Trial Outcomes & Findings for This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data. (NCT NCT05082428)

Results Overview

Participant's age at the time of ulcerative colitis diagnosis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

Recruitment status

COMPLETED

Target enrollment

252 participants

Primary outcome timeframe

At diagnosis (anytime between Jan 2010 and Dec-2021, approximately 12 years (from data collected and analyzed retrospectively over 5 months)

Results posted on

2024-09-23

Participant Flow

Participants with a diagnosis of ulcerative colitis (UC) between January 2010 and December 2021 and who initiated tofacitinib across Finland were included in this retrospective chart study. Data was collected from patient registers and charts in Finland. Index date was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Data was collected and analyzed over 5 months in this retrospective study.

Participant milestones

Participant milestones
Measure	Tofacitinib Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Overall Study STARTED	252
Overall Study COMPLETED	252
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Age, Continuous	38.94 Years STANDARD_DEVIATION 13.94 • n=252 Participants
Sex: Female, Male Female	77 Participants n=252 Participants
Sex: Female, Male Male	175 Participants n=252 Participants
Weight	81.54 Kilograms STANDARD_DEVIATION 19.47 • n=85 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Height	174.63 Centimeters STANDARD_DEVIATION 8.33 • n=54 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Smoking status Current	16 Participants n=220 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Smoking status Ex-smoker	43 Participants n=220 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Smoking status Non-smoker	161 Participants n=220 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Body Mass Index	26.5 Kilogram per meter square STANDARD_DEVIATION 5.8 • n=209 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Absolute Value of Plasma C-reactive Protein at Baseline	8.97 Milligrams per liter STANDARD_DEVIATION 11.93 • n=199 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Absolute Values of Blood leukocytes, lymphocytes, neutrophiles, and thrombocytes Blood leukocytes	10.86 10^9 cells per liter STANDARD_DEVIATION 32.06 • n=213 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Absolute Values of Blood leukocytes, lymphocytes, neutrophiles, and thrombocytes Blood lymphocytes	2.08 10^9 cells per liter STANDARD_DEVIATION 0.95 • n=149 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Absolute Values of Blood leukocytes, lymphocytes, neutrophiles, and thrombocytes Blood neutrophiles	5.78 10^9 cells per liter STANDARD_DEVIATION 3.85 • n=146 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Absolute Values of Blood leukocytes, lymphocytes, neutrophiles, and thrombocytes Blood thrombocytes	336.55 10^9 cells per liter STANDARD_DEVIATION 115.87 • n=210 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.
Absolute Value of Fecal Calprotectin at Index	1907.43 Milligrams per kilogram STANDARD_DEVIATION 1716.94 • n=189 Participants • 'Number Analyzed' signifies participants evaluable for specified rows.

PRIMARY outcome

Timeframe: At diagnosis (anytime between Jan 2010 and Dec-2021, approximately 12 years (from data collected and analyzed retrospectively over 5 months)

Population: All eligible participants for whom data was collected and analyzed were included.

Participant's age at the time of ulcerative colitis diagnosis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Age at the Time of Diagnosis	31.08 Years Standard Deviation 13.02

PRIMARY outcome

Timeframe: At index (from data collected and analyzed retrospectively over 5 months)

Population: All eligible participants for whom data was collected and analyzed were included.

Duration of ulcerative colitis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Duration of Ulcerative Colitis	7.91 Years Standard Deviation 7.79

PRIMARY outcome

Timeframe: At index (from data collected and analyzed retrospectively over 5 months)

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Montreal classification was used to classify UC based on extent of inflammation. Three subgroups of UC were: E1= ulcerative proctitis: involvement limited to rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided, distal colitis: involvement limited to portion of colorectum distal to splenic flexure and E3= extensive UC (pancolitis): involvement extends proximal to the splenic flexure. Index was considered as date of initiation of tofacitinib treatment for UC.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants With Extent of Colonic Involvement According to the Montreal Classification E3	180 Participants
Number of Participants With Extent of Colonic Involvement According to the Montreal Classification E1	5 Participants
Number of Participants With Extent of Colonic Involvement According to the Montreal Classification E2	67 Participants

PRIMARY outcome

Timeframe: At index (from data collected and analyzed retrospectively over 5 months)

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Mayo score was composed of four components: rectal bleeding, stool frequency, physician (doctors) assessment of disease activity, and endoscopy findings. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Mayo scores and sub-scores have been collected by doctors independently as part of standard of care.

Outcome measures

Outcome measures
Measure	Tofacitinib n=80 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Mayo Score at Initiation of Tofacitinib	7.45 Units on a scale Standard Deviation 2.43

PRIMARY outcome

Timeframe: At index (from data collected and analyzed retrospectively over 5 months)

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Partial Mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician (doctors) assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis. Partial Mayo scores and sub-scores have been collected by doctors independently as part of standard of care.

Outcome measures

Outcome measures
Measure	Tofacitinib n=203 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Partial Mayo Score at Initiation of Tofacitinib	4.75 Years Standard Deviation 2.06

PRIMARY outcome

Timeframe: At index (from data collected and analyzed retrospectively over 5 months)

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Endoscopic findings were graded from 0 to 3 where 0 = Normal or inactive disease (Normal vascular pattern with arborization of capillaries clearly defined, or with blurring or patchy loss of capillary margins), 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration). Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

Outcome measures

Outcome measures
Measure	Tofacitinib n=85 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants According to Endoscopic Findings Based on Histology Active disease	NA Participants Any participant groups of \<5 participants cannot be exported from the Finnish Health and Social Data Permit Authority (Findata) servers. Any information which enables to calculate \<5 participant group information based on information from another participants group will not be presented.
Number of Participants According to Endoscopic Findings Based on Histology Inactive disease	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants According to Endoscopic Findings Based on Histology Normal histology	0 Participants

PRIMARY outcome

Timeframe: At index (from data collected and analyzed retrospectively over 5 months)

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Endoscopic findings were graded from 0 to 3 where 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 3 = Severe disease (spontaneous bleeding, ulceration). Mayo score was composed of four components: rectal bleeding, stool frequency, physician assessment of disease activity and endoscopy findings. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.

Outcome measures

Outcome measures
Measure	Tofacitinib n=88 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants According to Endoscopic Sub Score Based on Mayo Score Sub score 1	10 Participants
Number of Participants According to Endoscopic Sub Score Based on Mayo Score Sub score 2	42 Participants
Number of Participants According to Endoscopic Sub Score Based on Mayo Score Sub score 3	36 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Percentage of participants who received tofacitinib is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52 Week 52	54.72 Percentage of Participants
Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52 Week 8	91.67 Percentage of Participants
Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52 Week 16	80.16 Percentage of Participants
Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52 Week 24	71.03 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a full Mayo score of less than or equal to (\<=) 2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings. Each subscore ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score which ranged from 0 to 12, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	5.49 Percentage of Participants
Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	9.52 Percentage of Participants
Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	14.66 Percentage of Participants
Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	20.16 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a partial Mayo score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	33.66 Percentage of Participants
Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	28.77 Percentage of Participants
Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	36.52 Percentage of Participants
Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	34.91 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical response in participants was defined as a full Mayo score decrease of greater than or equal (\>=) to 3 points and a decrease of \>=30 percent (%) from baseline, with a decrease of \>=1 point on the rectal bleeding sub score or an absolute rectal bleeding score of less than equal to (\<=)1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	32.5 Percentage of Participants
Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	38.75 Percentage of Participants
Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	35 Percentage of Participants
Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	26.09 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical response in participants was defined as a partial Mayo score decrease of \>=2 points and reduction of at least 25% in partial Mayo score from baseline with an accompanying decrease in rectal bleeding sub score of \>=1 point or absolute rectal bleeding sub score of \<=1. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	33.33 Percentage of Participants
Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	37.44 Percentage of Participants
Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	44.83 Percentage of Participants
Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	42.86 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a full Mayo score of \<=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	NA Percentage of Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	6.67 Percentage of Participants
Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	12.93 Percentage of Participants
Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	19.38 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a partial Mayo score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined for participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	10.5 Percentage of Participants
Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	31.74 Percentage of Participants
Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	30.17 Percentage of Participants
Percentage of Participants With Steroid-free Clinical Remission for All Participants Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	31.19 Percentage of Participants

SECONDARY outcome

Timeframe: At 1, 2, 3, 6, 12, 24 and 36 months

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies maximum participants evaluable at specified timepoints.

Time to clinical response was analyzed using a competing risk time-to-event model, where clinical response and drug discontinuation were assessed. Clinical response in participants was defined as full Mayo score decrease of \>=3 points \& decrease of \>=30% from baseline, with decrease of \>=1 point on rectal bleeding sub score or absolute rectal bleeding score of \<=1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, \& endoscopy findings. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Sub scores were summed up to give total score range: 0 to 12, Partial Mayo score consisted of 3 components without endoscopy findings. Each graded from 0 to 3, sub scores were summed up to give total score range: 0 to 9.Higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=203 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months 24 months	72.2 Percentage of participants Interval 66.1 to 78.8
Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months 1 month	15.3 Percentage of participants Interval 11.0 to 21.1
Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months 2 months	45.8 Percentage of participants Interval 39.4 to 53.2
Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months 3 months	56.2 Percentage of participants Interval 49.7 to 63.4
Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months 6 months	67.0 Percentage of participants Interval 60.8 to 73.8
Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months 12 months	70.5 Percentage of participants Interval 64.5 to 77.1
Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months 36 months	75.2 Percentage of participants Interval 68.8 to 82.2

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of participants with F-calprotectin reduction of \>=50% from baseline at Week 8, Week 16, Week 24 and Week 52 is presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52 Week 8	29.1 Percentage of Participants
Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52 Week 16	46.56 Percentage of Participants
Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52 Week 24	45.5 Percentage of Participants
Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52 Week 52	37.34 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of participants with F-calprotectin reduction of \>=75% compared to baseline at Week 8, Week 16, Week 24 and Week 52 is presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52 Week 8	20.63 Percentage of Participants
Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52 Week 16	36.51 Percentage of Participants
Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52 Week 24	37.04 Percentage of Participants
Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52 Week 52	32.28 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of participants with F-calprotectin reduction of \>=90% compared to baseline at Week 8, Week 16, Week 24 and Week 52 is presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52 Week 8	12.17 Percentage of Participants
Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52 Week 16	24.34 Percentage of Participants
Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52 Week 24	25.93 Percentage of Participants
Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52 Week 52	23.42 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of participants reaching F-calprotectin below 250mg/kg at Week 8, Week 16, Week 24 and Week 52 in those participants who had F-calprotectin above 250 mg/kg at Baseline is presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=171 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline Week 52	44 Participants
Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline Week 8	31 Participants
Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline Week 16	55 Participants
Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline Week 24	58 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. Baseline was considered as date of initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=171 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 With F-Calprotectin Above 250 mg/kg at Baseline Week 24	-1291.7 Milligrams per kilogram Standard Deviation 1589.91
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 With F-Calprotectin Above 250 mg/kg at Baseline Week 52	-1393.53 Milligrams per kilogram Standard Deviation 1727.43
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 With F-Calprotectin Above 250 mg/kg at Baseline Week 8	-594.83 Milligrams per kilogram Standard Deviation 1302.24
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 With F-Calprotectin Above 250 mg/kg at Baseline Week 16	-1100.28 Milligrams per kilogram Standard Deviation 1653.91

SECONDARY outcome

Timeframe: From Week 8 to Week 16, Week 24, and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Sustained remission in participants was defined as a full Mayo score of \<=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=5 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 8 to Week 16, Week 24, and Week 52 Week 8 to Week 16	100.0 Percentage of Participants
Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 8 to Week 16, Week 24, and Week 52 Week 8 to Week 24	NA Percentage of Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 8 to Week 16, Week 24, and Week 52 Week 8 to Week 52	NA Percentage of Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.

SECONDARY outcome

Timeframe: From Week 8 to Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Sustained remission in participants was defined as a partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=63 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 8 to Week 16, Week 24, and Week 52 Week 8 to Week 16	84.13 Percentage of Participants
Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 8 to Week 16, Week 24, and Week 52 Week 8 to Week 24	63.49 Percentage of Participants
Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 8 to Week 16, Week 24, and Week 52 Week 8 to Week 52	50.91 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 16 to Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Sustained remission in participants was defined as a full Mayo score of \>=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=10 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 52	75.0 Percentage of Participants
Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 24	90.0 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 16 to Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Sustained remission in participants was defined as a partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=84 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 24	76.19 Percentage of Participants
Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 52	64.29 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 16 to Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a full Mayo score of \<=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=7 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Steroid Free Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 24	85.71 Percentage of Participants
Percentage of Participants in Sustained Steroid Free Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 52	71.43 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 16 to Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=70 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Steroid Free Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 24	72.6 Percentage of Participants
Percentage of Participants in Sustained Steroid Free Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 52	60.66 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Mayo score was an instrument designed to measure disease activity of UC. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Baseline was considered as date of initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	-2.63 Units on a scale Standard Deviation 2.13
Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	-1.9 Units on a scale Standard Deviation 2.3
Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	-2.39 Units on a scale Standard Deviation 2.51
Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	-2.66 Units on a scale Standard Deviation 2.92

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Baseline was considered as date of initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	-1.62 Units on a scale Standard Deviation 2.22
Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	-2.21 Units on a scale Standard Deviation 2.32
Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	-2.4 Units on a scale Standard Deviation 2.13
Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	-2.43 Units on a scale Standard Deviation 2.61

SECONDARY outcome

Timeframe: From Week 8 to Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing = Mayo endoscopic sub score of 0 or 1. Endoscopic response= sub score reduction from baseline of \>=1. The Mayo endoscopic sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher sub scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=11 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 16	100 Percentage of participants
Percentage of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 24	100 Percentage of participants
Percentage of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 52	50 Percentage of participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Physician assessed histological remission was defined as inactive disease or normal histology. Inactive disease was characterized by marked architectural abnormalities in the absence of active inflammation.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52 Week 24	6.19 Percentage of Participants
Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52 Week 8	NA Percentage of Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52 Week 16	NA Percentage of Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52 Week 52	11.48 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Histology assessment was categorized as, 1= inactive disease or normal histology and 2 = active disease. Inactive disease was characterized by marked architectural abnormalities in the absence of active inflammation. Active disease was characterized by absence of active inflammation. Baseline was considered as date of initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52 Week 8	0 Units on a scale Standard Deviation 0
Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52 Week 16	-0.01 Units on a scale Standard Deviation 0.12
Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52 Week 24	-0.02 Units on a scale Standard Deviation 0.13
Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52 Week 52	-0.18 Units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: From Week 8 to Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies maximum number of participants evaluable for this outcome measure.

Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing was defined by Mayo endoscopic sub score of 0 or 1. Endoscopic response was defined as sub score reduction from baseline of \>=1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=4 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Full Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 16	NA Percentage of participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Full Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 24	NA Percentage of participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Full Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 52	NA Percentage of participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.

SECONDARY outcome

Timeframe: From Week 8 to Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies maximum number of participants evaluable for this outcome measure.

Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing was defined by Mayo endoscopic sub score of 0 or 1. Endoscopic response was defined as sub score reduction from baseline of \>=1. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=4 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Partial Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 16	NA Percentage of participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Partial Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 24	NA Percentage of participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants in Sustained Steroid Free Remission for All Participants Based on Partial Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52 Week 8 to Week 52	NA Percentage of participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24, and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Montreal classification was system used to classify UC based on the extent of inflammation. Three subgroups of UC were defined by extent of colonic involvement: E1= ulcerative proctitis: involvement limited to the rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided UC also known as distal colitis: involvement limited to portion of colorectum distal to the splenic flexure, E3= extensive UC (pancolitis): involvement extents proximal to splenic flexure. Clinical remission: full Mayo score of \<=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, \& endoscopy findings, each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give total score range of 0 to 12. Higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 8	0 Participants
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 16	0 Participants
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 24	0 Participants
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 52	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 8	0 Participants
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 16	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 24	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 52	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 8	5 Participants
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 16	8 Participants
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 24	15 Participants
Number of Participants With Clinical Remission Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 52	22 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24, and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Montreal Classification was system used to classify UC based on the extent of inflammation. Three subgroups of UC were defined by extent of colonic involvement: E1= ulcerative proctitis: involvement limited to the rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided UC also known as distal colitis: involvement limited to portion of colorectum distal to the splenic flexure, E3= extensive UC (pancolitis): involvement extents proximal to splenic flexure. Clinical remission: partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 24	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 8	12 Participants
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 16	21 Participants
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 24	17 Participants
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 8	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 16	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 52	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 52	16 Participants
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 8	50 Participants
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 16	62 Participants
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 24	63 Participants
Number of Participants With Clinical Remission Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 52	52 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24, and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Montreal Classification was used to classify ulcerative colitis (UC) based on extent of inflammation. Three subgroups of UC were: E1= ulcerative proctitis: involvement limited to rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided, distal colitis: involvement limited to portion of colorectum distal to splenic flexure and E3= extensive UC (pancolitis): involvement extends proximal to the splenic flexure. Clinical response: full Mayo score decrease of \>= 3 points \& decrease of \>=30% from baseline, with decrease of \>=1 point on rectal bleeding sub score or an absolute rectal bleeding score of less than equal to (\<=)1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12. Higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 52	11 Participants
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 8	0 Participants
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 16	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 24	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 52	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 8	8 Participants
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 16	11 Participants
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 24	10 Participants
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 52	6 Participants
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 8	18 Participants
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 16	19 Participants
Number of Participants With Clinical Response Based on Full Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 24	17 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24, and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Montreal Classification was used to classify ulcerative colitis (UC) based on extent of inflammation. Three subgroups of UC were: E1= ulcerative proctitis: involvement limited to rectum i.e, proximal extent of inflammation is distal to rectosigmoid junction, E2= left sided, distal colitis: involvement limited to portion of colorectum distal to splenic flexure and E3= extensive UC (pancolitis): involvement extends proximal to the splenic flexure. Clinical response: full Mayo score decrease of \>=3 points and decrease of \>=30% from baseline, with a decrease of \>=1 point on rectal bleeding sub score or an absolute rectal bleeding score of less than equal to (\<=)1. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 16	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 24	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 8	55 Participants
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 8	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E1 ulcerative proctitis, Week 52	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 8	20 Participants
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 16	24 Participants
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 24	24 Participants
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E2 left-sided UC, Week 52	14 Participants
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 16	65 Participants
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 24	61 Participants
Number of Participants With Clinical Response Based on Partial Mayo Score According to Montreal Classification at Week 8, Week 16, Week 24, and Week 52 E3 extensive UC, Week 52	43 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included.

Percentage of participants with corticosteroid tapering response was collected as Yes or No based on latest available data.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Corticosteroid Tapering at Week 8, Week 16, Week 24 and Week 52	NA Percentage of Participants As this was a retrospective study, doses were not recorded in patient registry

SECONDARY outcome

Timeframe: Up to Week 52

Population: All eligible participants for whom data was collected and analyzed were included.

Corticosteroid tapering rate is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Tapering Rate	NA Milligram per day Standard Deviation NA As this was a retrospective study, doses were not recorded in patient registry

SECONDARY outcome

Timeframe: Up to Week 52

Population: All eligible participants for whom data was collected and analyzed were included.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Corticosteroid Tapering Dose	NA Milligrams Standard Deviation NA As this was a retrospective study, doses were not recorded in patient registry

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Stool frequency sub score ranged from 0 to 3, where, 0 = Normal, 1 = 1 to 2 stools per day more than normal, 2 = 3 to 4 stools per day more than normal, 3 = 5 or more stools per day than normal. Percentage of participants with improvement in stool frequency sub score of 1 or more points is presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Improvement in Stool Frequency Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 Week 8	38.03 Percentage of Participants
Percentage of Participants With Improvement in Stool Frequency Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 Week 16	45.07 Percentage of Participants
Percentage of Participants With Improvement in Stool Frequency Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 Week 24	41.78 Percentage of Participants
Percentage of Participants With Improvement in Stool Frequency Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 Week 52	32.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.

Stool frequency sub score ranged from 0 to 3, where, 0 = Normal, 1 = 1 to 2 stools per day more than normal, 2 = 3 to 4 stools per day more than normal, 3 = 5 or more stools per day than normal.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52 Week 8	-0.62 Units on a scale Standard Deviation 0.97
Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52 Week 16	-0.86 Units on a scale Standard Deviation 1.03
Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52 Week 24	-0.97 Units on a scale Standard Deviation 0.99
Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52 Week 52	-1.01 Units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Rectal bleeding sub scores ranged from 0 to 3, where, 0 = None, 1 = Visible blood with stool less than half the time, 2 = Visible blood with stool half of the time or more, 3 = Passing blood alone. Percentage of participants with improvement in rectal bleeding sub score of 1 or more points are presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Improvement in Rectal Bleeding Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 Week 8	28.57 Percentage of participants
Percentage of Participants With Improvement in Rectal Bleeding Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 Week 16	29.49 Percentage of participants
Percentage of Participants With Improvement in Rectal Bleeding Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 Week 24	28.11 Percentage of participants
Percentage of Participants With Improvement in Rectal Bleeding Sub Score of 1 or More Points at Week 8, Week 16, Week 24 and Week 52 Week 52	22.83 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Rectal bleeding sub scores ranged from 0 to 3, where, 0 = None, 1 = Visible blood with stool less than half the time, 2 = Visible blood with stool half of the time or more, 3 = Passing blood alone. Baseline was considered as initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52 Week 8	-0.41 Units on a scale Standard Deviation 0.8
Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52 Week 16	-0.49 Units on a scale Standard Deviation 0.91
Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52 Week 24	-0.47 Units on a scale Standard Deviation 0.87
Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52 Week 52	-0.53 Units on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Normal values for the parameters were as follows: P-CRP: below 4 milligrams per liter (mg/L), B-hb: men: 134 to 167 grams per liter (g/L), women: 117-155 g/L, B-leuk: 3.4 to 8.2\*10\^9 cells/L, B-Thromb: 150 to 360\*10\^9 cells/L, B-ly: 1.3 to3.6\*10\^9 cells/L, B-Neutr: 1.5 to6.7\*10\^9 cells/L, P-alb: 18 to 39 years: 36 to 48 g/L, 40 to 69 years: 36 to 45 g/L, 70 years and over: 34 to 45 g/L.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-hb, Week 8	70.29 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-hb, Week 16	63.45 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-hb, Week 24	58.23 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-hb, Week 52	48.82 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-leuk, Week 8	59.92 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-leuk, Week 16	60.73 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-leuk, Week 24	53.85 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-Thromb, Week 16	59.92 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-Thromb, Week 24	55.65 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-CRP, Week 8	67.4 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-CRP, Week 16	61.63 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-CRP, Week 24	57.09 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-CRP, Week 52	44.55 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-leuk, Week 52	43.54 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-Thromb, Week 8	64.98 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-Thromb, Week 52	43.6 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-ly, Week 8	74.76 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-ly, Week 16	67.7 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-ly, Week 24	59.03 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-ly, Week 52	45.41 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-Neutr, Week 8	79.9 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-Neutr, Week 16	72.17 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-Neutr, Week 24	64.79 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-Neutr, Week 52	48.09 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-alb, Week 8	62.3 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-alb, Week 16	57.08 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-alb, Week 24	51.4 Percentage of participants
Percentage of Participants Reaching Normal P-CRP, B-hb, B-leuk, B-Thromb, B-ly, B-Neutr and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-alb, Week 52	45.55 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Baseline was considered as date of initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52 Week 8	-1.06 Milligrams per liter Standard Deviation 10.19
Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52 Week 16	-1.31 Milligrams per liter Standard Deviation 8.49
Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52 Week 24	-1.74 Milligrams per liter Standard Deviation 8.19
Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52 Week 52	-2.36 Milligrams per liter Standard Deviation 9.91

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Baseline was considered as date of initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-hb, Week 8	0.71 Grams per liter Standard Deviation 9.88
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-hb, Week 16	1.19 Grams per liter Standard Deviation 10.75
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-hb, Week 24	1.11 Grams per liter Standard Deviation 10.51
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 B-hb, Week 52	3.77 Grams per liter Standard Deviation 12.64
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-alb, Week 8	0.58 Grams per liter Standard Deviation 2.57
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-alb, Week 16	1.18 Grams per liter Standard Deviation 2.91
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-alb, Week 24	1.4 Grams per liter Standard Deviation 3.18
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52 P-alb, Week 52	1.83 Grams per liter Standard Deviation 3.23

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Baseline was considered as date of initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-leuk, Week 8	-3.31 10^9 cells per liter Standard Deviation 33.44
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-leuk, Week 16	-4.34 10^9 cells per liter Standard Deviation 36.02
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-leuk, Week 24	-4.81 10^9 cells per liter Standard Deviation 38.2
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-leuk, Week 52	-2.34 10^9 cells per liter Standard Deviation 3.12
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-ly, Week 8	0.18 10^9 cells per liter Standard Deviation 0.86
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-ly, Week 16	0.06 10^9 cells per liter Standard Deviation 0.81
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-ly, Week 24	-0.03 10^9 cells per liter Standard Deviation 0.85
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-ly, Week 52	-0.14 10^9 cells per liter Standard Deviation 0.73
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-neutr, Week 8	-1.27 10^9 cells per liter Standard Deviation 3.48
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-neutr, Week 16	-1.77 10^9 cells per liter Standard Deviation 4.37
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-neutr, Week 24	-2.22 10^9 cells per liter Standard Deviation 4.38
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-neutr, Week 52	-2.11 10^9 cells per liter Standard Deviation 3.43
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-Thromb, Week 8	-25.22 10^9 cells per liter Standard Deviation 77.73
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-Thromb, Week 16	-33.59 10^9 cells per liter Standard Deviation 93.49
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-Thromb, Week 24	-36.54 10^9 cells per liter Standard Deviation 99.47
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52 B-Thromb, Week 52	-40.14 10^9 cells per liter Standard Deviation 68.13

SECONDARY outcome

Timeframe: Week 8 and Week 16

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Percentage of participants with extended tofacitinib induction dose (additional 8 weeks with 10 mg) is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Extended Tofacitinib Induction Dose at Week 8, Week 16 Week 8	69.71 Percentage of participants
Percentage of Participants With Extended Tofacitinib Induction Dose at Week 8, Week 16 Week 16	36.25 Percentage of participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Percentage of participants with higher dose (10 mg) of tofacitinib (for all participants) is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52 Week 8	75.93 Percentage of Participants
Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52 Week 24	30.28 Percentage of Participants
Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52 Week 52	17.45 Percentage of Participants
Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52 Week 16	40.24 Percentage of Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Percentage of participants with higher (10 mg) dose of tofacitinib in participants who received treatment at different timepoints is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52 Week 8	183 Participants
Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52 Week 16	101 Participants
Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52 Week 24	76 Participants
Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52 Week 52	37 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: All eligible participants for whom data was collected and analyzed were included.

Time to survival without drug discontinuation, colectomy or UC-related hospitalization was calculated using time to event analysis.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Time to Drug Discontinuation, Colectomy or UC-related Hospitalization	14.3 Months Interval 10.0 to 25.0

SECONDARY outcome

Timeframe: Up to Week 52

Population: All eligible participants for whom data was collected and analyzed were included.

Number of previous treatments received by participants is presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Previous Treatments	4.5 Treatments Standard Deviation 1.3

SECONDARY outcome

Timeframe: Up to Week 52

Population: All eligible participants for whom data was collected and analyzed were included.

Number of participants according to type of their previous treatment received is presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants According to Type of Previous Treatment Adalimumab	61 Participants
Number of Participants According to Type of Previous Treatment Infliximab	159 Participants
Number of Participants According to Type of Previous Treatment Golimumab	20 Participants
Number of Participants According to Type of Previous Treatment Bio naïve	48 Participants
Number of Participants According to Type of Previous Treatment Corticosteroids	229 Participants
Number of Participants According to Type of Previous Treatment 5-aminosalicylic acid	237 Participants
Number of Participants According to Type of Previous Treatment Tiopurines combined	222 Participants
Number of Participants According to Type of Previous Treatment Azathioprine	182 Participants
Number of Participants According to Type of Previous Treatment 6-Mercaptopurine	93 Participants
Number of Participants According to Type of Previous Treatment Methotrexate	23 Participants
Number of Participants According to Type of Previous Treatment Ciclosporin	21 Participants
Number of Participants According to Type of Previous Treatment Ustekinumab	19 Participants
Number of Participants According to Type of Previous Treatment Vedolizumab	85 Participants
Number of Participants According to Type of Previous Treatment Bioexperienced	204 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a full Mayo score of \<=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	11 Participants
Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	0 Participants
Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	6 Participants

SECONDARY outcome

Timeframe: Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a partial Mayo score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined for participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 16	36 Participants
Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 8	NA Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 24	32 Participants
Number of Participants With Steroid-free Clinical Remission of Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 Week 52	32 Participants

SECONDARY outcome

Timeframe: At index (date of initiation of tofacitinib treatment for ulcerative colitis)

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Percentage of Participants That had f-Calprotectin Above 250 mg/kg at Baseline is presented.

Outcome measures

Outcome measures
Measure	Tofacitinib n=189 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants That Had f-Calprotectin Above 250 mg/kg at Baseline	90.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

F-calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. Baseline was considered as date of initiation of tofacitinib.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 Week 24	-1092.93 Milligrams per kilogram Standard Deviation 1583.33
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 Week 52	-1179.35 Milligrams per kilogram Standard Deviation 1728.6
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 Week 8	-511.55 Milligrams per kilogram Standard Deviation 1281.31
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52 Week 16	-955.7 Milligrams per kilogram Standard Deviation 1617.43

SECONDARY outcome

Timeframe: From Week 16 to Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies maximum number of participants evaluable for this outcome measure.

Clinical remission in participants was defined as a full Mayo score of \<=2 points, with no individual sub score exceeding 1 point with rectal bleeding sub-score of 0. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=4 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Full Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 24	NA Percentage of Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.
Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Full Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 52	NA Percentage of Participants Results having less than 5 participants with events could not be exported from the Finnish Health and Social Data Permit Authority (Findata) servers.

SECONDARY outcome

Timeframe: From Week 16 to Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Clinical remission in participants was defined as a partial score of less than 2 points with rectal bleeding sub-score of 0. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each sub score ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome measures
Measure	Tofacitinib n=36 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 52	44.83 Percentage of Participants
Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score From Week 16 to Week 24 and Week 52 Week 16 to Week 24	63.89 Percentage of Participants

SECONDARY outcome

Timeframe: From Week 8 to Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'No participants fulfilled the criteria for the analysis'.

Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing was defined by Mayo endoscopic sub score of 0 or 1. Endoscopic response was defined as sub score reduction from baseline of \>=1. Partial Mayo score consisted of 3 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity. Each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 9, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Week 8 to Week 16, Week 24 and Week 52

Population: All eligible participants for whom data was collected and analyzed were included. Here, 'No participants fulfilled the criteria for the analysis'.

Sustained endoscopic remission was defined as Mayo endoscopic sub score of 0. Mucosal healing was defined by Mayo endoscopic sub score of 0 or 1. Endoscopic response was defined as sub score reduction from baseline of \>=1. Full Mayo score consisted of 4 sub scores: rectal bleeding, stool frequency, physician assessment of disease activity, and endoscopy findings, each graded from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). These sub scores were summed up to give a total score range of 0 to 12, where higher scores indicated higher disease severity. Steroid-free clinical remission was defined as clinical remission in participants who were treated with corticosteroids at baseline and did not require any corticosteroid treatment during the period \>=4 weeks prior to the visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At index (from data collected and analyzed retrospectively over 5 months)

Population: All eligible participants for whom data was collected and analyzed were included. 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable at specified timepoints.

Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline are presented in this outcome measure.

Outcome measures

Outcome measures
Measure	Tofacitinib n=252 Participants Participants diagnosed with UC between January 2010 and December 2021 and who initiated tofacitinib were included.
Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline Blood hemoglobin (female)	126.73 Grams per liter Standard Deviation 12.64
Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline Blood hemoglobin (male)	139.22 Grams per liter Standard Deviation 15.99
Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline Plasma albumin	36.49 Grams per liter Standard Deviation 4.28

Adverse Events

Tofacitinib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

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