentration Week 16	-0.3 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between rectal bleeding PRO and fCAL concentration was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Rectal Bleeding and fCAL Concentration Baseline	0.2 Correlation Coefficient
Correlations Between Rectal Bleeding and fCAL Concentration Week 8	0.4 Correlation Coefficient
Correlations Between Rectal Bleeding and fCAL Concentration Week 16	-0.4 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between urgency of defecation and fCAL concentration was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Urgency of Defecation and fCAL Concentration Baseline	0.2 Correlation Coefficient
Correlations Between Urgency of Defecation and fCAL Concentration Week 8	0.1 Correlation Coefficient
Correlations Between Urgency of Defecation and fCAL Concentration Week 16	-0.2 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between abdominal pain and fCAL was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Abdominal Pain and fCAL Concentration Baseline	0.4 Correlation Coefficient
Correlations Between Abdominal Pain and fCAL Concentration Week 8	0 Correlation Coefficient
Correlations Between Abdominal Pain and fCAL Concentration Week 16	0.3 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between quality of sleep and fCAL concentration was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Quality of Sleep and fCAL Concentration Baseline	0 Correlation Coefficient
Correlations Between Quality of Sleep and fCAL Concentration Week 8	-0.2 Correlation Coefficient
Correlations Between Quality of Sleep and fCAL Concentration Week 16	0 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between daily fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Daily Fatigue and fCAL Concentration Baseline	-0.1 Correlation Coefficient
Correlations Between Daily Fatigue and fCAL Concentration Week 8	-0.1 Correlation Coefficient
Correlations Between Daily Fatigue and fCAL Concentration Week 16	0.2 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between weekly fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Weekly Fatigue and fCAL Concentration Baseline	0.2 Correlation Coefficient
Correlations Between Weekly Fatigue and fCAL Concentration Week 8	0.5 Correlation Coefficient
Correlations Between Weekly Fatigue and fCAL Concentration Week 16	-0.9 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between IBDQ score and fCAL concentration was assessed by Spearman correlation coefficient. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between IBDQ Score and fCAL Concentration Baseline	-0.4 Correlation Coefficient
Correlations Between IBDQ Score and fCAL Concentration Week 8	-0.1 Correlation Coefficient
Correlations Between IBDQ Score and fCAL Concentration Week 16	0.2 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between stool frequency PRO and IBDQ score was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Stool Frequency and IBDQ Score Baseline	-0.3 Correlation Coefficient
Correlations Between Stool Frequency and IBDQ Score Week 8	-0.7 Correlation Coefficient
Correlations Between Stool Frequency and IBDQ Score Week 16	-0.3 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between rectal bleeding PRO and IBDQ score was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Rectal Bleeding and IBDQ Score Baseline	-0.5 Correlation Coefficient
Correlations Between Rectal Bleeding and IBDQ Score Week 8	-0.6 Correlation Coefficient
Correlations Between Rectal Bleeding and IBDQ Score Week 16	-0.6 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between urgency of defecation and IBDQ score was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Urgency of Defecation and IBDQ Score Baseline	-0.7 Correlation Coefficient
Correlations Between Urgency of Defecation and IBDQ Score Week 8	-0.9 Correlation Coefficient
Correlations Between Urgency of Defecation and IBDQ Score Week 16	-0.1 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between abdominal pain and IBDQ score was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Abdominal Pain and IBDQ Score Baseline	-0.6 Correlation Coefficient
Correlations Between Abdominal Pain and IBDQ Score Week 8	-0.9 Correlation Coefficient
Correlations Between Abdominal Pain and IBDQ Score Week 16	-0.5 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between quality of sleep and IBDQ score was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Quality of Sleep and IBDQ Score Baseline	0.3 Correlation Coefficient
Correlations Between Quality of Sleep and IBDQ Score Week 8	0.5 Correlation Coefficient
Correlations Between Quality of Sleep and IBDQ Score Week 16	-0.4 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between daily fatigue and IBDQ score was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Daily Fatigue and IBDQ Score Baseline	0 Correlation Coefficient
Correlations Between Daily Fatigue and IBDQ Score Week 8	-0.8 Correlation Coefficient
Correlations Between Daily Fatigue and IBDQ Score Week 16	0.2 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between weekly fatigue and IBDQ score was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between Weekly Fatigue and IBDQ Score Baseline	0.3 Correlation Coefficient
Correlations Between Weekly Fatigue and IBDQ Score Week 8	0.7 Correlation Coefficient
Correlations Between Weekly Fatigue and IBDQ Score Week 16	0.1 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and stool frequency PRO was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and Stool Frequency Baseline	0.6 Correlation Coefficient
Correlations Between PMS and Stool Frequency Week 8	0.8 Correlation Coefficient
Correlations Between PMS and Stool Frequency Week 16	0.4 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and rectal bleeding PRO was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and Rectal Bleeding Baseline	0.6 Correlation Coefficient
Correlations Between PMS and Rectal Bleeding Week 8	0.6 Correlation Coefficient
Correlations Between PMS and Rectal Bleeding Week 16	0.7 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and urgency of defecation was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and Urgency of Defecation Baseline	0.4 Correlation Coefficient
Correlations Between PMS and Urgency of Defecation Week 8	0.7 Correlation Coefficient
Correlations Between PMS and Urgency of Defecation Week 16	0.1 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and abdominal pain was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and Abdominal Pain Baseline	0.4 Correlation Coefficient
Correlations Between PMS and Abdominal Pain Week 8	0.6 Correlation Coefficient
Correlations Between PMS and Abdominal Pain Week 16	-0.1 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and quality of sleep was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and Quality of Sleep Baseline	-0.1 Correlation Coefficient
Correlations Between PMS and Quality of Sleep Week 8	-0.5 Correlation Coefficient
Correlations Between PMS and Quality of Sleep Week 16	0.4 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and daily fatigue was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and Daily Fatigue Baseline	-0.1 Correlation Coefficient
Correlations Between PMS and Daily Fatigue Week 8	0.6 Correlation Coefficient
Correlations Between PMS and Daily Fatigue Week 16	-0.4 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Correlation between PMS and weekly fatigue was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.

Outcome measures

Measure	All Participants n=18 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Correlations Between PMS and Weekly Fatigue Baseline	-0.2 Correlation Coefficient
Correlations Between PMS and Weekly Fatigue Week 8	-0.6 Correlation Coefficient
Correlations Between PMS and Weekly Fatigue Week 16	0.6 Correlation Coefficient

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Clinical remission was defined as PMS of <= 2 with no subscore >1. Partial mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 8 and in those participants who did not have clinical remission at Week 8.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status fCAL concentrations at baseline in participants with clinical remission at Week 8	590 micrograms per gram Interval 297.0 to 616.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status fCAL concentrations at week 8 in participants with clinical remission at Week 8	466 micrograms per gram Interval 253.0 to 638.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status fCAL concentrations at week 16 in participants with clinical remission at Week 8	788 micrograms per gram Interval 681.0 to 894.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status fCAL concentrations at baseline in participants without clinical remission at Week 8	622 micrograms per gram Interval 376.0 to 984.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status fCAL concentrations at week 8 in participants without clinical remission at Week 8	586 micrograms per gram Interval 581.0 to 593.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status fCAL concentrations at week 16 in participants without clinical remission at Week 16	201 micrograms per gram Interval 64.0 to 498.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Clinical remission was defined as PMS of <= 2 with no subscore >1. Partial mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 16 and in those participants who did not have clinical remission at Week 16.

Outcome measures

Measure	All Participants n=15 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status fCAL concentrations at baseline in participants with clinical remission at Week 16	612 micrograms per gram Interval 304.0 to 633.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status fCAL concentrations at week 8 in participants with clinical remission at Week 16	586 micrograms per gram Interval 324.0 to 593.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status fCAL concentrations at week 16 in participants with clinical remission at Week 16	1000 micrograms per gram Interval 788.0 to 1000.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status fCAL concentrations at baseline in participants without clinical remission at Week 16	607 micrograms per gram Interval 328.0 to 903.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status fCAL concentrations at week 8 in participants without clinical remission at Week 16	642 micrograms per gram Interval 581.0 to 708.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status fCAL concentrations at week 16 in participants without clinical remission at Week 16	71 micrograms per gram Interval 58.0 to 201.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Clinical response was defined as a reduction in the PMS from baseline of >=2 points or achieving clinical remission. Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 8 and in those participants who did not have clinical response at Week 8.

Outcome measures

Measure	All Participants n=16 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status fCAL concentrations at baseline in participants with clinical response at Week 8	501 micrograms per gram Interval 211.0 to 616.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status fCAL concentrations at week 8 in participants with clinical response at Week 8	597 micrograms per gram Interval 390.0 to 679.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status fCAL concentrations at week 16 in participants with clinical response at Week 8	331 micrograms per gram Interval 71.0 to 575.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status fCAL concentrations at baseline in participants without clinical response at Week 8	819 micrograms per gram Interval 630.0 to 1000.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status fCAL concentrations at week 8 in participants without clinical response at Week 8	581 micrograms per gram Interval 581.0 to 587.0
Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status fCAL concentrations at week 16 in participants without clinical response at Week 8	1000 micrograms per gram Interval 1000.0 to 1000.0

SECONDARY outcome

Timeframe: Baseline, Week 8 and Week 16

Population: FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.

Clinical response was defined as a reduction in the PMS from baseline of >=2 points or achieving clinical remission. Clinical remission was defined as PMS of <= 2 with no subscore >1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 16 and in those participants who did not have clinical response at Week 16.

Outcome measures

Measure	All Participants n=15 Participants Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status fCAL concentrations at baseline in participants with clinical response at Week 16	603 micrograms per gram Interval 204.0 to 637.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status fCAL concentrations at week 8 in participants with clinical response at Week 16	586 micrograms per gram Interval 324.0 to 593.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status fCAL concentrations at week 16 in participants with clinical response at Week 16	575 micrograms per gram Interval 71.0 to 1000.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status fCAL concentrations at baseline in participants without clinical response at Week 16	706 micrograms per gram Interval 562.0 to 854.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status fCAL concentrations at week 8 in participants without clinical response at Week 16	642 micrograms per gram Interval 581.0 to 708.0
Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status fCAL concentrations at week 16 in participants without clinical response at Week 16	331 micrograms per gram Interval 331.0 to 331.0

Adverse Events

All Participants

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=18 participants at risk Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Gastrointestinal disorders Worsening Ulcerative Colitis	5.6% 1/18 • Maximum up to 20 weeks Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number).

Other adverse events

Measure	All Participants n=18 participants at risk Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.
Gastrointestinal disorders Worsening Ulcerative Colitis	11.1% 2/18 • Maximum up to 20 weeks Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number).
Gastrointestinal disorders Colitis	5.6% 1/18 • Maximum up to 20 weeks Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number).
Infections and infestations Enterocolitis infectious	5.6% 1/18 • Maximum up to 20 weeks Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number).
Infections and infestations Shingles	5.6% 1/18 • Maximum up to 20 weeks Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number).

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER