This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.

Retrospective Non-interventional Multicenter Patient Chart Data Study on Tofacitinib Realworld Experience in Ulcerative Colitis in Finland (FinTofUC)

The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis

• Study Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective non-interventional multicenter patient chart review study, collecting real world data from 21 Finnish hospital district databases and for whom data is available.

Description

Inclusion Criteria:

• Xeljanz (tofacitinib) usage for ulcerative colitis
• Diagnosis of ulcerative colitis (ICD-10: K51.0, K51.1, K51.2, K51.3, K51.5, K51.8, K51.9) between January 2010 and December 2021 (incident or prevalent).

Exclusion Criteria:

• Age < 18 years at the start of tofacitinib use
• Use of tofacitinib before reimbursement (1.3.2019)
• < 8 weeks of treatment with tofacitinib at the start of data mining
• History of panproctocolectomy, IPAA or ileostomy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients treated with Tofacitinib; Patients treated with tofacitinib for ulcerative colitis in Finland.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age at the Time of Diagnosis	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.	At diagnosis (anytime between Jan 2010 and Dec-2021, approximately 12 years (from data collected and analyzed retrospectively over 5 months)
Duration of Ulcerative Colitis	Duration of ulcerative colitis was presented in this outcome measure. Index was considered as date of initiation of tofacitinib treatment for ulcerative colitis.	At index (from data collected and analyzed retrospectively over 5 months)
Number of Participants With Extent of Colonic Involvement According to the Montreal Classification	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.	At index (from data collected and analyzed retrospectively over 5 months)
Mayo Score at Initiation of Tofacitinib	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.	At index (from data collected and analyzed retrospectively over 5 months)
Partial Mayo Score at Initiation of Tofacitinib	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.	At index (from data collected and analyzed retrospectively over 5 months)
Number of Participants According to Endoscopic Findings Based on Histology	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.	At index (from data collected and analyzed retrospectively over 5 months)
Number of Participants According to Endoscopic Sub Score Based on Mayo Score	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.	At index (from data collected and analyzed retrospectively over 5 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Received Tofacitinib at Week 8, Week 16, Week 24 and Week 52	Percentage of participants who received tofacitinib is presented in this outcome measure.	Week 8, Week 16, Week 24 and Week 52
Percentage of Participants With Clinical Remission Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52	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.	Week 8, Week 16, Week 24 and Week 52
Percentage of Participants With Clinical Remission Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52	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.	Week 8, Week 16, Week 24 and Week 52
Percentage of Participants With Clinical Response Based on Full Mayo Score at Week 8, Week 16, Week 24 and Week 52	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.	Week 8, Week 16, Week 24 and Week 52
Percentage of Participants With Clinical Response Based on Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52	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.	Week 8, Week 16, Week 24 and Week 52
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	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.	Week 8, Week 16, Week 24 and Week 52
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	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.	Week 8, Week 16, Week 24 and Week 52
Percentage of Participants According to Time to Response Based on Full or Partial Mayo Score at 1, 2, 3, 6, 12, 24, 36 Months	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.	At 1, 2, 3, 6, 12, 24 and 36 months
Percentage of Participants With Fecal (F)-Calprotectin Reduction of >=50% at Week 8, Week 16, Week 24 and Week 52	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.	Week 8, Week 16, Week 24 and Week 52
Percentage of Participants With F-calprotectin Reduction of >=75% at Week 8, Week 16, Week 24 and Week 52	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.	Week 8, Week 16, Week 24 and Week 52
Percentage of Participants With F-calprotectin Reduction of >=90% at Week 8, Week 16, Week 24 and Week 52	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.	Week 8, Week 16, Week 24 and Week 52
Number of Participants Reaching F-calprotectin Below 250 mg/kg of Those That Had F-calprotectin Above 250 mg/kg at Baseline	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.	Week 8, Week 16, Week 24 and Week 52
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	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.	Baseline, Week 8, Week 16, Week 24 and Week 52
Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 8 to Week 16, Week 24, and Week 52	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.	From Week 8 to Week 16, Week 24, and Week 52
Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 8 to Week 16, Week 24, and Week 52	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.	From Week 8 to Week 16, Week 24 and Week 52
Percentage of Participants in Sustained Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52	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.	From Week 16 to Week 24 and Week 52
Percentage of Participants in Sustained Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52	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.	From Week 16 to Week 24 and Week 52
Percentage of Participants in Sustained Steroid Free Remission Based on Full Mayo Score From Week 16 to Week 24 and Week 52	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.	From Week 16 to Week 24 and Week 52
Percentage of Participants in Sustained Steroid Free Remission Based on Partial Mayo Score From Week 16 to Week 24 and Week 52	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.	From Week 16 to Week 24 and Week 52
Change From Baseline in Full Mayo Score at Week 8, Week 16, Week 24 and Week 52	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.	Baseline, Week 8, Week 16, Week 24 and Week 52
Change From Baseline in Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52	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.	Baseline, Week 8, Week 16, Week 24 and Week 52
Percentage of Participants in Sustained Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52	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.	From Week 8 to Week 16, Week 24 and Week 52
Percentage of Participants With Physician Assessed Histological Remission at Week 8, Week 16, Week 24 and Week 52	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.	Week 8, Week 16, Week 24 and Week 52
Change From Baseline in Histology Assessment at Week 8, Week 16, Week 24 and Week 52	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.	Baseline, Week 8, Week 16, Week 24 and Week 52
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	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.	From Week 8 to Week 16, Week 24 and Week 52
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	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.	From Week 8 to Week 16, Week 24 and Week 52
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	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.	Week 8, Week 16, Week 24, and Week 52
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	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.	Week 8, Week 16, Week 24, and Week 52
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	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.	Week 8, Week 16, Week 24, and Week 52
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	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.	Week 8, Week 16, Week 24, and Week 52
Percentage of Participants With Corticosteroid Tapering at Week 8, Week 16, Week 24 and Week 52	Percentage of participants with corticosteroid tapering response was collected as Yes or No based on latest available data.	Week 8, Week 16, Week 24 and Week 52
Tapering Rate	Corticosteroid tapering rate is reported in this outcome measure.	Up to Week 52
Corticosteroid Tapering Dose		Up to Week 52
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	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.	Week 8, Week 16, Week 24 and Week 52
Change From Baseline in Stool Frequency Sub Score at Week 8, Week 16, Week 24 and Week 52	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.	Baseline, Week 8, Week 16, Week 24 and Week 52
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	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.	Week 8, Week 16, Week 24 and Week 52
Change From Baseline in Rectal Bleeding Sub Score at Week 8, Week 16, Week 24 and Week 52	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.	Baseline, Week 8, Week 16, Week 24 and Week 52
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	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.	Week 8, Week 16, Week 24 and Week 52
Change From Baseline in P-CRP Levels at Week 8, Week 16, Week 24 and Week 52	Baseline was considered as date of initiation of tofacitinib.	Baseline, Week 8, Week 16, Week 24 and Week 52
Change From Baseline in B-hb and P-alb Levels at Week 8, Week 16, Week 24 and Week 52	Baseline was considered as date of initiation of tofacitinib.	Baseline, Week 8, Week 16, Week 24 and Week 52
Change From Baseline in B-leuk, B-ly, B-neutr and B-Thromb Levels at Week 8, Week 16, Week 24 and Week 52	Baseline was considered as date of initiation of tofacitinib.	Baseline, Week 8, Week 16, Week 24 and Week 52
Percentage of Participants With Extended Tofacitinib Induction Dose at Week 8, Week 16	Percentage of participants with extended tofacitinib induction dose (additional 8 weeks with 10 mg) is presented in this outcome measure.	Week 8 and Week 16
Percentage of Participants With Higher Dose (10 mg) of Tofacitinib For All Participants at Week 8, Week 16, Week 24 and Week 52	Percentage of participants with higher dose (10 mg) of tofacitinib (for all participants) is presented in this outcome measure.	Week 8, Week 16, Week 24 and Week 52
Number of Participants With Higher Dose (10mg) of Tofacitinib of Those on Treatment at Week 8, Week 16, Week 24 and Week 52	Percentage of participants with higher (10 mg) dose of tofacitinib in participants who received treatment at different timepoints is presented in this outcome measure.	Week 8, Week 16, Week 24 and Week 52
Time to Drug Discontinuation, Colectomy or UC-related Hospitalization	Time to survival without drug discontinuation, colectomy or UC-related hospitalization was calculated using time to event analysis.	Up to Week 52
Number of Previous Treatments	Number of previous treatments received by participants is presented in this outcome measure.	Up to Week 52
Number of Participants According to Type of Previous Treatment	Number of participants according to type of their previous treatment received is presented.	Up to Week 52
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	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.	Week 8, Week 16, Week 24 and Week 52
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	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.	Week 8, Week 16, Week 24 and Week 52
Percentage of Participants That Had f-Calprotectin Above 250 mg/kg at Baseline	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.	At index (date of initiation of tofacitinib treatment for ulcerative colitis)
Change From Baseline in F-calprotectin at Week 8, Week 16, Week 24 and Week 52	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.	Baseline, Week 8, Week 16, Week 24 and Week 52
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	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.	From Week 16 to Week 24 and Week 52
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	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.	From Week 16 to Week 24 and Week 52
Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Partial Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52	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.	From Week 8 to Week 16, Week 24 and Week 52
Percentage of Participants in Sustained Steroid Free Remission for Those Treated With Corticosteroids at Baseline Based on Full Mayo Score and Endoscopic Remission, Mucosal Healing or Endoscopic Response From Week 8 to Week 16, Week 24 and Week 52	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.	From Week 8 to Week 16, Week 24 and Week 52
Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline	Absolute Values of Blood Hemoglobin and Plasma Albumin at Baseline are presented in this outcome measure.	At index (from data collected and analyzed retrospectively over 5 months)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: A3921390; FinTofUC (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.